The DEA reports that the FDA has never approved clenbuterol for human use in the United States under the Federal Food, Drug and Cosmetic Act. The only current FDA-approved clenbuterol product is a veterinary syrup for airway obstruction in horses; outside the United States, some countries permit clenbuterol prescriptions for human bronchial asthma.[7]
- Jurisdiction
- United States
- Product
- Clenbuterol (all human-use products)
- Indication
- No FDA-approved human indication; approved only as a veterinary bronchodilator (Ventipulmin Syrup) for airway obstruction in horses (1998)
- Record date
- 2026-09-08
- A US enforcement-agency fact sheet describing regulatory/control status; it does not itself establish clinical safety or efficacy for any population.
- Other countries' prescribing practices are described narratively and in general terms in this source, not verified jurisdiction-by-jurisdiction.
Inspection history
Clinical review: not reviewed by a qualified clinician.
· Added from a freshly inspected DEA fact sheet to state clenbuterol's US regulatory status precisely, addressing a named batch research priority (clenbuterol is not an approved human drug in the US). Independent editorial review pending; no qualified clinical review.