US agency releases draft document with instructions for new additive petitions, GRAS process
The U.S. Food and Drug administration has released a new draft Guidance for Industry document with detailed instructions for navigating animal food additive petitions and GRAS notices.
The agency is seeking stakeholder input to improve the GFI #262, which it hopes will make the submission process more efficient and effective in order to streamline the introduction of new products into U.S. markets, according to a February press release.
“The draft guidance strongly encourages stakeholders to contact FDA’s Center for Veterinary Medicine early in the FAP or GRAS notice development process,” the press release states. “Engaging with the agency while these submissions are still in progress allows stakeholders to discuss questions and concerns as they arise, and has the potential to improve the quality and success of FAPs or GRAS notice submissions.”
The draft outlines how to engage in pre-submission consultations with the FDA, what kind of information should be included in food additive petitions, and how best to communicate with the FDA regarding a new submission. It also details the circumstances in which the submission of a study protocol is recommended, and describes the FDA’s review process.
Leah Wilkinson, vice president of public policy and education at the American Feed Industry Association (AFIA), said the association was very glad to see the release of the draft and plans to submit comments.
“Improving the efficiency and effectiveness of the ingredient review processes in the U.S. is a top priority for AFIA,” she said. “Having ample and appropriate guidance to assist firms in developing their ingredient submission packages is vital and the GFI on pre-submission consultations provides components of that much needed information.”
She said the draft guidance goes above and beyond what the FDA was required to provide under the 2018 Animal Drug User Fee Act, which required the FDA to produce guidance on engaging in the pre-petition consultation process for food additives intended for use in animal feed.
Public comments on the draft are due April 13, 2020. Comments may be submitted electronically by typing FDA-2020-D-0064 in the search box. Written comments may be submitted by mailing submissions labeled with the docket number on each page to:
Dockets Management Staff
HFA-305
Food and Drug Administration
5630 Fishers Lane, Room 1061
Rockville, MD 20852
