Companies warned for selling unapproved opioid cessation products using deceptive claims

26 Jan 2018

The companies have 15 days to respond to the FDA and FTC.

FDA and the Federal Trade Commission (FTC) have posted joint warning letters to the marketers and distributors of 12 opioid cessation products, for illegally marketing unapproved products with claims about their ability to help in the treatment of opioid addiction and withdrawal.

Companies warned for selling unapproved opioid cessation products using deceptive claims

Health fraud scams like these can pose serious health risks. These products have not been demonstrated to be safe or effective and may keep some patients from seeking appropriate, FDA-approved therapies. Selling these unapproved products with claims that they can treat opioid addiction and withdrawal is a violation of the Federal Food, Drug, and Cosmetic Act. Making unsubstantiated therapeutic claims is also a violation of the Federal Trade Commission Act, which prohibits deceptive advertising.

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” & “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”)
  • King Bio, Inc. (“AddictaPlex”).
  • The FTC sent four additional warning letters to other marketers of opioid cessation products.

    The FDA and FTC have requested responses from each of the companies within 15 working days. The companies are directed to inform each agency of the specific actions taken to address each agency’s 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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