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FDA, FTC Warn 11 Companies For Selling Unapproved Opioid Cessation Products


The U.S. Food and Drug Administration and the Federal Trade Commission issued 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 and FTC issued warning letters 11 companies - Opiate Freedom Center for Opiate Freedom 5-Pack, U4Life, LLC for Mitadone, CalmSupport, LLC for CalmSupport, TaperAid for TaperAid & TaperAid Complete, Medicus Holistic Alternatives LLC for Natracet, NutraCore Health Products, LLC for Opiate Detox Pro, Healthy Healing, LLC for Withdrawal Support, Soothedrawal, Inc. for Soothedrawal, Choice Detox Center, Inc. for Nofeel, GUNA, Inc. for GUNA-ADDICT 1, and King Bio, Inc. for AddictaPlex.

According to the regulators, all of these companies use online platforms to make illegal claims about their products' ability to cure, treat, or prevent a disease. More than 2 million of Americans are found to be with an opioid use disorder.

FDA Commissioner Scott Gottlieb, said, "The FDA is increasingly concerned with the proliferation of products claiming to treat or cure serious diseases like opioid addiction and withdrawal,"

The FTC sent four additional warning letters to other marketers of opioid cessation products.

The FDA and FTC have requested responses from each of the companies within 15 working days.

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