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5 Tips to find the best FDA Medical Device Regulatory Consultant

Post author By Quality Smart Solutions
Post date February 15, 2023

Introduction:

Navigating the intricate web of medical device regulations can be daunting for businesses unfamiliar with the regulatory landscape. Hiring a professional medical device regulatory consultant can provide the expertise and knowledge necessary to ensure compliance with both federal and international laws.

Selecting the ideal FDA medical device regulatory consultant is crucial, particularly given regulatory compliance and quality assurance complexities. When choosing the right consultant for your US FDA medical device requirements, it’s imperative to consider various factors, including experience, regulatory proficiency, cost, and turnaround time expectations.

Understanding Your Regulatory Requirements

Before embarking on the search for a regulatory consultant, it is essential to have a clear understanding of your regulatory requirements. This preliminary step will help you identify the consulting firm that best fits your needs. Different firms specialize in distinct areas and levels of expertise, so a grasp of your requirements is paramount. Determine which regulations your product must adhere to and whether additional services like simulation studies or testing are necessary to ensure compliance.

Researching Different Consulting Options

During your search for the right regulatory consulting firm, take the time to research your options and compare them thoroughly. Evaluate the qualifications of their staff, their experience with similar medical device projects, and any specialized expertise that could benefit your needs. Reading reviews from current and past clients can also provide valuable insights into the level of service a company offers, helping you make an informed decision.

Analyzing Their Track Record of Success

A consultant’s track record of success and reputation should weigh heavily in your decision-making process. Before engaging a consultant, review their portfolio and success rate. Request client references to gain firsthand insights into their working relationship. This step will instill confidence in their ability to deliver valuable results, making them the ideal consultant for your project.

Seeking Testimonials and Referrals

Pay attention to available testimonials and referrals to ensure you’ve chosen the right consultant. These sources can offer valuable information about a consultant’s adherence to cost, quality, and timeliness standards. Additionally, they shed light on the consultant’s proficiency in understanding technical concepts and their problem-solving approach.

Evaluating Cost, Experience, and Expertise

In selecting a consultant, consider not only their cost but also their overall value. Experience is paramount; inquire about the number of FDA-registered medical devices they’ve consulted on, including development and 510(k) submissions. Ensure they are well-versed in recent regulations affecting your product and deeply understand other FDA regulations relevant to the medical device sector.

Considering Partnerships or Subcontractors

Consider whether a more prominent consulting firm is more advantageous than an individual consultant. Many larger firms offer subcontractors with specialized skills, providing extra support that can prove valuable during the consultation process. While larger firms may have a higher price tag, they often excel at navigating the unique challenges of FDA-regulated products. They have valuable connections with industry players, such as testing labs, which can facilitate product development and meet specific regulatory requirements.

Checking for Certifications

Before finalizing your choice of an FDA medical device consultant, verify their credentials and certifications. The FDA mandates that consultants offering guidance on regulated products hold relevant certifications, including Medical Device Quality System Regulation (QSR) and Quality System Standard for Medical Devices (QSd). Additionally, consider ISO 13485 certification for quality management system requirements and IEC/EN 62304 certification for software life cycle processes, if applicable to your product or production process.

Ensuring Proven Compliance Techniques and Supportive Resources

Hiring a consulting service should guarantee up-to-date regulations and assurance of device compliance. Ensure the consulting firm employs established techniques for streamlining submissions, obtaining timely approvals, and understanding international markets. Confirm the availability of supportive resources, such as project management teams and expertise in geographic markets, to facilitate your compliance journey.

Benefits of Hiring a Medical Device Regulatory Consulting Firm

1. Updated Regulatory Know-how: Regulatory consultants stay informed about ever-changing medical device regulations, ensuring your company complies with the latest industry developments and legal requirements.

2. Efficient and Cost-saving Strategies: These firms offer cost-effective strategies and help identify potential cost savings by optimizing processes and finding alternatives for product innovation.

3. Comprehensive Advice and Guidance: Specialized consultants provide various services, including regulatory strategy, market access consulting, compliance activities, and training programs, ensuring organizations remain compliant.

4. Time-saving Analysis of Regulations: Consultants simplify the complex task of researching and understanding regulatory requirements, allowing your company to focus on core activities.

5. Maximized Opportunity for Success: By relying on experienced consultants, you can quickly adapt to changes and seize opportunities in this highly regulated industry.

In conclusion, selecting the right medical device regulatory consultant is a critical decision that requires careful consideration of numerous factors. By conducting thorough research, evaluating experience and expertise, and ensuring compliance with certifications and regulations, you can make an informed choice that will help your business navigate the challenging regulatory landscape and achieve success in the medical device industry.

Tags 510k, 510k medical device, FDA Medical Device Consultant, ISO 13485, IVD, Medical Device Turnkey Solutions, SaMD

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The ultimate Generally Recognized As Safe GRAS Guide Unlocked

Post author By Quality Smart Solutions
Post date February 12, 2023

Introduction:

If you are wondering what foods and substances the FDA considers to be Generally Recognized As Safe (GRAS), you have come to the right place. This guide will explain the critical safety standards for GRAS regulation and provide an overview of what products are deemed safe by the FDA.

“Generally Regarded As Safe” (GRAS) is a category of food ingredients used in the United States. The FDA’s GRAS program allows companies to formulate, market, and sell their products without submitting safety data to the agency. The program helps speed up the regulatory process by making it easier for businesses to bring new products to market.

The FDA’s Generally Regarded as Safe (GRAS) regulations are essential to ensuring food additives’ safety in the United States. These regulations help to determine which substances are safe for use in food and which are not. In this article, we’ll take a closer look at the “Generally Regarded as Safe” GRAS regulations and how they work.

The role of the FDA in food safety regulation

The FDA plays a crucial role in ensuring the food’s safety. Its primary responsibility is to protect public health by regulating the production, distribution, and labeling of food products. The FDA’s authority extends to all food products except meat, poultry, and certain egg products, which the U.S. Department of Agriculture (USDA) regulates.

One of the key ways the FDA ensures food safety is by evaluating food ingredients. The FDA assesses the safety of food ingredients based on scientific evidence, industry data, and expert opinions. This evaluation process helps the FDA determine which ingredients are safe for consumption and which may pose a public health risk.

The History and Development of GRAS Regulations

The concept of GRAS has been around for decades, evolving and adapting to the changing landscape of the food industry. The initial regulations for GRAS were established in the 1950s by the U.S. Food and Drug Administration (FDA). These regulations aimed to provide a framework for determining the safety of food ingredients based on their common use in food before 1958 or their long history of safe consumption.

Over the years, the regulations surrounding GRAS have undergone revisions and updates to keep up with scientific advancements and changing dietary patterns. The FDA has been actively involved in evaluating and approving substances for GRAS status, ensuring that they meet the necessary safety criteria.

The criteria for achieving GRAS Status

To be considered GRAS, a substance must meet certain criteria that demonstrate its safety for consumption. These criteria are based on scientific evidence and are evaluated using a rigorous process. The primary factors considered when determining GRAS status include:

1. History of safe use: A substance must have a long history of safe consumption by a significant number of people. This history provides evidence of the substance’s safety over time.

2. Expert consensus: The scientific community should widely agree that the substance is safe for consumption. This consensus is reached through extensive research, studies, and peer-reviewed publications.

3. Scientific data: Scientific data, including toxicological studies, animal testing, and human trials, are essential in assessing the safety of a substance. This data helps determine the substance’s potential risks and any adverse effects it may have.

These criteria ensure that substances considered for GRAS status undergo a thorough evaluation process, leaving no room for ambiguity when it comes to consumer safety.

The process of self-determination and voluntary GRAS notification

One of the unique aspects of the GRAS program is the concept of self-determination. Under this concept, the responsibility for determining the safety of an ingredient lies with the manufacturer or supplier. Suppose a company believes that an ingredient meets the criteria for GRAS. In that case, it can make self-determination and use the ingredient in its products without seeking FDA approval.

However, the FDA encourages manufacturers to notify the agency of their GRAS determinations voluntarily. This allows the FDA to review the safety evaluation conducted by the manufacturer and provide feedback if necessary. While voluntary, this notification process helps ensure transparency and accountability in the GRAS determination process.

It’s important to note that the FDA does not approve or endorse GRAS determinations made by manufacturers. The agency’s role is to assess the safety of ingredients based on the available scientific evidence and expert opinions. The voluntary notification process allows the FDA to review and comment on the manufacturer’s safety evaluation.

The Process of Self-Determination and Expert Review for GRAS Status

Obtaining GRAS status involves a comprehensive evaluation process that includes self-determination and expert review. In the self-determination phase, the manufacturer or supplier of the substance conducts a thorough assessment of its safety based on scientific data and historical use. This assessment is documented and submitted to the FDA for review.

The FDA then conducts its review, which involves evaluating the submitted data, analyzing the scientific literature, and consulting with external experts. The expert review is a critical step in ensuring the credibility and accuracy of the self-determination process. The FDA may request additional information or studies if deemed necessary during this review.

Once the FDA is satisfied with the safety and supporting evidence, the substance is granted GRAS status. It is important to note that the FDA’s review process is transparent, allowing for public scrutiny and input.

The regulatory framework and oversight of GRAS Substances

GRAS substances are regulated by the FDA under the Federal Food, Drug, and Cosmetic Act. The FDA is responsible for ensuring the safety and integrity of food products, including those with GRAS status. The regulatory framework for GRAS substances includes several key elements:

1. Notification process: Manufacturers or suppliers must notify the FDA about their determination of GRAS status for a substance. This notification includes detailed information about the substance, its intended use, and the basis for its safety.

2. Publicly available records: The FDA maintains a database of GRAS notifications, which is accessible to the public. This transparency allows for public scrutiny and helps maintain accountability.

3. Continuous monitoring: Once a substance is granted GRAS status, it is subject to ongoing monitoring by the FDA. This includes reviewing new scientific data, conducting inspections, and taking appropriate action if safety concerns arise.

The regulatory framework ensures that GRAS substances are held to high standards of safety and undergo regular evaluation to maintain their status.

Controversies and challenges surrounding the GRAS determination process

While the GRAS program plays a vital role in ensuring food safety, it has its controversies and challenges. One of the main concerns is the role of industry self-determination in the GRAS process. Critics argue that the current system allows manufacturers to make self-serving determinations without sufficient oversight from the FDA.

Another challenge is the need for transparent guidelines for making GRAS determinations. The FDA provides general criteria for determining GRAS status. Still, there needs to be more specific guidance on how to conduct safety evaluations. This lack of clear guidelines can lead to inconsistencies in the evaluation process and raise concerns about the reliability of GRAS determinations. Furthermore, there have been cases where ingredients initially considered GRAS were later found to pose health risks. This highlights the need for ongoing monitoring and reassessment of GRAS ingredients to ensure safety.

Case studies of popular food ingredients and their GRAS status

To better understand the practical application of the GRAS program, let’s examine a few case studies of popular food ingredients and their GRAS status.

1. Salt (Sodium Chloride): Salt is a commonly used ingredient in food and has a long history of everyday use. It is considered GRAS by the FDA, but excessive salt consumption has been linked to health issues such as high blood pressure. This highlights the importance of moderation even with GRAS ingredients.

2. Caffeine: Caffeine is another widely used ingredient in coffee, tea, and other beverages. It is considered GRAS, but excessive consumption can lead to adverse health effects, such as insomnia and increased heart rate. Again, moderation is key.

3. Artificial Sweeteners: Artificial sweeteners like aspartame and sucralose are used as sugar substitutes in many products. These ingredients have undergone extensive scientific testing and are considered GRAS. However, some studies have raised concerns about their long-term effects on health.

Frequently asked Generally Recognized as Safe Questions we receive from food manufacturers:

What is FDA generally recognized as safe GRAS?

“Generally Regarded as Safe” (GRAS) is a designation the FDA gives to substances considered safe for food use. This designation is based on qualified experts’ scientific evaluation of the substance’s safety. The GRAS designation is critical because it allows food manufacturers to use certain substances in their products without needing FDA approval. However, it’s important to note that the GRAS designation is not a guarantee of safety, and the FDA can still take action if new information suggests a substance may not be safe.

How are substances determined to be GRAS?

Substances are determined to be GRAS through a scientific evaluation process by qualified experts. These experts review all available data on its importance, including studies on its safety and toxicity, and decide whether it is safe for use in food. The evaluation process also considers the intended use of the substance, the amount that will be used, and the potential for exposure. If the experts determine the ingredient is safe, it can be designated GRAS and used in food products without FDA approval.

What are the requirements for GRAS substances?

A substance must meet specific requirements set forth by the FDA to be considered GRAS. These requirements include a history of safe use in food, a general recognition of safety by qualified experts, and a lack of scientific evidence to suggest that the substance is harmful when used in food. Additionally, the GRAS compound must be used according to good manufacturing practices and not exceed the levels deemed safe by the FDA.

How are GRAS substances monitored for safety?

While GRAS substances are not subject to pre-market approval by the FDA, they are still monitored for safety. The FDA relies on various sources to gather information about the safety of GRAS substances, including scientific literature, reports from industry, and adverse event reports. If new data suggests that a GRAS substance may no longer be safe, the FDA can take action to remove it from the list of GRAS substances or require additional safety testing. Additionally, manufacturers must notify the FDA if they become aware of new information suggesting their GRAS substance is no longer safe.

What is the role of the FDA in GRAS regulations?

The FDA plays a crucial role in ensuring the safety of food additives through its “Generally Regarded as Safe” (GRAS) regulations. While GRAS substances are not subject to pre-market approval, the FDA monitors them for safety and can take action if new information suggests they may no longer be safe. The FDA also requires manufacturers to notify them if they become aware of further details suggesting their GRAS substance is no longer safe. Overall, the FDA’s role in GRAS regulations is to protect public health by ensuring the safety of food additives.

How does GRAS status apply to food products?

GRAS status is granted to products judged to be safe through scientific procedures and accepted by the FDA for use in the market without undergoing formal pre-market approval. When a product meets this classification, food product formulators can draw reasonable conclusions about its safety based on solid science, scientific principles, and existing data. GRAS status can mean different things for different products, so understanding GRAS and its implications is essential when launching your new venture.

What does GRAS mean?

“Generally Recognized As Safe” (GRAS) is a U.S. food and drug safety designation given to certain substances that can be used in food and drugs without additional regulatory approval. When consumed at the levels outlined in FDA regulations, GRAS recipes are extensively investigated and determined by qualified experts as having safe use, no harm, and no side effects. Substances must be proven through scientific tests or an extensive review of published scientific data to be considered GRAS.

How does the FDA determine GRAS status?

Once qualified experts have evaluated a substance, the FDA reviews the data, conclusions, and scientific evidence to determine GRAS status. If the FDA determines sufficient proof that particular implications are safe for food, drugs, or cosmetics, it will issue an official GRAS notice in the Federal Register. The FDA also requires manufacturers of GRAS substances to maintain records to document the safety assessment of their ingredients and to ensure continuous product safety.

What are some examples of common GRAS food substances?

The FDA has identified hundreds of substances as GRAS, including common food ingredients such as baking soda, vinegar, citric acid, and specific colors and flavorings. Other commonly used GRAS ingredients are preservatives like sodium benzoate and potassium sorbate, sweeteners like stevia and xylitol, and spices like capsaicin and ginger. Additionally, some novel ingredients from natural sources, such as seaweed extract gums and starches, have been deemed GRAS by the FDA.

What are the Differences Between GRAS Status, FFC Classification, and Additives Declaring GRAS Status on a Product Label?

It’s essential to understand the differences between FFC classification, GRAS status, and additives when declaring your product’s GRAS classification. The FFC (Food and Food Contact) classification is used for food components made with an ingredient that may be consumed as-is without further processing and that contact food during normal handling. An additive is a substance added to enhance the flavor or preserve the shelf life of food. Finally, GRAS status implies that a product poses no known risk of harm when consumed at the levels normally expected.

How do I declare GRAS status on a food product label?

When preparing to declare GRAS status on a product label, consider taking the following steps: First, determine whether your product is composed of FFC-classified ingredients or meets the definition of an additive. Then, review information on toxicity levels and safe usage data to determine whether the substance meets standards for GRAS classification. Finally, submit all necessary paperwork to the FDA for pre-market certification.

What potential risks are associated with claiming GRAS status on a product label?

Considering the potential risks and consequences of claiming GRAS status for a product is crucial. For instance, if a manufacturer makes a false claim about their product, they may face civil or criminal liability as outlined in the False Claims Act. Additionally, incorrect assertions about GRAS status for products can lead to recalls and other enforcement actions from the FDA.

What is the safety assessment system (SGS) for new self-GRAS ingredients?

The FDA also allows companies to make their safety assessments for novel ingredients and submit a self-GRAS notification. This is called a “self-determination” process; the company assesses the ingredient’s safety and makes a case for why it should be accepted without further FDA review. In most cases, self-GRAS will be subject to future FDA audits or periodic inspections to verify that the ingredient is safe for consumption.

What is the importance of product safety testing in determining GRAS status?

Before an ingredient is deemed generally recognized as safe (GRAS) by the FDA, it must undergo rigorous testing to ensure it meets safety standards. Companies must submit comprehensive safety data, including toxicological profiles, clinical trials, and other scientific evidence, to show that an ingredient is not harmful or dangerous when consumed at specified levels. This includes testing for potential allergens, contaminants, and by-products from production. Product safety testing will help to ensure that any item classified as GRAS does not pose a risk of harm to consumers.

How does the GRAS program help speed up the regulatory process?

The program aims to reduce the regulatory burden on all stakeholders, including industry and regulators. Someone can achieve this through increased transparency in the regulatory process and by preventing unnecessary delays in getting products to market. The number of applications submitted under this program has been growing steadily since its inception in 1992, with more than 50% coming from small businesses or universities with fewer than 500 employees.

How do I distinguish GRAS ingredients from non-GRAS ingredients?

When assessing potential ingredients for a product, there are several key factors to consider to ensure that you are using a GRAS (generally recognized as safe) ingredient. It’s essential to research the ingredient’s history and ensure that it has been reviewed and approved by the FDA or that an independent panel of experts has declared it safe. It must also be able to meet specific criteria about its characteristics, composition, intended use, and safety concerns. If these criteria are met, an ingredient can be considered GRAS by designation.

What are some commonly used natural GRAS ingredients?

Natural GRAS ingredients are widely used in the food, health, and beauty industries to add nutrition and provide supplemental benefits. Commonly used natural GRAS ingredients include:

Oils like coconut, palm, and olive oil.
Plant-based starches like tapioca starch.
Vitamins, minerals, herbs, and spices are derived from natural sources.
Probiotics.
Sweeteners like honey and agave syrup
Raw food dyes such as carmine, turmeric, saffron, and annatto

What are some benefits of using natural GRAS ingredients in formulations?

Using natural GRAS ingredients in formulations is beneficial for many reasons. Natural GRAS ingredients can offer health benefits such as increased energy, improved digestion, enhanced cognitive function, improved skin and hair quality, and weight management assistance. Natural GRAS ingredients are also often easier to digest than artificial options, which makes them more accessible for the body to utilize. Additionally, natural GRAS ingredients generally have fewer side effects than synthetic options.

How can I avoid potential safety hazards with proper research and testing?

To ensure natural GRAS ingredients are safe for consumption, it’s essential to research and test each component thoroughly and correctly. Someone must identify the potential safety hazards before any raw GRAS ingredients can be validated. It’s also important to double-check the source of all elements before sourcing and ensure they meet the specifications set forth by governing bodies. Additionally, products made with natural GRAS ingredients should have good quality assurance processes to ensure compliance with applicable laws and regulations.

What does “Generally Regarded as Safe” (GRAS) mean in food regulations?

Generally Regarded as Safe” (GRAS) is a designation used in food regulations to indicate that a substance is considered safe for consumption based on a history of everyday use in food or scientific evidence, without formal approval as a food additive.

How is a substance determined to be GRAS?

To be considered GRAS, a substance must have a consensus among qualified experts that it is safe for its intended use in food. This determination can be based on historical usage, scientific studies, or both. The safety assessment should be publicly available for scrutiny.

Who determines if a substance is GRAS?

Determining whether a substance is food manufacturers or ingredient suppliers typically makes GRAS. They compile scientific data and expert opinions to support the substance’s safety. The U.S. Food and Drug Administration (FDA) can review and question these determinations.

Is GRAS status permanent?

No, GRAS status is not permanent. It can be subject to change if new scientific evidence emerges suggesting a safety concern. The FDA can reevaluate and challenge GRAS determinations if necessary.

Are all food additives required to go through the GRAS process?

No, not all food additives need to go through the GRAS process. Some substances are explicitly recognized as safe by the FDA and are exempt from the GRAS determination process. Others, especially new additives, may require formal approval.

Can consumers find information about GRAS substances on food labels?

Generally, GRAS status is not listed on food labels. However, food manufacturers must ensure that all ingredients used in their products, including those with GRAS status, meet safety standards set by regulatory authorities.

What are some common examples of GRAS substances?

Common examples of GRAS substances include salt (sodium chloride), sugar (sucrose), vinegar (acetic acid), and various vitamins and minerals when used under established guidelines.

Is GRAS status the same globally?

No, GRAS status and regulations can vary from one country to another. Each country or region may have its criteria and process for determining whether a substance is generally considered safe for food use.

Can individuals petition for a substance to be considered GRAS?

Yes, individuals or organizations can submit a GRAS notification to the FDA, providing scientific evidence and expert opinions supporting the safety of a substance. The FDA reviews these notifications and can respond with their evaluation.

Are there any controversies or concerns related to GRAS determinations?

Yes, concerns have been raised about the transparency and potential conflicts of interest in GRAS determinations, as some decisions are made by the same companies that produce the substances in question. Efforts have been made to address these issues and enhance the rigor of the process.

Additional Reading about GRAS:

Tags generally recognized as safe GRAS, Generally Regarded As Safe, Generally Regarded As Safe FDA, GRAS, Gras determination, GRAS status

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Unlocking the FDA Guidelines for NAC Supplements

Post author By Quality Smart Solutions
Post date February 8, 2023

Introduction:

On August 1, 2022, the FDA announced the final guidance on FDA’s policy regarding products labeled as dietary supplements that contain N-acetyl-L-cysteine (NAC). NAC is a supplement form of cysteine, a semi-essential amino acid, which was approved by the FDA as a drug in 1963 to treat liver side effects from an overdose of Tylenol (acetaminophen) and to loosen the thick mucus in the lungs of people with cystic fibrosis or chronic obstructive pulmonary disease.

The new guidance explains the FDA’s intent to exercise enforcement discretion concerning the sale and distribution of certain NAC-containing products that are labeled as dietary supplements. This enforcement discretion policy applies to products that would be lawfully marketed dietary supplements if NAC were not excluded from the definition of “dietary supplement” and are not otherwise in violation of the Federal Food, Drug, and Cosmetic Act (FD&C Act).

To learn about the FDA’s enforcement discretion for NAC supplements click here:

Know the requirements for marketing NAC Supplements:

The FDA requires that the manufacturer or distributor of an NAC supplement follows certain guidelines for labeling and safety. Make sure to read all labels carefully, as the label should detail everything you need to know about the product, including any warnings about potential side effects and contaminants. Additionally, ask your provider questions about NAC supplements before including them in your health regimen. This can help ensure you’re making informed decisions about what products are safe and beneficial for you.

Be aware of NAC Supplement labeling requirements:

When purchasing an NAC supplement, it’s important to be aware of certain labeling requirements as put forth by the FDA. These include both general and product-specific labeling, such as itemized ingredients, a description of what the product does, information about nutraceuticals, usage instructions and dosage information, safety warnings about potential side effects or adverse reactions due to drug interactions, and expiration date. Additionally, all NAC supplements must clearly state if they are dietary supplements.

Need help with your NAC supplement compliance?

Contact Quality Smart Solutions today! We can help.

Understand safety guidelines for NAC supplement products:

As with any supplement, it’s important to make sure that the NAC product you purchase meets safety guidelines. Look for reliable suppliers of high-quality NAC supplements and pay attention to any warning labels about potential drug interactions or side effects when taking them. Be sure to read the information carefully before taking a NAC supplement so that you can accurately understand the benefits, risks, and dosing instructions. Additionally, look for products that have been third-party tested for quality and purity.

Pay attention to current NAC Supplement updates:

Be sure to pay attention to current updates about NAC supplement regulations to ensure that you are fully aware of all FDA requirements. The FDA regularly evaluates supplements and issues updated guidelines or product recalls as necessary. Understanding and following the latest instructions related to dosing, labeling, ingredients, and manufacturing standards can help you stay informed.

Utilize FDA resources for guidance and advice:

Make sure you understand all relevant safety, labeling, and manufacturing standards for NAC supplements by taking advantage of FDA resources. The FDA provides helpful tips and guidance on its website as well as regulatory update alerts about any changes that have been made to the regulatory requirements. Additionally, you can contact the FDA directly with questions or comments regarding your products.

Tags Fda, NAC Supplements

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Understanding the regulations for Class III Medical Devices

Post author By Quality Smart Solutions
Post date February 7, 2023

Introduction:

Class 3 medical devices are subject to the highest level of scrutiny and require special attention when it comes to meeting their regulatory requirements. This article will discuss what it takes for Class 3 medical devices to meet these stringent requirements.

Class 3 medical devices are especially complex and pose the highest risk to patients. To ensure patient safety, manufacturers of class 3 medical devices must strictly follow guidelines issued by the FDA to achieve quality assurance during production. These guidelines include requirements related to design validation, process validation, labeling, sterilization, and more.

Understand the Regulatory Requirements of Class 3 Medical Devices:

Class 3 medical devices have the most stringent regulatory requirements when compared to other device classes. To ensure they meet the specific standards set by regulators, manufacturers must thoroughly understand what their obligations are and how to meet them. This includes understanding device labeling, conducting necessary preclinical tests, and designing appropriate clinical trials as well as obtaining marketing authorization from local and international agencies. With little room for error, a company must pay ample attention to meeting these strict regulations.

The regulatory requirements for Class III medical devices are outlined in the Federal Food, Drug, and Cosmetic Act (FD&C Act), which the FDA enforces. The FD&C Act defines the classification of medical devices based on their intended use, design, and potential risks. Class III medical devices are subject to the most stringent regulatory requirements, which include premarket approval (PMA), premarket notification (510(k)), post-market surveillance, and adverse event reporting.

The FDA also requires that Class III medical devices meet specific labeling requirements and have a unique device identification (UDI) system to facilitate tracking and reporting of adverse events. Failure to comply with these regulations can result in significant fines, legal action, and damage to your company’s reputation.

What is the FDA approval process for class III medical devices?

The FDA approval process for Class III medical devices is complex and lengthy, requiring significant resources, time, and expertise. The approval process ensures that medical devices are safe and effective for their intended use and meet the regulatory requirements outlined by the FDA.

The FDA approval process for Class III medical devices consists of several stages, including preclinical testing, clinical trials, and post-market surveillance. The preclinical testing stage involves testing the device in animal models and conducting bench studies to assess the device’s safety and effectiveness.

The clinical trial involves testing the device on human subjects to evaluate its safety and effectiveness. The clinical trial data is then submitted to the FDA for review and approval. Clinical trials are typically conducted in three phases, each involving more subjects and more rigorous testing.

Once the device has been approved, it must undergo post-market surveillance to monitor its safety and effectiveness in real-world settings. This involves tracking adverse events and conducting post-market studies to assess the device’s long-term safety and efficacy.

What is preclinical testing for class III medical devices?

Preclinical testing is critical to the FDA approval process for Class III medical devices. Preclinical testing involves conducting laboratory experiments and animal studies to evaluate the device’s safety and effectiveness before it is tested in humans.
Preclinical testing typically involves testing the device in animal models to assess its safety and efficacy.

This may include conducting toxicity studies, biocompatibility testing, and other tests to evaluate the device’s performance and potential adverse effects.

The results of preclinical testing are used to determine whether the device is safe to test in humans and to design the clinical trial protocol. Preclinical testing is a vital step in the approval process for Class III medical devices, and it helps to ensure that the device is safe and effective before it is tested in humans.

Why are clinical trials required for Class III medical devices?

Clinical trials are critical to the FDA’s approval process for Class III medical devices. Clinical trials involve testing the device on human subjects to evaluate its safety and effectiveness. Clinical trials typically involve more issues and more rigorous testing in three phases.

Why are there clinical trial phases for Class III medical devices?

Phase I clinical trials typically involve a small number of healthy volunteers. They are designed to assess the device’s safety and potential adverse effects.

Phase II clinical trials involve a more significant number of subjects. They are designed to evaluate the device’s effectiveness and safety in patients with the target condition.

Phase III clinical trials involve a more significant number of subjects. They are designed to confirm the device’s safety and effectiveness in a larger patient population. The results of the clinical trials are then submitted to the FDA for review and approval.

What are class III medical device post-market surveillance and adverse event reporting?

Post-market surveillance is critical to the FDA’s regulatory process for Class III medical devices. Post-market surveillance involves monitoring the device’s safety and effectiveness in real-world settings and tracking adverse events.

Medical device manufacturers must report adverse events to the FDA and maintain records of these events. The FDA uses this information to monitor the safety and effectiveness of medical devices and, if necessary, take action to protect public health.
Suppose a medical device manufacturer becomes aware of a problem with a device. In that case, they are required to report it to the FDA. Failure to report adverse events or maintain records can result in significant fines and legal action.

What are the labeling requirements for class III medical devices?

Class III medical devices are subject to specific labeling requirements designed to ensure that patients and healthcare providers have access to essential information about the device’s use, risks, and benefits.

The labeling requirements for Class III medical devices are outlined in the FDA’s Code of Federal Regulations (CFR) and include information such as the device’s intended use, indications for use, warnings, and precautions.

The labeling must also include a unique device identification (UDI) system, which facilitates tracking and reporting adverse events. The UDI system consists of a unique identifier assigned to each medical device, which must be included on the device’s label.

Why is the Unique Device Identification (UDI) system important for Class III medical devices?

The Unique Device Identification (UDI) system is critical to the FDA’s regulatory process for Class III medical devices. The UDI system facilitates tracking and reporting adverse events and improves patient safety.

The UDI system includes a unique identifier assigned to each medical device, which must be included on the device’s label. The UDI system also consists of a database that contains information about each medical device, including its manufacturer, model number, and expiration date.

The UDI system helps improve patient safety by facilitating the tracking and reporting of adverse events. It also helps to improve supply chain management by providing a standardized method for identifying and tracking medical devices.

Why are compliance and enforcement important for Class III medical devices?

Compliance and enforcement are critical components of the FDA’s regulatory process for Class III medical devices. Medical device manufacturers must comply with the FDA’s regulatory requirements, and failure to do so can result in significant fines and legal action.
The FDA has the authority to conduct inspections and audits of medical device manufacturers to ensure compliance with regulatory requirements. The FDA can also issue warning letters, fines, and legal action against companies that fail to comply with regulatory requirements.

Medical device manufacturers must understand and comply with the FDA’s regulatory requirements to avoid fines, legal action, and damage to their company’s reputation.

Step-by-Step Guide for Medical Device Regulatory Compliance Process:

A step-by-step guide for Class 3 medical device manufacturers to prepare for and meet regulatory requirements is provided below:
1. Understand the local and international standards and regulations that apply to your product.
2. Perform risk assessments, identify hazards, and assess safety risks.
3. Develop appropriate device labeling information including instructions, warnings, indications, and contraindications.
4. Prepare preclinical tests related to the identified safety risks of the medical device.
5. Run clinical trials by applicable regulations and obtain relevant certification of efficacy, performance, or other features as necessary.
6. Submit marketing authorization applications to local or international agencies if required by applicable regulations or laws.
7. Develop post-marketing surveillance plans as may be needed going forward to ensure continued compliance with standards and regulations applicable to your device.

Guidelines for manufacturers for Managing Risk and Adverse Events:

The risk of adverse events is an ever-present reality for medical device manufacturers. Therefore, it is important to have a robust management system in place for risk and adverse event assessment, reporting, and monitoring to minimize the potential impact these may have on safety and efficacy. Manufacturers should clearly define criteria within product development plans to ensure appropriate assessments are taken during each product’s entire life cycle. This includes a systematic approach to suspending, withdrawing, or replacing devices deemed unsafe or ineffective due to adverse events. Additionally, manufacturers should be prepared to respond quickly and effectively whenever an adverse event or complaint is reported.

Conclusion: Importance of following regulations for Class III Medical Devices

In conclusion, the FDA highly regulates Class III medical devices to ensure their safety and effectiveness. Understanding the regulations governing Class III medical devices is essential for medical device
manufacturers and aspiring entrepreneurs.

Medical device manufacturers must also comply with specific labeling requirements and have a unique device identification (UDI) system to facilitate tracking and reporting of adverse events. Compliance and enforcement are critical components of the FDA regulatory process, and failure to comply with regulatory requirements can result in significant fines, legal action, and damage to your company’s reputation.

By following the regulations governing Class III medical devices, medical device manufacturers can ensure the safety and effectiveness of their devices and improve patient safety. Aspiring entrepreneurs can also navigate the complex world of medical device regulations and bring their innovative ideas to market.

Learn more about the class 3 medical devices application here:

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.

Tags Class 3 medical devices, FDA Medical Devices, Health Canada Medical Devices, medical devices

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What Does It Mean to be GFSI Certified in an FSMA Environment?

Post author By Quality Smart Solutions
Post date February 1, 2023

Introduction:

FSMA stands for the “Food Safety Modernization Act” which is a set of laws enacted by the US government to ensure food safety and decrease the risk of foodborne illness. Congress enacted FSMA in response to dramatic changes in the global food system and in our understanding of foodborne illness and its consequences, including the realization that preventable foodborne illness is both a significant public health problem and a threat to the economic well-being of the food system. About 48 million people (1 in 6 Americans) get sick, 128,000 are hospitalized, and 3,000 die each year from foodborne diseases, according to recent data from the Centers for Disease Control and Prevention. This is a significant public health burden that is largely preventable.

What is the FSMA Act?

The Food Safety Modernization Act (FSMA) enables FDA to better protect public health by strengthening the food safety system. It enables FDA to focus more on preventing food safety problems rather than relying primarily on reacting to problems after they occur. The law also provides FDA with new enforcement authorities designed to achieve higher rates of compliance with prevention- and risk-based food safety standards and to better respond to and contain problems when they do occur. The law also gives FDA important new tools to hold imported foods to the same standards as domestic foods and directs FDA to build an integrated national food safety system in partnership with state and local authorities.

What does FSMA require of food facilities?

For the first time, FDA will have a legislative mandate to require comprehensive, science-based preventive controls across the food supply. This mandate includes:

Mandatory preventive controls for food facilities: Food facilities are required to implement a written preventive controls plan. This involves: (1) evaluating the hazards that could affect food safety, (2) specifying what preventive steps, or controls, will be put in place to significantly minimize or prevent the hazards, (3) specifying how the facility will monitor these controls to ensure they are working, (4) maintaining routine records of the monitoring, and (5) specifying what actions the facility will take to correct problems that arise.
Mandatory produce safety standards: FDA must establish science-based, minimum standards for the safe production and harvesting of fruits and vegetables. Those standards must consider naturally occurring hazards, as well as those that may be introduced either unintentionally or intentionally, and must address soil amendments (materials added to the soil such as compost), hygiene, packaging, temperature controls, animals in the growing area, and water.
Authority to prevent intentional contamination: FDA must issue regulations to protect against the intentional adulteration of food, including the establishment of science-based mitigation strategies to prepare and protect the food supply chain at specific vulnerable points.

How does FSMA impact US food imports?

The FSMA gives FDA unprecedented authority to better ensure that imported products meet U.S. standards and are safe for U.S. consumers. New authorities include:

Importer accountability: For the first time, importers have an explicit responsibility to verify that their foreign suppliers have adequate preventive controls in place to ensure that the food they produce is safe. (Final regulation and guidance due 1 year following enactment)
Third Party Certification: The FSMA establishes a program through which qualified third parties can certify that foreign food facilities comply with U.S. food safety standards. This certification may be used to facilitate the entry of imports. (Establishment of a system for the FDA to recognize accreditation bodies is due 2 years after enactment)
Certification for high-risk foods: FDA has the authority to require that high-risk imported foods be accompanied by a credible third-party certification or other assurance of compliance as a condition of entry into the U.S.
Voluntary qualified importer program: FDA must establish a voluntary program for importers that provides for expedited review and entry of foods from participating importers. Eligibility is limited to, among other things, importers offering food from certified facilities. (Implementation due 18 months after enactment)
Authority to deny entry: FDA can refuse entry into the U.S. of food from a foreign facility if FDA is denied access by the facility or the country in which the facility is located.

What are GFSI Schemes?

A food safety scheme is recognized by GFSI when it meets the food safety requirements defined in the GFSI Guidance Documents. GFSI is an organization that benchmarks and approves different auditing standards. There isn’t technically any single audit called “The GFSI Audit,” but there are several standards that are GFSI-benchmarked. GFSI benchmarked schemes include:

Primus GFS
Global Aquaculture Alliance Seafood
Global Gap
FSSC 22000
Global Red Meat Standard
Canadagap
SQF
BRCGS Global Standard
IFS International Featured Standards
Japan Food Safety Management Association

If you are a food processor or manufacturer in the United States you can choose any of the applicable GFSI schemes, though, getting a GFSI audit will most likely mean getting a BRCGS or SQF audit.

What are the benefits of GFSI Certification?

GFSI certification is a way for companies to demonstrate that their products meet the highest standards of food safety. Food safety is a large part of GFSI’s mission, which is why they created this program. The GFSI sets out quality standards to create an environment where consumers can safely buy and consume products without worrying about whether or not they will become sick from eating them.

The benefits of using GFSI-certified raw materials are clear: you can be sure that your product will meet all requirements when it comes down to it. In turn, this reduces overall costs associated with making sure your goods are safe enough for consumption by users around the world.

Conclusion:

GFSI certification is a big deal and deserves some attention. As the world continues to look for ways to ensure food safety, GFSI certification will continue to be one of the most important standards in this industry.

Tags food facilities, FSMA, FSMA-FSVP Certification, GFSI Certification, GFSI Certification Audit, GFSI Schemes, US Food Importers

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GFSI Certification Requirements: How to get GFSI Certified?

Post author By Quality Smart Solutions
Post date January 31, 2023

Introduction:

The Global Food Safety Initiative (GFSI) is an international organization that sets standards for food safety and quality assurance. It was founded by the United Nations Food and Agriculture Organization (FAO), World Health Organization (WHO), and World Trade Organization (WTO).

The Global Food Safety Initiative (GFSI) is a collaboration between the world’s leading food safety experts from retailers, manufacturers, and food service providers. Founded in 2000 by CIES (The Consumer Goods Forum), GFSI brings together key actors of the food industry to collaboratively drive continuous improvement in food safety management systems around the world.

What is GFSI? It stands for Global Food Safety Initiative:

It is a voluntary initiative that was formed by CIES (The Consumer Goods Forum) in 2000. Since its inception, over 1 million companies have been certified through the program, including manufacturers like Nestle and Kellogg’s. The Global Food Safety Initiative (GFSI) is a collaboration between the world’s leading food safety experts from retailers, manufacturers, and food service providers.

The GFSI brings together key actors of the food industry to collaboratively drive continuous improvement in food safety management systems around the world. The GFSI sets global standards for audits, certifications, and training that are used by more than 10,000 companies worldwide.

Global Food Safety Initiative Program Requirements Today:

Today, GFSI has more than 600 members worldwide in over 50 countries across the globe. Members include Walmart and Nestle and food safety stakeholders like NSF International and SQFI (Sqf Institute). Essentially, GFSI is creating a platform for open dialogue on all aspects of food safety which aims to harmonize standards for food certification schemes. In turn, this helps to certify bodies and raise their level of compliance.

1. Ensure that employees understand their responsibilities

Companies must make sure that their employees understand what their job duties entail. This includes ensuring that they have the necessary training and education to do their jobs safely. Employees should also be trained on how to handle emergencies and how to report any issues they encounter while at work.

2. Have an effective system for monitoring food production processes

A company’s food safety program should include a written policy that outlines the responsibilities of each employee. It should also include a plan for implementing new practices and procedures as well as a process for evaluating them. Finally, the company should establish a procedure for reporting any potential hazards or violations.

3. Train staff on how to handle emergencies

Food safety programs must address emergencies such as recalls, product contamination, and other incidents that could harm consumers. Companies should train employees on how to respond to these events and what steps to take when they occur. They should also develop an emergency response plan that includes contact information for local authorities and a list of emergency contacts.

4. Maintain records of all food products produced or processed

A company must maintain records of its food production and processing activities. These records should include documentation of the source materials used, the processes applied, and any changes made during the manufacturing process.

5. Implement a quality management system

Companies must implement a quality management system (QMS) to help them meet these requirements. This includes documenting how products are produced, testing samples before release, and monitoring product quality throughout the supply chain.

What does the GFSI Initiative promote?

The Global Food Safety Initiative (GFSI) was started by CIES (The Consumer Goods Forum), in 2000. It brings together key actors of the food industry to collaboratively drive continuous improvement in food safety management systems around the world.

The GFSI promotes global harmonization of standards for a wide range of food safety certification schemes. The objective is to build confidence in products by providing a common standard that can be used across countries and regions, regardless of if they are developed independently or by international organizations such as the Codex Alimentarius Commission (CAC) or the World Health Organization (WHO).

GFSI food safety platform for food certification:

Essentially, GFSI is creating a platform for open dialogue on all aspects of food safety which aims to harmonize standards for food certification schemes. In turn, this helps to certify bodies and raise their level of compliance. The organization was founded in 1999 and it has over 600 members worldwide in over 50 countries across the globe.

GFSI’s main objective is to increase efficiency and effectiveness in food safety management systems by creating an environment where people can share information and learn from one another’s experiences. As such, they have established a network of professionals committed to raising global standards through continuous improvement within the industry’s supply chain – from farm to fork.

Since 2005, GFSI has been working on aligning standards with one another as well as recognizing each other so that every certification scheme meets a baseline of compliance:

Collaboration between GFSI Food Safety Experts:

The Global Food Safety Initiative (GFSI) is a collaboration between the world’s leading food safety experts from retailers, manufacturers, and food service providers. GFSI was launched in 2000 by CIES (The Consumer Goods Forum). Since 2005, GFSI has been working on aligning standards with one another as well as recognizing each other so that every certification scheme meets a baseline of compliance.

GFSI Certification makes sure that your company’s procedures meet international standards for good manufacturing practices (GMP), HACCP (Hazard Analysis and Critical Control Points), and International Food Standard Codex Alimentarius Commission recommendations and guidelines.

Conclusion:

GFSI is an initiative that has been around for over 15 years now. The organization is continuously growing and expanding its reach across the globe, which makes it a great place to start if you’re looking for certifications or want to learn more about food safety management systems in general. If you want to make sure your company complies with international standards, then GFSI certification may be right up your alley!

Need help obtaining your GFSI certification?

Contact Quality Smart Solutions today! We can help.

Tags GFSI BRC Standards, GFSI Certification, GFSI Certification Audit, GFSI Certification Benchmarking

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FDA to tighten regulatory process around CBD food & supplements

Post author By Quality Smart Solutions
Post date January 27, 2023

Introduction:

The FDA may have turned a blind eye to companies like Bio Steel in the past who’ve been selling supplements containing CBD in the United States but they’re like to start issuing more warning letters when drug claims are made. With the FDA enforcement of CBD supplements being like pet supplements the FDA is concluding that the existing regulatory framework isn’t appropriate for CBD supplements.

The cannabidiol (CBD) product market has seen accelerated growth in 2022, leading FDA to take a closer look at the regulatory pathways. They’ve since concluded that a new pathway for CBD is required to balance risks and desire for CBD products. While working with Congress to adjust regulations they’ve decided to deny petitions/rulemaking for marketing CBD products as dietary supplements.

The various usages of CBD (safety concerns):

Studies have shown that long-term usage of CBD has the potential to harm your liver, and the male reproductive system and interact negatively with various medications. CBD exposure can hurt young children and pregnant women. The new impending regulatory pathway would aim to benefit consumers by providing safety measures to minimize risks. This could be carried out by; CBD content limits, measures, minimum age requirements, prevention of contaminants, etc. The current authorities have very limited tools for managing the risks of CBD products and health officials plan to change that.

CBD impact on animals (pet supplements)

CBD also poses risks to animals, and people could be unknowingly exposed to CBD through meat, milk, and eggs from animals fed CBD. Because it is not apparent how CBD products could meet the safety standard for substances in animal food, we also do not intend to pursue rulemaking allowing the use of CBD in animal food. A new regulatory pathway could provide access and oversight for certain CBD-containing products for animals.

What do the FDA officials have to say?

“We have not found adequate evidence to determine how much CBD can be consumed, and for how long, before causing harm,” FDA Principal Deputy Commissioner Janet Woodcock said.

“A new regulatory pathway for CBD is needed that balances individuals’ desire for access to CBD products with the regulatory oversight needed to manage risks,” the agency said.

Conclusion:

Although as of January 26^th, 2023, the FDA said that it doesn’t intend to make any new guidance related to CBD, they may have to depend on how effective the framework proves to be once it’s created. Having mainly focused on unsubstantiated health claims of food/beverage and supplements in the past it will be interesting to see how they approach creating a regulatory framework for CBD.

The FDA has stated that the available data didn’t show how CBD products could meet the standards of safety for animal food substances and didn’t intend to provide new rules for its use in human or animal foods.

Tags Cbd, CBD Food Products, CBD Ingredients, CBD pet supplements, CBD safety concerns, CBD supplements, Fda

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10 tips to Prepare for the Safe Food License Application Process

Post author By Quality Smart Solutions
Post date January 25, 2023

Introduction:

There are many reasons that you might want to get licensed as a food processor or retail operator. You might be interested in expanding your business, or you might want to make sure that your food safety program is compliant with new regulations. Regardless of the reason, it’s important to know what you’re getting into and how much time it will take before you start applying for a license under Canada’s Safe Food for Canadians Regulations (SFCR).

A safe food for Canadians (SFC) license is essential for any credible food business. The process of obtaining a license can be complex and time-consuming, so it’s important to understand what steps you need to take to prepare for it and ensure your business meets all the necessary criteria. In this blog, we’ll provide you with suggestions to help you prepare for the Safe Food for Canadians License application process.

1. Set your goals.

The first step in the process of applying for a food license is to set goals. What are you trying to accomplish? What do you hope to achieve? How will this license help your business succeed, and what does that mean for you?

When thinking about your goals, it’s helpful to consider the end goal: what kind of restaurant do you want your establishment to be? Do you want it to be a place where people come in and get a quick bite before they run out the door again or are they going to sit down and enjoy their meal as part of an evening out with friends at one of the best restaurants in town? Your answers here will help guide how much time and energy should be spent on pursuing any number of different licenses.

2. Do your research.

When you’re preparing to apply for safe food for Canadians license, it’s important to do your research. There are plenty of ways to find out more about the regulator and their guidelines:

Check their website. Every regulator will have information on their website regarding how to apply for a safe food license or how to become a member of the industry association in your province/territory. This will give you an idea of what is expected from you during the application process and where you can go for help if necessary.
Look through local papers and social media channels like LinkedIn or Facebook groups where other food businesses can share advice on how they got through this process successfully (or not).
Talk with other people working in your field who may have already applied for a safe food license with another government department or authority in another part of Canada—they may be able to offer valuable insights into what makes that jurisdiction so different from yours!

3. Study the regulations.

You should start by learning about the regulations that govern your industry, which you can do by reading through the relevant sections of your provincial or local government’s website. Make sure to review all of the requirements for applying for a license and then check that you understand them before starting your application.

4. Check if you need a Safe Food License.

You can also check if you need a Safe Food License by checking the list of requirements for your business. There are two ways to do this:

Check the complete list of requirements on the federal Regulator’s webpage:
View a summary in our checklist below.

5. Gather Your Documentation.

Before applying for safe food for Canadians license, it is important to gather all the documentation you will need as part of the application process. This includes information about your business and products, proof of insurance, and any other certifications or licenses that may be required. Additionally, make sure you have up-to-date food safety documentation on hand. Having all of this information at hand will help expedite the application process and ensure you are following the proper procedures.

6. Make Sure Your Food Safety Plan Is Up to Date.

An integral part of the safe food for Canadians license application process is having an up-to-date food safety plan. This will help you demonstrate to regulators that your business is following current best practices in terms of food handling and preparation. Your food safety plan should outline steps taken to prevent contamination and set clear guidelines for employees when it comes to hygiene and sanitation.

7. Have a Plan for Testing and Record Keeping.

Testing and record keeping are crucial parts of the food safety plan. This helps ensure that you have evidence to demonstrate to regulators that your business is taking proper precautions about food safety. Regularly test products during all stages of processing and handling, as well as any equipment for potential contamination. Record results in a log and have it available for review by regulators when requested.

8. Prepare for the Inspector’s Visit.

An inspector may request to visit your site or review your food safety plan before a final license is approved. Before they come, make sure your facility is clean, organized, and up to health standards. Have all of the paperwork necessary for the inspection on hand, as well as relevant certificates from the government or your suppliers. Be prepared to answer any questions regarding your plan so you can show them why you should be approved for a safe food license.

9. Complete these activities before applying for a Safe Food License:

Make a list of activities that need to be completed before you apply for a license under the Safe Food for Canadians Regulations (SFCR). These are the preliminary steps you must complete to ensure that your application is complete and compliant.

Example:

Reviewing food safety program requirements and completing an internal audit of systems to determine what areas need improvements or changes. You will also want to consider how much time it will take for staff members who are currently responsible for preparing food to learn about new processes, as well as those who will be responsible for conducting audits, inspections, and reviews.

10. Show What You Know about Food Safety.

You will need to demonstrate you are knowledgeable about food safety regulations and that your establishment meets the requirements. Be sure to thoroughly research all applicable food safety requirements in your area, so you know the best practices for keeping food safe and healthy and how they should be applied to your premises. Understanding everything related to food safety not only helps with license approvals but also proves you are devoted to offering high-quality, safe products to customers.

How can we help?

Now that you know how important it is for someone else besides yourself to handle this process, what can our experts do exactly? The most important thing is that our consultants will look over all of your application materials thoroughly and make sure everything is up-to-date (guiding you on how to best update things). Then based on their expertise in food safety law, regulations, and standards set by governing bodies like the Canadian Food Inspection Agency (CFIA), etc., we’ll ensure everything looks good from both an internal perspective within your business as well as externally—from a regulatory standpoint.

Tags Cfia, food business, Food Labelling, food regulations, Safe Food for Canadians Regulations, safe food license

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Clearing Regulatory Hurdles with a 510K Premarket Notification

Post author By Quality Smart Solutions
Post date January 23, 2023

Submitting a 510K Premarket Notification is an essential step in the process of getting medical devices approved by the FDA. This notification includes detailed information about the device and its intended use and data regarding safety and efficacy. Learn more about the procedure for submitting a 510K Premarket Notification here.

What is the 510k process?

The 510k process is a regulatory pathway that medical device manufacturers must follow to gain clearance from the US Food and Drug Administration (FDA) to market their products. This process is named after the section of the Federal Food, Drug, and Cosmetic Act that outlines the requirements for clearance. The 510k process is designed to ensure that medical devices are safe and effective for their intended use. It requires manufacturers to demonstrate that their devices are substantially equivalent to devices that are already on the market and have been cleared by the FDA.

Who needs to submit a 510k application?

Any medical device manufacturer who wants to market a new device in the United States or make significant changes to an existing device must submit a 510k application to the FDA. This includes manufacturers of Class I, II, and III medical devices. Class I devices are considered low-risk and include items like bandages and tongue depressors. Class II devices are moderate-risk and include items like powered wheelchairs and pregnancy test kits. Class III devices are high-risk and include items like pacemakers and artificial heart valves.

What are the different types of 510k submissions?

There are three types of 510k submissions: traditional, abbreviated, and special. Traditional 510(k) submissions are for devices that have not been previously cleared by the FDA and require the most extensive documentation. Abbreviated 510k submissions are for devices that have already been cleared by the FDA and have a similar predicate device. Special 510(k) submissions are for devices that have minor changes to an existing device that do not affect its safety or effectiveness. It’s important to choose the right type of submission for your device to ensure a smooth and efficient process.

What are the key components of a successful 510k application?

A successful 510k application requires careful planning and attention to detail. Key components include a thorough description of the device and its intended use, a comparison to similar devices already on the market, detailed testing and validation data, and a comprehensive risk analysis. It’s also important to ensure that all documentation is complete and accurate, and that any questions or concerns raised by the FDA are addressed promptly and thoroughly. Working with experienced regulatory consultants can help ensure that your 510k application is successful and meets all necessary requirements.

How long does the 510k process take and what are the potential outcomes?

The length of the 510(k) process can vary depending on the complexity of the device and the completeness of the application. On average, the process can take anywhere from 3 to 12 months. The potential outcomes of a 510(k) submission include clearance, which allows the device to be marketed in the US, or a request for additional information or clarification from the FDA. In some cases, a device may be deemed not substantially equivalent to existing devices on the market and may require a more rigorous premarket approval process. It’s important to work closely with regulatory consultants and the FDA throughout the process to ensure the best possible outcome for your device.

What is a 510 K Premarket Notification?

A 510 K Premarket Notification is a type of federal regulatory filing that must be completed before the FDA will approve the marketing of any medical device in the United States. This notification must include extensive information about the device, its intended use, and how it works. Companies need to make sure their 510 K submission includes all the necessary components before submitting it to the FDA, as incomplete or incorrect filings can cause delays in the approval process.

When Should Companies File a 510k premarket notification?

Companies should submit the 510 K Premarket Notification as soon as they know that their product meets the criteria for medical device clearance. It’s important to note that some devices may require multiple filings or additional components like clinical studies. Companies should consider submitting their notification at least six months before marketing their product, allowing time for FDA review and approval.

How to Prepare and Submit the Notification?

A 510 K Premarket Notification consists of two parts: an Executive Summary and a Technical Document. The Executive Summary will provide the FDA with an overview of the medical device and will also include statements on how it meets the pre-defined criteria for submission. The Technical Document should include a detailed explanation of the design, performance, labeling, and quality of the device. Companies can work with regulatory consultants to ensure the submission is complete and accurate before submitting it to the FDA for review.

Benefits of Submitting a 510 K (PMN)?

Submitting a 510K Premarket Notification can help to reduce regulatory complexity and simplify the process of getting necessary FDA clearance for a medical device. It also helps speed up the timeline, as the FDA can review medical device applications more quickly with the information provided in the submission package. Submitting a 510K PMN allows organizations to gain an understanding of any potential risks associated with their product and make changes before launching it on the market.

Know the Time Frame for the submitted 510k PMN?

Most 510K submissions take 90-120 days for FDA approval. However, different factors can influence the speed of the process such as the complexity of the device, amount and quality of supporting information, type of product, and submission medium used. It is important to determine how long it typically takes before beginning the process to ensure that you work with realistic timelines and expectations.

Quality Smart Solutions FDA experts can help you prepare your FDA 510k Premarket Notification!

Tips to Successfully Navigate Through the FDA’s Medical Device 510(k) Submissions:

Submitting a 510(k) application to the FDA for your medical device can be a stressful and complicated process. Luckily, there are a few tips and tricks you can use to make the submission process easier and increase the likelihood of your device being approved. Here are helpful steps to help you get your device cleared by the FDA.

Collect Device Information and Data:

Before you can prepare your application, you’ll need to collect all of the relevant device information and data. This includes technical documentation such as user manuals, drawings, Schematics, and specifications. You should also provide safety and performance testing results (if applicable) as well as supporting clinical research or studies that validate the use of your device. Make sure to submit up-to-date documents so that the FDA gets an accurate picture of your device.

Understand FDA Requirements for a 510(k):

Before you can submit your Medical Device 510(k) application to the FDA, it is important to understand the FDA’s requirements and guidelines. Applications must include detailed information about your device, such as its intended use and components so that the FDA can assess whether or not it meets all applicable safety and performance standards. Additionally, complete and accurate labeling with clear instructions for use should also be provided. This information will help the FDA evaluate your device before approving it.

Formulate Your Submission Plan:

Creating a comprehensive plan will help you map out the steps required to successfully apply. This includes gathering all relevant device data, test results, and safety reports; determining any applicable FDA regulations and standards; and planning review and submission timelines. Additionally, if your device is being marketed internationally, it is important to familiarize yourself with the requirements in those countries so that you can ensure that your device meets all necessary criteria.

Create an FDA Regulatory Strategy:

When submitting a 510(k) application, it is important to create a regulatory strategy. This should include identifying any applicable FDA regulations and standards that your device needs to meet, as well as understanding the specific requirements for your type of product. Additionally, you will need to determine the most suitable submission process and pathway, such as traditional or abbreviated 510(k), Special 510(k), or notified body review/certification. Knowing which pathway works best for your device will ensure a successful and timely submission.

Compile your Test Results and Supporting Documentation:

Your 510(k) application will likely need to include a considerable amount of supporting documentation, such as full product specifications, results from preclinical testing, and comprehensive safety and performance data. These must be sourced, detailed, and organized into the submission package. This is one of the most important steps when submitting a 510(k) application as you must compile all relevant test results and device information that proves the safety and efficacy of your device before approval.

Tags 510k medical device, 510K Premarket Notification, 510k Registration, 510k Submission, Medical Device, Medical Device License, Medical Device Regulations

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How to Master the 12 Steps of HACCP Certification & 7 Principles

Post author By Quality Smart Solutions
Post date January 21, 2023

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.

Completing this certification program means completing seven important steps. In this guide, we’ll provide an overview of the 12 HACCP steps and 7 principles and help you get ahead on your certification process.

Understand HACCP Principles

The first step to getting certified in the HACCP system is to understand the seven principles that makeup HACCP guidelines.

These seven principles, developed by the Codex Alimentarius workgroup, were designed to ensure safe food production and handling. Knowing and understanding these principles will help you when it comes time to complete the certification steps.

Assign Responsibility & Authority

The fifth step of the HACCP certification process is to assign responsibility and authority. By doing this, it will enable all personnel involved in the HACCP system to adhere to the guidelines with a greater degree of consistency. This can be done by providing training to individuals assigned to positions related to HACCP and assigning personnel authority commensurate with their responsibilities within the system. Additionally, establish working relationships between groups of personnel who work together or provide oversight over any food safety process or part thereof.

Identify Critical Control Points (CCPs)

A critical control point (CCP) is a step of the process at which control can be applied to prevent or eliminate food safety hazards.

The seven principles for developing and managing a successful HACCP plan involve formally identifying CCPs, establishing critical limits for each CCP, monitoring these steps, ensuring corrective action is taken when necessary, verifying the system’s effectiveness, making sure all records are maintained, and conducting regular reviews. All of these steps contribute to the proper implementation of the HACCP plan.

Establish Critical Limits at CCPs

Establishing critical limits at CCPs is a hugely important step of your HACCP plan. These limits define the parameters which must be followed to ensure food safety. When determining the critical limits, it’s important to consider the type of hazard and its respective Severity of Consequence (SOC) should it occur. Upper and lower control points are sometimes established to describe the range in which an operation should work. For example, the time/temperature combination necessary for cooking a meat product may have an upper and lower limit that must be adhered to for the food to be considered safe.

Why are HACCP plans important for food businesses?

Food safety is a critical issue for any food business. Consumers expect that the food they consume is safe and of high quality. However, the food production process is complex, and many potential hazards, such as biological, chemical, and physical, can contaminate the food. These hazards can arise at any stage of food production, from receiving raw materials to shipping finished products. Therefore, food businesses need a systematic approach to identify and control these hazards.

This is where a HACCP plan comes in. A HACCP plan is a proactive approach to managing food safety hazards by identifying potential risks and implementing control measures to prevent or reduce them. A HACCP plan is a legal requirement in many countries, and failure to comply with these regulations can result in serious legal consequences for your business.

Implementing a HACCP plan can help your food business to minimize the risk of food safety hazards, thereby protecting your customers and your business. In addition, a HACCP plan can help you improve the quality of your products, reduce waste, and increase efficiency.

What food safety hazards should be considered in a HACCP plan?

Before developing a HACCP plan, it is essential to understand the different types of food safety hazards that can contaminate your food. There are three main types of food safety hazards: biological, chemical, and physical.

Biological hazards are microorganisms that can cause illness or disease, such as bacteria, viruses, and parasites. These hazards can arise from many sources, such as contaminated water, raw materials, or equipment.

Chemical hazards are substances that can cause illness or injury, such as pesticides, cleaning agents, or food additives. These hazards can arise from many sources, such as contaminated raw materials or the improper use of chemicals.

Physical hazards are foreign objects that can cause injury or illness, such as broken glass, metal fragments, or hair. These hazards can arise from many sources, such as equipment failure or poor handling practices.

Identifying potential hazards that can contaminate your food and developing control measures to prevent or reduce them is essential.

How do you develop a HACCP plan for your food business?

Developing a HACCP plan can be a complex process, but ensuring the safety and quality of your food products is essential. Conducting a hazard analysis is the first step in creating a HACCP plan. This involves identifying potential hazards at each stage of the food production process. Once you have identified the hazards, you can determine the CCPs and establish critical limits.

The next step is to develop monitoring procedures to ensure that the critical limits are met. Monitoring procedures can include visual inspections, measurements, or testing. You should also establish corrective actions to be taken if the required limits are not met. Disciplinary actions can include adjusting the process, stopping production, or disposing of contaminated products.

Once you have developed the monitoring and corrective action procedures, you should implement verification procedures to ensure the HACCP plan works correctly. Verification procedures can include testing, sampling, or reviewing records.

Finally, it would help if you established record-keeping and documentation procedures to document the HACCP plan. Records should be kept for a minimum of two years and should include hazard analysis, CCPs, critical limits, monitoring procedures, corrective actions, and verification procedures.

How do you implement a HACCP plan in your food business?

Implementing a HACCP plan can be challenging, but ensuring the safety and quality of your food products is essential. The first step in implementing a HACCP plan is to train your employees on the principles of HACCP and the procedures developed for your food business.

Establishing a HACCP team to oversee the plan’s implementation would be best. The HACCP team should include individuals with expertise in food safety, quality control, and production.

It is also essential to ensure that your equipment and facilities are designed and maintained to prevent contamination. It would help if you established cleaning and sanitation procedures to ensure that your equipment and facilities are free from contamination.
Finally, you should regularly audit your HACCP plan to ensure it works correctly. Audits can include reviewing records, testing, or observing the production process.

How do you maintain and update your HACCP plan?

Maintaining and updating your HACCP plan is essential to ensuring that it continues to meet the changing needs of your food business. You should regularly review your HACCP plan to ensure it effectively controls hazards.

You should also update your HACCP plan if there are any changes to your food production process, such as introducing new ingredients or equipment. You should also update your HACCP plan if there are any changes to food safety regulations.

Finally, you should ensure that your employees are trained on any updates to the HACCP plan.

What are the common HACCP process mistakes to avoid?

While implementing a HACCP plan can provide many benefits for your food business, there are also common mistakes that you should avoid. These mistakes include:
– Failing to conduct a thorough hazard analysis
– Failing to establish critical limits
– Failing to implement monitoring procedures
– Failing to establish corrective actions
– Failing to implement verification procedures
– Failing to keep accurate records
By avoiding these common mistakes, you can ensure that your HACCP plan effectively controls hazards and ensures the safety and quality of your food products.

Why are HACCP plan certification (12 steps and 7 principles) and training important?

HACCP plan certification and training can give your food business additional credibility and assurance that you are operating at the highest food safety and quality standards. Certification can also be a legal requirement in some countries.

HACCP plan certification involves an independent third-party verifying that your HACCP plan meets the required standards. Training can give employees the knowledge and skills to implement and maintain the HACCP plan effectively.

1. Establish a HACCP Team

The HACCP team consists of individuals possessing a wide range of disciplines and knowledge to contribute to the process of food safety. A typical team includes:

Team Leader: orchestrates and organizes the planning process; identifies the scope and specific problem(s) of the plan.
Specialist(s): provide consultation and formulation of the plan through their expertise and knowledge.
Front Line Staff: includes farmers, distributors, processors, etc.; have in-depth perspective on creating the food product.
Stakeholders: e.g. consumers, board of directors, departments, etc.

2. Describe the Product

A full description of the final product should have the following elements for the HACCP team to identify hazards in creating the product:

Ingredients, and their characteristics;
Formulation (aka “recipe”) of the product;
Process of packaging, storing, and transporting;
Shelf life.

3. Purpose of the Product

The team determines the main intent of how the product will be used. Will it be cooked, eaten directly, or require further processing? The team needs to identify its intended consumers and determine any vulnerabilities when using the product. Lastly, the team should consider the effects of misuse or abuse of the product on the general population.

4. Process Flow Diagram

A process flow diagram gives the HACCP team a broader view of the manufacturing process of the product. The diagram can also consist of a schematic of the facility, lending an easier understanding of the steps of each process.

5. On-Site Confirmation of Flow Diagram

The HACCP reviews the operating/manufacturing process to determine the quality of the flow diagram. Multiple reviews can be done and compared to iron out deficiencies in the process. The site for which the HACCP plan is being designed should be visited as many times as possible to make sure all relevant information is collected.

6. Identify and analyze hazards (Principle # 1)

While identifying potential hazards, the HACCP team must do some background research on the following:

Ingredients and materials used in the product
Activities performed in each step of the manufacturing process
Method of storage and distribution
Use/consumption of the product

During analysis, the HACCP evaluates the product’s effects on human, environmental, and organizational interaction.

Control measures are considered once hazards are identified and analyzed during the manufacturing process. At times, organizations may have to hire external food safety consultants to offer different perspectives.

7. Determine the Critical Control Points (CCPs) (Principle # 2)

A critical control point is a step in the process flow diagram that involves reducing, eliminating, and preventing food safety hazards. If CCPs are not in place, production will stop and cannot continue further.

8. Establish Critical Limits for each CCP (Principle # 3)

A critical limit measures the maximum/minimum value of certain factors that have an impact on reducing, preventing, and eliminating food safety hazards. Factors such as temperature, time, moisture level, and visual appearance are considered.

9. Establish a Monitoring Procedure (Principle # 4)

A general monitoring procedure consists of:

Ensuring critical limits of each CCP are being met;
Detecting any inefficiencies of the control measures;
Corrective actions need to be taken as quickly as possible to avoid and minimize the loss of the product;
Observing or measuring samples using a statistically-based sampling plan;
Common measurements taken are time, temperature, moisture, and content.

10. Establish Corrective Actions (Principle # 5)

Corrective actions must be taken immediately if critical limits are not being met. Management and employees should be trained on how to perform and respond appropriately.

11. Verify the HACCP Plan (Principle # 6)

Once the plan is drafted and CCPs have been validated, the HACCP plan can then be verified. The team must evaluate if CCPs and control measures are effective. Internal auditing may be required to demonstrate an ongoing commitment to complying with and updating the HACCP plan. Asking questions, observing operational procedures, and collecting samples are just some of the ways to verify the plan.

12. Keep Records (Principle # 7)

Record keeping is an essential step of the HACCP plan due to the following:

Offers traceability and transparency
Ensures due diligence
Provides a record of complaints with critical limits set
Identifies potential problems

Record keeping can be carried out in several ways, such as checklists or control charts. Manual and computer records are acceptable, but the documentation method should be designed such that it is appropriate for the size and nature of the organization.

What are the benefits of implementing HACCP principles?

Implementing HACCP principles in food manufacturing has numerous benefits. Firstly, it helps to prevent foodborne illnesses by identifying potential hazards and implementing controls to prevent them. This not only protects consumers but also protects the reputation of the manufacturer. Additionally, implementing HACCP principles can improve efficiency and reduce waste by identifying areas where processes can be streamlined. It can also help manufacturers comply with regulatory requirements and improve overall food safety management. Overall, implementing HACCP principles is crucial for any food manufacturer looking to maintain consumer trust and ensure the safety and quality of their products.

What is the role of HACCP in food safety regulations?

HACCP plays a critical role in food safety regulations by providing a systematic approach to identifying and controlling potential hazards in the food production process. Many countries have regulations in place that require food manufacturers to implement HACCP principles as part of their food safety management systems. By doing so, manufacturers can ensure that their products are safe for consumption and comply with regulatory requirements. HACCP also helps to prevent foodborne illnesses, which is a major public health concern. Overall, HACCP is an essential tool for ensuring the safety and quality of food products and maintaining consumer trust.

If you or your company is seeking assistance in implementing a HACCP plan we’re ready to serve you. Quality Smart Solutions has a team of experts who can implement a HACCP plan, coach, and train your staff. Get prepared now and contact us today to discuss how we can be your solution!

Common Challenges in Implementing HACCP and How to Overcome Them

Implementing HACCP can pose several challenges for businesses, including resistance to change, lack of resources, and complexity. However, these challenges can be overcome through careful planning, effective communication, and training.

Resistance to change can be addressed by creating awareness about the benefits of HACCP and involving employees in the decision-making process. Providing adequate resources, including training, equipment, and support, is crucial for successfully implementing HACCP. Moreover, simplifying the HACCP process and breaking it down into manageable steps can help overcome complexity-related challenges.

The Role of HACCP in Regulatory Compliance

HACCP plays a crucial role in regulatory compliance for businesses in the food industry. Many countries have regulatory requirements that mandate the implementation of HACCP for specific sectors, such as meat and poultry processing, seafood processing, and dairy production. By implementing HACCP, businesses can demonstrate compliance with these regulations and avoid penalties and legal consequences.

Moreover, HACCP provides a proactive approach to food safety and quality, which is highly regarded by regulatory authorities. By implementing HACCP, businesses can demonstrate their commitment to producing safe, high-quality food products and building trust with regulators and consumers.

HACCP Certification and Its Importance

HACCP certification is a voluntary process through which businesses can demonstrate their compliance with HACCP principles and standards. Certification is typically conducted by independent third-party organizations that assess the implementation and effectiveness of a company’s HACCP system.

HACCP certification provides several benefits for businesses. Firstly, it serves as a mark of credibility, demonstrating to consumers, regulators, and business partners that the company has implemented robust food safety and quality management systems. Secondly, certification can open doors to new markets and business opportunities, as many retailers and distributors require their suppliers to be HACCP-certified.

Overall, HACCP certification adds value to a company’s brand, enhances its reputation, and strengthens its position in the market. Below find a breakdown of the benefits of the HACCP process and plan.

Benefits of the HACCP Plan:

What are the primary benefits of implementing a HACCP plan in my business?
- Implementing an HACCP plan helps improve food safety, reduce the risk of foodborne illnesses, enhance product quality, and increase consumer confidence in your products.
How can a HACCP plan benefit my business’s reputation and brand?
- An effective HACCP plan demonstrates your commitment to food safety and quality, which can build trust with customers, retailers, and regulatory authorities, ultimately enhancing your brand reputation.
Does an HACCP plan lead to cost savings for my business?
- Yes, an HACCP plan can lead to cost savings by reducing product recalls, waste, and rework, as well as by minimizing the risk of legal and regulatory penalties associated with food safety violations.
Will implementing HACCP help me meet regulatory requirements and compliance standards?
- Yes, HACCP is a widely recognized and accepted food safety system that helps businesses meet regulatory requirements and comply with food safety standards such as those set by the FDA and USDA.
How can a HACCP plan benefit my supply chain relationships?
- Having an HACCP plan in place can improve relationships with suppliers and partners by ensuring consistency and quality throughout the supply chain.
Does HACCP provide a framework for continuous improvement in my food safety processes?
- Yes, HACCP emphasizes continuous monitoring and improvement, enabling your business to adapt to changing circumstances and improve food safety over time.

HACCP Process

What is the HACCP process, and how does it work?
- The HACCP process is a systematic approach to identifying, evaluating, and controlling food safety hazards. It involves seven principles, including hazard analysis, critical control point determination, and monitoring.
What are the key steps in developing an HACCP plan for my business?
- The key steps include conducting a hazard analysis, identifying critical control points, establishing critical limits, implementing monitoring procedures, taking corrective actions, verifying the system, and documenting the plan.
How can I identify critical control points (CCPs) in my food production process?
- Critical control points are identified through a thorough analysis of your process to determine where hazards can be prevented, eliminated, or reduced to an acceptable level.
What role does monitoring play in the HACCP process?
- Monitoring involves regularly checking and recording data at critical control points to ensure that the process is under control and that food safety hazards are being managed effectively.
What should I do if a deviation or non-conformance is detected during monitoring?
- If a deviation occurs, you must take corrective actions to bring the process back under control and prevent unsafe products from reaching consumers.
How do I verify the effectiveness of my HACCP plan?
- Verification involves reviewing and confirming that the HACCP plan is working as intended. This can include testing, reviewing records, and conducting audits.
Is documentation a crucial aspect of the HACCP process?
- Yes, thorough documentation is essential for HACCP compliance. It helps demonstrate that you have followed the process correctly and allows for traceability in case of issues.
Where can I find resources or training on implementing the HACCP process in my business?
- You can seek guidance from food safety consultants, industry associations, or take courses offered by reputable organizations and institutions specializing in food safety and HACCP.

Implementing an HACCP plan and following the HACCP process is critical for ensuring food safety, quality, and regulatory compliance in the food industry. It’s essential for business owners to understand the benefits and steps involved in HACCP to protect their customers and their business.

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What Should I know about the FDA GRAS Database & Notice

Post author By Quality Smart Solutions
Post date January 18, 2023

Introduction

Like most food businesses, you probably spend a lot of time thinking about what’s in your food and how to ensure it’s safe. One of the ways you can do this is by checking the FDA GRAS (Generally Recognized as Safe) database.

This database is a compilation of food substances/ingredients that are safe for human consumption. This means that when you see a food listed on the FDA GRAS Database, the Food and Drug Administration has determined that the food is generally considered safe for human consumption.

We will walk you through the process of accessing the FDA GRAS Database and show you some of the food substances that are currently listed.

What is an FDA GRAS Notice?

The FDA GRAS Notice is a formal notification from the FDA declaring that a food or food substance/ingredient is generally recognized as safe. The database of FDA GRAS Database can be accessed online here.

This database can be useful for scientists and researchers who are interested in determining if a particular food substance is safe to use in a food product or recipe during product development stages. It can also be used by manufacturers to determine which additives may be safely included in their products.

GRAS Notification Process:

The Food and Drug Administration (FDA) notifies the public of a food substance that has been determined to be Generally Recognized As Safe (GRAS). The GRAS notification dossier process follows a specific, standardized template that is published on the FDA’s website.

Food manufacturers must submit an application containing information about the food substance, as well as evidence that it is safe for use. Manufacturers can also request emergency approval if the substance is new and has not been previously tested by the FDA. After reviewing the application, the FDA will either issue a GRAS notification or determine that further safety testing is necessary.

If the substance is already listed in the FDA’s GRAS database, manufacturers do not need to submit an application or provide additional evidence. However, they must still follow all other applicable regulations when using this substance in food products.

FDA GRAS lists essential oils:

The FDA has updated its website to include a list of essential oils that are GRAS (Generally Recognized as Safe) according to the FDA. The essential oils on the list have been deemed safe by the FDA and they do not believe there to be any harmful effects associated with using these essential oils.

Some of the essential oils that are on the GRAS list are lavender, peppermint, thyme, rosemary, and chamomile. It is important to remember that these essential oils are only considered safe if used by the instructions on the bottle or package. If you are pregnant or breastfeeding, it is always best to speak with your doctor before using any type of essential oil.

FDA GRAS:

Until recently, the identities of many food additives were a closely guarded trade secret. But with the passage of the Food Quality Protection Act (FQPA) in 1996, this policy changed. Now all food additives must be listed in the Federal Register and be subject to public review and comment. This open process allows consumers and other interested parties to learn about potential hazards and health concerns associated with these ingredients.

Foods that contain GRAS substances are not required to disclose their contents, but they are still subject to regulatory scrutiny. In March of this year, FDA released its GRAS Notice database, which provides detailed information on more than 1,500 GRAS substances currently used in foods. This expansive database will help ensure that foods containing these ingredients are safely consumed by Americans.

The release of this database is an important step in ensuring that Americans have access to safe and healthy foods. By publicly disclosing the ingredients used in American food products, FDA is ensuring that consumers can make informed choices about what they eat.

Navigating the GRAS Notice process for new food products:

If you’re a food product developer, you may have heard of the GRAS notice process. This process is used to determine whether a substance is Generally Recognized As Safe (GRAS) for use in food. However, the process can be complex and overwhelming for those who are new to it. In this guide, we’ll break down the steps of the GRAS notice process and provide helpful tips for success.

Understand the basics of GRAS

Before diving into the GRAS notice process, it’s important to understand the basics of what it means for a substance to be Generally Recognized As Safe. According to the FDA, a substance is considered GRAS if it is generally recognized by qualified experts as safe for its intended use in food. This determination is based on scientific evidence and the substance’s history of safe use in food. It’s important to note that GRAS status is not a formal FDA approval, but rather a determination made by the food industry.

Conduct a thorough safety assessment

The first step in navigating the GRAS notice process is to conduct a thorough safety assessment of the substance in question. This assessment should include a review of all available scientific literature and data on the substance, as well as any relevant safety studies or toxicology reports. It’s important to consider all potential routes of exposure to the substance, including ingestion, inhalation, and skin contact. Additionally, any potential risks to vulnerable populations, such as children or pregnant women, should be carefully evaluated. A comprehensive safety assessment will help ensure that the substance is safe for its intended use in food and will increase the likelihood of a successful GRAS notice submission.

Prepare and submit your GRAS notice

Once you have completed your safety assessment and are confident that your substance is safe for its intended use in food, it’s time to prepare and submit your GRAS notice to the FDA. The notice should include a detailed description of the substance, its intended use in food, and the basis for its safety. It should also include a summary of the safety assessment and any supporting data or literature. It’s important to follow the FDA’s guidance on formatting and content requirements for GRAS notices to ensure that your submission is complete and meets all necessary criteria. Once your notice is submitted, the FDA will review it and provide feedback or request additional information as needed. With careful preparation and attention to detail, you can increase your chances of a successful GRAS notice submission and bring your new food product to market.

Work with the FDA to address any concerns or questions

During the GRAS notice process, the FDA may have questions or concerns about your submission. It’s important to work with them to address these issues and provide any additional information they may need. This can include providing more data or literature to support the safety of your substance, r addressing any potential risks or uncertainties. By working collaboratively with the FDA, you can ensure that your submission meets all necessary criteria and increase your chances of a successful outcome. Remember, the ultimate goal is to bring a safe and innovative new food product to market, and working with the FDA is an important part of that process.

Keep up with ongoing monitoring and reporting requirements

Once your substance has been deemed GRAS, it’s important to continue monitoring its safety and any potential risks. This includes ongoing testing and research, as well as reporting any adverse events or concerns to the FDA. It’s also important to keep up with any changes in regulations or guidelines related to your substance or the food industry as a whole. By staying informed and proactive, you can ensure the continued safety and success of your new food product.

Tags Fda, Food Labelling, food regulations, Food Safety, GRAS Database, GRAS Notice

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Dietary Supplement Labeling Guide: Everything you should know

Post author By Quality Smart Solutions
Post date January 11, 2023

Introduction:

The FDA offers an online dietary supplement labeling guide that provides labeling requirements for supplement manufacturers. The guide covers issues such as Supplement Facts Panel (SFP) labeling, ingredient labeling, and health claims.

In the USA, there are strict requirements for supplement labels. The FDA (Food and Drug Administration) requires all supplement labels to list the following: • Supplement name • Net quantity of contents • Direction for use • Warning statements if any • Supplement Facts Table • List of ingredients. All of this information must be displayed clearly and concisely.

You must comply with all the requirements if you want to do business in the USA, otherwise, the FDA may issue you a Warning Letter.

If you are unsure how to comply with these requirements, you can always consult a professional consultancy service, such as Quality Smart Solutions.

What is a dietary supplement?

A dietary supplement is a product that contains nutrients derived from food sources that are intended to supplement the diet. The most common type of dietary supplement is a vitamin or mineral supplement, which can be used to treat deficiencies or prevent health problems. Other types of dietary supplements include protein supplements, omega-3 fatty acid supplements, and herbal supplements.

Dietary supplements may be found in many forms, such as pills, tablets, capsules, gummies, soft gels, liquids, and powders. They can also be in the same form as a conventional food category, such as teas or bars, but only if the product is not represented as a conventional food or as a “sole item of a meal or the diet.” To be a dietary supplement, a product must also be labeled as a dietary supplement; that is, the product label must include the term “dietary supplement” or equivalent (e.g., “iron supplement” or “herbal supplement”).

Dietary supplements are not meant to replace food or medicine. They should be used as part of a healthy lifestyle.

Understanding Dietary Supplement Labeling

Dietary supplement labeling serves as an essential tool for both manufacturers and consumers. For manufacturers, it is an opportunity to provide accurate and informative information about their products. At the same time, it helps consumers make informed decisions. Understanding the importance of proper labeling is crucial in ensuring the safety and efficacy of dietary supplements.

Proper labeling helps consumers identify and select the right supplements for their needs and allows manufacturers to differentiate their products in a crowded market. Clear and concise labeling will enable consumers to understand the product’s purpose, ingredients, and recommended usage, allowing them to make informed choices.

FDA Regulations for Dietary Supplement Labeling

The Food and Drug Administration (FDA) is vital in regulating dietary supplement labeling in the United States. The FDA’s regulations ensure that supplement labels are accurate and transparent and do not mislead consumers. Compliance with these regulations is essential for manufacturers to avoid legal consequences and maintain consumer trust.

The FDA requires dietary supplement labels to include key components, such as a statement of identity, net quantity of contents, nutrition labeling, ingredient list, and manufacturer/distributor information. These requirements ensure that consumers have access to vital information about the product they are considering.

What are the labeling requirements for dietary supplements?

In order for a dietary supplement to be sold in the USA, it must comply with the FDA’s labeling requirements. These requirements are designed to ensure that consumers can make informed decisions about the supplements they purchase and to protect them from products that may be harmful.

Dietary supplements in the USA must be properly labeled according to the FDA’s requirements. The label must include the supplement’s name, net quantity of contents, list of ingredients, and the manufacturer’s or distributor’s name and address.

Additionally, the label must state any warnings or precautions associated with the supplement.

Need help with your dietary supplement labeling?

Contact Quality Smart Solutions today! We can help.

What are the key components of a Dietary Supplement Label?

A well-designed dietary supplement label contains several key components that provide essential information to consumers. These components include a statement of identity, net quantity of contents, nutrition labeling, ingredient list, and manufacturer/distributor information.
The statement of identity identifies the product and its intended purpose. It should concisely reflect the product’s nature, such as “Calcium Supplement” or “Herbal Sleep Aid.” The net quantity of contents indicates the amount of the product contained within the package. This information is crucial for consumers to determine the value and duration of use.

Nutrition labeling provides consumers with information about the product’s nutritional content. It includes serving size, calories, macronutrients, vitamins, and minerals. This information helps consumers understand the nutritional benefits of the supplement and make informed choices based on their dietary needs.

Nutritional Information and Serving Size Requirements

When it comes to dietary supplement labeling, providing accurate and comprehensive nutritional information is essential. The FDA requires supplement labels to include a serving size and the number of servings per container. This information helps consumers understand the appropriate dosage and duration of use.

The nutritional information should also include the total calories per serving and the amounts of macronutrients, such as carbohydrates, proteins, and fats. This applies to vitamins, minerals, and other essential nutrients and is also crucial to inform consumers about the product’s nutritional value.

Manufacturers must ensure that the nutritional information is accurate and based on reliable testing methods. Any claims made regarding nutritional benefits should be supported by scientific evidence.

Health Claims and Structure-Function Claims on Dietary Supplement Labels

Structure-function claims are the only type of claims that can be made on dietary supplement labels. Structure-function claims describe the role of a nutrient or ingredient in maintaining normal bodily functions. Other types of health claims may be deemed to be for the treatment of diseases or conditions, would be deemed drug claims and are not allowed for dietary supplements.

FDA does not approve health claims for dietary supplements. As such a disclaimer to this effect must appear on a dietary supplement label. The expectation is that health claims used on labels and on any other marketing related material including print and web media must be supported by significant scientific evidence.

On April 13, 2023 FTC warned over 600 dietary supplement companies about backing up claims made on their products and potential civil penalties if they don’t do so. The announcement can be found here.

Manufacturers must understand health and structure-function claims regulations to ensure compliance and avoid misleading consumers.

What are the requirements for dietary supplement Ingredient Lists and Allergen Declarations?

The ingredient list is one of the most important components of a dietary supplement label. It provides consumers with information about the ingredients used in the product, helping them identify potential allergens and make informed choices based on their dietary restrictions.
The FDA requires supplement labels to list all ingredients in descending order of predominance by weight. This means that the ingredient with the highest amount should be listed first, followed by the next highest amount, and so on.

In addition to listing the ingredients, manufacturers must declare any major food allergens. These allergens include common ingredients such as milk, eggs, fish, shellfish, tree nuts, peanuts, wheat, and soybeans. Clear allergen declarations help consumers with food allergies or sensitivities avoid products that may cause adverse reactions.

Additional Labeling Requirements for Specific Types of Dietary Supplements

Different dietary supplements may have specific labeling requirements based on their nature and intended use. For example, dietary supplements containing botanical ingredients may require additional labeling to provide detailed plant part information or extraction methods.

Manufacturers need to familiarize themselves with the specific regulations on their product type to ensure compliance and avoid any potential legal issues.

Designing an effective and visually appealing supplement label

In addition to meeting regulatory requirements, designing an effective and visually appealing supplement label is crucial for attracting consumers and standing out in a competitive market. A well-designed label should accurately represent the brand, clearly communicate the product’s benefits, and engage the target audience.

Consider font choice, color scheme, and layout to create a visually appealing label. It’s important to balance aesthetics and readability to ensure the information is easily accessible to consumers.

Including high-quality product images, relevant icons, and clear call-to-action statements can further enhance the label’s appeal and encourage consumers to purchase.

What are the common mistakes to avoid in Dietary Supplement Labeling?

While understanding the regulations and requirements for dietary supplement labeling is crucial, it is equally important to be aware of common mistakes that should be avoided. These mistakes can lead to regulatory non-compliance, legal consequences, and damage to brand reputation.

Some common mistakes in dietary supplement labeling include inaccurate ingredient listings, misleading health claims, incorrect serving size information, and failure to declare allergens. Poor design choices, such as illegible fonts or cluttered layouts, can negatively impact consumer perception and trust.

By being aware of these mistakes and taking proactive measures to avoid them, manufacturers can ensure that their supplement labels are accurate, compliant, and effective in attracting consumers.

What information must be included on the supplement label?

All dietary supplements must be labeled with the following information:

The product’s name/identity and contact information for the manufacturer or distributor
The term “dietary supplement” or equivalent on the principal display panel
A list of all ingredients
The recommended dosage
Net quantity of contents
Nutrition labeling/Supplement Facts Panel
Any warnings or precautions associated with the product
The expiration date or “best before” date

Who is responsible for ensuring that dietary supplements are labeled correctly?

It is the responsibility of the supplement brand owner, whether that is the manufacturer or a marketing company to ensure that their products are properly labeled by American law. The Dietary Supplement Health and Education Act of 1994 (the DSHEA) defines what a “dietary supplement” is, and includes specific labeling requirements for dietary supplements, as well as optional labeling statements.

The FDA recommends that consumers consult a healthcare professional before taking any dietary supplements, especially if they have pre-existing health conditions.

Can I sell my Natural Health Product that has an NPN in the United States without changing packaging?

FDA’s rules for dietary supplements are different than those in Canada including what type of health claims can be made, route of administration (eg. topical products are only cosmetics and drugs in the United States), label formatting and structure.

What do I need to do before selling dietary supplements in Canada?

You need to obtain a Natural Product Number (NPN). This is a license issued by Health Canada for Dietary Supplements. The process to obtain a license can take 10 to over 210 days depending on the ingredients in the formula.
You must have a compliant label, both in terms of content and layout as well as a bilingual label that is in both English and French.
Your manufacturing facility has to be annexed to a Natural Health Product site licensed importer (these licenses are only issued to Canadian businesses). Quality IMPORT Solutions is a Health Canada site license holder to act as an import agent for natural health products into Canada.

Supplement Facts Panel (SFP):

The nutrition label for a dietary supplement is called a “Supplement Facts” panel. The major differences between the “Supplement Facts” panel and the “Nutrition Facts” panel are as follows:

You must list dietary ingredients without Recommended Daily Intake (RDIs) or Daily Reference Values (DRVs) in the “Supplement Facts” panel for dietary supplements. You are not permitted to list these ingredients in the “Nutrition Facts” panel for foods.
You may list the source of a dietary ingredient in the “Supplement Facts” panel for dietary supplements. You cannot list the source of a dietary ingredient in the “Nutrition Facts” panel for foods.
You are not required to list the source of a dietary ingredient in the ingredient statement for dietary supplements if it is listed in the “Supplement Facts” panel.
You must include the part of the plant from which a dietary ingredient is derived in the “Supplement Facts” panel for dietary supplements. You are not permitted to list the part of a plant in the “Nutrition Facts” panel for foods.
You are not permitted to list “zero” amounts of nutrients in the “Supplement Facts” panel for dietary supplements. You are required to list “zero” amounts of nutrients in the “Nutrition Facts” panel for food.

You must list the names and quantities of dietary ingredients present in your product, the “Serving Size” and the “Servings Per Container.” However, the listing of “Servings Per Container” is not required when it is the same information as in the net quantity of contents statement.

What are the penalties for mislabeling dietary supplements?

The penalties for mislabeling dietary supplements in the USA can be severe. The FDA generally issues warning letters if companies are illegally marketing dietary supplements which can vary from minor infractions (eg. font size of Supplement Facts verbiage, missing source material for ingredients) to major infractions such as making drug claims, high risk subpopulation risk statements missing and other. If the warning letter is not addressed or acknowledged, more severe compliance and enforcement steps can be taken including seizure of product, recall and civil penalties.

Prohibited Health Claims:

Prohibited health claims are those that are considered drug claims. These claims are:

Claims that the product can cure, treat, or prevent any disease
Claims that the product can have an immediate or dramatic effect on the structure or function of the body
Claims that the product is completely safe and has no side effects

In addition, all health claims made on dietary supplement labels must be supported by scientific evidence. It means that you will need to do your research and have studies to back up any claims you make about your product.

What is the role of the FDA in regulating dietary supplements?

The Food and Drug Administration (FDA) is a federal agency responsible for regulating the safety and efficacy of food, drugs, and medical devices in the United States. The FDA also has jurisdiction over dietary supplements, defined as products containing one or more nutritional ingredients such as vitamins, minerals, herbs, or amino acids. However, unlike drugs, dietary supplements do not require FDA approval before being marketed to consumers. Instead, the FDA regulates dietary supplements under the Dietary Supplement Health and Education Act (DSHEA) of 1994. Under this law, dietary supplement manufacturers must ensure their products are safe, properly labeled, and free from contaminants.

Despite these regulations, the FDA needs more resources to monitor the dietary supplement industry. As a result, it relies heavily on manufacturers to comply with laws and report any adverse events associated with its products. This creates a potential for inaccurate labeling, which can seriously affect consumer health.

Risks of inaccurate labeling

Inaccurate labeling is a significant risk for consumers who rely on dietary supplements to maintain their health and wellness. When supplements are mislabeled, consumers may not get the intended amount of the active ingredient or may be exposed to harmful contaminants. This can lead to adverse reactions, including allergic reactions, toxicity, or drug interactions. Sometimes, inaccurate labeling can lead to serious health complications, such as liver damage or kidney failure.

Moreover, inaccurate labeling can lead to false claims of effectiveness, which can be misleading to consumers. For example, a supplement may claim to cure a disease or condition without any scientific evidence to support such claims. This can lead consumers to delay or forego medical treatment, which can have serious consequences.

What are the common types of inaccurate dietary supplement labeling?

Consumers should be aware of several common types of inaccurate labeling when purchasing dietary supplements. One is the mislabeling of the active ingredient. For example, a supplement may claim to contain a certain amount of a particular vitamin or mineral. Still, in reality, it contains less than the advertised amount. This can lead to a deficiency in the nutrient, which can have serious health consequences.
Another type of inaccurate labeling is misidentifying the plant species used in herbal supplements. Some supplements may claim to contain a specific herb, but a different, potentially harmful plant species was used. This can lead to toxicity or other adverse reactions.

Finally, some supplements may contain harmful contaminants, such as heavy metals or pesticides, not listed on the label. This can lead to serious health complications, especially if the supplement takes a long time.

The impact of inaccurate labeling on the supplement industry

Inaccurate labeling can have a significant impact on the dietary supplement industry as a whole. When consumers experience adverse reactions or do not get the expected results from a supplement, they may lose confidence in the industry. This can lead to decreased sales and negatively impact the industry’s reputation.

Moreover, inaccurate labeling can lead to increased regulation and oversight by the FDA. This can be costly and time-consuming for manufacturers and may limit consumer choice in the marketplace.

Legal consequences of misleading labeling

Misleading labeling can have serious legal consequences for dietary supplement manufacturers. Under the DSHEA, manufacturers must ensure that their products are safe, properly labeled, and free from contaminants. Failure to comply with these regulations can result in fines, recalls, and criminal charges.

Moreover, consumers who experience adverse reactions or are misled by false claims may be able to file lawsuits against the manufacturer. This can result in significant financial damages and damage the manufacturer’s reputation.

Resources and Tools for Creating Compliant Supplement Labels

Creating compliant supplement labels can be a complex task. Still, several resources and tools are available to help manufacturers navigate the process. The FDA’s website provides detailed guidance on dietary supplement labeling requirements, including downloadable resources and examples.

Additionally, there are software solutions and online platforms specifically designed to assist in creating compliant supplement labels. These tools often provide templates, label design options, and regulatory compliance checks to ensure that labels meet all requirements. By leveraging these resources and tools, manufacturers can streamline the labeling process and ensure accuracy and compliance.

Conclusion:

In conclusion, the FDA dietary supplement labeling regulations are very important to follow. They help ensure that your dietary supplement is safe for use. The FDA’s dietary supplement labeling guide provides clear and concise requirements for supplement labels in the USA.

These requirements ensure that consumers can easily understand the key information about a supplement, including its benefits, risks, and how to use it safely. By following these guidelines, manufacturers can provide consumers with the information they need to make informed decisions about their health and well-being.