FDA gets heavy on ‘unscrupulous’ opioid addiction product sellers
The US FDA has issued warning letters to eleven companies for marketing unapproved products claiming to treat opioid addiction and withdrawal, In-Pharma Technologist reports.
The US is in the midst of an opioid epidemic. According to the US Department of Health and Human Services (HHS), 116 people died per day in 2016 from opioid-related overdoses, and 11.5 million people misused prescriptions opioids.
While there are pharma companies looking to develop approved treatments for opioid addiction and withdrawal, others are making unsubstantiated claims their unapproved products can treat the problem according to warning issued by the US Food and Drug Administration (FDA) and Federal Trade Commission (FTC).
“The FDA is increasingly concerned with the proliferation of products claiming to treat or cure serious diseases like opioid addiction and withdrawal,” Commissioner Scott Gottlieb said.
“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 capitalise on the opioid epidemic by taking advantage of consumers and selling products with baseless claims.”
The eleven companies issued with warning letters from either the FDA’s Center for Drug Evaluation and Research or Center for Food Safety and Applied Nutrition are: Opiate Freedom Center, U4Life LLC, CalmSupport LLC, Medicus Holistic Alternatives LLC, NutraCore Health Products LLC, Healthy Healing LLC, Soothedrawal Inc., Choice Detox Center Inc., GUNA Inc., and King Bio Inc.
According to the agency the firms have all made unsubstantiated claimed their products can cure, treat, or prevent opioid addiction and withdrawal via online platforms.
“These products have not been demonstrated to be safe or effective and may keep some patients from seeking appropriate, FDA-approved therapies,” the Agency said. “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.”
A further four additional warning letters were sent by the FTC to other marketers of opioid cessation products.