WASHINGTON — The FDA and the Federal Trade Commission accused 11 companies of using “deceptive” marketing practices and failing to seek required approvals for products billed as treatments for opioid addiction or withdrawal.
Warning letters were sent to the firms, with products such as “Mitadone” and “Opiate Freedom 5-Pack,” the agencies announced Wednesday.
“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, MD, in a statement. “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.”
The statement said four other companies selling opioid cessation products also received warning letters, but neither the firms nor the products were named.
“All of the companies use online platforms to make illegal claims about their products’ ability to cure, treat, or prevent a disease,” the agencies said.
Recipients were told to respond within 15 days, detailing their plans to address the agencies’ concerns.
In addition, the FTC and the Substance Abuse and Mental Health Services Administration on Wednesday put out a fact sheet for consumers on approved therapies for opioid addiction and withdrawal.