In a series of FDA Safety Alerts, Recall Notices, and Enforcement Actions over the last couple of years, the Agency has notified consumers of dozens of OTC products that contain undeclared and dangerous drugs. These products cover a variety of treatments, but most are targeted to erectile dysfunction and weight loss. In the latest recall notice (here), FDA cited a specific product called Smart Lipo as containing undeclared sibutramine, desmethylsibutramine, and phenolphthalein.
This product is a triple threat of active drugs, particularly sibutramine, which is an appetite suppressant that was withdrawn from the U.S. market in October 2010. Sibutramine is known to substantially increase blood pressure and/or pulse rate in some patients and may present a significant risk for patients with a history of coronary artery disease, congestive heart failure, arrhythmias or stroke. Phenolphthalein is an ingredient previously used in over-the-counter laxatives, but, because of concerns of carcinogenicity, it is not currently approved for marketing in the United States.” Desmethylsibutramine is a salt of sibutramine and presumably raises the same safety concerns.
Continued evidence of products marketed as dietary supplements containing undeclared drug ingredients gives the entire dietary supplement business a bad name. In a post on April 2013 (here), I asked whether it was time to relook at the dietary supplement industry and regulations. Recently, the FDA held a public meeting to discuss the homeopathic products and the FDA enforcement policy (here). We need to remember that neither of these classes of products requires FDA approval. As the safety of the supply chain is ever increasingly on minds of FDA and Congress, we might not be too far away from a complete review of these types of products and whether the processes for marketing of these products need to be revised. While I am not 100% convinced one way or the other, the continued barrage of “bad” products containing undeclared and unsafe ingredients certainly starts to push one in a certain direction. Let’s see what Congress does in its next session, or if FDA starting sounding more of an alarm bell.