The Federal Trade Commission and the FDA on Wednesday issued joint warning letters to 11 marketers and distributors of 12 unapproved opioid cessation products.
Here are three things to know.
1. In its warning letter, the FDA said these products are not effective treatments for opioid addiction or opioid withdrawal symptoms, despite being marketed for such uses.
"The FDA is increasingly concerned with the proliferation of products claiming to treat or cure serious diseases like opioid addiction and withdrawal," said FDA Commissioner Scott Gottlieb, MD. "People who are addicted to opioids should have access to safe and effective treatments and not be victimized by unscrupulous vendors who are trying to capitalize on the opioid epidemic by taking advantage of consumers and selling products with baseless claims."
2. The warning letters call for each of the 11 companies to respond to the agencies within 15 business days. Responses must include details on how the companies plan to address the issues raised in the warning letters.
3. The regulatory move earned praise from the American Medical Association.
"Physicians have several tools to help patients overcome an opioid addiction. If patients are drawn to unapproved treatments, they face delays — and even death — by the time they realize the ineffectiveness of these heavily promoted 'treatments,'" said Patrice Harris, MD, chair of the AMA Opioid Task Force, in a statement emailed to Becker's. "Our patients have enough obstacles in accessing treatment, whether it is prior authorization, insurance issues or a shortage of treatment options. Thanks to the FDA and FTC action, they have one fewer obstacle."
To see a full list of the companies and products, click here.
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