Friday, February 2, 2018
Unapproved Opioid Cessation Products
On January 11, the FDA, as well as the Federal Trade Commission, 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.
This marketing can pose a serious health risk, as these products have not been demonstrated to be both safe and effective. Selling these products is a violation of the Federal Food, Drug, and Cosmetic Act.
Reducing the number of Americans who are addicted to opioids has become a huge priority as there are currently 2 million people with an opioid use disorder. “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.”
The 11 companies who received warning letters are: 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 FDA and FTC have requested responses from each of the companies within 15 working days.
Read the FDA's official statement here.
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