FDA, FTC Issues Warning Over Illegal Opioid Withdrawal Treatments

Agencies send warning letters to companies selling products with unsubstantiated claims about treating opioid misuse disorder.

The FDA and the Federal Trade Commission (FTC) recently posted warning letters to the manufacturers and distributors of 12 opioid cessation products. These unapproved products were marketed illegally with claims that they could treat opioid misuse disorder and withdrawal, according to a press release.

“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, in a press release. “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. We’ll continue to work with our partners at the FTC to step up our actions against unapproved products being marketed for the treatment of opioid addiction and withdrawal.”

Claims such as those addressed in the letter can pose serious risks to patients because the products have not been deemed safe or effective, the FDA noted. The drugs may also prevent patients from seeking treatment with FDA-approved medications.

Distribution of unapproved products that claim to treat opioid addiction and withdrawal violates the Federal Food, Drug, and Cosmetic Act and making unsubstantiated therapeutic claims violate the Federal Trade Commission Act, according to the release.

“Opioid addiction is a serious health epidemic that affects millions of Americans,” said Acting FTC Chairman Maureen K. Ohlhausen in a press release. “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.”

Addressing the burden of the opioid epidemic and reducing the number of new addictions has become a top public health priority. The FDA has taken steps to ensure that medication-assisted treatments are available to patients with opioid use disorder and reduce stigma associated with the therapy, according to the release.

The FDA/FTC warning letter was issued to 11 companies, while the FTC sent letters to another 4 companies selling opioid cessation products. These companies used online marketing to make illegal claims, including “#1 Selling Opiate Withdrawal Brand,” and “Break the pain killer habit,” according to the release.

The companies are required to respond to the letter within 15 business days and to detail how they will address each specific concern. Failure to correct the violations may result in seizure or injunction, according to the FDA.

The FTC also created a fact sheet that aims to help patients receive help for opioid misuse disorder and avoid products that make unsubstantiated claims. This guidance also includes tips for both consumers and providers on how to support individuals seeking help for opioid addiction or withdrawal.