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FDA, FTC Send Warning over Illegal Opioid Cessation Products

January 26, 2018
The illegal distribution and marketing of alleged opioid addiction and withdrawal products has drawn federal attention.

A PPM Brief

The US Food and Drug Administration and the Federal Trade Commission issued joint Warning Letters to the marketers and distributors of 12 alleged opioid cessation products for illegal marketing of unapproved projects.

“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 an FDA 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.”

In addition to posing serious safety risks, which violate the Federal Food, Drug, and Cosmetic Act, these companies have made unsubstantiated therapeutic claims, which violate the Federal Trade Commission Act. Some of the sham-marketing claims include: “#1 Selling Opiate Withdrawal Brand” and “Break the pain killer habit.”

The following companies received Warning Letters for their products / marketing; they have 15 working days to provide a response to the agencies: Opiate Freedom Center, U4Life LLC, CalmSupport LLC, TaperAid, Medicus Holistic Alternatives LLC, NutraCore Health Products LLC, Healthy Healing LLC, Soothedrawal, Inc., Choice Detox Center, Inc., GUNA, Inc., and King Bio, Inc.

Last updated on: January 26, 2018
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