Supplement Trade Group CRN Wants More Transparency on Self-GRAS, Without an FDA Backlog

FDA’s proposal to end self-affirmed GRAS is open for comment. A leading supplement trade group is staking out its position.

TLDR

• CRN wants more transparency around self-affirmed GRAS determinations.
• It opposes a premarket review system FDA cannot manage.
• CRN is building a list of ingredients sold before 1994 to give companies a safe harbor.
• It also wants targeted fixes to the drug preclusion rule.

The GRAS Position

Steve Mister, president and CEO of the Council for Responsible Nutrition (CRN), told NutraIngredients at the CRN Convergence 2026 conference that the group wants more transparency around self-affirmed GRAS without creating an unmanageable premarket review system. He warned that requiring FDA review of every new ingredient could create a backlog the agency does not have the resources to clear.

GRAS stands for “generally recognized as safe.” Today, companies can decide on their own that an ingredient is GRAS without telling FDA. In August, FDA proposed requiring companies to notify the agency instead. Comments on the proposal close December 9.

Other Priorities

CRN is working with other trade groups on an authoritative list of ingredients marketed before the Dietary Supplement Health and Education Act of 1994. “The list becomes more of a safe harbor that if you’re on the list, you know you’re protected,” Mister said. He said FDA buy-in is essential.

On drug preclusion, which can block an ingredient from supplements once it is studied as a drug, Mister called for targeted reform. “What we need to do is we need to go in surgically and fix the things that are wrong,” he said.

Why It Matters

Supplements and fortified foods often share ingredients, and many rely on self-affirmed GRAS. How FDA balances transparency against its own limited capacity will decide how quickly new protein, fiber and functional ingredients reach the market.

Source: NutraIngredients. Read the report.