Concerns Over Dietary Supplements Raised

In the editorial, Gerald Weissmann, M.D. Editor-in-Chief of the journal and Research Professor of Medicine and Director of the Biotechnology Study Center at NYU School of Medicine, examines litigation involving StarCaps dietary supplement weight loss capsules to illustrate regulatory loopholes that make it impossible for the FDA to prevent dangerous substances sold with health claims from reaching the market.

"You don't need to be a pharmacologist to suspect that almost anything that really affects the structure or function of the human body might have an unwanted side effect (a.k.a., toxicity)," Weissmann states. "Indeed, a search in PubMed for 'herbal drugs/toxic effects' finds such 460 articles...These range from hepatotoxicity from herbals and weight-loss supplements in the United States to kidney failure as a result of aristolochia, a Chinese herb used worldwide."

In the editorial, Weissmann looks back to the late 1800s to point out that Coca Cola once made medicinal claims fueled by an original recipe that included secret amounts cocaine among other drugs. A 1902 trial where Coca Cola's secret ingredients came to light, ultimately helped lead to the landmark Pure Food and Drug Act of 1906, provisions of which still guide today's FDA. Then, through the course of his editorial, Weissmann explains how and why the dietary supplement industry is at odds with the FDA's origins and mission, and that these supplements represent little more than unregulated drugs that have tangible personal and professional consequences that go well beyond anything described on their labels.

"If the economy tanked because of subprime mortgages, perhaps the time has come to look at subprime drugs," says Weissmann. "I'd call drugs 'subprime' if they affect bodily functions without having undergone tests of safety and efficacy by the FDA."