FDA, FTC Crack Down on Unapproved, Illegally Marketed Opioid Cessation Products

JANUARY 24, 2018
Officials with the FDA and the Federal Trade Commission (FTC) today issued joint warnings to companies selling unapproved opioid cessation products with deceptive claims about their ability to treat opioid addiction and withdrawal, according to a FDA press release.

The warning letters addressed marketers and distributors in violation of the Federal Food, Drug, and Cosmetic Act for the selling of 12 illegally marketed, unapproved opioid cessation products, according to the press release. The FDA emphasized that these products have not been demonstrated to be safe or effective and may be keeping patients from seeking appropriate, FDA-approved therapies for opioid addiction.

All of the companies use online platforms to make unsubstantiated therapeutic claims about their product’s ability to treat opioid addiction and withdrawal, according to the statement.

Overall, the FDA and FTC issued the 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)
  • King Bio, Inc. (AddictaPlex)
In addition, FTC officials sent 4 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 with specific actions taken to address the agency’s concerns.

Reference

FDA, FTC warn companies for selling illegal, unapproved opioid cessation products using deceptive claims [news release]. FDA’s website. . Accessed January 24, 2018.

 

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