FDA, FTC Warn Makers of 12 Opioid Cessation Products

FDA and the Federal Trade Commission have posted joint Warning Letters to the marketers and distributors of 12 opioid cessation products. The letters say the companies are illegally marketing unapproved products with claims about their ability to help treat opioid addiction and withdrawal.

An FDA statement says the products have not been demonstrated to be safe or effective and may keep some patients from seeking appropriate FDA-approved therapies. All the companies receiving the letters use online platforms to make illegal claims about their products’ ability to cure, treat, or prevent a disease, FDA says.

The two agencies have requested responses from each of the companies within 15 days listing specific actions they are taking to address the agencies’ concerns. The letters also state that failing to correct violations may result in law enforcement action such as seizure or injunction.