FDA Approval for Food Additives for Animals
*Routes of Approval:
The ingredients in animal feed can be approved for animal food manufacturers' use in one of three ways:
- Using the Generally Recognized as Safe (GRAS) provisions required by the Federal Food, Drug and Cosmetic Act (FFDCA);
- Recognized by the Association of American Feed Control Officials (AAFCO) in its annual Official Publication (OP), the legal listing recognized by the states and other countries for ingredient definitions allowed on commercial feed labels; or
- By the Food and Drug Administration through the Food Additive Petition (FAP) process, also mandated by FFDCA.
*FDA Approval Procedure for Food Additives for Animals:
- The first process is of certifying an ingredient as GRAS does not require pre-market review and approval by the FDA as a food additive; only bioequivalence has to be proven.
- The process of gaining recognition through AAFCO's OP is very similar to the FDA's FAP process. In either instance, the FDA requires the submitting company to provide the agency and AAFCO with animal and human safety data, the analytical methodology used to cultivate that data, detailed lists of the manufacturing processes involved, toxicology results on any harmful substances in the ingredient, data to show the ingredient will be manufactured consistently, and a proposed legal definition for the product. If - during the AAFCO review process, the FDA finds any potential problems in the data submitted, then the FDA may require a more formal FAP to be submitted.
- The FDA's FAP process is the most thorough of the three, typically requiring more data and several more years for the FDA's Center for Veterinary Medicine to review.
A manufacturer or other sponsor may petition the FDA for approval of a new animal food additive, or he or she may petition for a new use of an already approved animal food additive. For demonstrating that the additive is safe for the proposed use in animal food, the sponsor submits the FAP. The FAP must include sufficient information to establish that the food additive is safe and accomplishes its intended use, under the conditions of use specified in the petition; and once this has been demonstrated, the FDA can issue a regulation addressing the food additive and its use. The regulation may specify the types of animal food that may contain the additive, the amount of the additive that may be used in animal food, and/or the requirements for labeling the additive or the animal food containing the additive. Once approved, the animal food additive must be used within the constraints of its established regulation.
*List of Forms/Documents for Food Additives for Animals:
*Information that is required in a submitted FAP is described in 21 CFR 571.
Below is a list of the general information that should be included in the FAP.
1. Identity and composition of the additive, including manufacturing methods and controls;
2. Intended use, use level, and labeling (cautions, warnings, shelf life, directions for use);
3. Data establishing the intended effect (physical, nutritional, or other technical effects);
4. Analytical methods (for the additive and animal foods containing the additive);
5. Safety evaluation (target animal and human food)
6. Proposed tolerances for the food additive;
7. Proposed regulation; and
8. Environmental assessment
*Mode of Filing: