What is GRAS Certification and who does It?

GRAS certification signifies that a substance is Generally Recognized as Safe (GRAS) and can/should be used in various products meant for human consumption. The certification process is overseen by the US Food and Drug Administration (FDA). Companies must apply for GRAS certification in order to ensure the safety of their products and to ensure compliance with relevant regulations. Certification is typically required for any product that goes through FDA's regulatory process.

What are the requirements for obtaining GRAS Certification?

To obtain GRAS certification, companies must meet all requirements laid out by the FDA. Companies must have an extensive knowledge of their product's ingredients, manufacturing processes, and testing methods. The application should include supporting research data and evidence to demonstrate the safety and efficacy of the product in question. Companies are also required to disclose any potential adverse effects associated with use of their product. All applications should be accompanied by data that support safety claims so that a full review can be conducted by FDA. Once approved, companies may start marketing products as GRAS certified.

How do I apply for a GRAS Certification?

To apply for GRAS certification, companies must submit an application to the FDA outlining their product and all of its components. In the application, companies need to describe the product’s ingredients and manufacturing process, as well as provide supporting research data and evidence to demonstrate the safety and efficacy of the product. Companies are also required to disclose any potential adverse effects associated with use of their product. All applications should be accompanied by adequate data that support safety claims so that a full review can be conducted by FDA. Once approved, companies may start marketing products as GRAS certified.

What is the GRAS FDA program?

The GRAS FDA program, or "Generally Recognized as Safe" program, is a voluntary program that allows food manufacturers to self-affirm that their food additives are safe for consumption. This program was established in 1958 as part of the Food Additives Amendment to the Federal Food, Drug, and Cosmetic Act. The program is overseen by the FDA and requires manufacturers to provide scientific evidence to support their safety claims. Once a substance is determined to be GRAS, it can be used in food products without further FDA approval.

What is the history of the GRAS FDA program?

The GRAS FDA program was established in 1958 as part of the Food Additives Amendment to the Federal Food, Drug, and Cosmetic Act. The program was created to provide a streamlined process for food manufacturers to self-affirm the safety of their food additives. Prior to the program's establishment, food additives were subject to a lengthy and costly approval process by the FDA. The GRAS program allowed manufacturers to avoid this process by providing scientific evidence to support their safety claims. Over the years, the program has evolved to include more rigorous safety standards and increased oversight by the FDA.

What are the regulations and requirements for GRAS status?

To achieve GRAS status, food manufacturers must provide scientific evidence that the additive is safe for its intended use. This evidence can come from a variety of sources, including published studies, historical use in food, and expert opinions. The manufacturer must also provide a detailed description of the additive, including its chemical composition, intended use, and potential exposure levels. The FDA reviews all GRAS notifications and may request additional information or conduct its own safety assessments. If the FDA determines that an additive is not GRAS, it may take enforcement action to remove the additive from the food supply.

What are GRAS ingredients?

GRAS ingredients are substances that are considered safe for use in food products by the U.S. Food and Drug Administration (FDA). These ingredients have been extensively studied and have a long history of safe use in food. They are generally recognized as safe based on scientific evidence and expert opinion. GRAS ingredients can include substances such as vitamins, minerals, and certain food additives. It's important for food manufacturers to understand GRAS ingredients and their use in order to ensure the safety and quality of their products.

How are GRAS ingredients regulated?

GRAS ingredients are regulated by the U.S. Food and Drug Administration (FDA) under the Federal Food, Drug, and Cosmetic Act. The FDA maintains a list of substances that are generally recognized as safe for use in food products. However, it's important to note that the FDA does not approve GRAS ingredients in the same way that it approves food additives. Instead, it is the responsibility of the food manufacturer to determine the safety of a GRAS ingredient and ensure that it is used in accordance with FDA regulations. The FDA can take action against a GRAS ingredient if it is found to be unsafe or if new information emerges that raises concerns about its safety.

What are some common GRAS ingredients and their uses?

There are many GRAS ingredients that are commonly used in food products. Some examples include salt, sugar, vinegar, baking soda, and spices. These ingredients are often used for flavoring, preservation, or texture. Other GRAS ingredients include vitamins, minerals, and amino acids, which are added to food products to enhance their nutritional value. It's important for food manufacturers to carefully consider the use of GRAS ingredients in their products and ensure that they are used in accordance with FDA regulations.

What are some benefits and challenges of using GRAS ingredients?

One of the main benefits of using GRAS ingredients is that they are generally recognized as safe by the FDA, which means that they do not require pre-market approval. This can save time and money for food manufacturers. Additionally, many GRAS ingredients are natural and can be used to enhance the nutritional value of food products. However, there are also challenges associated with using GRAS ingredients. For example, some consumers may be concerned about the use of certain additives in their food. Additionally, there is always a risk of contamination or misuse of GRAS ingredients, which can lead to food safety issues. It's important for food manufacturers to carefully consider the benefits and challenges of using GRAS ingredients and ensure that they are used safely and appropriately in their products.

What are the top benefits of GRAS certification?

1. Enhanced consumer trust: Consumer trust is the foundation of any successful brand. GRAS certification is a powerful tool to build and maintain consumer trust. Food manufacturers can instill confidence in their customers by demonstrating that their products have undergone rigorous safety assessments, leading to repeat purchases and positive word-of-mouth recommendations. 2. Compliance with regulatory standards: As mentioned earlier, GRAS certification helps businesses meet the regulatory requirements set by authorities such as the FDA. By obtaining GRAS status for their ingredients, companies can ensure that their products align with the latest food safety regulations. This reduces the risk of legal consequences and helps companies stay ahead of the curve in an ever-evolving regulatory landscape. 3. Access to new markets: Many countries have adopted similar safety standards to those set by the FDA in the United States. By obtaining GRAS certification, food manufacturers can confidently expand their reach and tap into new markets. The certification provides a recognized and respected standard of safety that can help businesses navigate international trade barriers and gain access to global consumers. 4. Positive brand reputation: In today's age of social media and online reviews, a positive brand reputation is vital for sustained success. GRAS certification enhances a company's reputation by showcasing its commitment to safety and quality. This can translate into increased brand loyalty, positive media coverage, and a competitive advantage over rivals without GRAS certification. 5. Risk mitigation: The food industry is no stranger to product recalls and safety scares. By obtaining GRAS certification, companies can mitigate the risk of such incidents. The rigorous evaluation process involved in getting GRAS status ensures that ingredients are thoroughly tested for safety, reducing the likelihood of unexpected issues arising down the line. This proactive approach to risk management can save businesses significant costs and protect their reputation. 6. Ability to innovate: GRAS certification is not just limited to existing ingredients; it also applies to new substances introduced into the market. This opens up opportunities for food manufacturers to innovate and develop new products that meet consumer demands while ensuring safety. By obtaining GRAS certification for novel ingredients, companies can stay at the forefront of industry trends and maintain a competitive edge.

What is the process of obtaining GRAS certification?

Now that we understand the benefits of GRAS certification let's delve into the process involved in obtaining it. The journey towards obtaining GRAS certification can be complex and time-consuming. Still, the rewards make it well worth the effort. Here are the key steps involved: 1. Review of scientific literature: The first step in the GRAS certification process is conducting a comprehensive review of existing scientific literature related to the ingredient in question. This includes published research papers, safety studies, and relevant data supporting the ingredient's safety. 2. Expert panel selection: Once the scientific literature has been reviewed, a panel of experts needs to be assembled. This panel should consist of qualified individuals with expertise in relevant areas such as toxicology, nutrition, and food science. The panel members play a crucial role in evaluating the ingredient's safety and reaching a consensus on its GRAS status. 3. Preparation of a GRAS notification: A detailed GRAS notification needs to be prepared based on the scientific literature review and expert panel discussions. This notification should include all relevant information about the ingredient, its intended use, and the scientific evidence supporting its safety. The notification should also address any potential concerns or limitations associated with the ingredient. 4. Submission to regulatory authorities: Once the GRAS notification is complete, it needs to be submitted to the relevant regulatory authorities for review. In the United States, this would be the FDA. All supporting documentation and data, including the scientific literature review and expert panel findings, should accompany the notification. 5. Evaluation and response: The regulatory authorities will evaluate the GRAS notification and supporting documents to determine whether the ingredient meets the safety standards for GRAS certification. This evaluation process may involve additional questions, requests for clarification, or the need for further data. The food manufacturer must respond promptly and comprehensively to address regulatory authorities' concerns. 6. GRAS determination: Once all the evaluation and response processes are complete, the regulatory authorities will finalize the GRAS status of the ingredient. If the authorities conclude that the ingredient is safe for consumption, GRAS certification will be granted. The food manufacturer can then use the ingredient in their products and promote it as GRAS-certified.

What are the common misconceptions about GRAS certification?

While GRAS certification offers numerous benefits to food businesses, some common misconceptions must be addressed. These misconceptions can lead to clarity and interpretation of the certification process. Let's debunk some of the most prevalent misconceptions surrounding GRAS certification: 1. Misconception: GRAS certification is a one-time process. Reality: GRAS certification is not a past event. It requires ongoing monitoring and assessment of the safety of the ingredient. Regular updates and re-evaluations are necessary to ensure that the ingredient meets the safety standards set by regulatory authorities. 2. Misconception: GRAS certification guarantees complete safety. Reality: While GRAS certification provides a level of assurance regarding the safety of an ingredient, it does not ensure absolute safety. The certification is based on the available scientific evidence and the expert panel's judgment. Ongoing research and monitoring are essential to identify potential risks or emerging safety concerns associated with the ingredient. 3. Misconception: GRAS certification is only for large food manufacturers. Reality: GRAS certification is not limited to large companies; it is available to all food manufacturers, regardless of their size. Smaller companies can benefit greatly from GRAS certification as it helps level the playing field and provides a competitive advantage in the market. 4. Misconception: GRAS certification is a lengthy and expensive process. Reality: While the GRAS certification process can be complex, it does not have to be overly time-consuming or costly. The key is approaching the process systematically and seeking expert guidance when needed. By working with experienced consultants and following best practices, food manufacturers can streamline the certification process and minimize costs.

GRAS Certification & GRAS Notification: Food Businesses

FDA GRAS Notification To FDA

Generally Regarded as Safe (GRAS) dossier preparation supporting safety for intended use filed with the FDA

FDA Self Affirmed GRAS

A technical dossier supporting safety of an ingredient for its intended use in foods without filing with FDA.

New Dietary Ingredient (NDIN) Notification

A New Dietary Ingredient (NDI) notification for an ingredient used in dietary supplements that was not marketed prior to October 15, 1994.

Food Additive Petition & GFSI Certification Requirements

Prepare dossier and application for non-nutritive food component to Office of Food Additive Safety at FDA.” to “Prepare a dossier for non-nutritive food components for submission to the FDA’s Office of Food Additive Safety.

Is there an expedited GRAS notice process available & what are the benefits of GRAS notification?

No, the FDA does not offer an expedited process for application review. The full GRAS certification process takes 9 to 24 months and involves multiple stages of review before a determination is made by the FDA (no questions or comments decision). Additionally, the cost for submission of documentation can be expensive since companies are required to provide comprehensive research data to support their claims which may include toxicity studies. Companies should also plan for ample preparation time and resources when applying any deficiencies in materials that could delay the review process.

A GRAS notification is a testament to the safety of your product and provides you with access to multiple markets. With this certification, manufacturers can gain confidence in selling products directly to consumers, since they are sure that they are safe and effective. Additionally, the process of filing documentation serves to increase quality control measures throughout the manufacturing process. This ensures that manufacturers only produce top-quality products that meet all safety standards established by the FDA.

What is a GRAS Notice?

If you’re looking to get your food product approved by the FDA, a GRAS Notice is essential. A GRAS Notice is a notice submitted by a company to the FDA which provides evidence that an ingredient or additive used in food has been evaluated for safety and is generally recognized as safe (GRAS). To obtain a GRAS Notice, companies must provide sufficient scientific evidence demonstrating the safety of their ingredient or additive. The FDA reviews the evidence to determine if it supports the request for GRAS status.

How to establish the Safety of Your GRAS Ingredient?

Before you can obtain a GRAS Notice, you must first analyze the safety of your product. This includes evaluating the toxicity of your ingredient or additive, taking into account factors such as dietary exposure and age limitations. Additionally, you should examine existing scientific research for similar products to determine any potential risks associated with your product. Companies must also consider whether there are any unlikely hazards due to genetic engineering or other bioengineering methods used in the production process. Once you have established that your product is safe, you can proceed with applying for a GRAS Notice.

What are the 7 sections of a GRAS Technical Dossier?

As outlined in CFR 21.1.B.170 outlines 7 parts to a GRAS dossier including:

Part 1: Signed Statements and Certification

Part 2: Identity, method of manufacture, specifications, and physical or technical effect

Part 3: Dietary exposure

Part 4: Self-limiting levels of use

Part 5: Experience based on common use in food before 1958

Part 6: Narrative

Part 7: List of supporting data and information related to the GRAS dossier

What are the different types of GRAS Notices?

The GRAS Notice process is composed of two different determinations: Generally Recognized As Safe (GRAS) and GRAS Affirmed. A GRAS determination indicates that an ingredient is recognized as safe for use in food, and a GRAS Affirmed determination confirms that an ingredient has been reviewed against all available scientific evidence and determined to be safe for its intended use. Depending on the intended use of your ingredient, one or the other may be necessary in order to obtain a positive evaluation from the FDA. It’s important to determine which type of notice your product requires before submitting it for consideration. Once you’ve made this decision, you can start preparing the necessary documents for submission.

What are your responsibilities following a GRAS Determination?

After submitting your GRAS Notice and receiving a positive determination from the FDA, there are a few responsibilities you must follow. You must make sure that the safety of your food ingredient stays consistent and keep current with any scientific developments or new data relevant to the safety of your ingredient. You should continue monitoring the possible risks associated with your product, as well as remain up-to-date in compliance with labeling requirements. Additionally, you must ensure that all postmarket surveillance activities required by the FDA are implemented and completed. Reviewing past studies conducted on your ingredient and listing any observations for future research can be beneficial in order to maintain accurate records of all possible risks associated with your food ingredient.

How to submit an FDA GRAS Notification?

Before submitting an FDA GRAS Notification, you must collect several pieces of evidence demonstrating the safety of your food ingredient. You must carefully review and analyze any data your company has compiled, such as scientific studies related to toxicity or other potential risks associated with your product. Additionally, you will need to document manufacturing methods and processes used in the production of your ingredient, including genetic engineering and other bioengineering methods. Once you have collected this evidence and written a detailed safety assessment for your product, you can proceed with submitting a GRAS Notice to the FDA.

Our FDA GRAS Ingredient Services Include:

GRAS and NDIN Services

Our team consists of toxicologists, biostatisticians, regulatory and quality assurance experts who collectively have the experience and know-how to strategize and work with your team so you can obtain the necessary regulatory status and approvals that ingredient buyers are seeking.

Gap and Feasibility Review

We will review your data and conduct a thorough search from public sources to find evidence to determine if the evidence is sufficient to proceed with GRAS or NDIN pathway. We will provide recommendations and strategies for any identified gaps.

Dossier Technical Writing

The dossier will be written following guidelines set forth by FDA for GRAS (7 sections as outlined above) or the preferred structure for NDIN. Upon completion, the dossier is QA checked by another team member to ensure accuracy and correctness.

Dietary Exposure Estimation

Our biostatistician conducts a complex statistical calculation using data from the intake from the toxicological studies and from other sources such as NHANES, CSFII, MRCA and other relevant data to determine the ADI and EDI of the substance.

Expert Panel Coordination and Management

A panel of experts, if required, is interviewed, screened and chosen to review the GRAS dossier. The FDA's guidance for choosing expert panels is followed.

GRAS or NDIN Dossier Submission to FDA

If requested for GRAS, the dossier is submitted to FDA for review. FDA review time for GRAS dossiers is typically 9 to 18 months. NDIN must be submitted to FDA and review time is 75 days.

Facility Registration, US Agent & FSVP Agent for ingredient suppliers

We will register your facility with FDA, act as US Agent for the site (if outside USA) and be your Foreign Supplier Verification (FSVP) agent as per FSMA.

FAQ FDA GRAS

What is the difference between Self Affirmed GRAS and GRAS Notification?

Self-affirmed GRAS is a dossier to support safety of an ingredient but the documents are not filed with FDA. GRAS Notification typically has the same contents as self-affirmed GRAS but is structured to conform with FDA’s requirements for their review.

What is the difference between GRAS and NDI?

GRAS is used to support safety of food ingredient but could also support a dietary ingredient found in the food supply. NDI supports safety of the ingredient to be used in dietary supplements. GRAS is not mandatory but NDI filings are mandatory. Also NDI safety data can be confidential whereas GRAS safety data must be public information.

Does GRAS apply to pet food ingredients too?

Yes, GRAS applies to pet food and animal feed ingredients. Evidence must support safety in the respective animal species which the substance is intended to be fed.

Does FDA have to approve an ingredient as GRAS?

GRAS notifications are a voluntary program. Self-affirmation GRAS is another route that does not involve filing a GRAS notice with FDA.

How long does FDA take to review a GRAS Notification?

Though this timeline has been impacted by covid, FDA’s performance standard is to respond to the GRAS notice within 180 days and an extension of 90 days beyond the 180-day timeframe. It is important to remember that depending on the complexity of the product, it can take anywhere from 6 months up to 3 years for FDA to review and approve your GRAS Notice. Depending on the regulatory pathway chosen there could also be fees associated with the notice submission, so manufacturers should make sure they understand all potential costs before getting started.

What decision does FDA make when they review a GRAS Notification?

FDA will conclude if they have no further questions based on the information provided in the GRAS notice dossier. FDA also includes statements that the letter is not an affirmation. This is a legal disclaimer to absolve FDA from any liability or responsibility.

What are your fees to file a GRAS Notification or GRAS Self-Affirmation?

Preparing a GRAS notification or self-affirmed GRAS depends on several factors related to the ingredient its respective complexity that determines the scope of work involved. Call us at 1-800-396-5144 to speak to a sales specialist who can assist you.

Generally Recognized as Safe (GRAS) and New Dietary Ingredient Notification (NDIN) Compliance Solutions