By Louise Calderwood, AFIA Director of Regulatory Affairs
The U.S. Food and Drug Administration (FDA) is evaluating potential changes to the Generally Recognized as Safe (GRAS) framework, which will include animal feed and pet food ingredients. These possible changes could reshape how new ingredients are reviewed, documented and approved, making it essential for feed manufacturers to understand what’s driving the discussion and how it could affect their operations. The American Feed Industry Association (AFIA) will closely follow the process and submit comments based on input from members.
The GRAS system, established in 1958, allows ingredients which have a long history of common use or have been independently reviewed and found safe for an intended use, to enter the market. Under pressure from the Make America Healthy Again movement, the FDA has announced that GRAS will undergo revision; they are expected to require federal review of GRAS conclusions for new animal food ingredients. The FDA has not yet indicated if they will conduct a post-market review of GRAS ingredients already in use.
Under the current system, companies can make GRAS determinations independently, without notifying the FDA. Some companies choose to submit their findings voluntarily through the formal GRAS notification program, but most companies find the FDA notification process to be unduly burdensome and therefore do not notify the FDA.
While all the data used to inform a GRAS determination must be publicly available, critics feel there are gaps in public access to safety data and limits in the FDA’s ability to monitor emerging ingredients. A revised regulation may require mandatory notification and public disclosure of GRAS determinations.
Consumers and international markets are increasingly focused on the safety, sustainability and traceability of animal feed ingredients. Strengthening the GRAS framework may be beneficial for U.S. manufacturers to maintain market trust and reduce future regulatory risk.
In the nearly seven decades since the GRAS system was developed, animal food ingredients have evolved far beyond traditional grains and minerals to include biotechnology, fermentation and synthetic biology to develop novel ingredients. The FDA aims to align the GRAS process with current scientific standards—ensuring that evaluations for microbial proteins, enzymes and other novel materials meet modern safety benchmarks.
In 2024, the FDA gathered input from feed industry representatives, including the AFIA, to identify weaknesses in the current GRAS notification process and areas for improvement; feedback which should be incorporated into the proposed rule. The FDA’s revision process for the GRAS regulations will follow the federal rulemaking framework, allowing for public input and industry engagement. The proposed rule may include requirements for mandatory GRAS notifications, updated definitions of “expert consensus” and changes to recordkeeping or safety substantiation. Once draft revisions are developed, the FDA will publish them in the Federal Register. The public and trade associations, such as the AFIA, will have the opportunity to submit feedback on the proposed rule, an essential step to ensure that new regulations are scientifically sound, practical and cost-effective for real-world operations. After reviewing and possibly incorporating comments, the FDA will finalize the rule and set a timeline for compliance. Industry education and guidance documents will be developed to help companies adapt.
Feed ingredient manufacturers may be wise to begin reviewing their internal GRAS procedures now, particularly documentation practices, expert panel methodologies and data transparency policies. By proactively engaging in the rulemaking process and aligning practices with evolving expectations, feed manufacturers and ingredient suppliers can help shape a system that supports innovation while ensuring safety and regulatory confidence across the animal food industry.