
Feature|Articles|October 13, 2026
FDA’s Proposed GRAS Rule, and What Industry Should Do Now
Author(s)Ashish R. Talati
The proposed notification requirement is straightforward, but its legal and commercial consequences are not.
Advertisement
Advertisement
On August 10, 2026, FDA proposed a rule that would generally make GRAS notification mandatory. Companies could still reach independent GRAS conclusions, but they would largely lose the option of keeping those conclusions private. For industry, the proposal raises important questions about FDA’s legal authority, the treatment of existing ingredients, and what greater scrutiny could mean for bringing products to market.
Related to this article

The trade group says the denial does not settle its concerns about a law that limits minors' access to supplements marketed for weight loss or muscle building, and the case now returns to district court.

A year-to-date look at the federal and state measures shaping supplement oversight, access, and classification.

A panel at The Outlook on Active Nutrition discussed quality in sports nutrition focused on testing, liability, and what buyers now expect from suppliers.

Trade groups say the law's broad criteria could restrict access to supplements with uses beyond weight loss or muscle building.

Part 2 of our interview with Todd Harrison, co-chair of the FDA practice group at Venable LLP covers preclusion's structural gaps: no defined end point, no tracking registry, and a push for mandatory drug-sponsor engagement.

Todd Harrison, co-chair of the FDA practice group at Venable LLP, details the Dietary Supplement Innovation Act's language, its unintended consequences, and what industry stakeholders should watch for.

The company plans to unveil a clinically studied ingredient on opening day and host a longevity session alongside its cognitive, mobility, and metabolic health portfolio.
Advertisement
Advertisement

