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U.S. warns against illegal, unapproved opioid addiction products

Posted at 3:59 PM, Jan 24, 2018
and last updated 2018-01-24 18:16:00-05

SILVER SPRING, Md., — The U.S. Food and Drug Administration and the Federal Trade Commission Wednesday posted joint warning letters to the marketers and distributors of 12 opioid cessation products, for illegally marketing unapproved products with claims about their ability to help in the treatment of opioid addiction and withdrawal.

The FDA says 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, the agency said in a news release.

A huge influx of opioids has led to a wave of overdose deaths across the U.S. in recent years.

"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, M.D. "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."

The warning letters were sent to the 11 companies for their products:

  • Opiate Freedom Center ("Opiate Freedom 5-Pack")
  • U4Life, LLC ("Mitadone")
  • CalmSupport, LLC ("CalmSupport")
  • TaperAid ("TaperAid" & "TaperAid Complete")
  • Medicus Holistic Alternatives LLC ("Natracet")
  • NutraCore Health Products, LLC ("Opiate Detox Pro")
  • Healthy Healing, LLC ("Withdrawal Support")
  • Soothedrawal, Inc. ("Soothedrawal")
  • Choice Detox Center, Inc. ("Nofeel")
  • GUNA, Inc. ("GUNA-ADDICT 1")
  • King Bio, Inc. ("AddictaPlex").

The FTC sent four additional warning letters to other marketers of opioid cessation products. All of the companies use online platforms to make illegal claims about their products' ability to cure, treat, or prevent a disease. Examples of claims made include:

  • "#1 Selling Opiate Withdrawal Brand"
  • "Imagine a life without the irritability, cravings, restlessness, excitability, exhaustion and discomfort associated with the nightmare of addiction and withdrawal symptoms"
  • "Safe and effective natural supplements that work to ease many physical symptoms of opiate withdrawal"
  • "Break the pain killer habit"
  • "Relieve Your Symptoms.addiction, withdrawal, cravings."

The FDA and FTC have requested responses from each of the companies within 15 working days. The companies were directed to inform each agency of the specific actions taken to address each agency's concerns, the news release said.  

The warning letters also state that failure to correct violations may result in law enforcement action such as seizure or injunction.