FDA, FTC Warn Companies About Unapproved Opioid Therapies
Abstract
The FDA and the Federal Trade Commission (FTC) last week issued joint warning letters to the marketers and distributors of unapproved products that the companies claim help treat opioid addiction and withdrawal.
The 11 companies warned (and their products) are as follows: Opiate Freedom Center (Opiate Freedom 5-Pack), U4Life LLC (Mitadone), CalmSupport LLC (CalmSupport), TaperAid (TaperAid and 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).
The companies were given 15 days to inform each agency of the specific actions they have taken to address their concerns. Failure to correct violations may result in law enforcement action such as seizure or injunction. ■