The American Feed Industry Association (AFIA) and the National Grain and Feed Association (NGFA) filed joint comments on November 12 to the US Food and Drug Administration (FDA) regarding Recommendations for Preparation and Submission of Animal Food Additive Petitions. The comments are AFIA and NGFA's recommendation to assist FDA in providing important information in making informed decisions on the correct ingredient approval path to pursue and to assist the industry in properly submitting a Food Additive Petition (FAP) for animal feed ingredients.
"The US feed industry has a long history of providing safe ingredients and animal feed for use domestically and abroad. Ingredient review processes that function efficiently are extremely important for the industry," the groups stated in the comments.
Both AFIA and NGFA applaud FDA for providing the draft guidance document, which has been in development, with feed industry backing, for several years.
"The American Feed Industry Association along with the National Grain and Feed Association find the draft guidance to be an overall helpful document for the industry," said Leah Wilkinson, AFIA director of ingredients, petfood and state affairs. "We drafted comments to FDA as a request for clarification in order to help make the review processes to approve new animal food ingredients function more efficiently for the industry as a whole."
In the comments, AFIA and NGFA noted FDA's lack of clarity on terms such as mixture, components and material balance and asked those terms be defined. The groups commented on FDA's request in the FAP for companies to submit an unrealistic level of manufacturing information, particularly since a manufacturing process is not a regulatory requirement when manufacturing food additives that meet existing food additive regulations and ingredient specifications. Additional guidance was also requested in areas where FDA had specific recommendations but did not provide supporting information in the FAP, including areas such as types of studies for homogeneity, stability and intended effects.
"FDA's guidance document details specific information that should be submitted for manufacturing processes and raw data. This information is typically proprietary to individual companies," said David Fairfield, NGFA vice president of feed services. "NGFA and AFIA requested FDA clarify in the guidance document what information can be disclosed under the Freedom of Information Act."
FIA and NGFA believe that due to the nature of the approval process and the investments made by a company to approve a product, a final guidance document should be issued by FDA as soon as possible. The completion of an expedited document will greatly assist the industry in the development of their submissions for FDA review.