The US Food and Drug Administration (FDA) announced that it was collecting information on best practices for establishing a Generally Recognized as Safe (GRAS) panel on Wednesday. The comment period will be open for 180 days after the draft is published.
The agency also released a regulatory framework for producers who sell a product that is considered GRAS.
The process to have a new feed ingredient recognized by the FDA has grown more expensive and complicated, said Richard Sellers, senior vice president of public policy and education with the American Feed Industry Association (AFIA). “Recently, many of our members have been increasingly frustrated with FDA’s overly cumbersome, costly, and time-intensive regulatory review processes,” he added.
“FDA staff has told us that there is a lack of resources needed to complete the increasing number of applications the agency is receiving, but we believe it is more complicated than that,” he said.
The association has been working to streamline the process used to review ingredients to shorten the time needed to bring them to market, he said.
In addition to welcoming the guidance, AFIA said it would like to see the FDA move to adopt the American Association of Feed Control Official’s (AAFCO) Official Publication as a way in federal regulation to document the historical use of feed ingredients.
“We believe the agency’s authority on accepting the publication as the ‘official ingredient list’ will clarify the existing patchwork of state feed laws,” said Sellers.
Currently there are three ways of having ingredients approved for use in animal feed in the US including through the GRAS provisions, having an item recognized by AAFCO’s official publication or going through the FDA’s food additive safety review process, the AFIA reported.
AAFCO has started to include GRAS certifications in its publication, the association said. However, not every state’s feed agency recognizes GRAS ingredients, which is establishing a patchwork series of regulations and making it harder for manufacturers.
If the FDA would recognize the AAFCO publication as an official ingredient list for all states, it would help provide opportunities for new ingredients to reach the marketplace, said AFIA.
Draft guidance overview
The draft guidance document on practices was established to offer recommendations on best practices to be used when establishing a panel of experts able to evaluate available scientific data, information and practices used to check if a substance is safe for its intended use in food or feed, said the FDA. And to be able to tell if using that substance in feed is lawful according to provisions of the Federal Food, Drug and Cosmetic Act.
The panel is one method of demonstrating the safety of a proposed feed ingredient, said the FDA. Members of the group are intended to act as proxies for the larger scientific community.
The draft guidance was established to offer best practices regarding how to identify panel members who have the appropriate experienced, steps to follow to reduce the risk of bias or appearance of bias in members, and establish appropriate criteria to provide information to panel members, the agency said. It was designed for producers who want to make use of a GRAS panel, the person who establishes the panel and offers a framework for members and those who are interested in the process of convening a panel.
The guidance for industry offered criteria used to determine if a substance is eligible for GRAS certification for a given use and reminded producers of the details involved in the process of attempting to establish that a product should receive a GRAS certification, said the agency.