CRN seeks regulatory clarity on drug preclusion, self-GRAS and supplement innovation

The Council for Responsible Nutrition (CRN) is pursuing regulatory changes to improve certainly for supplement companies, from drug preclusion and ingredient grandfathering to the future of self-affirmed GRAS, said president and CEO Steve Mister.

Speaking to NutraIngredients at CRN Convergence 2026, Mister described the Supreme Court’s decision to not hear CRN’s appeal in its challenge to New York’s age restriction law as a setback but not the end of the road. With California having recently passed similar legislation, he said CRN must consider the potential for other states to follow suit and evaluate further litigation.

Mister also called for targeted reforms to the drug preclusion framework established under DSHEA, arguing that the current framework has moved away from the original balance between drug development and innovation.

“What we need to do is we need to go in surgically and fix the things that are wrong,” he said, pointing to secret investigational new drug filings and the need for the FDA to consider differences in dosage forms and ingredient levels when determining whether drug preclusion applies.

When it comes to ingredient grandfathering, Mister confirmed CRN is work with other trades to develop an authoritative list of ingredients marketed before DSHEA. However, Mister said FDA buy-in would be essential for the initiative to provide meaningful certainty for companies.

“The list becomes more of a safe harbor that if you’re on the list, you know you’re protected,” he explained, noting that companies should still be able to establish an ingredient’s pre-DSHEA status through their own evidence.

CRN is also advocating for greater transparency around self-affirmed GRAS determinations without creating an unmanageable premarket review system. Mister warned that requiring FDA review of every new ingredient could create a backlog the agency doesn’t have the resources to clear.

Mister also pointed to growing FDA recognition of the supplement industry’s economic significance, describing it as approaching $70 billion. He said CRN sees opportunities to work with the Make America Healthy Again (MAHA) movement on preventive health and empowering consumers to take a more proactive role in their healthcare.

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