DSHEA and US dietary supplement regulation
DSHEA is the Dietary Supplement Health and Education Act of 1994. FDA explains that supplement firms have initial responsibility for product safety and labeling; dietary supplements are not approved by FDA before marketing. Your launch review still needs to address ingredients, claims, labels and manufacturing.
What DSHEA means for a founder
FDA’s questions and answers explain the dietary supplement category and the responsibilities of manufacturers and distributors. The absence of routine premarket product approval is not a safety certification or permission to market an unsafe or misbranded product.
Separate ingredient review from product approval
An NDI notification is a distinct requirement for certain new dietary ingredients. If required, allow at least 75 days before introduction into interstate commerce. Review the ingredient’s identity and intended use, rather than assuming that a familiar marketing name resolves the question.
Separate claims from label format
A structure/function claim has substantiation, disclaimer and notification requirements. A complete label review is broader: use FDA’s labeling guide to review the identity statement, net quantity, Supplement Facts, ingredient listing and responsible business information.
Next steps
Sources
Sources checked . Company descriptions are their own statements; they are not certification verification.
- FDA: questions and answers on dietary supplements
- FDA: NDI notification procedures and timeframes
- FDA: dietary supplement labeling guide
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