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GRAS Notification: The Key to FDA Approval for Your Food Product

GRAS NotificationIntroduction: In the dynamic realm of food innovation, ushering in new ingredients responsibly and securely is of paramount importance. This article is your guide through the systematic GRAS (Generally Recognized as Safe) notification process—a vital pathway that paves the way for the approval and integration of novel ingredients. Join us as we demystify the step-by-step journey of GRAS notification for new ingredients, ensuring you’re well-equipped to embark on this regulatory expedition.

What is the history of the GRAS Notification Process?

The concept of GRAS dates back to the 1950s when the FDA began to distinguish between food additives that required premarket approval and those that were exempt from such requirements. The original GRAS list included substances widely recognized as safe based on their long food use history, such as salt and sugar. In the 1990s, the FDA began encouraging food manufacturers to voluntarily notify the agency when they believed an ingredient was GRAS. This notification process allowed the FDA to review the safety of new ingredients more efficiently and to provide guidance to the industry on the scientific evidence required to support a GRAS determination.

In 1997, the FDA issued a final rule establishing a voluntary notification process for the GRAS determination of food ingredients. This rule set criteria for the scientific evidence required to support a GRAS determination and a procedure for submitting a GRAS notification to the FDA.

What is GRAS notification, and why is it important?

GRAS notification stands for Generally Recognized as Safe Notification. It is a voluntary process that food manufacturers or producers can go through to demonstrate to the FDA that their food ingredient is safe for consumption. This is important because the FDA has strict regulations to ensure the food supply’s safety. By going through the GRAS notification process, manufacturers can provide the FDA with the necessary information to make an informed decision about the safety of their product. This can help speed up the approval process and give consumers confidence in the safety of the food they are consuming.

How to determine if your ingredient is eligible for GRAS status?

To determine if your ingredient is eligible for GRAS status, you need to thoroughly review the available scientific literature and data on the ingredient. This includes studies on the ingredient’s safety, toxicity, and potential health effects. You may also need to conduct your studies or tests to gather additional data. Once you have gathered all the necessary information, you can submit a GRAS notification to the FDA for review. It’s important to note that the FDA does not approve or certify GRAS status but instead reviews the information provided and decides based on the available evidence.

When to conduct a thorough safety assessment of your GRAS ingredients?

Conducting a thorough safety assessment of your GRAS ingredients before submitting a notification to the FDA is essential. This includes reviewing all available scientific literature and data on the ingredient and conducting your studies or tests if necessary. It is also vital to consider the component’s potential health effects or toxicity. By conducting a thorough safety assessment, you can ensure that your GRAS notification is accurate and complete, increasing your chances of FDA approval for your food product.

How to prepare and submit your GRAS notification to the FDA?

You must follow a specific process to prepare and submit your GRAS notification to the FDA. First, as mentioned earlier, you will need to conduct a thorough safety assessment of your GRAS ingredient. Then, you must prepare a notification that includes all relevant information about the ingredient, such as its identity, intended use, and safety data. This notification should be submitted to the FDA through the agency’s online portal and any supporting documentation or data. Once the FDA receives your notification, they will review it and provide feedback or request additional information. If your GRAS notification is approved, you will receive a letter from the FDA confirming your ingredient’s GRAS status.

What is the FDA’s role in the GRAS notification process?

The FDA’s role in the GRAS notification process is to review the scientific evidence submitted by the notifier and to determine whether the evidence supports a GRAS determination. The FDA does not “approve” GRAS determinations but acknowledges them after reviewing the scientific evidence.

The FDA’s review of a GRAS notification focuses on the ingredient’s safety, not nutritional or other qualities. The agency considers factors such as the ingredient’s intended use, the amount expected to be consumed, and the population groups exposed to the component.

If the FDA determines that the evidence supports a GRAS determination, the agency will issue a “no objection” letter to the notifier. This letter acknowledges that the FDA has no questions or objections regarding the notifier’s GRAS determination. The “no objection” letter is not a formal approval but a statement that the FDA has reviewed the scientific evidence and found it sufficient to support a GRAS determination.

Understanding GRAS: Before we dive into the process, let’s establish a clear understanding of GRAS. This status is bestowed upon ingredients that experts deem safe for consumption based on solid scientific evidence and a history of safe use. Attaining GRAS certification not only facilitates the introduction of new ingredients but also upholds consumer safety as a paramount priority.

Step 1: Safety Evaluation and Data Compilation: Our journey begins with a meticulous safety evaluation of the new ingredient. This phase involves gathering scientific data, conducting comprehensive studies, and rigorously assessing potential health risks. The goal is to establish a strong foundational basis of evidence attesting to the ingredient’s safety profile.

Step 2: Expert Panel Assessment: The amassed safety assessment data is submitted to an accomplished panel of experts spanning fields such as toxicology, chemistry, and nutrition. This panel conducts an impartial evaluation of the data, scrutinizing it against stringent scientific criteria to ascertain the ingredient’s safety.

Step 3: Crafting the GRAS Notification: With the panel’s evaluation as a guiding compass, the subsequent step entails crafting a comprehensive GRAS notification dossier. This dossier meticulously outlines the safety evaluation process, presents scientific evidence, and substantiates the ingredient’s alignment with GRAS criteria.

Step 4: Submission to the FDA: The completed GRAS notification dossier is then submitted to the U.S. Food and Drug Administration (FDA). The FDA undertakes a meticulous review, scrutinizing the dossier to confirm the robustness of the ingredient’s safety assessment and the veracity of the evidence presented.

Step 5: FDA Review and Response: During its review, the FDA evaluates the notification with precision, assessing the congruence between the evidence and the claim of safety. Should the FDA concur with the findings, the ingredient is officially acknowledged as GRAS, effectively permitting its utilization in food products.

Step 6: Ongoing Vigilance: Obtaining GRAS certification doesn’t signal the culmination of the journey. Instead, it marks the beginning of an ongoing commitment to vigilance. Manufacturers are entrusted with the responsibility of staying informed about scientific advancements related to their ingredient and promptly addressing any potential concerns.

Benefits of the GRAS Notification Process:

  • Fostering Innovation: The GRAS process serves as a gateway for innovative ingredients, enriching the culinary landscape.
  • Transparency and Trust: Stringent evaluation and scrutiny foster transparency, bolstering consumer confidence.
  • Regulatory Adherence: Attaining GRAS status underscores unwavering adherence to regulatory standards.
  • Market Readiness: GRAS-certified ingredients enjoy wider market accessibility and acceptance.

What are the drawbacks of the GRAS Notification process?

The GRAS notification process has several benefits for food manufacturers, suppliers, and distributors. First, it provides a clear regulatory pathway for introducing new ingredients into the food supply. Second, it allows for a more efficient review of safety data by the FDA, which can reduce the time and cost of bringing new ingredients to market. Third, it promotes transparency and public accountability by requiring scientific evidence to be publicly available and subject to peer review.

However, the GRAS notification process also has some drawbacks. First, it is a voluntary process, which means that not all manufacturers may choose to notify the FDA of their GRAS determinations. Second, the process can be time-consuming and expensive, especially for smaller companies needing more resources to conduct the necessary safety studies. Third, the GRAS determination applies only to the specific use of an ingredient evaluated by the FDA, which can create uncertainty and regulatory challenges for new benefits or applications.

What common mistakes should be avoided during the GRAS Notification process?

There are several common mistakes that companies make during the GRAS notification process. These mistakes can delay the review process, increase costs, and even lead to a rejection of the GRAS determination. Some of the most common mistakes include:
1. Failing to conduct a thorough safety assessment of the ingredient or to identify potential risks or hazards.
2. Failing to consult with experts in the field to ensure that the safety assessment meets the FDA’s criteria for a GRAS determination.
3. Failing to provide all of the required elements in the GRAS notification, such as the identity and intended use of the ingredient, the basis for the GRAS determination, and any supporting safety data.
4. Failing to respond promptly to requests for additional information or clarification from the FDA.
5. Failing to update the safety assessment as new information becomes available.

What is GRAS status, and why is it important?

GRAS status is a designation given to food additives considered safe for consumption. This designation is based on scientific evidence and a comprehensive safety assessment conducted by qualified experts. When an additive is determined to be GRAS, it does not require pre-market approval by the FDA. This provides manufacturers a with streamlined process for introducing new additives to the market.

Obtaining GRAS status is vital for several reasons. Firstly, it demonstrates a commitment to safety and regulatory compliance. Manufacturers can build trust with consumers and regulatory authorities by conducting a thorough safety assessment and providing scientific evidence to support the additive’s safety.

Secondly, achieving GRAS status expedites the product development process. Since GRAS substances do not require pre-market approval, manufacturers can bring new products to market faster, allowing them to respond to consumer demands and stay ahead of the competition.

Lastly, GRAS status provides a competitive advantage. Consumers are becoming increasingly conscious of the ingredients in their food. They are more likely to choose products that are made with GRAS substances. By achieving GRAS status, manufacturers can differentiate their products and attract consumers who value safety and transparency.

What are the benefits of achieving GRAS status?

Obtaining GRAS status for a food additive offers several advantages for manufacturers and ingredient suppliers. Let’s take a closer look at some of the key benefits:

1. Streamlined regulatory process: GRAS substances do not require pre-market approval, so manufacturers can introduce new additives without waiting for FDA review. This streamlines the regulatory process and allows for faster product development.
2. Consumer trust and confidence: Achieving GRAS status demonstrates a commitment to safety and regulatory compliance. This builds trust with consumers, who are likelier to choose products made with GRAS substances.
3. Competitive advantage: In a market where consumers are increasingly conscious about the ingredients in their food, having GRAS status can differentiate products and give manufacturers a competitive edge. Consumers are more likely to choose products made with ingredients they perceive as safe.
4. Flexibility and innovation: Having GRAS status allows manufacturers to explore new ingredients and formulations, enabling them to stay ahead of consumer demands and innovate in the food industry.
5. Cost savings: Avoiding the lengthy and costly pre-market approval process can result in significant cost savings for manufacturers.
It is important to note that achieving GRAS status is complicated. It requires a thorough safety assessment and a comprehensive notification process. Let’s dive into the critical steps involved in the GRAS notification process.

How do I prepare for the GRAS notification submission?

The next step is to prepare a robust GRAS notification submission to inform the FDA about the additive’s safety. The submission should include comprehensive information about the additive, the safety assessment conducted, and the scientific evidence supporting its safety.
The submission should be well-organized and present the data and information concisely and coherently. It should include detailed information about the additive’s chemical composition, intended use, exposure levels, and any relevant studies or research conducted.
Additionally, the submission should address any potential concerns or questions the FDA may have regarding the additive’s safety. This proactive approach demonstrates a commitment to transparency and helps facilitate the review process.

What are the common challenges to achieving GRAS status, and how to overcome them?

Navigating the GRAS notification process can be challenging, and manufacturers may encounter various obstacles. Here are some common challenges and strategies to overcome them:

1. Lack of expertise: Conducting a comprehensive safety assessment and preparing a GRAS notification submission requires specialized expertise. Manufacturers can overcome this challenge by hiring qualified experts or consulting with regulatory professionals with GRAS notification experience.
2. Data gaps: Insufficient scientific data or studies can pose a challenge when preparing the GRAS notification submission. Manufacturers can overcome this by conducting additional studies or gathering relevant data to fill the gaps. Collaborating with research institutions or partnering with expert consultants can help.
3. FDA feedback and concerns: Addressing FDA concerns and providing additional information can be time-consuming and require careful attention to detail. Manufacturers should closely collaborate with the FDA and promptly respond to any requests or concerns raised during the review process.
4. Cost implications: Conducting safety assessments, gathering scientific data, and preparing the GRAS notification submission can be costly. Manufacturers should carefully consider the budget and allocate resources accordingly. Seeking external funding or partnering with other stakeholders can alleviate the financial burden.
5. Time constraints: The GRAS notification process can be time-consuming, and manufacturers must plan accordingly. It is essential to start the process early and allocate sufficient time for the safety assessment, submission preparation, and potential revisions.

By being aware of these challenges and implementing proactive strategies, manufacturers can navigate the GRAS notification process more effectively and increase their chances of obtaining GRAS status.

Hiring a consultant to navigate the GRAS notification process

Given the complexities and challenges of the GRAS notification process, many manufacturers hire a consultant to guide them. A consultant with expertise in FDA regulations and the GRAS notification process can provide valuable insights, assist in conducting safety assessments, and help prepare a robust submission.

When hiring a consultant, choosing someone with a proven track record and extensive experience in navigating the GRAS notification process is vital. They should deeply understand FDA regulations, toxicology, and food science. Additionally, the consultant should have strong communication skills and the ability to work collaboratively with the FDA and other stakeholders.

A consultant can help streamline the process, ensure compliance with FDA requirements, and increase the chances of successfully achieving GRAS status. They can also provide ongoing support and guidance throughout the review process, addressing any concerns or requests from the FDA.

Submitting and waiting for FDA feedback

Once the GRAS notification submission is complete, it should be submitted to the FDA for review. The FDA will evaluate the compliance and provide feedback to the manufacturer. This feedback may include requests for additional information or clarification on certain aspects of the submission.

It is important to note that the FDA does not make a formal approval or rejection decision during this review process. Instead, the FDA provides feedback to the manufacturer, allowing them to address any concerns or provide additional information if needed.

After submitting the notification, manufacturers must be patient and wait for the FDA’s response. The review process can take several months, depending on the notification’s complexity and the FDA’s workload.

Addressing FDA concerns and revising the submission if necessary

If the FDA raises any concerns or requests additional information, manufacturers should promptly address these concerns and provide the requested information. This may involve conducting further studies, gathering more data, or revising certain aspects of the submission.
Addressing FDA concerns promptly and thoroughly is crucial to ensure a smooth review process. Manufacturers can increase the chances of obtaining GRAS status by providing the necessary information and addressing any potential issues.

When should you follow up with the FDA to maintain GRAS Status?

Once the FDA has approved your GRAS notification, it’s crucial to maintain your ingredient’s GRAS status by keeping up with any new safety information or changes in use. You should also follow up with the FDA if you make any changes to your ingredient or its use that could affect its safety. Additionally, the FDA may require periodic reevaluations of your ingredient’s safety, so staying up-to-date on regulatory requirements is essential. By staying proactive and informed, you can ensure that your element maintains its GRAS status and remains a safe and reliable food product component.

For more information on self-affirmed GRAS and what achieving the Generally Recognized as Safe (GRAS) could mean for your food products contact us for a complimentary consultation.

Conclusion

Navigating the GRAS notification process is critical to FDA compliance for food manufacturers and ingredient suppliers. Achieving GRAS status for food additives demonstrates a commitment to safety and regulatory compliance while offering numerous benefits such as a streamlined regulatory process, consumer trust, competitive advantage, flexibility for innovation, and cost savings.

To successfully navigate the GRAS notification process, manufacturers must conduct a comprehensive safety assessment, gather scientific evidence, prepare a robust submission, address FDA concerns, and collaborate effectively with the FDA. Hiring a consultant with expertise in the GRAS notification process can provide valuable guidance and support.

By understanding the essential steps involved in the GRAS notification process and leveraging expert guidance, manufacturers can ensure FDA compliance, maintain consumer trust, and thrive in the ever-changing landscape of the food industry. So, take the first step towards achieving GRAS status and begin navigating the GRAS notification process today.

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FDA Furls: How do they affect medical device manufacturers?

medical device manufacturers FDA FURLS

If you’re in the medical device manufacturing business, you’re likely familiar with the FDA’s regulations, including FDA Furls. However, understanding these regulations can be complex and confusing. This guide breaks down FDA Furls into easy-to-understand terms, so you can better understand how they affect your business.

What are FDA Furls, and why do they matter?

FDA Furls, or the FDA’s Unique Device Identification (UDI) System, is a regulation that requires medical device manufacturers to label their products with a unique identifier. This identifier helps improve patient safety by allowing for better tracking and identification of medical devices. It also helps streamline the recall process in the event of a safety issue. Compliance with FDA Furls regulations is mandatory for medical device manufacturers, and failure to comply can result in fines and other penalties.

What are the different types of FDA Furls?

There are two main types of FDA Furls: the device identifier (DI) and the production identifier (PI). The DI is a unique code that identifies a medical device’s specific model and version, while the PI identifies the particular unit or batch of devices. Both identifiers must be included on the device’s label and in any electronic tracking systems used by the manufacturer. Medical device manufacturers must understand the differences between these types of Furls and ensure they properly implement them in their labeling and tracking processes.

How to navigate the FDA approval process for your medical device?

Navigating the FDA approval process can be daunting for medical device manufacturers. However, it is crucial to understand and comply with these regulations to ensure your product’s safety and effectiveness. One critical step is to work closely with your regulatory team to ensure all necessary information is included in your device labeling and tracking systems. It’s also essential to stay up-to-date on any changes or updates to the Furl requirements, as they can evolve. By staying informed and proactive, you can navigate the FDA Furls process with confidence and ensure the success of your medical device business.

How to stay compliant with FDA FURLS regulations?

Staying compliant with FDA regulations can be a challenge for medical device manufacturers, but it’s essential for ensuring the safety and effectiveness of your products. One tip is to establish a robust quality management system that includes regular audits and reviews of your processes and procedures. It’s also essential to stay up-to-date on any changes or updates to FDA regulations and to work closely with your regulatory team to ensure that all necessary information is included in your device labeling and tracking systems.

Finally, consider investing in employee training and education to ensure everyone knows the latest FDA requirements and best practices for compliance. FDA Furls, or the FDA’s Unique Device Identification (UDI) System, is a set of regulations requiring medical device manufacturers to label their products with unique identifiers and submit product information to a centralized database.

While these regulations can be complex and time-consuming to implement, they are essential for ensuring patient safety and improving supply chain efficiency. By complying with FDA regulations, medical device manufacturers can also improve their reputation and competitiveness in the industry.

Why is compliance with FDA Furls important?

Compliance with the FDA’s FURLS system is critical for food industry professionals. Failing to comply with FDA regulations can result in serious consequences, including fines, legal action, and even facility closure. Non-compliance can also damage a company’s reputation and lead to a loss of consumer trust.

In addition to the regulatory requirements, complying with FDA FURLS is important for maintaining a competitive advantage. Companies compliant with FDA regulations are more likely to receive positive reviews, gain repeat customers, and attract new business.

What are the common mistakes and consequences of non-compliance with FDA FURLS regulations?

One of the most common mistakes food industry professionals make is submitting incomplete or inaccurate information on their FDA registration or renewal forms. This can result in delays in the processing of the application and may even lead to rejection of the application.

Another common mistake is failing to renew the registration on time. The FDA requires all food facilities to renew their registration every two years, and failure to do so can result in a facility being considered “inactive” and removed from the FDA’s database.

The consequences of non-compliance can be severe. The FDA can issue warning letters, impose fines, or even initiate legal action against non-compliant facilities. In some cases, non-compliance can result in suspending or revoking a facility’s registration.

Tips for navigating FDA Furls

Navigating the FDA’s FURLS system can be challenging. Still, several tips and strategies can help make the process easier.

  • First, it’s important to familiarize yourself with the FDA’s regulations and guidelines. The FDA provides a wealth of information on its website, including guidance documents, FAQs, and training materials.
  • Second, ensuring that all information submitted on your registration or renewal form is accurate and complete is important. This includes providing up-to-date contact information and ensuring that all required fields are filled out.
  • Finally, keeping track of important deadlines and renewing your registration on time is important. The FDA sends out reminders before the expiration of a facility’s registration. Still, the facility’s ultimately responsible for ensuring its registration is renewed on time.

Best practices for FDA Furls compliance

In addition to the tips outlined above, several best practices can help ensure compliance with FDA FURLS. One best approach is establishing a system for maintaining accurate and up-to-date records. This includes keeping track of important dates, such as the expiration of a facility’s registration, and ensuring that all documents related to FDA compliance are properly filed and organized.

Another best practice is to establish clear communication channels with the FDA. This includes designating a point person within the facility to handle all communications with the FDA and ensuring that all communication is timely and accurate.

Finally, it’s important to establish a culture of compliance within the facility. This means ensuring that all employees are trained on FDA regulations and guidelines and that compliance is a top priority for all staff members.

Tools and resources for managing FDA Furls

Several tools and resources are available to help food industry professionals manage their FDA FURLS compliance.

  • One tool is the FDA’s FURLS system, which provides a user-friendly interface for completing registration and renewal forms.
  • Another tool is FDAzilla, a subscription-based service that provides access to a wide range of FDA compliance resources, including warning letters, inspection data, and regulatory news.

Finally, it may be beneficial to work with a consultant or compliance expert who can provide guidance and support in navigating the FDA’s regulations and guidelines.

Case studies of successful FDA Furls compliance

One example is a small bakery that worked with a consultant to ensure compliance with FDA regulations. The consultant guided completing the registration and renewal forms and advised on establishing a culture of compliance within the facility. As a result, the bakery was able to achieve compliance with FDA regulations and avoid any penalties or fines.

Another example is a large food manufacturer implementing a system for maintaining accurate and up-to-date records. This included establishing a central database for tracking important dates and documents related to FDA compliance. The company also provided training to all employees on FDA regulations and guidelines, which helped to establish a culture of compliance within the facility.

Future trends and updates in FDA Furls regulations

The FDA constantly updates its regulations and guidelines, and food industry professionals must stay up-to-date on these changes.
One trend likely to continue is an increased emphasis on food safety and security. The FDA has made food safety a top priority in recent years, and this trend is likely to continue as the agency works to ensure the safety and security of the food supply in the United States.
Another trend is an increased focus on transparency and accountability. The FDA has made efforts to increase transparency in its regulatory processes and is likely to continue.

Working with FDA consultants for compliance and success

Working with an FDA consultant can be a valuable investment for food industry professionals. A consultant can provide guidance and support in navigating the FDA’s regulations and guidelines and help ensure compliance with all requirements.

When choosing an FDA consultant, looking for someone with a track record of success in working with food industry professionals is important. It’s also important to ensure that the consultant understands the specific regulations and guidelines that apply to your facility.

Conclusion

Navigating the FDA’s FURLS system can be challenging. Still, it’s possible to achieve compliance and success with the right strategies and tools. By familiarizing yourself with FDA regulations and guidelines, submitting accurate and complete information, and establishing a culture of compliance within your facility, you can ensure your business is on the path to success. Remember, observation is important not only for avoiding penalties and fines but also for maintaining a competitive advantage and gaining consumer trust. So, whether you’re a seasoned industry professional or just starting, take the time to navigate FDA FURLS with care and attention to detail.

Our experts at Quality Smart Solutions are here to help and offer medical device-related regulatory advice and support on successfully securing your medical device license.  We can help you by responding to potential information requests, keeping your license updated, and reviewing your device labels (510k Medical Device Registration, Facility Registration & FURLS, IVD Device Registration, and SaMD Classification

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FTC puts nearly 700 companies on notice of product claim civil penalties

substantiation reports dossiers FTC regulations

Introduction:

On April 13th, the Federal Trade Commission sent letters to warn hundreds of marketers to refrain from misleading customers with product claims in their marketing material that cannot be supported or substantiated. The FTC issued notifications to the businesses warning that it would not hold back in using its power to pursue offenders with severe civil penalties.

Companies must follow FTC regulations to provide solid evidence for any claims made regarding the capabilities of their products. Any health or safety benefits praised by a firm for a product must be backed-up by scientific data. A business must provide evidence to support any claims that a product can support general well-being and prevent nutrient deficiency or disease through scientific testing. Furthermore, general health products and dietary supplements should not be making any claims to “diagnose, treat, cure or prevent any disease,” because only a drug can legally make such a claim.  As the FTC authority continues to take enforcement action your business can face serious penalties.

In our blog, we’ll break down everything you should know about the FTC regulations and how to act if your company is on the warning list.

Why is a substantiation report important due to the new FTC regulations?

To sell your dietary supplement in the U.S.A the label must meet FDA regulations and any health claims they make (structure-function claims) need to be substantiated. Most companies in the past have chosen not to have a substantiation report but with this update we anticipate this changing significantly with the increased risks.

Who is the Federal Trade Commission (FTC) and what does the FTC do?

The Federal Trade Commission (FTC) is an independent, bipartisan agency of the U.S. government tasked with protecting consumers and ensuring a strong competitive market. The FTC works to prevent fraudulent, deceptive, and unfair business practices and marketing. FTC activities include investigating fraud or false advertising, congressional inquiries, and pre-merger notification. The FTC also oversees frauds and unfair or predatory business practices.

Is the FDA the same as FTC?

No. The FDA (Food and Drug Administration) is the United States’ regulatory agency for food, medical, and an array of other products. The FDA is responsible for ensuring the safety and efficacy of regulated products and acting against any adulterated or misbranded health products, devices, foods, or other regulated product after they reach the market. The FTC (Federal Trade Commission) regulates the advertising of all health products, dietary supplements, and most other products sold to consumers.

Which businesses will be receiving a notice from the FTC? Did yours make the list?

full list of the businesses receiving the notice from the FTC is available on the Commission’s website. The fact that a receiver is on the list in no way implies that they have behaved dishonestly or unfairly. The warning used to be distributed to individuals who were making or were likely to make health claims. However, it is applicable to any marketer who makes claims about the performance or efficacy of their products.

The letter to the recipients also provides them with a copy of a previously approved notice of penalty offenses regarding the use of endorsement and testimonials. “In that notice, it is discussed what constitutes falsely claiming an endorsement by a third party, misrepresenting whether a third party endorser is an actual, recent, or recent user, misrepresenting whether a third party endorser is a user, using an endorsement to make false claims about performance, failing to disclose an unexpected material connection with a third party endorser, and misrepresenting that an endorser’s experience is typical or ordinary for consumers.

Lastly, the letters advised the recipients to review the FTC staff’s recently released Health Products Compliance Guidance.”

What should you do if you received a letter from the FTC?

If you received the notice, you should move quickly to prepare your claims and supporting documentation because you will be on the front lines of an impending wave of enforcement. We would still advise the same thing even though you might be a little more anonymous if you did not receive a letter.

Compliance is important, but most people have labels with regulatory infractions that they are unaware of and do not care about. A lot of your competitors likely have their products made in factories that advertise that they are “cGMP-compliant” and “GMP-Certified,” even though they frequently begin by falling short of the requirements as soon as they receive raw materials. Your product should make no unsubstantiated claims.

What is the FTC product substantiation penalty offense authority doing?

To remind advertisers of the legal duty to have a reasonable basis for objective product claims and to discourage them from making false claims in the future, the FTC is currently employing its penalty offence authority.

Approximately 670 businesses that market over-the-counter medications, homoeopathic remedies, dietary supplements, or functional foods have received notices of penalty offences.  The FTC is warning them that failure to adequately substantiate their product claims in ways that are inconsistent with the litigated decisions of prior FTC administrative cases could result in serious civil penalties.

Notices of penalty offenses by the FTC:

A corporation that participates in conduct that has been ruled illegal in a prior FTC administrative decision, other than a consent order, may be subject to civil penalties from the agency, which can reach a charge of $50,120 per violation. This is possible using notices of penalty offences.

The warnings list particular illegal acts and behaviors, such as failing to have:

1) a reasonable basis consisting of competent and reliable evidence for objective product claims.

2) competent and reliable scientific evidence to support health or safety claims; and

3) at least one well-controlled human clinical trial to support claims that a product is effective in curing, mitigating, or treating a serious disease.

Misrepresenting a claim’s level or type of substantiation is another example of an unlawful act or practice, along with misrepresenting that a claim’s been clinically or scientifically proven.

What are the benefits of ensuring your products claims are substantiated?

Did you know that we have done about 5,000 substantiation dossiers for dietary supplements making it a very popular service of ours.  Additionally, US substantiation dossiers can also be used for Canada for Natural Health Product (NHP) licensing or vice versa.  We have experience in creating strategy around avoiding regulatory disruptions and distractions. Other benefits of substantiating your claims are avoiding legal civil suits and product development.

Sources:

https://www.ftc.gov/news-events/news/press-releases/2023/04/ftc-warns-almost-700-marketing-companies-they-could-face-civil-penalties-if-they-cant-back-their?utm_source=govdelivery

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Navigating the GRAS process: A guide for food manufacturers

Navigating the GRAS process

Introduction:

If you’re a food manufacturer, you need to understand the generally recognized as safe (GRAS) process. This process determines whether a substance is safe to use in food products without the need for pre-market approval from the FDA. This guide will provide you with a comprehensive overview of the GRAS process, including its history, requirements, and benefits.

What is the GRAS process?

The generally recognized as safe (GRAS) process is a way for food manufacturers to determine whether a substance is safe to use in food products without the need for pre-market approval from the FDA. This process was established in 1958 as part of the Food Additives Amendment to the Federal Food, Drug, and Cosmetic Act. The GRAS process involves a thorough evaluation of the available scientific data on a substance to determine its safety for use in food products. If a substance is determined to be GRAS, it can be used in food products without the need for pre-market approval from the FDA.

Who regulates the GRAS process?

The GRAS process is regulated by the U.S. Food and Drug Administration (FDA). The FDA is responsible for ensuring the safety of the food supply in the United States, and the GRAS process is one way that they do this. The FDA provides guidance to food manufacturers on how to conduct a GRAS evaluation, and they review the safety data submitted by manufacturers to determine whether a substance is GRAS. It’s important for food manufacturers to follow the FDA’s guidance and regulations when conducting a GRAS evaluation to ensure the safety of their products.

What are the requirements for a substance to be considered GRAS?

To be considered GRAS, a substance must meet two requirements. First, it must be generally recognized, among qualified experts, as safe for its intended use. This means that there must be a consensus among experts in the field that the substance is safe for use in food. Second, the safety of the substance must be supported by scientific evidence. This evidence can come from a variety of sources, including published studies, historical use of the substance in food, and other relevant data. Food manufacturers must provide this evidence to the FDA as part of their GRAS evaluation.

How to conduct a GRAS determination?

Conducting a GRAS determination involves a thorough evaluation of the safety of a substance for its intended use in food. This evaluation should be conducted by qualified experts in the field, who will review all available scientific evidence to determine whether the substance meets the requirements for GRAS status. The evaluation should include a review of published studies, historical use of the substance in food, and any other relevant data. Once the evaluation is complete, the results should be documented in a GRAS determination report, which should be submitted to the FDA for review.

What are the benefits of obtaining GRAS status for your food ingredient?

Obtaining GRAS status for your food ingredient can provide several benefits for your business. Firstly, it can help to increase consumer confidence in your product, as it demonstrates that your ingredient has been thoroughly evaluated for safety. This can be particularly important for new or innovative ingredients that may be unfamiliar to consumers. Additionally, having GRAS status can help to streamline the regulatory process, as it can reduce the need for additional safety testing or documentation. Finally, it can provide a competitive advantage in the marketplace, as it can differentiate your product from others that do not have GRAS status.

For more information on  self-affirmed GRAS and what achieving the Generally Recognized as Safe (GRAS) could mean for your food products contact us for a complimentary consultation.

Additional Reading about GRAS:

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How to get your Food Handlers License: Ultimate 5 step guide

food handler license

If you work in the food service industry, you may need to obtain food handlers license to ensure that you are properly trained in food safety and handling. This guide will walk you through the steps to get certified, including training requirements, exam preparation, and application procedures.  We’ll also provide timing estimates and let you know if you require the food handler’s license.

To learn more about the requirements for a food handlers license or food license insurance in each state I suggest you refer to the FDA website.

If you are looking to get certified in Canada here is a good certification training you can try.

Who needs a Food Handlers License?

The Food Handlers Certificate is a certification that any individual who works with food must have. This includes:

  • Any person who works in a restaurant, cafeteria, or school cafeteria as an employee or volunteer
  • Any individual who handles food for sale at a farmers’ market

In addition to these situations, you may also need this license if you want to work with food but don’t fall into the categories above. For example, if you’re planning on opening your own restaurant or catering business and need employees who can handle the preparation and serving of meals safely and efficiently then they will need their Food Handlers Certificates before they can start working at your establishment.

Where can I get my food handlers certificate?

If you want to get your food handler’s certificate, there are several places you can go.

  • The local health department or county office will usually offer a class for free or at a reduced price. This is the most common place people go because it’s convenient and they have been doing this for years.
  • A community college may also offer classes in person or online through their continuing education program (if they have one). The advantage of taking a course at a community college is that they are usually more affordable than other options and tend to give more practical information on preparing safe food as opposed to just passing an exam as some other providers do!

How long does it take to get a Food Handlers License?

It takes about 10 days to get your food handler’s license. If you are in a hurry, you can pay extra for expedited service, and it will take only 2 days.

What are the steps to obtaining a Food Handlers License?

Step 1: Determine the requirements in your state or jurisdiction!

Before you begin the process of getting your food handlers license, it’s important to determine the specific requirements in your state or jurisdiction. Some states may require specific training courses or exams, while others may have different application procedures. You can typically find this information on your state or local health department’s website, or by contacting them directly. Make sure to familiarize yourself with the requirements before proceeding with the certification process.

Step 2: Complete a food handler training course!

Once you have determined the specific requirements in your state or jurisdiction, the next step is to complete a food handler training course. This course will cover important topics such as food safety, proper hygiene practices, and preventing foodborne illnesses. There are many options for completing this training, including online courses or in-person classes. Make sure to choose a course that is approved by your state or local health department. After completing the course, you will typically need to pass an exam to receive your food handler’s certificate.

Step 3: Pass the food handlers certification exam!

After completing your food handlers training course, the next step is to pass the exam. The exam will test your knowledge of food safety, proper hygiene practices, and preventing foodborne illnesses. The exam may be taken online or in person, depending on the requirements in your state or jurisdiction. Make sure to study and review the material covered in your training course before taking the exam. Once you pass the exam, you will receive your food handlers’ certificate, which is required to work in many food service jobs.

Step 4: Apply for your food handler’s license!

Once you have completed your food handlers training and passed the exam, it’s time to apply for your license. The process may vary depending on your state or jurisdiction, but typically you will need to fill out an application and provide proof of your training and exam completion. Some states may also require a background check or additional documentation. Make sure to follow all instructions carefully and submit your application promptly to avoid any delays in receiving your license. With your food handlers license in hand, you’ll be ready to start working in the food service industry.

Step 5: Renew your food handlers license as required!

Once you have obtained your food handlers license, it’s important to remember that it will need to be renewed periodically. The frequency of renewal may vary depending on your state or jurisdiction, but it’s typically every 2-3 years. Make sure to keep track of when your license is set to expire and begin the renewal process in advance to avoid any lapses in certification. Some states may require additional training or exams for renewal, so be sure to check the requirements in your area. By staying up-to-date on your license renewal, you’ll be able to continue working in the food service industry and ensure the safety of those you serve.

What are the common mistakes in food handler certificate application renewal?

Renewing your food handlers’ certificate can be a simple process, but it is essential to avoid common mistakes that could lead to rejection. One of the most common mistakes is submitting an incomplete application. Only complete applications can ensure the renewal process and lead to rejection. Reviewing the application requirements and ensuring you have provided all the necessary information is essential.

Another common mistake is failing to meet the eligibility requirements. It is essential to review the eligibility requirements before submitting your application. For example, some states require food handlers to complete specific training hours before renewing their certificate. You must meet these requirements to ensure that your application is accepted.

How to avoid rejection of your food handlers certificate renewal application?

To avoid rejection of your renewal application, it is essential to follow these tips:

1. Review the application requirements and eligibility criteria before submitting your application.
2. Ensure that you have provided all the necessary information and documentation.
3. Complete any required training hours before submitting your application.
4. Disclose any criminal convictions or other relevant information accurately and honestly.
5. Review your application before submitting it to ensure all the information is accurate and up-to-date.

What are the steps to take if your food handler license application is rejected?

If your renewal application is rejected, taking the necessary steps to rectify the situation and obtain a valid certificate is essential. Depending on the reason for rejection, you may need to retake the food handlers’ course, provide additional documentation, or appeal the decision. Understanding your state’s specific requirements and taking the necessary steps to comply is essential.

Renewal Alternatives – Online Courses, In-Person Classes, etc.  Renewing your food handlers’ certificate can be a manageable task. Several renewal alternatives include online courses, in-person classes, and self-study materials. These options provide flexibility and convenience, allowing you to renew your certificate on your schedule. It is essential to ensure that your state approves the renewal option you choose and that it meets all the eligibility criteria.

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Everything you should know about FDA GRAS Status in 2023

FDA GRAS Status

Have you ever wondered what it means for a food or ingredient to be ‘Generally Regarded as Safe’ (GRAS)? This article will explain what GRAS is and how to obtain it from the U.S. Food and Drug Administration (FDA) so you can stay updated on the latest FDA regulations.  

What is GRAS Status?

GRAS stands for Generally Regarded as Safe and is status that the FDA has given to foods and ingredients, commonly known as “GRAS substances”. The FDA reviews scientific data about a substance intended for food use and can confer GRAS status based on its safety when used in accordance with their established conditions of use. Food manufacturers must comply with all applicable FDA regulations to obtain GRAS status.

Why Is it Important to achieve GRAS Status?

Obtaining GRAS status is important for food manufacturers as it allows them to add approved ingredients with specific uses and application levels to their products. This ensures that the foods are safe for consumers, as well as comply with applicable FDA regulations. It also protects food makers from potential liability in the event an ingredient or product is found to be unsafe or not correctly labeled.

What are the requirements for a product to have GRAS Status?

In order for a product to have GRAS status, it must meet the requirements set forth in the FDA’s Generally Recognized as Safe (GRAS) regulations. The criteria includes demonstrating that there is a consensus among qualified experts that the ingredient or product is safe under its intended conditions of use, has a history of safe use or has reliable scientific data to support its safety. Additionally, manufacturers must keep current records regarding any changes to the uses and applications of their products to ensure they remain in compliance with GRAS requirements.

How to get started on the FDA GRAS Application Process?

The application process to obtain GRAS status can vary significantly depending on the product. Generally, it involves an evaluation of the evidence available that indicates the product or ingredient is safe. This may include scientific data, compositions, safety assessment studies and/or published literature. After gathering the necessary information and documents, you must submit an application package to the FDA for review.

Tips on submitting a complete and accurate application:

Filing a complete and accurate application is the first step to obtaining GRAS status from the FDA. To ensure your application is thorough, here are some helpful tips. Make sure to include all necessary documents as outlined in the regulations, as omitting such documents could result in your application not being accepted by the FDA. It’s also a good idea to double-check your data and literature to make sure they are factually correct before submission. All of this can help streamline the review process and improve your chances of success!

Conclusion:

The GRAS pathway is a possible pathway for a probiotic ingredient found in the food supply and one derived from non-food sources. The GRAS pathway requires pivotal safety data to be publicly available. A conclusion of GRAS may or may not be notified to FDA.

Determining the best pathway to regulatory compliance can seem overwhelming but considering the above factors can direct you to the most appropriate path for your specific novel probiotic. RNI is also available to help you determine the best path forward based on your ingredient needs and goals and can support the development of your GRAS and NDIN dossiers for regulatory compliance.  Learn more about self-affirmed GRAS here:

Additional Reading about GRAS:

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The role of Critical Control Points in your HACCP Plan

HACCP Certification Critical Control Points In the food industry, ensuring the safety of the products you produce is of utmost importance. One key aspect of this is understanding critical control points (CCPs) and implementing measures to control them.

Critical control points (CCPs) are specific points in the food production process where potential hazards can be controlled or eliminated to ensure food safety. Understanding CCPs is essential for businesses seeking Hazard Analysis and Critical Control Points (HACCP) certification, which is a globally recognized food safety management system. In this article, we’ll explore what CCPs are, why they are important, and how they can be identified and managed.

Are you looking to get certified in the Hazard Analysis and Critical Control Points (HACCP) system?  The purpose of a Hazard Analysis Critical Control Points (HACCP) plan is to identify and control any hazards that may arise during the process of manufacturing, storing, distributing, and consuming food products. HACCP plans are meant to reduce, eliminate, and avoid risks that may negatively impact the consumer and the organization. They will vary based on the product, process and other factors that can occur in the facility. Developing a HACCP plan consists of 12 tasks with seven principles, which are further explained below.

What is HACCP certification?

HACCP certification is a food safety management system that is recognized globally. It is designed to identify and control potential hazards in the food production process to ensure that the final product is safe for consumption. HACCP certification is important for businesses that want to demonstrate their commitment to food safety and meet regulatory requirements. It involves a thorough analysis of the entire food production process, from raw materials to finished products, to identify potential hazards and implement controls to prevent them.

What are critical control points (CCPs)?

Critical control points (CCPs) are specific points in the food production process where potential hazards can be controlled or eliminated. These points are identified during the hazard analysis stage of HACCP certification and are critical to ensuring the safety of the final product. CCPs can include steps such as cooking, chilling, and packaging, and must be monitored and documented to ensure that the controls are effective. Failure to control a CCP can result in a food safety hazard and potentially harm consumers.

How do CCPs help ensure food safety?

CCPs are essential in ensuring food safety because they allow for the identification and control of potential hazards in the food production process. By monitoring and documenting CCPs, food safety managers can ensure that the controls put in place are effective in preventing hazards from reaching the final product. This helps to reduce the risk of foodborne illness and ensures that consumers can have confidence in the safety of the food they are consuming. Without CCPs, it would be much more difficult to identify and control potential hazards, putting consumers at risk.

What are some examples of CCPs in food production?

Examples of CCPs in food production include temperature control during cooking or cooling, pH control during fermentation or acidification, and metal detection during packaging. Other examples may include monitoring of water activity, time and temperature control during storage, and sanitation procedures. The specific CCPs will vary depending on the type of food being produced and the potential hazards associated with that food. It is important for food safety managers to identify and document all CCPs in their HACCP plan to ensure effective control of potential hazards.

What is the importance of monitoring documentation of CCPs?

Monitoring documentation of CCPs is crucial in ensuring that food safety management systems are effective and compliant with HACCP certification requirements. By documenting CCPs, food safety managers can track and analyze data to identify trends and potential areas for improvement. This documentation also serves as evidence of compliance during audits and inspections. Without proper documentation, it can be difficult to identify and address potential hazards, putting consumers at risk and jeopardizing the reputation of the food production facility.

Why are critical control points important in food safety?

Critical control points are important in food safety because they are the points in the production process where a hazard can be prevented, eliminated, or reduced to an acceptable level. By identifying and controlling these points, food industry professionals can ensure that their products are safe for consumption and minimize the risk of foodborne illness outbreaks. Failure to identify and control CCPs can result in serious consequences, including product recalls, legal action, and damage to a company’s reputation.

How to identify critical control points in your food production process?

The first step in identifying critical control points in your food production process is to conduct a hazard analysis. This involves identifying potential hazards that could occur at each stage of the production process, from raw materials to finished products. Once hazards have been identified, the next step is to determine which ones are critical and require control. This can be done by considering factors such as the severity of the hazard, the likelihood of it occurring, and the effectiveness of control measures. Once critical control points have been identified, appropriate control measures can be implemented to prevent or reduce the risk of hazards occurring.

How to establish critical limits and monitoring procedures?

Once critical control points have been identified, it is important to establish critical limits and monitoring procedures. Critical limits are the maximum or minimum values that must be met to ensure that a hazard is under control. Monitoring procedures involve regularly checking that critical limits are being met and taking corrective action if they are not. This can involve using tools such as thermometers, pH meters, and visual inspections. It is important to document all critical limits and monitoring procedures to ensure that they are consistently followed and to provide a record of compliance for regulatory purposes.

How to take corrective actions and maintain records for critical control points?

Taking corrective action is crucial when critical limits are not met. This involves identifying the cause of the deviation and taking steps to correct it. For example, if a temperature critical limit is not met, the corrective action may involve adjusting the temperature or removing the affected product from the production line. It is important to document all corrective actions taken, including the date, time, and nature of the deviation, as well as the steps taken to correct it. This documentation is important for regulatory compliance and can also help identify trends and areas for improvement in the food safety system.

The Seven Principles of HACCP (Hazard Analysis and Critical Control Points)
The Hazard Analysis and Critical Control Points (HACCP) system is a food safety management system businesses use worldwide. The system is based on seven principles, which provide a framework for identifying and controlling potential hazards in the food production process.

The seven principles of HACCP are as follows:

1. Conduct a hazard analysis: This involves identifying potential hazards in the food production process.
2. Determine the critical control points: This involves identifying the facts in the food production where potential hazards can be controlled.
3. Establish critical limits: This involves setting limits for essential points of control, such as minimum cooking temperatures or maximum storage times.
4. Establish monitoring procedures: This involves establishing procedures for monitoring critical control points to ensure that they are within the specified limits.
5. Establish corrective actions: This involves establishing procedures for taking corrective action if a critical control point deviates from the established limits.
6. Establish verification procedures: This involves establishing procedures for verifying that the HACCP system is working as intended.
7. Establish record-keeping and documentation procedures: This involves establishing procedures for documenting the HACCP system and keeping records of critical control points.

How to identify CCPs in the food-handling process?

Identifying critical control points (CCPs) in food handling involves a systematic approach to identifying potential hazards and determining where control measures are needed. This process typically involves four steps:

1. Conduct a hazard analysis: This involves identifying potential hazards in the food handling process, including physical, chemical, and biological hazards.
2. Determine where control measures are needed: This involves identifying the points in the food handling process where potential hazards can be controlled.
3. Establish critical limits: This involves setting limits for critical control points, such as minimum cooking temperatures or maximum storage times.
4. Establish monitoring procedures: This involves establishing procedures for monitoring critical control points to ensure that they are within the specified limits.

Why is it essential to monitor and document CCPs?

Monitoring critical control points (CCPs) is a crucial component of the Hazard Analysis and Critical Control Points (HACCP) system. Monitoring involves checking that critical control points are within the established limits and taking corrective action if necessary. The monitoring process should be documented to provide a record of the food handling process.

Documentation is vital for several reasons. Firstly, it provides a record of the food handling process, which can be used to demonstrate compliance with food safety regulations and standards. Secondly, it provides a form of any deviations from critical limits and the corrective actions taken. This information can improve the food handling process and prevent future variations.

When to take corrective actions for CCP deviations?

Corrective action must be taken if a critical control point (CCP) deviates from the established limits. Corrective action involves identifying the cause of the deviation and taking steps to prevent it from happening again. The corrective action process typically involves the following steps:

1. Identify the cause of the deviation: This involves investigating the cause and determining what steps must be taken to prevent it from happening again.
2. Take immediate corrective action: This involves correcting the deviation, such as disposing of contaminated products or adjusting the cooking temperature.
3. Review the HACCP plan: This involves reviewing the HACCP plan to determine whether any changes need to be made to prevent future deviations.
4. Document the corrective action: This involves documenting the corrective action taken, including the cause of the deviation and the steps taken to prevent it from happening again.

Why is CCP verification and validation necessary?

CCP verification and validation are essential components of the Hazard Analysis and Critical Control Points (HACCP) system. Verification involves checking that the HACCP system is working as intended. In contrast, validation ensures that the system effectively controls potential hazards.

Verification and validation should be conducted regularly to ensure the HACCP system works effectively. Verification activities may include reviewing records, conducting on-site inspections, and testing products for potential hazards. Validation activities may consist of conducting scientific studies or trials to ensure that the HACCP system effectively controls potential hazards.

What is the role of critical control points in food safety management systems?

Critical Control Points (CCPs) are specific points in the food manufacturing process where controls can be implemented to prevent, eliminate, or reduce food safety hazards. CCPs are an essential part of a food safety management system as they help prevent foodborne illnesses and ensure the safety and quality of food products.

Identifying and managing CCPs is part of a broader Hazard Analysis and Critical Control Points (HACCP) program. HACCP is a systematic approach to food safety that aims to identify, assess, and control hazards throughout food production.

HACCP is a preventive system that helps identify potential hazards before they occur and implement measures to control them.
CCPs can be identified at any stage of the food production process, from raw material handling to processing, packaging, and distribution. Identifying CCPs requires a thorough understanding of the food production process, including the potential hazards that may arise at each stage.

In summary, CCPs are critical to food safety management systems as they help prevent, eliminate, or reduce food safety hazards. By identifying and managing CCPs, food manufacturers, distributors, and retailers can ensure the safety and quality of their food products.

How do you identify critical control points in your food safety system?

Identifying CCPs is critical to developing an effective food safety management system. CCPs can be placed through hazard analysis, a systematic process of identifying potential hazards in food production.

The hazard analysis involves identifying potential hazards, assessing their likelihood and severity, and determining the appropriate control measures to prevent, eliminate, or reduce the danger.

A team of experts should conduct the hazard analysis process with a thorough understanding of the food production process and the potential hazards that may arise at each stage.
Once potential hazards have been identified, the next step is determining which critical stakes require control measures. Acute risks are those that have the potential to cause harm to consumers and must be controlled to ensure the safety and quality of food products.

In summary, identifying CCPs requires a thorough hazard analysis process that involves identifying potential hazards, assessing their likelihood and severity, and determining which critical threats need control measures.

How do you evaluate critical control points and determine their significance?

Once CCPs have been identified, the next step is to evaluate their significance and determine the appropriate control measures. The relevance of a CCP is determined based on the severity of the hazard and the likelihood of occurrence.

CCPs deemed significant require effective control measures that prevent, eliminate, or reduce the hazard. The control measures must be validated to ensure they effectively control the risks.

Validation involves testing the control measures to ensure they effectively control the hazard. Proof can be done through experiments, data analysis, or expert judgment.

In summary, evaluating CCPs requires determining their significance based on the severity of the hazard and the likelihood of occurrence. CCPs deemed significant require effective control measures that prevent, eliminate, or reduce the danger.

How do you develop control measures for critical control points?

Once CCPs have been identified and evaluated, the next step is to develop effective control measures that prevent, eliminate, or reduce the hazard. Control measures can be physical, chemical, or biological. They must be validated to ensure they effectively control the threat.

Control measures must be specific to the hazard and the CCP. They must be implemented and monitored to ensure they effectively control the risk. The effectiveness of the control measures should be monitored regularly to ensure that they remain effective in preventing the threat.

In summary, developing control measures for CCPs requires developing criteria specific to the hazard and the CCP and monitoring their effectiveness regularly.

How do you implement and monitor critical control points?

Implementing and monitoring CCPs is a critical step in ensuring the safety and quality of food products. CCPs must be implemented according to the control measures developed. They must be monitored regularly to ensure they effectively control the hazard.

The monitoring process involves collecting data on the CCP and the control measures. The data collected should include measurements of the CCP and the control measures and any deviations from the control measures.

If a deviation is detected, corrective action must be taken immediately to prevent the hazard from occurring. Disciplinary action may involve adjusting the control measures, retraining employees, or modifying the production process.

In summary, implementing and monitoring CCPs requires implementing the control measures developed and monitoring their effectiveness regularly. Corrective action must be taken immediately if a deviation is detected.

What are some common challenges in addressing critical control points?

Addressing CCPs can be challenging for food manufacturers, distributors, and retailers. Some common challenges include:
1. Lack of resources: Addressing CCPs requires time, money, and personnel. Small businesses may need help allocating the resources required to address CCPs effectively.
2. Lack of expertise: Addressing CCPs requires expertise in food safety and HACCP principles. Small businesses may need more knowledge to develop effective food safety management systems.
3. Resistance to change: Addressing CCPs may require modifications to the production process, which may be met with resistance from employees or management.
4. Complexity: Addressing CCPs can be complex, requiring a thorough understanding of the food production process and the potential hazards that may arise at each stage.

Addressing CCPs can be challenging for food manufacturers, distributors, and retailers due to the need for more resources, expertise, resistance to change, and complexity.

How do you address critical control points in your food safety system?

Addressing CCPs requires a systematic approach that involves identifying potential hazards, evaluating their significance, developing control measures, implementing and monitoring them, and taking corrective action if necessary. Some best practices for addressing CCPs include:

1. Develop a HACCP plan: A HACCP plan is a systematic approach to food safety that involves identifying, assessing, and controlling hazards throughout food production. Developing a HACCP plan is essential in identifying and addressing CCPs effectively.
2. Conduct regular hazard analyses: Regular hazard analyses are essential in identifying potential hazards and ensuring that the control measures remain effective in controlling the stake.
3. Train employees: Training employees on food safety and HACCP principles is essential in ensuring they understand the importance of addressing CCPs and their role in maintaining food safety.
4. Communicate effectively: Effective communication is essential in ensuring that everyone involved in the food production process understands the importance of addressing CCPs and their role in maintaining food safety.

In summary, addressing CCPs requires a systematic approach that involves developing a HACCP plan, conducting regular hazard analyses, training employees, and communicating effectively.

Why are training and communication essential in critical control point management?

Training and communication are critical in ensuring the effective management of CCPs. Training employees on food safety and HACCP principles is essential in ensuring they understand the importance of addressing CCPs and their role in maintaining food safety.

Effective communication is also essential in ensuring that everyone involved in the food production process understands the importance of addressing CCPs and their role in maintaining food safety. Communication should be clear, concise, and consistent to ensure everyone is on the same page.

Training employees on food safety and HACCP principles and communicating effectively are essential in ensuring everyone understands the importance of addressing CCPs and their role in maintaining food safety.

Conclusion: The Importance of CCPs in Ensuring Safe Food Handling

In conclusion, Critical Control Points (CCPs) are essential for ensuring safe food handling. By identifying and controlling potential hazards at critical points in the food handling process, businesses can minimize the risk of foodborne illness outbreaks, protect the health and safety of customers, and maintain their reputation in the market. The use of CCPs is a crucial component of the Hazard Analysis and Critical Control Points (HACCP) system, a food safety management system used by businesses worldwide. By implementing CCPs and following the seven principles of HACCP, companies can ensure that their products are safe for consumption and comply with food safety regulations and standards.

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Software as Medical Devices SaMD Registration Everything you should know

software-as-a-medical-device-samd

 

As technology continues to advance, the use of Software as Medical Devices (SaMD) is becoming more prevalent in the healthcare industry. SaMD refers to software that is intended for medical purposes, such as diagnosing or treating a disease. However, with the rise of SaMD comes the need for regulations to ensure their safety and effectiveness. This guide provides an overview of SaMD and its regulations.

In this article, we provide a comprehensive overview of Software as Medical Devices SaMD so that you can remain compliant with FDA and Health Canada regulations. We’ll also cover everything from the basics of SAMD registration to its importance in ensuring compliance and market access. We’ll also walk you through the step-by-step process of registering your medical device, including the required documentation and submission guidelines. Additionally, we’ll discuss common challenges and pitfalls to watch out for and valuable tips and best practices to maximize your chances of a successful SAMD registration.

What is Software as Medical Devices (SaMD)?

Software as Medical Devices (SaMD) refers to software that is intended for medical purposes, such as diagnosing or treating a disease. SaMD can be standalone software or part of a larger system, and it can be used on a variety of devices, including smartphones, tablets, and computers. SaMD is becoming increasingly popular in the healthcare industry due to its potential to improve patient outcomes and reduce healthcare costs. However, SaMD must meet certain regulatory requirements to ensure its safety and effectiveness.

How is SaMD regulated?

SaMD is regulated by various regulatory bodies, depending on the country or region where it is being marketed. In the United States, the Food and Drug Administration (FDA) regulates SaMD as medical devices under the Federal Food, Drug, and Cosmetic Act. In the European Union, SaMD is regulated under the Medical Device Regulation (MDR) and In Vitro Diagnostic Regulation (IVDR). These regulations require SaMD to undergo a rigorous process of testing and evaluation to ensure its safety and effectiveness before it can be marketed to the public.

What are the benefits and challenges of SaMD?

SaMD offers many benefits in the healthcare industry, including improved patient outcomes, increased efficiency, and cost savings. SaMD can also provide remote monitoring and diagnosis, allowing for more personalized and timely care. However, there are also challenges associated with SaMD, such as the need for continuous updates and maintenance, potential cybersecurity risks, and the need for regulatory compliance. It is important for healthcare organizations to carefully consider these benefits and challenges before implementing SaMD in their practice.

What are some examples of SaMD in healthcare?

Examples of SaMD in healthcare include mobile health apps, clinical decision support software, and telemedicine platforms. These technologies can assist with patient monitoring, diagnosis, and treatment, as well as provide valuable data for healthcare providers. However, it is important to note that not all software used in healthcare qualifies as SaMD and may not be subject to the same regulations. It is important for healthcare organizations to carefully evaluate any software they plan to use as a medical device.

What are some likely future trends and developments in SaMD?

As technology continues to advance, the future of SaMD looks promising. One trend is the integration of artificial intelligence (AI) and machine learning (ML) into SaMD, allowing for more personalized and accurate diagnoses and treatment plans. Another development is the use of virtual and augmented reality in healthcare, which can enhance patient experiences and improve outcomes. Additionally, the use of blockchain technology in SaMD can improve data security and interoperability. As SaMD continues to evolve, healthcare organizations need to stay up-to-date on these trends and developments to provide the best possible care for their patients.

Why has the FDA classified Software as a Medical Device (SaMD)?

It is no secret that many nations throughout the world are still unaware of the enormous and significant benefits linked to the use of software for healthcare systems. Because of this, there is a need to raise public knowledge of its significance, importance, and overall influence of it on the healthcare system. The benefits of this software need to be made clear to the general public because they go well beyond those of conventional medical equipment. Harmonizing medical device regulations will be made easier with an understanding of these facts. FDA has classified software as a medical device to observe even further benefits of it in the future. IMDRF develops internationally agreed-upon documents related to a wide variety of topics affecting medical devices. In 2013, IMDRF formed the Software as a Medical Device Working Group (WG) to develop guidance supporting innovation and timely access to safe and effective SaMD globally.

 

Seeking Software as a Medical Device (SaMD) Registration & Licensing?

How to know if your product is a part of the FDA? 

The definitions of Software as a Medical Device (SaMD) provided by IMDRF, and the FDA are essentially the same. It is also another supporting information that the FDA is also a member of IMDRF so when your product is approved by FDA, your software product can achieve the status of SaMD.

Firstly, it is important to know the quality of your product and whether it has the potential to be regarded as a medical device. The quality and the ability of the intended product can easily be evaluated in the light of the definition by IMDRF which says, “intended for one or more medical purposes”. FDA cites the FD&C act’s section 181(h) definition of a device, which reads as follows:

An item that is a tool, machine, implement, implant, contraption, in vitro reagent, or another similar or related item, including a component or accessory.

It must be:

  • recognized in the official National Formulary, or the United States Pharmacopoeia, or any supplement to them,
  • intended for use in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment, or prevention of disease, in man or other animals, or
  • intended to affect the structure or any function of the body of man or other animals, and which does not achieve its primary intended purposes through chemical action within or on the body of man or other animals and which does not achieve its primary intended purposes through chemical action within or on the body of man or other animals and which is not dependent upon being metabolized for the achievement of its primary intended purposes.

Note: The term “device” does not include software functions excluded according to section 520(o).

Here it is worth mentioning that the term “intended use” refers to the actual use for which that particular software is designed and which particular problem it will address as a medical device.

How does SaMD qualify for 510k Registration?

The FDA is the regulatory body that sets out the standards for medical device registration. It reviews and approves any new medical device before it can be sold in the United States. The FDA is responsible for ensuring that these devices are safe and effective, as well as meeting certain requirements set out by law. A 510(k) clearance refers to a notification of a substantially equivalent device to an already cleared device. This notification allows the company to market its product without additional testing, providing that they abide by certain conditions set out by the FDA.

What are the advantages of using (SaMD) in Healthcare?

SaMD offers numerous opportunities and has the potential to refine integral systems in a healthcare setting. This is due to the possibility of automating certain aspects that can lead to better treatment for patients. SaMD’s main advantages include improving healthcare outcomes and faster response times. 

There are several intended uses for SaMD that can benefit both the patient and the provider, 

  • Treat or diagnose– information provided by SaMD can be used to accurately detect a disease or condition and help reduce the time from diagnosis to treatment.
  • Drive clinical/patient management– SaMD can help better identify early warning signs and provide real time recommendations. Also, can aid clinicians with making a definitive diagnosis, by analyzing relevant information.
  • Inform clinical/patient management- SaMD allows clinicians to better advise their patients regarding options for personalized treatment plans. 

What is SAMD registration?

SAMD registration, short for System for Award Management and Device Registration, is mandatory for businesses that manufacture, distribute, or import medical devices in the United States. The FDA (Food and Drug Administration) developed the SAMD registration system to ensure the safety and effectiveness of medical devices in the market. By registering with SAMD, companies provide essential information about their medical devices, including their intended use, manufacturing processes, and quality control measures.

SAMD registration serves as a means for the FDA to monitor and regulate medical devices in the marketplace. It enables the FDA to identify and track devices, perform inspections, and enforce safety standards. Without SAMD registration, businesses cannot legally sell their medical devices in the United States. Now that you understand the importance of SAMD registration let’s explore who needs to register for SAMD.

Why is SAMD registration necessary?
SAMD registration is of utmost importance for businesses involved in the medical device industry. Here are a few key reasons why SAMD registration should be a priority for you:

1. Compliance with FDA regulations: SAMD registration ensures that your medical devices comply with the FDA’s rules and standards. By registering your devices, you demonstrate your commitment to safety, quality, and effectiveness, which are critical factors in gaining FDA approval and maintaining compliance.
2. Market access: Without SAMD registration, your medical devices cannot be legally sold in the United States. Registering with SAMD opens doors to the vast U.S. market, allowing you to reach a wide range of healthcare providers, distributors, and end-users.
3. Enhanced credibility: SAMD registration adds credibility to your business and products. It reassures potential buyers, investors, and partners that your devices meet the safety and quality requirements set by the FDA.

Now that you understand the importance of SAMD registration let’s discuss who needs to register for SAMD.

Who needs to register for SAMD?

SAMD registration is mandatory for any business involved in the manufacturing, distributing, or importing of medical devices in the United States. This includes both domestic and foreign companies. Whether you’re a startup developing a groundbreaking medical device or an established manufacturer expanding into the U.S. market, SAMD registration is a legal prerequisite for selling your products.

It’s worth noting that SAMD registration requirements may vary depending on the type of medical device and the level of risk associated with it. The FDA categorizes medical devices into different classes based on their intended use and potential risks. Class I devices, such as tongue depressors or bandages, have the lowest chance. In contrast, Class III devices, like implantable pacemakers or prosthetic heart valves, pose the highest risk.

Regardless of the device class, all manufacturers, distributors, and importers must register with SAMD. The registration process ensures that the FDA has accurate information about the devices sold in the U.S. market and allows them to take appropriate regulatory actions when necessary.

What does the SAMD registration process consist of?

The SAMD registration involves several steps, from preparing for registration to submitting your application and payment. Let’s break down each step to help you navigate the process smoothly.

a. Preparing for SAMD registration

Before you begin the SAMD registration process, gathering all the necessary information and documents is essential. This will streamline the registration process and prevent any delays or complications. Here’s what you need to do:

1. Determine the device class: Identify the correct classification of your medical device according to the FDA’s classification system. This will determine the level of regulatory control and the specific requirements for your device.
2. Conduct a thorough review: Review the FDA regulations and guidance documents related to your device class. Familiarize yourself with the specific requirements, including labeling, quality control, clinical data, and performance testing.
3. Establish a quality management system: Implement a robust quality management system (QMS) that complies with the FDA’s quality system regulation (21 CFR Part 820). A well-documented QMS will help streamline your registration process and demonstrate your commitment to quality and compliance.

b. Gathering required documents

Once you’ve prepared for SAMD registration, the next step is to gather the required documents. The documents may vary depending on the device class and the type of registration you seek. However, here are some standard documents that you will likely need:

1. Device listing: Prepare a comprehensive list of the medical devices you intend to sell in the United States. Include device names, models, intended use, and labeling.
2. Device description and specifications: Provide a detailed description of each medical device, including its intended use, technical specifications, and any unique features or design elements.
3. Quality control documentation: Submit documentation demonstrating compliance with the FDA’s quality system regulation. This may include standard operating procedures, test reports, calibration certificates, and records of quality control activities.

c. Completing the SAMD registration application

With all the required documents, you’re ready to meet the SAMD registration application. The application is an online form that collects essential information about your company and the medical devices you intend to register. Here are the key steps to complete the application:

1. Create an account: If you still need to, create an account on the FDA’s online registration system. This will allow you to access the SAMD registration application and track the progress of your submission.
2. Provide company information: Enter your company’s name, address, contact details, and other relevant information. Ensure to provide accurate and up-to-date information to avoid delays or complications.
3. Enter device details: Provide detailed information about each medical device you register, including its classification, intended use, and any relevant certifications or clearances. Be as thorough and accurate as possible to ensure compliance with FDA regulations.

Submitting the SaMD application and payment

Once you’ve completed the SAMD registration application, it’s time to submit it to the FDA. Before submitting, please review all the information carefully to ensure its accuracy. Any errors or omissions could result in delays or rejection of your application. Additionally, you will need to pay the required registration fees. The fees vary depending on the device class and the registration type. The FDA’s online registration system will guide you through the payment process.

Congratulations! You’ve completed the SAMD registration process. However, it’s important to note that SAMD registration is not a one-time requirement. To maintain compliance and continue selling your medical devices in the United States, you must renew your registration annually and update any changes to your devices or company information.

Tips for a successful SAMD registration

While the SAMD registration process may seem daunting, following these tips will increase your chances of a successful registration:

1. Start early: Begin the registration process well before your planned market launch. This will allow ample time to gather the required documents, address any challenges, and ensure a smooth registration experience.
2. Seek expert guidance: Consider engaging the services of regulatory consultants or experts who specialize in SAMD registration. Their expertise and knowledge can help you navigate complex requirements and increase the efficiency of your registration process.
3. Maintain accurate records: Keep detailed records of your registration process, including all documents submitted, communication with the FDA, and any changes or updates made to your devices or company information. These records will be invaluable for future renewals and audits.

What are the common mistakes to avoid during SAMD registration?

During the SAMD registration process, it’s crucial to avoid common mistakes that could delay or jeopardize your registration. Here are a few pitfalls to watch out for:

1. Inaccurate or incomplete information: Ensure that all information in your SAMD registration application is accurate, complete, and up-to-date. Any errors or omissions can lead to delays or rejection of your application.
2. Insufficient documentation: Submit all required documentation promptly and ensure it meets the FDA’s requirements. Inadequate or missing documentation can result in rejection or additional requests for information.
3. Non-compliance with regulations: Failure to establish and maintain a robust quality management system compliant with FDA regulations can hinder your SAMD registration process. Ensure that your quality control processes are well documented and aligned with the FDA’s quality system regulations.

SAMD registration fees and timelines

The fees and timelines for SAMD registration vary depending on your device class and the type of registration you seek. The FDA provides a fee schedule outlining the registration fees for different devices on its website.

Regarding timelines, starting the registration process well before your planned market launch is essential. The FDA encourages businesses to submit their applications at least 90 days before the desired start of commercial distribution. This allows sufficient time for the FDA to review your application, request additional information if needed, and issue a registration number.

What are the benefits of SAMD registration?

SAMD registration offers several benefits for businesses involved in the medical device industry. Here are a few key advantages:
1. Market access: SAMD registration allows you to legally sell your medical devices in the United States, one of the world’s largest and most lucrative healthcare markets. This opens up vast opportunities for growth and expansion.
2. Compliance and regulatory support: By registering with SAMD, you demonstrate your commitment to compliance with FDA regulations. This enhances your reputation, builds customer trust, and minimizes the risk of regulatory enforcement actions.
3. Competitive advantage: SAMD registration adds credibility to your business and products. It differentiates you from non-compliant competitors and positions your devices as safe, effective, and high-quality. This can give you a significant competitive edge in the market.

Frequently asked questions about SAMD Registration

1. Is SAMD registration mandatory?
Yes, SAMD registration is mandatory for businesses involved in the manufacturing, distributing, or importing of medical devices in the United States.

2. Is there a deadline for SAMD registration?
There is no specific deadline for SAMD registration. However, completing the registration process before your planned market launch is advisable.

3. Can I register multiple medical devices under a single SAMD registration?

Yes, you can register multiple medical devices under a single SAMD registration. However, each device must meet the FDA’s requirements and be accurately described in your registration application.

4. What happens if I fail to renew my SAMD registration?

Please renew your SAMD registration annually or update any changes to your devices or company information to avoid the suspension or cancellation of your registration. This would prevent you from legally selling your medical devices in the United States.

Compliance Measures 

The FDA and Health Canada have similar SaMD classification guidelines based on risk categorization. The class and/or category of SaMD is determined by the state of the healthcare situation and the significance of information provided by SaMD to make a healthcare decision. Other factors of consideration include the degree of invasiveness in the body, duration of contact and local versus systemic effects. Both regulatory bodies have stated that as the medical device software field evolves, policy reform will follow to prioritize patient safety and clinical effectiveness. 

Aligned Interests 

Are you a company operating in the medical device software space and need help navigating the complex classification system or want to enter the medical device software market? Our team of knowledgeable subject matter experts can provide the necessary regulatory support with respect to preparing and submitting SaMD applicationsContact us today or call us at 1-800-396-5144!  For more information on SaMD regulations in Canada click here:

Conclusion

Navigating the SAMD registration process is crucial for businesses looking to sell medical devices in the United States. By understanding the basics of SAMD registration, its importance, and the step-by-step process, you can ensure compliance, gain market access, and establish credibility in the industry. Remember to start early, gather all the necessary documents, and avoid common mistakes to maximize your chances of a successful SAMD registration. With the knowledge and insights gained from this guide, you can confidently tackle the SAMD registration process and unlock the doors to success in the U.S. medical device market. Good luck, if you need assistance please trust our experts!

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An overview of the BRC certification process in Canada

BRC Certification Process in Canada

BRC certification is a globally recognized standard for food safety and quality management. In Canada, it is becoming increasingly important for food manufacturers to obtain this certification in order to meet the demands of consumers and retailers. This guide will provide an overview of the BRC certification process and requirements for Canadian food manufacturers.

What is BRC certification?

BRC certification is a globally recognized standard for food safety and quality management. It was developed by the British Retail Consortium (BRC) and is used by food manufacturers, retailers, and certification bodies around the world. The BRC standard sets out requirements for food safety, quality management, and legal compliance, and is designed to help food manufacturers ensure that their products are safe, legal, and of high quality.

Why is BRC certification important for Canadian food manufacturers?

BRC certification is becoming increasingly important for Canadian food manufacturers for several reasons. Firstly, it is a globally recognized standard that can help manufacturers demonstrate their commitment to food safety and quality management. This can be particularly important for companies that export their products to other countries, as BRC certification is often a requirement for entry into certain markets. Additionally, BRC certification can help manufacturers identify areas for improvement in their operations and implement best practices to ensure the safety and quality of their products. Finally, BRC certification can help manufacturers build trust with their customers and other stakeholders by demonstrating their dedication to producing safe, high-quality food products.

What is the BRC certification process in Canada?

The BRC certification process in Canada involves several steps. First, a food manufacturer must choose an accredited certification body to conduct the audit. The certification body will then review the manufacturer’s documentation and conduct an on-site audit to assess compliance with the BRC standard. If the manufacturer meets the requirements of the standard, they will be awarded BRC certification. However, if any non-conformities are identified during the audit, the manufacturer will need to address these issues and undergo a re-audit before certification can be awarded. BRC certification must be renewed annually, and manufacturers must undergo regular audits to maintain their certification.

Need help with obtaining your BRC certification?

What are the requirements for BRC certification?

The requirements for BRC certification vary depending on the specific standard being used. However, some common requirements include having a documented food safety management system in place, conducting regular risk assessments, implementing effective corrective actions, and providing ongoing training to employees. Additionally, manufacturers must comply with all relevant legal and regulatory requirements, as well as any customer-specific requirements. It’s important for manufacturers to thoroughly review the BRC standard they are seeking certification for and ensure they meet all requirements before undergoing the audit process.

What are the benefits of BRC certification for Canadian food manufacturers?

BRC certification offers numerous benefits for Canadian food manufacturers. Firstly, it demonstrates a commitment to food safety and quality, which can help build trust with customers and increase sales. Additionally, BRC certification is often a requirement for doing business with certain retailers and distributors. It can also help manufacturers identify areas for improvement in their food safety management system and make necessary changes to prevent issues from occurring in the future. Finally, BRC certification can help manufacturers stay up-to-date with the latest industry standards and best practices, ensuring they remain competitive in the marketplace.

Why is BRC certification important for businesses in Canada?

BRC Certification is an internationally recognized standard for food safety and quality management. It assures customers that the food they buy is safe and high-quality. In Canada, BRC certification is becoming increasingly important as consumers become more aware of food safety and quality issues. In addition, many major retailers and food service companies require their suppliers to be BRC-certified. If you want to do business with these companies, you must have BRC certification.

BRC certification is also vital for businesses because it can help you improve your processes and reduce costs. By implementing the BRC Standards, you can identify areas for improvement in your business and make changes that will help you operate more efficiently. This can lead to cost savings and increased profitability. In addition, BRC certification can help you build trust with your customers and suppliers, leading to increased business and a more substantial reputation in the industry.

What are the BRC standards?

The BRC Global Standard for Food Safety is a comprehensive set of requirements that cover all aspects of food safety and quality management. The standard is divided into seven sections, which cover the following areas:

1. Senior Management Commitment and Continuous Improvement
2. The Food Safety Plan – HACCP
3. Food Safety and Quality Management System
4. Site Standards
5. Product Control
6. Process Control
7. Personnel

Each section of the standard contains a set of requirements that must be met to achieve certification. These requirements are designed to ensure businesses have a robust food safety and quality management system.

How do I get BRC certification?

The BRC certification process is a rigorous one that involves several steps. The first step in the process is to determine which BRC standard is appropriate for your business. Once you have chosen the relevant standard, you must implement the standard’s requirements in your industry. This may involve making changes to your processes and procedures and training your staff on the new requirements.

Once you have implemented the standard’s requirements, you will need to undergo an audit to determine whether you meet the requirements for certification. The audit is typically conducted by a third-party certification body, which will assess your business against the needs of the BRC Standard. If you meet the standard’s requirements, you will be awarded BRC certification.

What are the steps to prepare for BRC certification?

Preparing for BRC certification can be a complex and time-consuming process. Here are some steps that you can take to ensure that your business is ready for accreditation:

1. Determine which BRC standard is appropriate for your business. This will depend on the type of food products that you produce and the market that you serve.
2. Familiarize yourself with the requirements of the BRC Standard. This will help you understand what changes you need to make to your business to meet the requirements.
3. Develop a plan for implementing the standard’s requirements in your business. This may involve making changes to your processes and procedures and training your staff on the new requirements.
4. Conduct a gap analysis to identify areas where your business does not meet the standard’s requirements. This will help you prioritize areas for improvement.
5. Implement the changes required to meet the requirements of the standard.
6. Conduct internal audits to ensure that your business meets the standard’s requirements.
7. Engage a third-party certification body to conduct a pre-audit. This will help you identify areas where your business may need to meet the standard’s requirements before the official audit.
8. Finally, undergo an official audit by a third-party certification body to determine whether you meet the requirements for certification.
Common challenges businesses face during the BRC Certification process

What are the challenges in the BRC certification process?

The BRC certification process can be challenging for businesses, particularly those new to the process. Some common challenges that companies face include:

1. Understanding the standard’s requirements: The BRC Standard is a comprehensive set of conditions that can be difficult to understand, particularly for new businesses.
2. Making changes to processes and procedures: Implementing the requirements of the BRC Standard may involve making significant changes to your processes and procedures. This can be a time-consuming and costly process.
3. Managing documentation: The BRC Standard requires businesses to maintain detailed records of their processes and procedures. This can be challenging for companies that must manage large amounts of documentation.
4. Staff training: The BRC Standard requires businesses to train their staff on the standard’s requirements. This can be challenging for companies with a large and diverse workforce.

How can BRC certification enhance food safety?

Food safety is paramount in the food industry, and BRC certification can help you ensure the security of your products. BRC Global Standards provides a comprehensive framework for managing food safety risks, including hazard analysis, critical control points (HACCP), and traceability. By implementing these measures, you can identify potential risks and take action to prevent them from occurring.

BRC certification also requires businesses to have a robust food safety management system. This includes regular monitoring and testing of products and training for staff on food safety best practices. Adhering to these standards can reduce the likelihood of foodborne illness outbreaks and protect your customers from harm.

How does BRC certification enhance brand reputation?

In today’s digital age, brand reputation is more important than ever. Consumers are increasingly aware of the products and companies they buy from. BRC certification can help you build customer trust by demonstrating your commitment to safety, quality, and legality.

BRC Global Standards is recognized by many of the world’s leading retailers, and certification can give you a competitive edge in the marketplace. By displaying the BRC logo on your products and marketing materials, you can show your customers that you meet
the highest standards of quality and safety.

How can BRC certification help you access new markets?

BRC certification can also help you expand your business by giving you access to new markets. Many retailers and food service organizations require their suppliers to be BRC certified, and certification can be a prerequisite for doing business with these companies.

BRC certification can also help you meet the requirements of regulatory bodies in different countries. For example, the US Food and Drug Administration (FDA) recognizes BRC Global Standards as a benchmark for food safety, and certification can help you comply with US regulations.

How does BRC certification compare to other food safety standards?

Several food safety standards are on the market, including ISO 22000, SQF, and FSSC 22000. However, BRC Global Standards is widely recognized and trusted by retailers and food service organizations worldwide. It provides a comprehensive framework for managing food safety risks and ensuring your products’ safety, quality, and legality.

What are the BRC certification costs and timeline?

The cost and timeline for BRC certification will vary depending on the size and complexity of your business. Some factors that can impact the cost and timeline include:

1. The BRC Standard that you are certifying against
2. The size and complexity of your business
3. The number of locations that require certification
4. The level of support that you require from your certification body

The cost of BRC certification can range from several thousand dollars to tens of thousands. The certification timeline will depend on your business’s readiness and the certification body’s availability. On average, the certification process can take several months to a year.

Want to know where to get a BRC Certification? 

Quality Smart Solutions is a global consulting firm that provides strategic support for products, NHPs, pharmaceuticals, and medical devices. They are trusted by many clients in the industry to provide them with guidance on quality standards and regulations.

The FSMA-FSVP Certification training course will equip you with knowledge on the importance of food safety, how to be compliant with the regulations set by FSMA-FSVP, and how to implement food safety best practices in your workplace. The certification process at Quality Smart Solutions is designed to help companies comply with the FDA’s Food Safety Modernization Act (FSMA) and the Foreign Supplier Verification Program (FSVP) requirements.

Get In Touch With Experts To Know Which Level Of Certification You Need!

Conclusion: Why BRC Certification is worth considering for Your Food Business

In conclusion, BRC certification can help you ensure the safety and quality of your products, build trust with your customers, and expand your business. It provides a comprehensive framework for managing food safety risks and meeting the requirements of customers and regulatory bodies. By obtaining BRC certification, you can take your business to the next level and compete in the global marketplace. While the certification process can be challenging and costly, it’s worth considering for the long-term success of your food business.

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Top 5 benefits of hiring an Importer of Record for International Trade

Importer of Record export

Introduction

Importing goods can be a complex process, especially when it comes to navigating customs regulations and compliance requirements. That’s where an importer of record (IOR) can come in handy. By working with an experienced IOR, you can save time, money, and avoid potential headaches that come with importing goods. Learn more about the benefits of hiring an IOR.

In this blog, we outline the top 5 benefits of hiring an Importer of Record.

What are the legal and financial risks of not having an Importer of Record?

Not having an importer of record for your imports can lead to serious legal and financial consequences. Without an IOR, you may face fines, penalties, and even criminal charges for non-compliance with local laws and regulations. Additionally, your goods may be seized or delayed at customs, leading to lost revenue and damaged relationships with suppliers and customers. It is crucial to have a trusted and experienced IOR to ensure compliance and avoid these risks.

What are the benefits of having an Importer of Record?

Having an importer of record for your imports can provide numerous benefits. Firstly, it ensures compliance with local laws and regulations, reducing the risk of fines, penalties, and legal issues. Secondly, it can expedite the customs clearance process, minimizing delays and ensuring the timely delivery of goods. Additionally, an experienced IOR can provide valuable guidance and support throughout the import process, helping you navigate complex regulations and avoid potential pitfalls. Overall, having an importer of record can help you streamline your import operations and protect your business from unnecessary risks.  Here are the top 5 benefits in our expert opinion.

1.     Expertise in Import Regulations and Compliance

One of the biggest benefits of hiring an importer of record is their expertise in import regulations and compliance. Importing goods requires navigating a complex web of regulations and requirements, including customs clearance, tariffs, and taxes. An experienced IOR can help ensure that your imports are in compliance with all applicable regulations, reducing the risk of costly fines and delays. Additionally, they can provide guidance on how to optimize your supply chain to minimize costs and improve efficiency. Overall, working with an IOR can help streamline your importing process and give you peace of mind knowing that your imports are in good hands.

2.     Streamlined Customs Clearance Process

One of the biggest benefits of hiring an importer of record is the streamlined customs clearance process they can provide. With their expertise in import regulations and compliance, an experienced IOR can help ensure that your imports are processed quickly and efficiently through customs. This can save you time and money, as delays in customs clearance can result in additional fees and storage costs. Additionally, an IOR can help you navigate any issues that may arise during the customs clearance process, such as inspections or documentation requirements. Overall, working with an IOR can help ensure that your imports are cleared through customs smoothly and without any unnecessary delays or complications.

3.     Reduced Risk of Penalties and Fines

Another benefit of hiring an importer of record is the reduced risk of penalties and fines. Importing goods can be a complex process, and there are many regulations and requirements that must be followed to avoid penalties and fines. An experienced IOR can help ensure that your imports are compliant with all relevant regulations and requirements, reducing the risk of penalties and fines. This can save you money and protect your business from legal and financial consequences. By working with an IOR, you can have peace of mind knowing that your imports are being handled by experts who understand the regulations and requirements of the importing process.

4.     Cost Savings on Import Taxes and Duties

Another major benefit of hiring an importer of record is the potential cost savings on import taxes and duties. An experienced IOR can help you navigate the complex world of import taxes and duties, ensuring that you are paying the correct amount and taking advantage of any available exemptions or reductions. This can result in significant cost savings for your business, especially if you are importing large quantities of goods. Additionally, an IOR can help you avoid costly mistakes that could result in overpayment of taxes and duties, further reducing your expenses. Overall, working with an importer of record can be a smart financial decision for businesses that import goods regularly.

5.     Access to Global Networks and Suppliers

Another benefit of hiring an importer of record is gaining access to their global networks and suppliers. An experienced IOR will have established relationships with suppliers and manufacturers around the world, giving you access to a wider range of products and potentially better pricing. This can be especially beneficial for businesses looking to expand their product offerings or source unique items. Additionally, an IOR can help you navigate any language or cultural barriers that may arise when working with international suppliers, ensuring a smooth and efficient importing process.

Related Reading:

IOR Compliance and customs clearance

Medical Device Importer Benefits

FSVP Importer Food Importing

NHP Third-Party Importer Benefits

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GRAS List for Food Additives – Your Step-by-Step Guide to Safety

GRAS List for Food Additives

Have you ever wondered what goes into the food you eat every day? Various food additives enhance our food’s taste, texture, and appearance, from the preservatives in your favorite snacks to the color additives in your morning cereal. But how do we know that these additives are safe for consumption? That’s where the FDA GRAS List comes in. “Generally Recognized as Safe” is a database of food additives reviewed and deemed safe for consumption by the Food and Drug Administration. In this article, we’ll dive into everything you need to know about the FDA GRAS List, including how it works, what food additives are included, and why it’s essential for ensuring the safety of our food supply. So sit back, grab a snack, and prepare to learn all about the fascinating world of food additives!

What are food additives?

Food additives are substances added to food to enhance its taste, texture, appearance, or nutritional value. They can include preservatives, color additives, emulsifiers, stabilizers, and flavor enhancers. Food additives have been used for centuries, with salt being one of the earliest known additives. Today, food additives are used in many processed foods, from sodas and candies to frozen dinners and snack foods.
While some people are wary of food additives, they are essential to our food supply. Without additives, many foods would spoil quickly or would not have the desired taste or texture. However, it’s crucial to ensure these additives are safe for consumption.

What is the FDA GRAS List?

The FDA GRAS List is a database of food additives reviewed and deemed safe for consumption by the Food and Drug Administration. GRAS stands for “Generally Recognized as Safe,” which means that the substance is considered safe based on a long history of everyday use in food or on the results of scientific research.

The FDA established the GRAS List in 1958 as part of the Food Additives Amendment to the Federal Food, Drug, and Cosmetic Act. The list’s purpose was to provide a way for food manufacturers to determine whether a food additive was safe without going through the costly and time-consuming process of obtaining FDA approval.

Who maintains the GRAS list?

The GRAS list is maintained by the U.S. Food and Drug Administration (FDA). The FDA is responsible for evaluating the safety of food additives and determining whether they can be used in food products. The agency also reviews new substances to decide whether or not they should be added to the GRAS list. In addition, the FDA may consult with outside experts to help make these determinations. Food manufacturers must stay up-to-date on the GRAS list and any changes that may be made to ensure their products’ safety.

What is the history and evolution of the FDA GRAS List?

The FDA GRAS List has evolved in response to changing scientific knowledge and public concerns. In the early years of the list, substances were added based on their long history of everyday use in food. However, as scientific knowledge advanced, the FDA began to require more rigorous safety testing for new additives.

In 1997, the FDA introduced the concept of “self-determination” for GRAS status. Food manufacturers could determine whether a substance was GRAS without going through the FDA approval process. The FDA still had the authority to review the safety of these substances, but the burden of proof was on the agency to show that the substance was not safe.

How is the GRAS list evolving, and what are the implications for the food industry?

The GRAS list constantly evolves as new GRAS ingredients are evaluated and added. GRAS ingredients can have significant implications for the food industry, as manufacturers may need to reformulate their products to comply with new safety standards. Additionally, consumer demand for natural and organic ingredients has led to increased scrutiny of some components on the GRAS list, such as artificial flavors and colors. As a result, some manufacturers are voluntarily removing these ingredients from their products to meet consumer preferences. Overall, staying up-to-date on the latest developments with the GRAS list is crucial for food manufacturers to ensure the safety and quality of their products.

How do food additives get added to the GRAS List?

Food additives can be added to the GRAS List in two ways: through a petition process or self-determination. The petition process involves submitting a formal request to the FDA to review the safety of a substance. This process can take several years and requires extensive safety testing and data analysis.

Self-determination, conversely, allows food manufacturers to determine whether a substance is GRAS on its own. This process is faster and less expensive than the petition process, but it also places the burden of proof on the manufacturer to show that the substance is safe.

What is the difference between GRAS and non-GRAS food additives?

Not all food additives are included on the GRAS List. These non-GRAS additives are typically newer substances that have yet to be extensively tested for safety. Most food additives are not considered GRAS and require FDA approval before they can be used in food.

Non-GRAS additives must undergo a rigorous review before the FDA approves them. This process can take several years and requires extensive safety testing and data analysis. Once a substance has been approved, it is added to the list of approved food additives, which is separate from the GRAS List.

Are there controversies surrounding the GRAS List?

The GRAS List has been controversial over the years, with some critics arguing that it is too lenient in its criteria for determining safety. In particular, critics have raised concerns about the self-determination process, which allows food manufacturers to decide whether a substance is GRAS.

Critics argue that this process allows manufacturers to use substances that may not be safe, as they are not subject to the same level of scrutiny as substances that go through the petition process. Additionally, some critics have raised concerns about conflicts of interest, as food manufacturers have a financial incentive to use substances that are deemed GRAS.

What are the common food additives on the GRAS List?

There are hundreds of food additives included on the GRAS List, ranging from preservatives and color additives to flavor enhancers and emulsifiers. Some of the most common food additives on the GRAS List include:
– Sodium benzoate: a preservative commonly used in soft drinks, fruit juices, and condiments
– Aspartame: a low-calorie sweetener used in diet sodas, chewing gum, and other products
– Caffeine: a stimulant found in coffee, tea, and many soft drinks
– Titanium dioxide: a color additive used in a wide range of products, including toothpaste, sunscreen, and food products
– Xanthan gum: a thickener and stabilizer commonly used in salad dressings, sauces, and baked goods

How do I find the GRAS status for a specific food additive?

If you’re curious about the GRAS status of a specific food additive, you can search the FDA’s database of GRAS notices. This database includes information on substances self-determined to be GRAS and has gone through the petition process.

Remember that just because a substance is included on the GRAS List does not necessarily mean it is safe for everyone. Some people may have allergies or sensitivities to certain food additives, and it’s essential to be aware of any potential risks.

Food additives are chemicals added to food products to enhance flavor, texture, or color. Fortunately, there is a list of food additives that the Food and Drug Administration (FDA) has determined to be “generally recognized as safe” (GRAS). In this guide, you’ll find an updated and comprehensive list of GRAS food additives. You’ll also learn how substances are determined to be GRAS, who manages the GRAS List, how it’s used, and why it’s essential for food safety.

What are the risks and benefits of each food additive?

When looking through the GRAS list of food additives, it’s important to remember that even though these ingredients are deemed safe for consumption, they may still have certain risks. For instance, some food additives contain preservatives or artificial sweeteners, potentially adversely affecting long-term health. Therefore, weighing the risks and benefits of each ingredient before you decide to use it in your food products is crucial.

What is the GRAS notification process?

The GRAS Notification Process is a voluntary submission to the U.S. Food and Drug Administration (FDA) that provides evidence to support the safety of a substance for its intended use in food. The notification includes a detailed description of the ingredient, its intended use, and the scientific data supporting its safety. The FDA then reviews the report and either issues a letter of no objection or requests additional information. Once the FDA issues a letter of no protest, the substance can be added to the GRAS list.

How do I conduct a comprehensive GRAS safety assessment?

Conducting a comprehensive safety assessment is crucial in getting your ingredient on the GRAS list. This assessment should thoroughly review all available scientific data on the substance, including toxicology studies, clinical trials, and other relevant research. It’s also important to consider the intended use of the substance and any potential exposure levels. Working with a qualified toxicologist or food safety expert can help ensure that your safety assessment is thorough and meets all requirements for GRAS notification.

How is the GRAS list determined?

The GRAS list is determined through a rigorous scientific evaluation process. Manufacturers or food ingredient suppliers can submit a GRAS notification to the FDA, which includes scientific data and information supporting the ingredient’s safety. The FDA then reviews the notification and may consult with independent experts to determine if the component is generally recognized as safe for its intended use. If the FDA agrees, the ingredient is added to the GRAS list. It’s important to note that the GRAS list is not exhaustive, and new GRAS ingredients may be added as they are evaluated and deemed safe.

How do I prepare and submit a GRAS notification to the FDA?

Once you have completed a comprehensive safety assessment and determined that your ingredient is safe for its intended use, the next step is to prepare and submit a GRAS notification to the FDA. This notification should include a detailed description of the substance, its intended use, and the scientific data supporting its safety. It’s essential to follow all necessary formatting and content requirements outlined by the FDA to ensure your notification is complete and accurate. Once submitted, the FDA will review your information and determine whether your ingredient can be added to the GRAS list.

How is a substance determined to be GRAS?

A substance can be determined to be GRAS through two different pathways: scientific procedures or everyday use in food. If an undefined ingredient has been used in food for an extended period without any known harmful effects, it may be considered GRAS. Alternatively, if a substance is new or has limited use in food, it may undergo scientific testing to determine its safety for consumption. The decision to add a substance to the GRAS list is made by the FDA or a panel of experts.

What are the benefits of being on the GRAS list?

Being on the GRAS list can provide several benefits for food manufacturers. First and foremost, it means that the substance has been determined to be safe for use in food products by the FDA. This can provide reassurance to consumers that the product is safe to consume. In addition, being on the GRAS list can streamline the regulatory process for food manufacturers, as they do not need to go through the lengthy and expensive process of obtaining FDA approval for the use of the substance in their products. Finally, being on the GRAS list can provide a competitive advantage for food manufacturers. It can signal to consumers that their products are made with safe and high-quality ingredients.

What are the potential risks of using a substance not on the GRAS list?

Using a substance not on the GRAS list can pose several potential risks for food manufacturers. First and foremost, it could lead to regulatory issues, as the FDA may require additional testing or approval before allowing the substance to be used in food products. This can be a lengthy and expensive process and may delay the release of new products. In addition, using a substance not on the GRAS list could lead to consumer concerns about the product’s safety, harming the manufacturer’s reputation. Finally, there may be legal implications if a substance not on the GRAS list is found to be harmful to consumers.

How do you get your ingredients on the GRAS List?

The Generally Recognized as Safe (GRAS) list is a compilation of ingredients the FDA has deemed safe for consumption in food and beverages. If you’re looking to get your ingredient on this list, there are specific steps you need to follow to ensure it meets the FDA’s safety requirements and gains approval.

1. Conduct a thorough safety assessment

Conducting a thorough safety assessment is the first step in getting your ingredient on the GRAS list. This assessment should include reviewing all available data on the component, including toxicology studies, clinical trials, and any other relevant information. You should also consider the intended use of the ingredient, as well as any potential exposure levels. This assessment should be conducted by qualified experts in the field, such as toxicologists or food safety specialists. Once you have completed this assessment, you can use the results to support your GRAS determination and submit your application to the FDA.

2. Gather supporting data and research

You must gather supporting data and research demonstrating its safety to get your ingredient on the GRAS list. This includes toxicology studies, clinical trials, and any other relevant information that can help establish your ingredient’s safety. You should also consider the intended use of the ingredient, as well as any potential exposure levels. Working with qualified experts, such as toxicologists or food safety specialists, is essential to ensuring your thorough and accurate assessment. Once you have gathered the necessary data, you can use it to support your GRAS determination and submit your application to the FDA.

3. Submit a GRAS notification to the FDA

Once you have gathered all of the necessary data and research to support the safety of your ingredient, you can submit a GRAS notification to the FDA. This notification should include all relevant information about your ingredient, including its intended use, exposure levels, and supporting data. It would be best if you also had a detailed description of the safety assessment process used to determine that your ingredient is safe for use in food. The FDA will review your notification and may request additional information or clarification before deciding about the safety of your GRAS ingredient. If your GRAS ingredient is determined to be GRAS, it can be used in food products without pre-market approval from the FDA.

4. Respond to any FDA inquiries or requests for additional information

After submitting your GRAS notification to the FDA, it’s essential to be responsive to any inquiries or requests for additional information. The FDA may have questions or concerns about your ingredient or the safety assessment process that you used. It’s essential to address these inquiries promptly and thoroughly to ensure your component is approved for use on the GRAS list. Failure to respond to FDA inquiries or requests for additional information could result in delays or even rejection of your GRAS notification. Stay organized and keep detailed records of all communication with the FDA throughout the process.

5. Maintain ongoing compliance with FDA regulations

Once your ingredient is approved for use on the GRAS list, it’s essential to maintain ongoing compliance with FDA regulations. This includes ensuring that your ingredient meets the safety requirements outlined in your GRAS notification and complying with any labeling or marketing requirements. It’s also essential to stay up-to-date on any changes to FDA regulations or guidelines that may impact your ingredient. Regularly reviewing and updating your safety assessments can help ensure ongoing compliance and prevent any issues with the FDA in the future.

What must I do after submitting my GRAS notification to the FDA?

After submitting your GRAS notification, the FDA may provide feedback or request additional information. It’s essential to respond promptly and thoroughly to any requests or concerns raised by the FDA. This may involve giving other data or clarifying the information in your notification. Working closely with the FDA throughout the review process ensures that your ingredient meets all necessary safety requirements and can be added to the GRAS list.

What should business owners know about the FDA Food Additive list?

  1. What is the FDA Food Additive List, and why is it important for my business?

    • The FDA Food Additive List is a comprehensive list of substances that can be used in food production. It’s crucial for your business because it dictates which additives you can legally use in your food products.
  2. How can I access the FDA Food Additive List?

    • You can access the FDA Food Additive List on the official FDA website. It’s usually available in the form of regulations or guidance documents.
  3. What are food additives, and why are they regulated by the FDA?

    • Food additives are substances added to food for various purposes, such as enhancing flavor, texture, or shelf life. The FDA regulates them to ensure they are safe for consumption and do not pose health risks.
  4. Do all food additives require FDA approval?

    • No, not all food additives require FDA approval. Some substances are generally recognized as safe (GRAS) and do not need specific FDA approval if they meet certain criteria. However, many additives do require pre-market approval.
  5. How can I determine if an additive is on the FDA Food Additive List?

    • You can search for specific additives on the FDA’s online database or consult the relevant regulations and guidance documents to check if the additive is listed.
  6. What is the process for getting FDA approval for a new food additive?

    • The process typically involves submitting a food additive petition to the FDA, providing scientific data demonstrating the additive’s safety, and undergoing a rigorous review process.
  7. Are there any fees associated with obtaining FDA approval for a new food additive?

    • Yes, there are usually fees associated with the FDA’s review of food additive petitions. These fees can vary depending on the type of petition and the size of your business.
  8. What are the labeling requirements for food products that contain additives from the FDA Food Additive List?

    • Food products containing additives should adhere to FDA labeling regulations. This includes listing the additive by its common or usual name in the ingredient list and providing accurate information about its usage.
  9. What happens if I use an additive not on the FDA Food Additive List in my food products?

    • Using an unapproved food additive can lead to legal consequences, including product recalls, fines, and damage to your business’s reputation. It’s essential to ensure compliance with FDA regulations.
  10. Can the FDA remove an additive from the Food Additive List?

    • Yes, the FDA has the authority to remove additives from the list if new scientific evidence suggests they are unsafe for consumption. Businesses should stay informed about any changes to the list.

Conclusion:

While food additives are vital to our food supply, they must be safe for consumption. The FDA GRAS List is a valuable tool for ensuring the safety of our food supply. The GRAS List provides a way for food manufacturers to determine whether a substance is safe without going through the costly and time-consuming process of obtaining FDA approval. However, as with any regulatory system, the GRAS List has limitations and controversies. It’s essential to stay informed and aware of any potential risks associated with the food additives we consume daily.

Additional Reading about GRAS:

We hope this post helped you understand food additives and preservatives a little better. There are many different kinds, and they can have a big impact on your health.

Please contact our team for more information on food classification, ingredient feasibility questions, ingredient submissions, and food labeling projects. Our specialists are here to help with the following services: Novel Food Notifications, SFCR License application, HACCP & PCP program, TMA License for Supplemented Foods, Nutrition Facts Table (NFT) Creation and label compliance!

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FDA to close VCRP to prepare for MOCRA registration in 2023

VCRP to prepare for the MOCRA registration

Introduction:

In a recent update released on March 27, 2023, the FDA announced it has stopped accepting and processing VCRP submissions to the Voluntary Cosmetics Registration Program.

Instead, in accordance with the Modernization of Cosmetics Regulation Act of 2022, the FDA is creating a programme that cosmetic businesses will use to submit facility registrations and cosmetic product listings. When the new registration programme is ready, cosmetic facilities with VCRP registrations will need to resubmit their information.  

In this article you’ll learn why VCRP was canceled, how information will transfer, will information need to be re-submitted and how to make the cosmetic facility registration process easier.

What caused the VCRP to be abandoned? 

To gather data from cosmetic facilities about the cosmetic products they were distributing in the United States, the FDA created the VCRP in 1972. 

Despite being voluntary, the programme remained the only means by which the FDA could evaluate data regarding cosmetics companies, product ingredients, and customer usage. 

The recent passage of MoCRA eliminated the need for a voluntary registration programme by establishing mandatory registration and product listing requirements for cosmetic businesses. 

FDA states that a new system needs to be implemented so it can manage the influx of submissions because of the large number of cosmetic businesses that will be registering. 

Will the New Program Receive the VCRP Information? 

No, the VCRP’s info won’t be carried over to the new system. FDA will archive the data presently stored in the VCRP without allowing businesses to change it going forward. 

When the new programme becomes accessible, if your cosmetic facility is already registered with the VCRP, will you need to resubmit your registration information? 

It is necessary to finish all facility registrations and product listings, even if they have already been added to VCRP. The FDA says it will continue to inform the industry on the launch date of the new system. 

The organisation has also launched a specific MoCRA webpage to disseminate updated data and assist the business in staying current as FDA moves forward with MOCRA regulations.

How to ensure your Cosmetic Family Registration is done properly?

The cosmetics business is shocked by the cancellation of the VCRP. Numerous businesses thought data would be moved from the VCRP to the new licencing programme.  

Businesses might discover that resubmitting their registration along with all the product description information will take a lot of time and be difficult to delegate to internal teams. 

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Understanding the Regulatory Framework of Dietary Supplements

FDA Regulatory Framework of Dietary Supplements

Navigating the complexities of the  regulatory requirements for dietary supplements  can be daunting. However,  by understanding the framework, you can help  to ensure your supplements are safe and effective, while keeping your business up-to-date on changes  to the regulatory landscape. This guide provides you with  the information you need to stay informed about the FDA dietary supplement regulatory framework.

Which dietary supplement products does FDA Regulate?

The FDA will regulate any product that is represented on the label as a dietary supplement. These products can be represented by either containing a “dietary ingredient” or being intended for use as a supplement to the diet. The FDA regulates both the finished product of a dietary supplement as well as the individual dietary ingredients.  Facilities that manufacture, process, pack, or store dietary supplements or dietary ingredients for consumption in the United States must register with FDA. If the product does not contain dietary ingredients, it could  have a different product classification. For example, as a food, beverage, or conventional drug. In this case, the product must meet all applicable standards for those sectors. Products that claim to diagnose, prevent, cure, treat or otherwise mitigate diseases are automatically considered drugs and must meet drug requirements.

What are the cGMP Requirements?

It is essential to understand the Current Good Manufacturing Practice (cGMP) requirements for the various roles including dietary supplement manufacturers, distributors and ingredient suppliers. These FDA regulations outline specific quality requirements that all companies in the industry must adhere to, such as proper testing methods and procedures, labeling requirements, and storage conditions. Failure to meet cGMP requirements can lead to serious legal implications, including product seizures and monetary fines.

How to ensure your complying with the FDA dietary supplement requirements?

The FDA has outlined the specific requirements for dietary supplement labeling, and failure to comply can lead to legal repercussions. Be sure to include informative statements about the product on both the label and in any other accompanying informational materials, such as safety warnings, dosage instructions, ingredient list, usage information, contact information for reporting adverse events and more. Also be aware of special labeling rules for anything labeled as a “dietary supplement” or “nutritional health supplement.” When in doubt, consult with an attorney knowledgeable about dietary supplement regulations.

How to recognize the Implications of Interactions with Drugs and Food products?

It is important to be aware of any potential interactions between dietary supplements and drugs or foods that could cause an adverse reaction. To assess the impact of an individual supplement on a patient’s combination of medications, it is advisable that they talk to their doctor or pharmacist before taking a dietary supplement. Additionally, manufacturers must inform consumers about any potentially dangerous interactions with common foods such as grapefruit juice, alcohol, and caffeine-containing drinks. Be sure to include clear warnings and instructions on labels for all products containing ingredients with potential interactions.

How to handle recalls and adverse Event Reports Properly?

Recalls and adverse event reports play an important role in helping to ensure the safety of dietary supplements. As a manufacturer, it is essential that you have an established system and procedure for reviewing these instances and evaluating whether a recall is required or if other interventions are necessary such as including warning labels on products. Be familiar with the requirements for properly handling recall and adverse event reporting processes, as stipulated by relevant regulatory agencies such as the U.S. Food and Drug Administration (FDA). Additionally, pay close attention to any changes in regulations that could affect your product labels, adverse event or recall handling procedures.

Looking for regulatory assistance for your FDA dietary supplements? We can assist you with your; dietary supplement label review, supplement facts panel creation, Health Claims Substantiation Dossier, structure-function claims pre-market notification, facility registration and renewal, Prior Notice FDA Clearance, Foreign Facility U.S. Agent Service, NDIN, and more.

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How to get GRAS Certified faster in 2023?

GRAS certificationGRAS certification is an important step for any manufacturer who wants to market a food or food-related product. By following the proper procedures, you can ensure that your product is recognized as safe and accelerate the approval process so it can reach the market faster.

This guide will provide you with an overview of the process and what to expect, as well as some of the benefits and drawbacks of pursuing GRAS certification.

What is GRAS Certification?

GRAS (Generally Recognized as Safe) certification is a designation from the U.S. Food and Drug Administration that a product or material meets safety standards. This certification may be necessary if you plan to produce, distribute, or market your products in the United States. In order to obtain GRAS status, a product must demonstrate that it is safe for its intended use before it can be sold legally in the country.

What are the benefits of GRAS Certification?

GRAS certification provides a number of benefits for companies that obtain the designation. Consumers will have increased confidence in products that are backed by evidence-based research, and it’s also a necessary legal requirement for certain companies to operate in the United States. GRAS certification can also provide improvements to production and distribution processes, as well as safeguard against potential lawsuits due to food safety concerns.

What are the challenges of implementing GRAS Certification?

Implementing GRAS certification can be a time-consuming and expensive process, with some companies taking upwards of five years to obtain the designation. There are assessment fees, research costs for data gathering, administrative fees, and other expenses that can add up quickly. Additionally, if a company’s product undergoes any changes, the GRAS certification process typically has to be re-commenced at an additional cost. For some companies, this may present barriers to certification and hinder growth in certain markets.

What Are Key Requirements for GRAS Compliance?

In order to be granted GRAS status, an organization must prove that its products and production methods meet specific criteria set by regulating bodies. Companies must create a detailed application and substantiate their claims with research data. The application should include independently confirmed evidence of the product’s safety, including information on the ingredients and additives being used in the manufacturing process. The process can take anywhere from six months to several years depending on how much research is required before certification is granted.

How to make successful GRAS Applications? 

It can seem like a tall task to obtain GRAS certification, and no two applications will be the same. However, by following some key tips, manufacturers can make successful applications much easier and help ensure that their product meets all current regulations and requirements. Start with planning and research, which should involve investigation into any current or pending regulation changes, including ingredient composition, facility specifications, and labeling requirements. Next, work on building out the paperwork for submitting an application with substantiated scientific data collected from industry experts. Lastly, seek support from specialized advisors who understand the process to guide you through any potential roadblocks in order to gain approval of your application.

What are the GRAS Certification Requirements?

Understanding the GRAS certification requirements is an important first step in achieving approval and getting your product to market quickly. Make sure you’re familiar with the necessary documents, such as petitions and equipment tests, that are needed for certification. Additionally, familiarize yourself with any relevant data submissions and other components required by the FDA or other regulating bodies in your jurisdiction. Familiarity with these regulations can streamline contract negotiations and speed up the process of gaining approval.

Research Certified GRAS Ingredients and Safety Data:

Researching certified ingredients and obtaining safety data is an important part of the approval process. Make sure you’re familiar with FDA requirements, including any guidance documents related to GRAS status. Additionally, review your company and product-specific safety assessments to ensure that all safety components are addressed before submitting an application for GRAS certification. This research can help you identify risks, assess potential liabilities, and understand the process required for successful approval.

Analyze Your Product’s Overall Safety Profile With an Expert Evaluator:

Make sure your safety profile is complete by bringing in a qualified expert evaluator. This independent, third party will assess the product’s ingredients and provide objective feedback on any potential risks. Additionally, they can help you understand any additional processes or formalities required by the FDA for GRAS approval. This step is critical for smoothly transitioning from submission to approval and ultimately receiving your certification.

Assemble Your Official GRAS Application Package:

Once you have identified any areas of potential risk and your safety profile is complete, the next step is to compile all the materials into an official application package. This will contain every element that the FDA requires for GRAS certification, including documentation of relevant data and research, a review of potential adverse effects, product labeling details, and other pertinent information. Be sure to double-check that you have included everything needed to ensure a successful submission.

How to submit your GRAS certification application to the FDA for Final Approval?

Now that you have your application package ready to go, it’s time to submit it to the FDA for review. The agency will thoroughly assess all of the data and evidence provided in your submission and make a determination about GRAS classification for your product. Once approved, you can use the official letter from the FDA as tangible proof that your product is safe for human consumption.

Conclusion:

The GRAS pathway is a possible pathway for a probiotic ingredient found in the food supply and one derived from non-food sources. The GRAS pathway requires pivotal safety data to be publicly available. A conclusion of GRAS may or may not be notified to FDA. Suppose a probiotic is GRAS and placed into the food supply. In that case, the probiotic may be used in a dietary supplement as a new dietary ingredient without the required NDI notification, provided the dietary supplement does not contain significantly higher levels of the NDI than is used in already established conventional foods or does not exceed the levels established as safe in a GRAS conclusion.

Determining the best pathway to regulatory compliance can seem overwhelming but considering the above factors can direct you to the most appropriate path for your specific novel probiotic. RNI is also available to help you determine the best path forward based on your ingredient needs and goals and can support the development of your GRAS and NDIN dossiers for regulatory compliance.  Learn more about self-affirmed GRAS here:

We hope this post helped you understand food additives and preservatives a little better. There are many different kinds, and they can have a big impact on your health.

Please contact our team for more information on food classification, ingredient feasibility questions, ingredient submissions, and food labeling projects. Our specialists are here to help with the following services: Novel Food Notifications, SFCR License application, HACCP & PCP program, TMA License for Supplemented Foods, Nutrition Facts Table (NFT) Creation and label compliance!

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