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Dietary supplements and lessons to be learned from GRAS
1Burdock & Associates, Inc., 622 Beachland Boulevard, Vero Beach, Florida, 32963, USA.
Regulatory Toxicology and Pharmacology : RTP
|March 15, 2000
Summary
The 1994 Dietary Supplement Health and Education Act (DSHEA) governs dietary supplements. Applying the general recognition of safety (GRAS) principles from food additives could improve current supplement regulation.
Area of Science:
- Regulatory Science
- Food and Drug Law
- Nutritional Science
Background:
- The dietary supplement industry has grown significantly, reaching a $12 billion market.
- The Food and Drug Administration (FDA) implemented restrictive actions, leading to new legislation.
- The Dietary Supplement Health and Education Act (DSHEA) was enacted in 1994.
Purpose of the Study:
- To compare current dietary supplement regulation with the general recognition of safety (GRAS) concept.
- To propose applying GRAS principles to address challenges in dietary supplement oversight.
Main Methods:
- Comparative analysis of regulatory frameworks.
- Review of historical application of GRAS principles in food additive regulation.
Main Results:
- The DSHEA introduced more permissive regulations for dietary supplements.
- The GRAS concept, established in 1958, provides a precedent for safety assessments.
Conclusions:
- Lessons learned from decades of GRAS determinations can inform dietary supplement regulation.
- A framework based on GRAS principles may offer a more effective approach to ensuring supplement safety.