Under the Dietary Supplement Health and Education Act of 1994, the U.S. Food and Drug Administration is prohibited from reviewing dietary supplements for safety or efficacy before they are marketed.

Verified by Lenz · Mar 25, 2026

The Short Version

DSHEA does not require FDA premarket approval for most dietary supplements, and products need not be proven safe or effective before sale. However, the claim that FDA is "prohibited from reviewing" supplements before marketing overstates the law. DSHEA requires a 75-day premarket notification for New Dietary Ingredients, during which FDA receives and may review safety information. The accurate framing is that FDA lacks mandatory premarket approval authority — not that it is categorically barred from any premarket review.

Caveats

The claim conflates 'no premarket approval required' with 'prohibited from reviewing,' which are legally distinct concepts — DSHEA limits FDA's premarket authority but does not impose a blanket prohibition.
DSHEA's New Dietary Ingredient (NDI) notification process requires manufacturers to submit safety information to FDA at least 75 days before marketing, a premarket review mechanism the claim entirely omits.
The word 'prohibited' implies a statutory ban on FDA action, but the actual legal framework is better described as the absence of mandatory approval authority, with FDA retaining some premarket review capacity for new ingredients.

The Receipts

Current regulatory guidelines and resources to support research of ...
PubMed Central (PMC)Jan 1, 2019
21 U.S. Code § 350b - New dietary ingredients
Legal Information Institute (Cornell LII)
Dietary Supplement Health and Education Act of 1994
ods.od.nih.govOct 25, 1994
Understanding DSHEA: How it Shapes the Dietary Supplement Market - Palmer Holland
palmerholland.com
Dietary Supplement Health & Education Act (DSHEA) | Council for Responsible Nutrition
crnusa.org
1994 Dietary Supplement Health and Education Act (DSHEA) - FDA - USP: Partners in Public Health
usp.orgOct 7, 2010
Dietary supplements are regulated by FDA and FTC
CRNUSA.org
Do Dietary Supplements Require FDA Approval Before Marketing?
CIRS-Group.com

Filed Under

Dietary Supplement Health and Education Act of 1994 United States Food and Drug Administration

Under the Dietary Supplement Health and Education Act of 1994, the U.S. Food and Drug Administration is prohibited from reviewing dietary supplements for safety or efficacy before they are marketed.

The Short Version

Caveats

The Receipts

Filed Under

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