DSHEA (Dietary Supplement Health and Education Act)
RegulatoryAlso known as: DSHEA 1994, Dietary Supplement Act
The 1994 law that defines dietary supplements and sets the regulatory framework for the US market.
What It Means
DSHEA (1994) established dietary supplements as a distinct regulatory category under FDA. Key provisions: supplements are regulated as food (not drugs), manufacturers are responsible for safety (not FDA pre-approval), structure/function claims are allowed with disclaimers, new dietary ingredients require pre-market notification (NDI), and FDA can take action against unsafe products post-market. DSHEA created the regulatory landscape that every supplement company operates within.
What It Is Not
DSHEA does NOT mean supplements are unregulated. It means they follow a different regulatory model than drugs: post-market rather than pre-market oversight. The manufacturer bears the burden of proof for safety, and FDA can remove unsafe products.
Evidence and References
- legislationDSHEA full text
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