Todd Harrison was quoted in the SupplySide Food & Beverage Journal article “Closing Self-Affirmed GRAS Requires Rewriting Law, Experts Warn,” discussing the FDA's anticipated self-GRAS proposal. The following is an excerpt:
On July 3, the U.S. Office of Information and Regulatory Affairs (OIRA) published the 2026 Unified Agenda of Federal Regulatory and Deregulatory Actions. The new agenda provided, among other updates, a revised timeline for the Food and Drug Administration's (FDA’s) proposed rule RIN 0910-AJ02, which, if finalized, would mandate premarket notification for GRAS (generally recognized as safe) ingredients. This would eliminate the long-standing self-affirmed GRAS “loophole,” where ingredient manufacturers have been allowed to validate their own safety research and submit it to FDA on a voluntary basis.
The proposed rule has slimmed down over the years. For example, the new agenda specifies that mandatory notifications will only be required for “certain uses of food substances” and introduces the idea of a "streamlined submissions" pathway, which sounds suspiciously like the system that’s already in place. Read a full breakdown of the changes by attorney Todd Harrison, partner and cochair of the FDA group at law firm Venable LLP.
“Would it surprise me in December if we get another announcement that it’s being pushed back again?” Harrison posited to SupplySide Food & Beverage Journal. “No, that wouldn’t surprise me. At the same time, it wouldn't surprise me at all if they dropped something on December 24th and then got out of town … but there will be nothing final.”
According to Harrison, FDA already has the authority to take ingredients off the market — such as intoxicating hemp-derived THC — but they have, historically, refused to exercise it. The reasons why are only known inside the Department of Justice.
“Even if everything fell into place tomorrow, you're still 2 to 3 years away from a final rule,” Harrison estimated. Regardless, his advice for food and beverage manufacturers was firm. “In the meantime, make sure your GRAS dossiers are really GRAS. What people don't understand is that GRAS is GRAS; whether FDA is notified or not, the standard remains the same. So, do your due diligence. Make sure the ingredients you're using pass muster.”
For the full article, click here.