JAMA Letter Explores Adulterated Supplements, Recalls

TORONTO A new research letter in Journal of American Medical Association Internal Medicine calls dietary supplements into question, specifically analyzing recalls and contamination. In the report, researchers from the University of Toronto analyzed class 1 drug recalls from FDA Enforcement Reports from 2004 to 2012. Of the 465 drugs recalled, 51 percent were classified as dietary supplements rather than pharmaceutical products. Scientists found sexual enhancement (40 percent), body-building (31 percent) and weight-loss (24 percent) were the most commonly recalled products. No adverse events were noted in the FDA reports.

As a result, the researchers, including lead writer Ziv Harel, MD, of St. Michael's Hospital in Toronto, called for more stringent enforcement and "a standard of regulation similar to that for pharmaceuticals."

However, dietary supplement trade organizations and industry leaders are standing up to claims of an unregulated market.  "They refer to the industry as unregulated, but NPAand other organizationsfully supports increased efforts and resources to improve regulation," said Cara Welch, Ph.D., senior vice president of scientific and regulatory affairs, Natural Products Association (NPA).

Welch also noted the study's discussion of pharmaceutical ingredient adulteration. Once the pharmaceutical ingredient is added, she explained, the product is no longer a dietary supplement. "It's an unapproved new drug and needs to be treated as such," she said.

Above all else, Welch said these attacks are nothing newthe dietary supplement industry has seen these claims before, and it will see them again.

"It's just one more reason to continue education and clean up the dietary supplement industry's image."