GRAS Self Determinations and FDA Notifications

GRAS Self Determination and FDA Notification is a requirement for any substance that is intentionally added to food (i.e. a food additive) and is subject to premarket review and approval by the FDA under sections 201(s) and 409 of the Federal Food, Drug, and Cosmetic Act (the Act), unless there is reasonable certainty that the ingredient will not cause harm or the ingredient is excluded from the definition of a food additive.

 

There are 2 ways an ingredient can achieve GRAS status: 1) submit a GRAS notice to the FDA and receive a letter with no questions from FDA or 2) Self-affirmation of GRAS status. With self-affirmation of GRAS status, there is no legal requirement for the FDA’s review and approval of the scientific evidence you have gathered demonstrating that the substance is safe under the conditions of its intended use. However, some companies prefer to know that the FDA has reviewed its notice of a GRAS determination, without raising safety or legal issues, before marketing.

 

Our services for GRAS Self Determinations and FDA Notifications include the following:

  • Analysis of whether GRAS status is necessary for your ingredient and assisting with the development of a successful regulatory strategy
  • Conducting literature searches and data gathering
  • Identifying technical and scientific data gaps and recommending solutions
  • Coordinating the conduct of toxicological studies when required
  • Research for scientific evidence demonstrating that the substance is safe under the conditions of its intended use
  • Preparation and submission of GRAS notifications and liaison with FDA and USDA