FDA considers dietary supplements containing DMAA or DMHA adulterated/illegal under the applicable US food law. The two are separate substances; DMAA toxicity reports cannot establish an identical clinical risk profile for DMHA.[1][2][3]
- Jurisdiction
- United States
- Product
- Dietary supplements containing DMAA or DMHA
- Indication
- No dietary-supplement authorization; FDA adulteration determination
- Record date
- 2026-09-08
- Jurisdiction- and product-category-specific determination; not a claim of identical pharmacology.
- FDA's own DMAA-page wording is "illegal"/"unsafe food additive"; the word "adulterated" for DMAA specifically is corroborated by the federal court rulings the page cites (Hi-Tech Pharmaceuticals, affirmed by the 11th Circuit in 2019) rather than an identical standalone sentence to the DMHA page's direct "we consider...adulterated" wording. Both routes reach the same legal conclusion under the same statute.
Inspection history
Clinical review: not reviewed by a qualified clinician.
· Independent source inspection; applicability narrowed and inherited assertions excluded where unsupported. No qualified clinical review.
· Independently reopened all three FDA pages (default requests User-Agent was blocked; retrieved with a standard browser User-Agent). Confirmed DMAA (1,3-dimethylamylamine/methylhexanamine) and DMHA (1,5-dimethylhexylamine/octodrine) are named as chemically distinct substances on their respective pages, and confirmed the exact adulteration/illegality wording cited above. No correction needed to the claim text; no qualified clinical review.