The letters are the latest effort to combat what FDA Commissioner Scott Gottlieb called a “proliferation” of unapproved products claiming to treat opioid addiction. In a statement, Gottlieb excoriated “unscrupulous vendors who are trying to capitalize on the epidemic by taking advantage of consumers and selling products with baseless claims.”
The FDA chief has pushed for the greater use of medication-assisted approaches to fight the opioid epidemic and warned that phony remedies could divert people from getting the right treatment.
All told, 11 companies were sent warning letters; they have 15 days to respond. A failure to correct violations, the agencies said, “may result in law enforcement action such as seizure or injunction.”
The FDA said that because the products are unapproved drugs that claim to ease or cure disease, they are subject to FDA authority. The FTC has jurisdiction over deceptive advertising.
The agencies, in announcing the letters, cited some of the language used to market the products: “break the killer pain habit,” “relieve your symptoms . . . addiction, withdrawal, cravings,” and reduce the “irritability, cravings, restlessness, excitability, exhaustion and discomfort associated with the nightmare of addiction and withdrawal symptoms.”
The claims were made on product labels and websites, which also often featured YouTube videos with consumer testimonials.
Some of the language on the websites appears to have been changed, perhaps after the letters were received. For example, the warning letter said that the Opiate Freedom Center in Eagle, Idaho, touted its OFC Freedom 5-Pack, as “Made for Opiate Withdrawals.” But on Wednesday, the link for that product led to an error message that said the page did not exist.
Soothedrawal in Acworth, Ga., which also was sent a warning letter, was still touting its products on its website Wednesday as working “directly to alleviate and soothe the symptoms of opiate withdrawal.”
Opiate Freedom Center and Soothedrawal did not immediately return requests for comment on the letters from the FDA and the FTC.
In December, the nonprofit Center for Science in the Public Interest called on the two agencies to take action against firms touting dietary supplements as treatments for opioid addiction. The group said it had contacted eight companies making such claims and asked for scientific proof. It said the responses were “often flip, cursory, riddled with pseudoscientific jargon or frighteningly ill-informed.”
On Wednesday, Peter Lurie, president of CSPI and a former FDA official, praised the federal agencies' actions, which involved several companies cited by the nonprofit organization in December. But, he added, “the Internet moves so fast that there is every reason to believe at this very moment that someone is trying to come up with new products to market, especially given the gravity of the opioid epidemic and the limited number of treatment slots for people.”