FDA and FTC Warn Companies for Selling Illegal, Unapproved Opioid Cessation Products

PUBLISHED: Jan 25, 2018
Relevant to: Ambulatory Care, Critical Access Hospitals, Long Term Care, Medical Office, Pharmacy

The U.S. Food and Drug Administration and the Federal Trade Commission have together 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.

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.

Using products with unsubstantiated claims may prevent those addicted to opioids from seeking approved treatments that have been demonstrated to be safe and effective, delay their path to recovery, and put them at greater risk of death. In fact, patients receiving FDA-approved medication-assisted treatment cut their risk of death in half, according to the Substance Abuse and Mental Health Services Administration (SAMHSA).

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”), and 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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