Todd Harrison shared his insights with AgFunderNews on the FDA's anticipated self-GRAS proposal and the significant changes reflected in its latest regulatory agenda. The following is an excerpt:
A proposed rule to eliminate the self-affirmed GRAS (Generally Recognized as Safe) pathway for food ingredients—which had been expected in the spring—will now be published in December, says the Office of Information and Regulatory Affairs (OIRA).
The latest description of the proposed rule just published by OIRA also features “significant changes from prior descriptions,” says Todd Harrison, partner at law firm Venable and co-chair of the firm’s FDA group.
Notably, the new outline says the rule will apply only to “certain uses of food substances,” although it does not define what these are. It also removes language covering indirect food substances such as food-contact materials that featured in OIRA’s spring 2025 outline and introduces new concepts including a “streamlined submissions” pathway, although this is not defined.
It goes on to refer to a submission “window of availability” before the rule comes into effect, suggesting a defined period during which companies may have to bring existing self-affirmed GRAS substances into compliance, although this is not stated explicitly.
Previous language stating that products that are already GRAS by regulation or are subject to “no questions” letters will be exempted is also absent from the new outline, although it is unclear whether this is a deliberate omission, Harrison told AgFunderNews.
‘Streamlined submissions’
Given the reference to “streamlined submissions” in the latest document, it’s possible that the FDA is considering a middle way whereby firms that currently have self-affirmed GRAS ingredients on the market may be allowed to file something short of a full GRAS notification, said Harrison. However, this is purely speculative, he acknowledged.
“Maybe you do some type of submission that notifies the agency that you have this ingredient on the market without a full submission, but it’s unclear exactly what they’re thinking. It could just come down to they just want to know all the ingredients that are out there in the marketplace. And then FDA could then take a look at the list and do a risk-based analysis [to determine where full submissions may be needed].”
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