FDA, FTC Try to Stop Opioid Cessation Products

Advertising Law

Marketers of opioid cessation products received warning letters from the Food and Drug Administration (FDA) and the Federal Trade Commission (FTC), cautioning them about unproven claims for the treatment of opioid addiction and withdrawal.

The 11 recipients of joint letters were warned that claims that their products were intended for use in the cure, mitigation, treatment or prevention of disease could violate both the Food, Drug and Cosmetic Act and Section 5 of the Federal Trade Commission Act.

For example, a letter to the Idaho-based Opiate Freedom Center, which marketed the “Opiate Freedom 5-Pack,” highlighted the problems. The website’s mission (“We want to help people of all ages, from all places, achieve their fullest potential, by bringing into the world the best and newest tools and information to support withdrawal relief, effective detox, and lasting recovery from addiction”) and other claims (“Introducing the best NATURAL opioid withdrawal relief supplements” and “The #1 Supplement System for Safe & Natural Nutrient Replenishment at Home … Made for Opiate Withdrawals”) drew the FDA’s warning.

As for the FTC, it explained that health-related claims must be supported by competent and reliable scientific evidence, and it cautioned recipients about two prior FTC law enforcement actions challenging unsupported claims for the treatment of opiate addiction and/or opiate withdrawal symptoms. In both cases, the orders imposed monetary judgments and required the defendants to cease making deceptive claims.

“The FTC strongly urges you to review all health-related claims that you and any of your affiliates are making in any medium,” according to the letters. “Competent and reliable scientific evidence for a product claiming to treat opiate withdrawal symptoms or opiate addiction consists of randomized, controlled, human clinical testing of that product. If any of your claims are not supported by competent and reliable scientific evidence, you should delete or revise them immediately.”

In addition to the joint missives with the FDA, the FTC sent four additional warning letters of its own.

To read the letters, click here.

Why it matters: Emphasizing the serious health risks posed by products that have not been demonstrated to be safe or effective, the FTC referenced its prior actions and vowed to continue its efforts to halt opiate addiction withdrawal scams. “Opioid addiction is a serious health epidemic that affects millions of Americans,” Maureen K. Ohlhausen, acting chair of the FTC, said in a statement about the letters. “Individuals and their loved ones who struggle with this disease need real help, not unproven treatments. We will continue to work together with the FDA to address this important issue.”



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