Amazon Seller Compliance

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

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.

Gras Notice

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.

GRAS Expedited application process

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:

  • Conduct a gap assessment of your ingredient to determine Generally Recognized as Safe (GRAS) or New Dietary Ingredient (NDI) status
  • Determine gaps in evidence to support safety and layout a strategy to obtain GRAS status either as self-affirmation or with a GRAS notice to the FDA
  • If applicable, with one of our clinical trial partners, organize a toxicological study
  • Prepare the GRAS notification dossier, engage expert panel members, where applicable, to attest to GRAS status
  • If applicable, file with the FDA and answer all questions from the agency
  • If applicable, have a pre-submission meeting with the FDA (on-site or virtual)
FDA GRAS Notice Certification

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

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.

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.

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.

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

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.

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.

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.

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