(April 6, 2007, Silver Spring, MD) -- In an April 4, 2007, letter addressed to Dr. Andrew von Eschenbach, Commissioner of the Food and Drug Administration, U.S. Representative Henry Waxman (D-CA) chastised FDA for "fail[ing] to investigate serious allegations of potentially dangerous levels of lead in some vitamin products." Waxman is the chairman of the House Government Reform Committee, which has broad oversight and subpoena authority.
Citing a recent report that claimed to find 15.3 micrograms of lead in the daily dose of one brand of a multi-vitamin for women, Waxman acknowledged, "There is no uniform standard for permissible amounts of lead in food or dietary supplements." He went on to identify several “relevant standards,” including FDA's "provisional total tolerable intake levels" of daily dietary lead, with daily limits of 75 micrograms for adults, 25 micrograms for pregnant women, and 6 micrograms for children age five and under. He observed that the daily amount of lead in this multi-vitamin "is more than half of FDA's suggested 'total tolerable level' for a pregnant woman … and more than twice the suggested tolerable level for a small child."
Waxman went on to state, "Given the potential public health hazard posed by this product, I was disturbed to learn that your agency had taken no meaningful steps to investigate these allegations." He also stated that the cited report is "far from isolated," and referred to an article published in the Journal of the American Medical Association in 2004 that found extremely high levels of lead in some imported "herbal medicine products" that contained ingredients that were deliberately processed with heavy metals, including lead, and also mercury. Such processing is not allowed for herbal ingredients sold in the United States.
Congressman Waxman concluded the letter by posing four questions to the FDA Commissioner:
1) What steps has FDA taken in response to the findings of lead contamination in this women's multivitamin?
2) What steps does FDA plan to take to address the issue of lead contamination in vitamins by any manufacturer?
3) Does FDA need additional legal authority to respond to these findings? If so, what additional authority would be necessary for FDA to respond effectively?
4) Does FDA need additional resources to respond to these findings? If so, what additional resources would be necessary for FDA to respond effectively?
"AHPA and its members might consider whether it could be in our long-term interest for FDA to initiate a dialogue on the second question raised in Chairman Waxman's letter," commented Michael McGuffin, president of the American Herbal Products Association (AHPA). "Lead and other heavy metals are ubiquitous in the food supply, but without clearly specified regulatory limits manufacturers face a moving target in trying to limit the levels of these naturally occurring, but clearly undesirable compounds."
McGuffin also noted, in reference to Waxman's question about "additional resources," that "AHPA has long supported legislation that would provide FDA with the resources that it needs to enforce the regulations that apply to dietary supplements."
Waxman's letter is posted on the AHPA website and can be accessed at http://www.ahpa.org/portals/0/pdfs/07_04_Waxman.pdf.