FDA, FTC warn companies marketing supplements as opioid addiction withdrawal aids

Bottle of Mitadone, an anti-opiate

Warning letters follow CSPI investigation and request for enforcement action

The U.S. Food and Drug Administration and the Federal Trade Commission today warned marketers and distributors of 12 dietary supplements marketed as opioid withdrawal aids that they can no longer market these products with drug treatment claims—a big step toward getting these harmful products off the market. The FDA also replied directly to CSPI in a letter.

The move follows a CSPI investigation in December exposing eight companies that were marketing supplements online as opioid withdrawal aids, despite lack of evidence that they help people get off opioids.

Furthermore, consumers who believe the supplements’ claims could be diverted from the three FDA-approved medically assisted treatments for opioid withdrawal that have been shown to be effective in rigorous studies.

“The FDA and FTC’s decision to warn these exploitative companies could save consumers’ lives and is a very welcome step,” says CSPI President Dr. Peter G. Lurie. “These ineffective withdrawal aids pose an imminent danger to very vulnerable consumers who are desperate to treat their opioid addiction.”

The CSPI investigation identified products from six of the 11 companies to which the FDA and FTC sent joint warning letters today: U4Life, LLC; TaperAid; CalmSupport, LLC; Medicus Holistic Alternatives LLC; NutraCore Health Products, LLC; and Opiate Freedom. When CSPI contacted the eight companies in our investigation and requested that each point to scientific studies showing that its product is more effective than a placebo, the responses were shockingly ill-informed and misleading. For example, CSPI e-mailed NutraCore Health Products, LLC, the company behind Opiate Detox Pro, asking for evidence on the product’s efficacy. A representative responded: “Scientific studies are very costly, so no, there is no study.”

U.S. Senators Richard Blumenthal (D-CT) and Edward J. Markey (D-MA) also sent a letter to the agencies supporting enforcement action on these products.

The FDA and FTC also sent letters to Healthy Healing, LLC; Soothedrawal, Inc.; Choice Detox Center, Inc.; GUNA, Inc.; and King Bio, Inc. In addition, the FTC sent letters to four companies whose names the agency would not reveal. CSPI is submitting a FOIA request to learn the names of the companies. 

Contact Info:  Jeff Cronin (jcronin@cspinet.org) or Richard Adcock (radcock@cspinet.org)