FDA: Increasing Number of Companies Selling Unapproved Opioid Cessation Txs
The Food and Drug Administration (FDA) and the Federal Trade Commission (FTC) issued warning letters to the marketers and distributors of 12 opioid cessation products for illegally marketing unapproved drugs with claims to help treat opioid addiction and withdrawal.
Joint warning letters were sent to following 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")
- King Bio, Inc. ("AddictaPlex")
In addition, the FTC issued 4 additional warning letters to other marketers for opioid cessation products. These companies have posted unsubstantiated claims about their products' ability to cure, treat, or prevent a disease on the internet.
These products have not demonstrated safety or efficacy and may prevent patients from accessing appropriate, FDA-approved treatments. The marketing of these unapproved products with claims to treat opioid addiction and withdrawal is a violation of the Federal Food, Drug, and Cosmetic Act; the false advertising with unproven therapeutic claims also violates the Federal Trade Commission Act.
"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," stated FDA Commissioner Scott Gottlieb, MD.
The Companies are required to respond within 15 business days; failure to correct violations may lead to law enforcement action such as seizure or injunction.
Health professionals are encouraged to report any adverse events related to these products to the FDA's MedWatch Adverse Event Reporting program.
For more information call (888) 463-6332 or visit FDA.gov.