The U.S. Food and Drug Administration and the Federal Trade Commission today 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.
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.
All of the companies use online platforms to make illegal claims about their products’ ability to cure, treat, or prevent a disease. Examples of claims made include:
– “#1 Selling Opiate Withdrawal Brand”
– “Imagine a life without the irritability, cravings, restlessness, excitability, exhaustion and discomfort associated with the nightmare of addiction and withdrawal symptoms”
– “Safe and effective natural supplements that work to ease many physical symptoms of opiate withdrawal”
– “Break the pain killer habit”
– “Relieve Your Symptoms – addiction, withdrawal, cravings.”
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.
Also today, the FTC, in coordination with SAMHSA of the U.S. Department of Health and Human Services (HHS), issued a fact sheet to help consumers get real help for opioid addiction or withdrawal, while avoiding products that promise but do not deliver help. The fact sheet has tips that consumers and health practitioners alike can share with those considering help for opioid addiction or withdrawal.
Health care professionals and consumers are encouraged to report any adverse events related to these products to the FDA’s MedWatch Adverse Event Reporting program. To file a report, use the MedWatch Online Voluntary Reporting Form. The completed form can be submitted online or via fax to 800-FDA-0178.