In 2021 police officers arrested a woman after offering undercover agents fake Botox injections in a makeshift clinic he set up in a Los Angeles hotel room. A year later, a California-based doctor pleaded guilty to hidden from patients that the drugs he had injected into them were not brand-name Botox, but unapproved versions he bought online.
Now, federal and state health officials are investigating a series of illnesses linked to counterfeit or improperly administered Botox that has sickened 22 people in 11 states.
“It’s like Groundhog Day,” said Timothy Mackey, a professor at the University of California, San Diego who studies counterfeit drugs. Since 2012, federal agencies have sent more than 2,000 warning letters to doctors or medical centers who bought counterfeit or unapproved Botox for use in injections. Experts said there were two main factors fueling the problem: Consumers often don’t know how to check that what they’re getting is real, and fake products are readily available.
“Our supply chain has been infiltrated with counterfeit Botox — historically, currently and will be in the future,” said George Karavetsos, former director of the Food and Drug Administration’s Office of Criminal Investigation.
The brand-name cosmetic Botox, which is used to reduce wrinkles and signs of aging, contains small amounts of botulinum toxin that are not harmful when given in the right dose. But unapproved products may contain incorrect or even dangerously high doses, unpurified versions of these toxins, or possibly no drug at all, Mr. Karavetsos said. “It could be anything from saline to tap water to an extremely strong concentration of botulinum toxin A, which could kill you,” he said.
An internet search found several websites selling products matching the FDA’s description of the fake Botox linked to the diseases currently being investigated. Dr. David Shafer, a plastic surgeon in New York, said that while he only buys Botox directly from the manufacturer, he regularly receives emails advertising unauthorized or off-brand versions from overseas. One such message advertised “Korean” Botox — “We are ready to offer the best price,” the email read, with a WhatsApp number to contact the seller.
“If you go online and Google and someone says they have botox, more often than not, that’s not going to be a legitimate source,” said Sam Louis, an attorney who has prosecuted cases related to fake Botox at the Department of Justice.
Experts also warned that some people giving injections may not be properly trained to give them. In the current case series, the injured patients were either injected by “licensed or untrained individuals” or received the shots in non-medical settings, such as homes or spas, the Centers for Disease Control and Prevention he has said. In King County, Washington, three people sought medical treatment after receiving botulinum toxin injections at the same cosmetic spa, a local health department spokesman told The Times.
People who haven’t had Botox before can be especially susceptible to fake Botox if they’re looking for a discounted price, said Dr. Ladan Shahabi, director of cosmetic dermatology at UCLA Health in Santa Monica. They may seek injections advertised on Groupon or try to get care at facilities that are not properly accredited.
“Just because you walk into a treatment room and someone has a white coat doesn’t mean they’re a doctor,” said Dr. Seth L. Mataraso, a cosmetic dermatologist and president of the American Society for Dermatologic Surgery. But even doctors with the proper credentials have been found injecting fake Botox in the past.
Many consumers consider the injections a cosmetic procedure, not a medical one, and just think they’re getting the real product, Dr. Mackey said. “Most patients are never going to see the box, the vial, anything,” he said.
How consumers can stay safe
FDA released pictures counterfeit packaging, warning people to avoid a certain lot number, as well as boxes that say they contain 150 units. The FDA he has said Original Botox does not come in this unit.
Dr. Andrea Best, vice president of safety and clinical sciences for aesthetics and devices at AbbVie, which makes approved Botox, said the company is working with regulators and law enforcement agencies to investigate counterfeit products. She advised people to ask providers to look at the product and packaging before injecting, trying to ensure it has a tamper-proof seal.
But counterfeit products can sometimes be complicated and difficult to spot even by looking at the packaging, Mr. Karavetsos said, which is one reason why it’s essential to see a properly accredited and trained provider.
Health officials in New York, where three people became ill after injections from non-medical providerswarned not to take Botox by beauticians or beauticians. Dr. Shahabi recommended looking for a medical facility and licensed provider—such as a board-certified dermatologist—who has experience in cosmetic treatments.
“Consumers need to be the first point of surveillance for themselves,” Dr Mackey said.
