FDA — Disease-Treatment & Drug-Classification Claims

Under the federal Food, Drug, and Cosmetic Act, a product that claims to treat, cure, prevent, or diagnose a disease is legally classified as a drug — which requires FDA approval. Dietary supplements are not drugs, so marketing copy that makes disease-treatment claims, "safe and effective" claims (FDA drug-approval language), or unqualified pediatric/pregnancy safety claims puts the product at regulatory risk. What it means for you: keep supplement copy in structure-function territory ("supports a calm mood") rather than disease territory ("treats anxiety"). This is a reference summary, not legal advice — confirm with counsel.

Jurisdiction

United States (Federal) (federal)

Citation

21 USC §321(g)(1)

Severity

block

Corpus version

v1-929074c7ba3b

Applies to (categories)

Applies to (channels)