Supplement regulation in the US is fundamentally different from drug regulation. Understanding how it works helps you make smarter choices about what you buy.
The Legal Framework: DSHEA
The Dietary Supplement Health and Education Act of 1994 (DSHEA) defines how supplements are regulated:
Supplements are regulated as foods, not drugs.
No pre-market approval required. Supplements can be sold without proving efficacy or submitting safety data to the FDA.
The burden of proof is reversed. For drugs, companies must prove safety before sale. For supplements, the FDA must prove danger to remove products.
Manufacturers are responsible for ensuring their products are safe and labels are accurate.
What the FDA Does (and Doesn't) Do
The FDA CAN: - Require Good Manufacturing Practices (GMP) - Take action against unsafe products after they're on the market - Issue warning letters for illegal health claims - Order recalls for contaminated or dangerous products
The FDA CANNOT: - Review supplements before they're sold - Require proof that supplements work - Test products before market (they do spot checks) - Prevent new ingredients from entering the market automatically
The GMP Requirement
Since 2010, the FDA requires supplement manufacturers to follow Good Manufacturing Practices:
- Proper identity testing of ingredients - Control of contaminants - Accurate labels - Clean facilities - Quality control procedures
The catch: Enforcement is limited. The FDA only inspects a small fraction of facilities annually. Some companies follow GMP rigorously; others treat it loosely.
What This Means for You
The regulatory environment puts more responsibility on consumers:
Quality varies widely. Some products are exactly what the label says. Others contain different amounts, different ingredients, or contaminants.
Third-party testing matters. NSF, USP, ConsumerLab, and Informed Sport provide independent verification that companies aren't required to get.
Claims are limited but often stretched. Supplements can't claim to treat, cure, or prevent disease. But "structure/function" claims ("supports immune health") are allowed and often vague.
Reputation matters. Established brands with something to lose generally maintain better quality control.
The Bottom Line
Supplement regulation is lighter than most consumers assume. This doesn't mean all supplements are bad, but it does mean you need to be a discerning buyer. Stick to reputable brands, look for third-party testing, and be skeptical of extreme claims.