Scientific Evidence:
A thorough review of existing scientific data and literature to demonstrate the safety of the ingredient.
GRAS, or “Generally Recognized as Safe,” is a designation by the U.S. Food and Drug Administration (FDA) for substances added to food. It means that the substance is considered safe by experts, and therefore, it is exempt from the usual food additive tolerance requirements. GRAS applies to substances that are widely accepted by qualified experts as safe under the conditions of its intended use.
Achieving GRAS status is vital for companies that wish to introduce new ingredients to the U.S. market. GRAS compliance assures consumers, regulatory bodies, and partners that the ingredients used in products meet the highest safety standards. It also minimizes the risk of regulatory issues and enhances consumer trust.
Companies can determine GRAS status through self-assessment or by submitting a notification to the FDA. Self-Affirmed involves conducting an internal review and keeping detailed records of the evidence supporting the safety of the ingredient. GRAS notification, on the other hand, involves submitting this information to the FDA for review.
The GRAS determination process involves rigorous scientific assessment, including:
A thorough review of existing scientific data and literature to demonstrate the safety of the ingredient.
A panel of qualified experts assesses the safety data to determine if the ingredient meets GRAS criteria
Although not mandatory, companies often submit a GRAS notification to the FDA for their records. The FDA then evaluates the submission to confirm that the ingredient is recognized as safe.
The term “GRAS” stands for “Generally Recognized As Safe.” It’s a designation by the US Food and Drug Administration (FDA) signifying that a substance can be added intentionally to food products without requiring premarket approval from the FDA.
Understanding GRAS compliance ensures you know when FDA approval is necessary for your food ingredient and when a GRAS designation might be a viable alternative.
GRAS status is just one aspect of FDA compliance. If you’re dealing with dietary supplements, food additives, or other ingredients, understanding the different regulatory pathways is critical. Whether it’s filing a New Dietary Ingredient Notification (NDIN) or submitting a Food Additive Petition, each pathway has its own set of requirements and challenges.
Demonstrate the safety of a substance for its intended use, filed with the FDA under the Generally Recognized As Safe (GRAS) criteria.
Independently conclude that an ingredient is GRAS based on scientific evidence and FDA guidelines.
Notify the FDA about a new dietary supplement ingredient, demonstrating its safety for the intended use.
Submit a formal application to the FDA’s Office of Food Additive Safety to approve a non-nutritive food component.
Navigate the complex regulatory landscape with confidence and ensure your product’s safety and market readiness with GRAS Experts.
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Self-affirmed GRAS is a dossier to support the 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 ingredients but can also support a dietary ingredient found in the food supply. NDI supports safety of the ingredients 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 in which the substance is intended to be fed.
No, the FDA does not 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.
The FDA aims to respond to most GRAS notices within 180 days [FDA GRAS Notification Program] 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 and 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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