FDA Cracks Down on Unapproved Opioid Addiction Products

Roni Shye
Roni Shye, PharmD BCGP BCACP, is a licensed pharmacist in the states of Florida, Ohio, and Pennsylvania.
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Opioid abuse is a serious public health issue that affects almost every community in some way. According to the Centers for Disease Control and Prevention (CDC), more than 600,000 people have died from an opioid drug overdose since 2000. The U.S. Department of Health and Human Services estimates that 52 million people have used prescription drugs for non-medical reasons at least once in their lifetimes.   

Treatment for opioid addiction is somewhat different compared to other addictions like tobacco or gambling. Whereas tobacco cessation products can be purchased over the counter, opioid treatments are usually given under the supervision of a doctor. Prescription medications and behavioral therapy can help to restore normal brain functioning, prevent relapse, reduce cravings, and the risk of overdose or death.

Recently, the Food and Drug Administration (FDA) and the Federal Trade Commission (FTC) found several companies illegally marketing 12 unapproved products that claimed to help in the treatment of opioid addiction and withdrawal.

In response to this, the FDA released a press release:

“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.”

What are the FDA and FTC doing in response to this?

The FDA and FTC have issued joint warning letters to 11 companies for the following products:

The companies are directed to inform each agency of the specific action taken to address the FDA and FTC’s concerns, and are responsible for preventing the recurrence of future violations. The warning letters state that failure to correct violations may result in legal action.

The FTC has consumer information available for those who are looking to get help for opioid dependence or withdrawal.

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