FDA Guidance for Animal Food Additive Petitions: Expanding FDA’s Reach?
Food and Drug Administration’s (FDA) Center for Veterinary Medicine (CVM) released (September 11, 2013) draft guidance describing the types of information that CVM recommends for inclusion in food additive petitions (FAPs) for food additives to be used in animal food/feed. FDA has stated that the guidance was prepared in order to better help the petitioner to submit an FAP and the information contained within, in a “consistent and appropriate manner.” However, does the guidance focus on the information relevant to the determination of safety of the ingredient to be added to feed, or does the guidance suggest that FDA is extending its reach (in this petition format) beyond what is pertinent to evaluating the safety of a feed ingredient? And, does the release of draft guidance result in FDA citing this level of information standard for every petition, for which all other petitions should be rejected? Actions by other FDA offices may provide some indication of FDA’s path forward.
The format of the guidance document follows the general format provided by FDA for FAPs as stated within the regulation in the U.S. Code of Federal Regulations (21 CFR §571), and in many cases provides additional discussion on such issues as chemical identity, safety information and intended effect (i.e., “the purposes for which it [the food additive] is proposed…”). However, there are statements within the draft guidance that lead to additional questions, not answers. For example, the draft guidance states that “for mixtures, you should identify as many of the components of the mixture as is feasible and to reasonably define the composition of the mixture. In addition, information on the chemical composition and identity of each component in the mixture is needed and a material balance should be provided.” How far does “as feasible” need to be taken? An ingredient such as a plant seed meal (e.g., corn meal, soybean meal, quinoa meal) is technically a complex mixture of potentially hundreds of volatile oils, fats, carbohydrates and minerals, each of which would need to be defined as indicated by this guidance. The phrase “as is feasible” contributes to the confusion, as analytical technology has made it “feasible” to differentiate the constituents of mixtures to the point that it could take years to “identify” each component within a plant seed meal, further, these constituents could vary qualitatively and quantitatively from year to year.
Moreover, what is “feasible” may not be relevant to the determination of safety at any level of detection. FDA’s general request for manufacturing methods and controls within the guidance is consistent with the regulations, but the level of detailed description being requested by CVM suggests that the level of scrutiny is not only to evaluate the safety of a food ingredient, but to evaluate the process under the Food Safety and Modernization Act (FSMA).