The Food and Drug Administration (FDA) and the Federal Trade Commission (FTC) sent joint warning letters today to 11 companies that have been illegally marketing and distributing products with unapproved claims about their ability to help in the treatment of opioid addiction and withdrawal.
The 12 products in question 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 and also a violation of the deceptive advertising prohibitions of the Federal Trade Commission Act.
FDA Commissioner Scott Gottlieb, MD, and Acting FTC Chairman Maureen K. Ohlhausen (Source: fda.gov, ftc.gov)
The FDA is increasingly concerned with the proliferation of products claiming to treat or cure serious diseases like opioid addiction and withdrawal. 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.
– FDA Commissioner Scott Gottlieb, MD
Opioid addiction is a serious health epidemic that affects millions of Americans. Individuals and their loved ones who struggle with this disease need real help, not unproven treatments. We will continue to work together with the FDA to address this important issue.
– Acting FTC Chairman Maureen K. Ohlhausen
Over 2 million Americans have an opioid use disorder, according to the FDA. The agency is focusing on making safe and effective medication assisted treatments available to those who suffer from opioid use disorder and to reduce the stigma that is sometimes associated with use of these therapies. 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. 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 these 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”).
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, including, for example:
- “#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, by which time the companies must 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.