FDA accuses Southlake spa of using illegal, off-brand Botox
A Southlake spa has been accused of using illegal, off-brand Botox, according to a letter sent to the spa by the Food and Drug Administration.
The FDA wrote in an April 1 letter that Pure Indulgence, at 1695 E. Southlake Blvd. in Southlake, had “dispensed significantly more Botox units than documented purchases from AbbVie (the manufacturer of Botox), thereby indicating a major discrepancy.” The letter was first reported by Star-Telegram news partner WFAA.
The FDA accused the spa of obtaining drugs from unauthorized sources and claiming it was authentic Botox.
The FDA wrote that Pure Indulgence “failed to comply” with the Drug Supply Chain Security Act. The agency said that its findings were “particularly concerning from a public health perspective” because Botox comes with a boxed warning, often known as a “black box warning,” which is the strongest warning the FDA requires, according to the letter. The warning cautions that Botox may cause symptoms of botulism, which happens when the botulinum toxin “attacks the body’s nerves and causes difficulty breathing, muscle paralysis, and even death,” according to the U.S. Centers for Disease Control and Prevention.
Pure Indulgence did not immediately reply to a request for comment from the Star-Telegram, but said in a statement to WFAA: “We are currently working directly with the FDA to address the matters identified in the letter,” according to the statement. “Because this process is ongoing, it would be inappropriate to comment on specific details at this time. We remain committed to providing safe, high-quality care to our patients and will continue to cooperate fully with regulators.”
Bridget Goddard, the manager of Pure Indulgence, previously pleaded guilty to similar accusations for a day spa she owned and operated in California. Goddard pleaded guilty to one count of receipt and delivery of a misbranded drug, according to the U.S. Department of Justice. Goddard said in her plea agreement that she had purchased Botox over the internet from Canadian companies, and that the drugs were not approved by the FDA for distribution in the U.S., according to federal prosecutors.
This isn’t the first time Pure Indulgence has caught the eye of regulators. In 2023, the Texas Medical Board found that Dr. Stephen Todd Newman, the spa’s medical director, had “failed to exercise diligence in the treatment of one patient,” according to the board’s order. Newman’s attorney did not immediately respond to a request for comment. Newman did not admit or deny the findings, according to the board.
