WASHINGTON, D.C. – Federal authorities are taking action against companies marketing unapproved products with claims they help with opioid addiction and withdrawal.
The U.S. Food and Drug Administration and the Federal Trade Commission sent warning letters related to 12 “opioid cessation” products that were illegally marketed.
“The FDA is increasingly concerned with the proliferation of products claiming to treat or cure serious diseases like opioid addiction and withdrawal,” said FDA Commissioner Scott Gottlieb, M.D. “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.”
The 12 products have not been proven to be safe or effective by the FDA, and they could pose serious health risks.
Marketers made several illegal claims. Examples include:
- “#1 Selling Opiate Withdrawal Brand”
- “Break the pain killer habit”
- “Relieve Your Symptoms…addiction, withdrawal, cravings.”
The companies have 15 days to respond to the FDA letter, or they could face law enforcement action.
According to the FDA, the following companies were issued joint warning letters: 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”).
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