FDA, FTC crack down on unapproved opioid addiction, withdrawal meds

FDA, FTC crack down on unapproved opioid addiction, withdrawal meds

The U.S. Food and Drug Administration (FDA) and the Federal Trade Commission (FTC) have sent joint warning letters to a dozen makers, marketers and distributors of what are called “opioid addiction cessation products” – various herbal and other concoctions that claim to help people withdraw from opioid dependence.

There’s nothing wrong with wanting to help. But the problem is that making medical claims for products that have never been tested and approved is simply illegal – whether the substances being sold are helpful or not.

The FDA is involved because claims were made that the products can treat opioid addiction and withdrawal, an unproven medical claim that makes it a violation of the Federal Food, Drug, and Cosmetic Act.

The FTC is involved because the medical claims are “unsubstantiated” – a violation of the Federal Trade Commission Act which prohibits deceptive advertising.

"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."

Many products in the past have made health claims that turned out to be bogus, some even injuring or killing people. Some may actually have been helpful, but because they didn’t seek FDA approvals, they were also breaking the law by marketing them as medical therapy or treatment.

It should be understood that claims by customers or patients that it was helpful is not a defense. Without federal approvals following established scientific testing procedures, you can’t make medical or treatment claims.

The FTC and the Substance Abuse and Mental Health Services Administration have published a fact sheet listing “approved therapies” for opioid addiction and withdrawal.

The safest approach for anyone seeking help with opioid withdrawal is to contact a legitimate treatment facility like Novus Medical Detox Center, and get some real professional advice. If that applies to you, call us right away. We’ll give you the kind of advice we’ve been giving people like you for many years to help you get on the road back to a drug-free life.

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