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The agencies sent warning letters to several companies that the agencies say are illegally marketing unapproved products to treat opioid addiction and withdrawal.
On Jan. 24, 2018, FDA and the Federal Trade Commission (FTC) announced the two agencies sent joint warning letters to marketers and distributors of opioid cessation products. According to FDA, these companies are illegally marketing unapproved products claiming to help treat opioid addiction and withdrawal. The agencies state that failure to correct violations listed in the warning letters may result in law enforcement action such as seizure or injunction.
The opioid epidemic in the United States has spurred a number of federal and state programs to combat abuse of these types of drugs. FDA has taken steps to make medication assisted treatments safe, effective, and available to patients with opioid use disorder. The agency says that unapproved products that claim to help these patients may prevent people from seeking approved treatments, therefore possibly delaying or preventing recovery.
The 11 online-platform companies that received warning letters are 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”), and King Bio, Inc. (“AddictaPlex”). FTC sent four letters to additional marketers. Some of these companies, according to the agencies, are making illegal claims about their unapproved products that include promises that their products are safe, natural, and will relieve withdrawal symptoms.
“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 press 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. 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.”