CDC Cites Spa for Using Unapproved Botulinum Toxin

A Colorado medical spa received a formal complaint against its license after three women experienced neurologic symptoms following injection of cosmetic botulinum neurotoxin (BoNT) products not approved by the FDA. The event and subsequent investigation were detailed in a recent report published in the CDC’s Morbidity and Mortality Weekly Report. It’s the latest example of adverse reactions to unapproved BoNT.“BoNT purchased from an unauthorized supplier might not be FDA-approved and might be counterfeit, contaminated, improperly stored, or otherwise unsafe,” wrote the authors of the report, led by first author Pallavi Oruganti, DVM, of the CDC’s Epidemic Intelligence Service. “Persons should be encouraged to seek treatment only from licensed providers administering FDA-approved BoNT products. Providers should not purchase or administer unapproved BoNT products from unauthorized sources.”The communication did not name the spa or the specific BoNT product in question but noted that all three patients received injections in the upper brow, glabella, or upper lip within approximately one day of each other. The women reported numbness and tingling, muscle weakness, dysphonia, blurred vision, or neck stiffness. One patient sought medical care, while the others reported symptoms that resolved without medical attention. “Three persons experienced transient neurologic symptoms after injections of an unapproved BoNT product by a licensed provider in Colorado,” the authors wrote. “The clinical features reported included both adverse reactions listed on the package insert of the product and reactions that were not listed on the package insert…. Although approved in other countries, the administered product is not approved for use in the United States.”After investigators confirmed that the product in question was unapproved, a facility assessment from the Colorado Department of Public Health and Environment and a local public health agency also found inappropriate use and storage of other products. The spa received a public health order to stop using the unapproved products, with a formal complaint submitted to the Colorado Department of Regulatory Agencies. The provider informed investigators it would no longer use the unapproved products.“Based on findings from the investigation, potential causes [of the adverse effects] include unknown product concentration, product contamination, improper preparation, and improper administration or storage of the product,” the authors wrote. “This response highlights the importance of communication and collaboration among poison centers, healthcare providers, and public health authorities in reporting patients with symptoms after receiving BoNT injections.”The federal government has a history of taking action against providers who use non-FDA-approved BoNT therapies, as well as the purveyors who manufacture and sell them. In 2025, the FDA sent formal warnings to 18 websites for selling unapproved BoNT products. Also in 2025, the CDC reported that three individuals were hospitalized with botulism-type symptoms following self-injection of BoNT products they had purchased online. In 2024, the CDC investigated reports of four women in Tennessee and three women in New York City who fell ill after receiving BoNT injections in nonmedical settings.Oruganti did not disclose any relevant financial relationships with industry.Scott Harris has been covering dermatology for more than a decade. He lives near Washington, DC.