FDA Considers New Rules for GRAS Substances in Supplement Industry
What happened
Experts discussed regulatory priorities for the supplement industry, noting that potential changes to the Generally Recognized as Safe (GRAS) pathway are a major issue since the Dietary Supplement Health and Education Act (DSHEA) was passed in 1994. A new rule, proposed in August and open for consultation until December 9, would replace the FDA’s voluntary notification system for GRAS substances.
From nutraingredients.com
Why it matters
The proposed federal oversight of GRAS substances and unresolved questions about New Dietary Ingredient Notifications (NDINs) are expected to test the industry. Companies are advised to prepare for stricter evidence governance, state monitoring, and increased regulatory strategy.
From nutraingredients.com
Who's involved
- FDARegulatory agency overseeing the supplement industry
- PharmaviteDietary supplements company that was part of the industry discussion
Who could feel it
Possible knock-on effectsThese are possibilities Brind reasoned out, not predictions, and not advice. Most are not stated in any report.
- PharmaviteSpeculative
Could face increased compliance costs and legal exposure due to mandatory GRAS notification rules
Keep exploring
The entities involved
Related events
- The FDA's GRAS status allows supplements to bypass full review, a point targeted by Kennedy and analyzed by experts like Professor Cohen, involving Calley Means and Harvard Medical School.
- New FDA rule threatens the ability to import medicines.
- Reduced FDA oversight fueled supplement industry growth, while Monsanto faced lawsuits over weedkiller safety claims.
- Lawsuits filed in Seattle involve FDA oversight, while the FDA investigates food safety issues in New Jersey.
- PAVmed is facing the requirement of regulatory clearance for its company products, while also attracting institutional investment interest.