FDA, FTC Warn Companies Selling Unapproved Opioid Cessation Products

The sale of these unapproved products with claims about treating opioid addiction and withdrawal violates the Federal Food, Drug, and Cosmetic Act, and these unsubstantiated therapeutic claims violate the Federal Trade Commission Act against deceptive advertising.

The U.S. Food and Drug Administration and the Federal Trade Commission posted joint warning letters on Jan. 24 to the marketers and distributors of 12 opioid cessation products for illegally marketing unapproved products by claiming they are able to help in the treatment of opioid addiction and withdrawal.

"The FDA is increasingly concerned with the proliferation of products claiming to treat or cure serious diseases like opioid addiction and withdrawal," FDA Commissioner Dr. Scott Gottlieb said. "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."

Health fraud scams like these can pose serious health risks because the products have not been demonstrated to be safe or effective and could keep some patients from seeking appropriate, FDA-approved treatment. The sale of these unapproved products with claims about treating opioid addiction and withdrawal violates the Federal Food, Drug, and Cosmetic Act, and these unsubstantiated therapeutic claims violate the Federal Trade Commission Act against deceptive advertising, according to the agencies.

The FDA and FTC issued joint warning letters to 11 companies for their products: Opiate Freedom Center ("Opiate Freedom 5-Pack"), U4Life, LLC ("Mitadone"), CalmSupport, LLC ("CalmSupport"), TaperAid ("TaperAid" and "TaperAid Complete"), Medicus Holistic Alternatives LLC ("Natracet"), NutraCore Health Products, LLC ("Opiate Detox Pro"), Healthy Healing, LLC ("Withdrawal Support"), Soothedrawal, Inc. ("Soothedrawal"), Choice Detox Center, Inc. ("Nofeel"), GUNA, Inc. ("GUNA-ADDICT 1"), and King Bio, Inc. ("AddictaPlex").

The FTC also sent four warning letters to other marketers of opioid cessation products.

All of the companies use online platforms to make illegal claims about their products' ability to cure, treat, or prevent a disease. Examples of claims made include:

  • "#1 Selling Opiate Withdrawal Brand"
  • "Imagine a life without the irritability, cravings, restlessness, excitability, exhaustion and discomfort associated with the nightmare of addiction and withdrawal symptoms"
  • "Safe and effective natural supplements that work to ease many physical symptoms of opiate withdrawal"
  • "Break the pain killer habit"
  • "Relieve Your Symptoms…addiction, withdrawal, cravings."

The agencies have requested responses from each of the companies within 15 working days, directing the companies to inform each agency of the specific actions taken to address their concerns. The warning letters also state that failure to correct violations may result in law enforcement action, such as seizure or injunction.

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