Overview
- The enforcement action targets cosmetic-focused retailers that the agency says marketed counterfeit or misbranded injectables as Botox-like products.
- The FDA named 18 sites in violation, including Acecosm, Glamderma and Filler Outlet, and said the products had not been approved by the agency.
- Officials reported adverse reactions and toxic side effects tied to the unauthorized products, including symptoms consistent with botulism.
- FDA-approved botulinum toxin medicines are prescription treatments that carry a boxed warning for rare but serious complications such as breathing or swallowing problems.
- Consumers are urged to receive injections only from licensed, trained professionals and to seek immediate medical care for trouble swallowing or breathing, slurred speech or muscle weakness.