Food and Drug Administration

The Food and Drug Administration appears in Why is there a supplement craze if they don’t even work? as the U.S. regulator whose authority over supplements is much weaker than its authority over drugs. The source contrasts drug approval, which requires rigorous evidence, with Dietary Supplement Regulation, where many products can reach the market without proving effectiveness or ordinary premarket safety.

The episode also uses the FDA in the Prevagen story. According to the source, the agency questioned whether the jellyfish-protein ingredient met the relevant safety threshold and later questioned NeuroShake, but the company still used GRAS Self-Certification to move through the food-to-supplement pathway described by Melanie Benish.

Connections

• Dietary Supplement Health and Education Act - legal frame limiting FDA supplement oversight.
• Supplement Structure Function Claims - claim category that avoids drug-like disease language.
• GRAS Self-Certification - food-law route described in the Prevagen case.
• Prevagen and NeuroShake - source case where FDA concerns did not quickly remove the product from the market.
• Federal Trade Commission - advertising-enforcement agency that acts on a different part of the problem.