The Federal Food, Drug, and Cosmetic Act (FD&C Act) gives FDA the authority to regulate substances used in animal food, including substances that are food additives and substances that are generally recognized as safe (GRAS) for their intended uses in food.
Since 1920, the Association of American Feed Control Officials (AAFCO) has maintained the AAFCO Official Publication, which contains, among other things, a comprehensive list of animal food ingredients, including FDA-approved animal food additives, substances that are GRAS for a use, and animal food ingredient definitions established through the AAFCO Ingredient Definition Request Process. In 2007, FDA entered into an MOU with AAFCO that outlines how FDA would provide its scientific and technical expertise to AAFCO in reviewing ingredient definitions requested by industry or AAFCO. This MOU has been renewed and revised several times. The current MOU 225-07-7001 expires on October 1, 2024, and it will not be renewed.
Following the expiration of the MOU, FDA plans to assess its animal Food Additive Petition and GRAS Notification programs to determine if changes are needed to promote the efficient development and review of new animal food ingredients. To provide an additional way for engagement during this evaluation period, the AFIC process will be available for assessment of ingredients for which firms may have otherwise utilized the AAFCO ingredient definition process. AFIC will provide a process that will help FDA be aware of new ingredients that are marketed in interstate commerce and any potential safety concerns associated with them. AFIC will serve to provide a baseline of safety information available about such an ingredient, making it easier to compare developments that might occur during marketing. AFIC also will give FDA an opportunity to discuss any potential safety concerns with the developer, ideally before the ingredient is marketed. The AFIC process will also allow for public awareness of and input on such ingredients. In addition, this guidance describes FDA’s enforcement policy for certain ingredients assessed using the AFIC process.
Download the Draft Guaidance – https://www.fda.gov/media/180442/download
Read the Federal Register Notice – https://www.federalregister.gov/documents/2024/08/09/2024-17778/animal-food-ingredient-consultation-draft-guidance-for-industry-availability
Posted in FDA and USDA Regulatory Update, Foods.