The Food and Drug Administration issued a final rule that amended and clarified the criteria in FDA regulations for when a substance is generally recognized as safe (GRAS) under the conditions of its intended use. GRAS means that a food for humans or animals is not subject to the premarket approval requirements of the Federal Food, Drug and Cosmetic Act.
FDA also amended their regulations to replace the voluntary GRAS affirmation petition process with a voluntary notification procedure under which any person may notify us of a conclusion that a substance is GRAS under the conditions of its intended use.
While FDA review of the GRAS submission does not constitute formal approval by the agency, it does offer some reassurance to the company that its determination of GRAS was justified. Also, by public acknowledgement that a reviewed substance raised “no questions” with FDA, there is a means by which consumers and state regulators can verify that the data to support safe use have been evaluated by someone other than the company itself.
GRAS notification process for pet food
FDA first proposed the GRAS notification process to replace the GRAS affirmation process over in 1997. The center within FDA responsible for human food safety evaluation has been accepting GRAS notifications for years. In 2010, FDA Center for Veterinary Medicine (CVM) started doing the same for animal feed ingredients.
The first step in GRAS notification for pet food ingredients is to compile a dossier of all available information on the substance. To be generally recognized as safe, all of the pivotal data to support safe use must be available for public review, such as research published in peer-reviewed scientific journals.
Components of a GRAS dossier may include:
- Description of the substance (name, composition, physical form, etc.);
- Description of the manufacturing process;
- Stability, methods of analysis, other specifications;
- Intended use (utility, species, inclusion rates, etc.);
- Data to support safety (target animal, human, environmental); and
- Any evidence that potentially contradicts safe use.
An unbiased expert panel must then review the dossier. A minimum of three panelists should vary in expertise so all aspects are covered. For example, a veterinary nutritionist, a veterinary toxicologist and a scientific authority on the substance in question may be a good complement of expertise for evaluating many petfood ingredients.
The panel discusses the dossier and may ask for more information or investigate further on its own. The panel must reach a consensus that there is reasonable certainty of no harm under the intended conditions of use before a determination of GRAS may be reached. Only then may the sponsor submit the GRAS notification to FDA.