THE American Feed Industry Assn. (AFIA) and the National Grain & Feed Assn. (NGFA) filed joint comments Nov. 12 to the U.S. Food & Drug Administration regarding its draft guidance "Recommendations for Preparation & Submission of Animal Food Additive Petitions."
The comments are the two groups' recommendation to assist FDA in providing important information for 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.
Both AFIA and NGFA applauded FDA for providing the draft guidance document, which has been in development, with feed industry backing, for several years.
Leah Wilkinson, AFIA director of ingredients, pet food and state affairs, said AFIA and NGFA both find the draft guidance to be an overall helpful document for the industry. She explained that the goal with any FDA draft guidance is to make the process clear and easily understood by those in the industry so as to not lead to further questions.
Although the FDA document represents a "great first step," she said there are still some areas that need additional clarification upfront before a final guidance is issued.
In the comments, AFIA and NGFA noted FDA's lack of clarity on terms such as "mixture," "components" and "material balance" and asked that those terms be defined.
The groups additionally 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," David Fairfield, NGFA vice president of feed services, said. "NGFA and AFIA requested that FDA clarify in the guidance document what information can be disclosed under the Freedom of Information Act."
AFIA and NGFA believe that due to the nature of the approval process and the investments a company makes 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 its submissions for FDA review, the associations said in a joint statement.
Wilkinson said in order to ensure that comments were considered, FDA called for submission by Nov. 12. She said a final guidance could take a couple of months or even years before final publication.