FDA Warns Companies Over Illegal Opioid Addiction/Withdrawal Products

U.S. regulators have sent warning letters to a number of companies connected with 12 illegal, unapproved products that the companies claim treat or cure opioid addiction and withdrawal.

The warnings were issued Jan. 24 by the Food and Drug Administration and the Federal Trade Commission.

"The FDA is increasingly concerned with the proliferation of products claiming to treat or cure serious diseases like opioid addiction and withdrawal," FDA Commissioner Dr. Scott Gottlieb said in a government news release.

"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," Gottlieb said.

The products have not been proven safe or effective, and may prevent some patients from seeking effective, approved treatments for opioid addiction or withdrawal, potentially putting their health at risk.

"Opioid addiction is a serious health epidemic that affects millions of Americans," Acting FTC Chairman Maureen Ohlhausen said in the news release. "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."

The joint FDA-FTC warning letters were sent to 11 companies. Here are the companies and their products: Opiate Freedom Center -- Opiate Freedom 5-Pack; CalmSupport, LLC -- CalmSupport; TaperAid -- TaperAid and 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.

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