The low-down and dirty on supplements

A story in last week's Chicago Tribune sketches a detailed (and often disgusting) portrait of the appalling conditions in which many dietary supplements are manufactured. The lengthy piece draws on recent FDA reports that have found manufacturing violations in half of the 450 supplement firms the agency has inspected since 2008, describing unsanitary factories and haphazard recipes. And it s getting worse: So far this year, writes the Tribune reporter, FDA inspectors have found violations of good manufacturing practices during two-thirds of the 204 inspections they have conducted in nearly 200 supplement firms' facilities.. Seventy of these inspections resulted in the agency's most serious rating. The Tribune article also highlights cases of poisonings and deaths that have resulted from ingredient mix-ups and bad batches.

Yet as deplorable as these quality control problems are, they obscure a more basic problem. While the FDA began conducting inspections in 2008 to evaluate adherence to new regulatory standards for the manufacturing, packaging, and storing of dietary supplements, any inherent quality being regulated is dubious at best. Unlike pharmaceutical companies, whose products undergo a rigorous circuit of testing, dietary supplement firms are not required to prove that their products are safe or effective before marketing them to a medically-unsophisticated public. And while they're not allowed to make specific medical claims for supplements, vague claims of "support" or "enhancement" are fair game and typical.

This dearth of regulation can be traced to the Dietary Supplement Health and Education Act of 1994 (DSHEA). As ACSH's Dr. Josh Bloom explained in an op-ed this spring, the DSHEA "provided the supplement industry with a legal but anti-scientific end-run around the FDA by introducing some terms that permitted the marketing of unregulated drugs. As long as they were called 'dietary supplements' and made no specific health claims, they could be sold. But these 'restrictions' are wholly disingenuous." Thus, ACSH scientific advisor Dr. John Lupien points out, "Virtually all of the products covered by DSHEA are not effective for the health problems they are intended to address, and controlled clinical trials continue to show their ineffectiveness."

"Considering how precautionary the FDA typically is," says ACSH's Dr. Beth Whelan, "it's terribly ironic how lax the agency is when it comes to the safety and efficacy of supplements. That wrong-headed law essentially forces the FDA to ignore the vast supplement scam.

We at ACSH have been complaining about the lack of supplement oversight since 1995, adds ACSH s Dr. Ruth Kava. Unfortunately, it will probably take another act of Congress to really address this situation.

For more analysis of this problem, we encourage you to revisit what Dr. Bloom and ACSH's Dr. Gilbert Ross have said in the pages of The American Spectator and MedPage Today. You can also see what else Dr. Bloom has to say about the Tribune story in his latest blog post for Medical Progress Today.