FDA Cracks Down On Supplements That Claim to Treat Opioid Withdrawal And Addiction

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FDA Cracks Down On Supplements That Claim to Treat Opioid Withdrawal And Addiction

Last week federal regulators said they are cracking down on distributors selling products that illegally claim to treat opioid withdrawal and dependence. Earlier this month, the Federal Trade Commission and Food and Drug Administration sent warning letters to marketers of products that target persons who are trying to find relief from their drug dependencies.

Products included “Calm Support” and “Opiate Freedom 5-Pack” and products were being sold as dietary supplements or homeopathic remedies.

In a statement, FDA Commissioner Scott Gottlieb called the marketers “unscrupulous vendors who are trying to capitalize on the epidemic by taking advantage of consumers and selling products with baseless claims.” Recently, Gottlieb advocated for expanded use of medication-assisted therapy to battle the opioid crisis and is concerned that false remedies could deter people from getting appropriate treatment.

Eleven companies were sent warning letters and have two weeks to respond. The agencies warned that if the companies “fail to correct violations, it may result in law enforcement action such as seizure or injunction.”

The FDA further stated that because the products are unapproved to purport to relieve or cure disease, they are subject to FDA authority.

When announcing the letters, the agencies noted some of the language the companies used to market the products such as “relieve your symptoms . . . addiction, withdrawal, cravings.” These claims were made on both product labels and websites, and were sometimes featured in YouTube videos.

Since the letters were sent, however, it appears some of the claims on the websites have been amended. For example, the link for the OFC Freedom 5-Pack, which once claimed to be “Made for Opiate Withdrawals” now leads to an error message saying the page no longer exists.

However, at the time of this writing, Soothedrawal’s website was still claiming that its products worked “directly to alleviate and soothe the symptoms of opiate withdrawal.”

Last December the Center for Science in the Public Interest urged the two agencies to take action against companies that touted their dietary supplements as treatments for opioid dependence. The group states that it had contacted several companies that were making these claims and requested scientific proof, and responses were often “riddled with pseudoscientific jargon or frighteningly ill-informed.”

~ G. Nathalee Serrels, M.A., Psychology

References

https://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2018/default.htm

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