Todd Harrison and Thomas Smith were featured in Pet Food Industry discussing the FDA's proposed rule requiring mandatory GRAS notifications for animal food. The article highlights the attorneys' guidance that companies should begin evaluating existing ingredient portfolios now, noting that the proposal could significantly affect legacy products, AAFCO-recognized ingredients, and future compliance obligations. The following is an excerpt:
What companies should do now
Attorneys Todd A. Harrison and Thomas Smith of Venable LLP said in a memorandum analyzing the proposed rule that pet food manufacturers, premix operations, feed companies and integrators should not wait for a final rule to assess their exposure.
Among the firm's key takeaways:
- Legacy portfolios are the primary exposure.The notification obligation is not limited to new substances. “FDA expressly states it applies to ingredients ‘already in the food supply,’” wrote the attorneys. “Companies with established product lines may face the largest compliance burden.”
- AAFCO recognition is partial, static and conditional.FDA's proposal incorporates only the "Official Names and Definitions" section of the 2024 AAFCO Official Publication, frozen at that edition and excluding post-2024 ingredients, and subject to a "public statement of concern" that can eliminate the exception for a given use.
- SRIS cannot automatically satisfy any exception.As drafted, novel ingredients reviewed through the AAFCO/Kansas State University SRIS pathway still require a full federal GRAS notice. “This is a potential bottleneck for the industry's primary non-FDA review mechanism,” they noted.
- The streamlined pathway is narrow and time-limited.Subpart F offers a one-time, one-year window requiring data — including target species, use levels and, for food-producing animals, quantities of residues to which humans may be exposed that many companies may not have assembled.
- Enforcement discretion is not a strategy.Certain ingredients, including glucosamine and chondroitin in pet food, face threshold questions at the food/drug boundary that the proposed rule's disclosure mechanisms could bring to a head, they wrote.
Venable said noncompliance carries no direct statutory penalty as drafted, but a mandatory, publicly verifiable federal filing requirement could still surface in retailer qualification standards, private-label specifications, competitor challenges and litigation — making early preparation, rather than reliance on enforcement discretion, the best course for companies evaluating their ingredient portfolios ahead of the Dec. 9 comment deadline.
For the full article, click here.