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Generally Recognized as Safe (FDA GRAS Certification) 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.

What is GRAS Certification the Requirements and Who Does It? How do I apply for GRAS Certification?

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 to ensure the safety of their products and ensure compliance with relevant regulations. Certification is typically required for any product that goes through FDA’s regulatory process.

To obtain GRAS certification, companies must meet all requirements laid out by the FDA. Companies must have 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 the 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.

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 the 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.

GRAS Certification Application

Is there an expedited GRAS Application process available & what are the benefits of certification?

No, the FDA does not offer an expedited process for application review. The full GRAS certification process takes 3-4 months and involves multiple stages of review before a determination is made by the FDA. Additionally, the cost for submission of documentation can be expensive since companies are required to provide comprehensive research data to support their claims. Companies should also plan for ample preparation time and resources when applying any deficiencies in materials that could delay the review process.

A GRAS certification 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.

Establishing the Safety of Your Product

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.

Gras Notice

Submitting an FDA GRAS Notification for Ingredients

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.

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.

Understanding 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 Notice
Gras Notice

Our FDA GRAS Ingredient Services Include:

  • Conduct a feasibility review of your ingredient to determine Generally Recognized as Safe 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, through 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 meeting with the FDA (on-site or virtual)
FDA GRAS Notice Certification

FAQs FDA GRAS Notice and Certification

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.

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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