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 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."
Health fraud scams like these can pose serious health risks. These products 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. Making unsubstantiated therapeutic claims is also a violation of the Federal Trade Commission Act, which prohibits deceptive advertising.
"Opioid addiction is a serious health epidemic that affects millions of Americans," said Acting FTC Chairman Maureen K. Ohlhausen. "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."
Reducing the number of Americans who are addicted to opioids and cutting the rate of new addiction is one of the Administration's highest priorities. This work includes promoting more widespread innovation and access to opioid addiction treatments for the more than 2 million of Americans with an opioid use disorder. The FDA is taking new steps to make safe and effective medication assisted treatments (MAT) 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. In fact, 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 11 companies for their products:
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:
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.
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