The FDA sent letters to 18 website owners warning that they were selling unapproved botulinum toxin products, giving them 15 days to tell the agency the steps they will take to address its concerns.

In a statement issued on November 5, the agency said it was aware of adverse events associated with unapproved and misbranded botulinum toxin products — “commonly called Botox” — including botulism symptoms.

“Today we’re taking action to protect American consumers and prevent online entities from selling these dangerous products,” FDA Commissioner Marty Makary, MD, MPH, said in the statement.

Many of the websites warned by the agency were continuing to sell their products at press time.

It is far from the first time the FDA has warned about counterfeit or unapproved botulinum toxin. In 2012, the agency sent more than 300 letters to medical practices that had purchased unapproved versions of botulinum toxin from a foreign supplier. A year later, the agency wrote to another 300 practices warning they had purchased unapproved botulinum toxin from an online supplier.

In 2024, the FDA alerted healthcare professionals and consumers that counterfeit versions of botulinum toxin had been administered to consumers in multiple states. The FDA and the CDC reported that from November 2023 to April 2024, 17 people from nine states experienced symptoms that included blurry and double vision, drooping eyelids, difficulty swallowing, dry mouth, slurred speech, difficult breathing, fatigue, and generalized weakness, “after receiving injections with counterfeit products, products from unverified sources, or from individuals who were not following state or local requirements.” Thirteen people were hospitalized and six were treated with botulism antitoxin because of concerns that botulinum toxin could have spread beyond the injection site.

Asked by Medscape Medical News to comment on the latest FDA warning and the ongoing proliferation of unapproved botulinum toxin products, M. Laurin Council, MD, MBA, president of the American Society for Dermatologic Surgery (ASDS), said, “Patients should not be receiving medical care off a website.”

She added, “lack of regulation and enforcement has enabled many to offer medical procedures for cosmetic purposes outside of their training and expertise.”

Council, professor of dermatology at WashU Medicine, St. Louis, said that board-certified dermatologists should urge patients who may seek injections at sites that are not physician offices, such as a medical spa, to determine who owns and operates the spa and whether injectors are licensed and trained to give the injection. Patients should also ask whether the product being injected is approved by the FDA and obtained from a reliable source.

The ASDS Association, the ASDS education and advocacy arm, is encouraging states to adopt model legislation crafted by the organization, the “Medical Spa Safety Act.” The proposal calls on states to require medical procedures to be performed under physician oversight and includes staff education requirements and notification to the public if a physician is not on-site.

Healthcare professionals and consumers can report adverse events to the FDA’s MedWatch program.

Alicia Ault is a St. Petersburg, Florida-based freelance journalist whose work has appeared in many health and science publications, including Smithsonian.com. You can find her on X @aliciaault and on Bluesky @aliciaault.bsky.social.