Is Botulinum toxin type A legal in the United States?

A large bacterial protein that works as an enzyme, not a peptide. It was first approved in 1991 and carries the FDA's strongest warning, about the toxin spreading beyond where it was injected. Its medical uses far outnumber its cosmetic ones. In pooled migraine studies of 1384 people, headache days fell 8.4 a month on the toxin and 6.6 on dummy shots. For wrinkles, results are graded on frown-line scales and last roughly 3 to 6 months.

Botulinum toxin type A is in this archive for one reason. Peptide creams such as argireline are sold as alternatives to it, and that comparison needs a true reference point.

How it works: One half of the toxin grabs onto nerve endings that control muscles and glands, and the toxin gets pulled inside. The other half is an enzyme.

Approval history: FDA-approved. Botox was first approved on 9 December 1991 under BLA 103000. Other type A products were approved separately, including abobotulinumtoxinA, incobotulinumtoxinA, prabotulinumtoxinA and daxibotulinumtoxinA. Approved uses include chronic migraine, overactive bladder, stiff tight muscles (spasticity), neck muscle spasms (cervical dystonia), heavy underarm sweating, eyelid spasms and crossed eyes. There are separate cosmetic approvals for facial lines. All type A products carry a boxed warning, the FDA's strongest kind, that the toxin's effect can spread beyond the injection site. Units differ from product to product and cannot be swapped between brands.

Approves prescription drugs, each for a named use. It also acts against unapproved products, including peptides sold online. Compounding pharmacies, which mix drugs to order, may make some compounds with a prescription. That only applies when the FDA puts the compound in a category of bulk ingredients it allows.

The legal category above is how The Longevity Archive reads U.S. Food and Drug Administration listings for Botulinum toxin type A on the reviewed date. It is not a legal opinion. Rules change. Bringing a compound into the country, prescribing it and owning it can each be treated differently. Check with the agency before you act on anything here.

Check FDA directly

Whether Botulinum toxin type A is banned in sport is set by the World Anti-Doping Code and by military rules, not by its legal status in the United States. Before you compete or get tested, look up Botulinum toxin type A by name on the Prohibited List, or look up a named product in Global DRO. Under the World Anti-Doping Code, category S0 bans, at all times, any drug-like substance that meets two tests. No other section of the List covers it. And no government health regulator anywhere has a current approval for it as a treatment in people. Many substances that are approved somewhere are banned by name in another section. So approval does not mean a substance is allowed in sport.

• WADA Prohibited List
• Global DRO (check a named product)
• USADA (US athletes)
• Operation Supplement Safety (US service members)

The rules you compete or serve under decide this, not this page.