FDA and the Federal Trade Commission on Wednesday said the agencies have taken action against the distributors and marketers of 12 products that illegally claim to help people with opioid use disorders.
The agencies sent warning letters to 11 companies and four marketing companies regarding 12 products, 10 of which are marketed as dietary supplements and two as homeopathic remedies. The products include CalmSupport, Opiate Freedom 5-Pack, and Soothedrawal.
The agencies in a release said the products' marketing includes language that claims the products can help individuals "break the painkiller habit" or reduce the "irritability, cravings, restlessness, excitability, exhaustion, and discomfort associated with the nightmare of addiction and withdrawal symptoms."
However, the agencies said the products have not be proven to be safe or effective at treating individuals with opioid use disorder and withdrawal symptoms. As such, the agencies said the products' marketing language violates the Federal Food, Drug, and Cosmetic Act, as well as the Federal Trade Commission Act, which prohibits deceptive advertising.
In the letters, the agencies gave the companies 15 working days to inform federal regulators how they plan to address each agency's concerns. The agencies said failure to address violations could result in law enforcement action such as seizure or injunction.
Frank King—founder of King Bio which received a letter for its product, AddictaPlex—said the company had stopped selling the product in order to avoid potential litigation. "We choose to not fight it but to just go ahead and pull that particular product just because it was not a battle worth well over six figures to fight," King said.
According to Reuters, the other companies that received warning letters did not responded to requests for comment (Gever, Medpage Today, 1/24; Reuters, 1/24; McGinley, "To Your Health," Washington Post, 1/24; FDA release, 1/24).
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