Waxman Seeks FDA Action Following ConsumerLab Vitamin Lead Testing

Recent concerns about lead levels in dietary supplements have spurred Rep. Henry Waxman, D-Calif., to ask FDA Commissioner Andrew von Eschenbach whether the agency needs additional legal authority, more resources, or both, to address issues regarding product contamination.

Waxman, chairman of the House Committee on Oversight and Government Reform, says in an April 4 letter he is "disturbed" to learn FDA has not taken any steps to investigate ConsumerLab.com's finding that the Vitamin Shoppe's Especially for Women multivitamins contain "dangerous levels" of lead.

Vitamin Shoppe voluntarily removed its multivitamin from store shelves in January after ConsumerLab.com tests found a daily dose of the product contained 15.3 mcg of lead (¹ 'The Tan Sheet' Jan. 29, 2007, In Brief).

While the congressman asks what steps FDA plans to take to address the issue, many industry members disagree with Waxman's concerns.

Because Vitamin Shoppe's product has been removed from the market, there is "no additional action that needs to be taken by the FDA," according to Natural Products Association Vice President of Scientific Affairs Daniel Fabricant, Ph.D.

"I know of no other similar letter recently written regarding any other FDA regulated product recalls, whether food or pharmaceutical, both of which happen with much greater frequency," he adds.

Council for Responsible Nutrition President and CEO Steve Mister says Vitamin Shoppe "did the most responsible thing by issuing a prompt recall and conducting a thorough investigation; therefore, no additional action by the agency is necessary."

However, the contamination issue underscores a bigger problem at FDA, according to food and drug lawyer Marc Ullman of Ullman Shapiro & Ullman.

Lack of enforcement is eroding public confidence in products, Ullman said. "I think it's remarkable that a regulated industry would have to go to its regulators and say, 'Would you please come out and do some enforcement?'"

According to FDA, the agency's practice "is to follow up on reports of contaminated products. However, such activity can take some time."

The agency "monitors vitamins sold to the public for contaminants, as we do for all foods," a spokesperson says. FDA "has the authority to take action against products that contain unsafe levels of contaminants like lead."

Relying on ConsumerLab reports is also problematic, according to some industry veterans.

"Neither the congressman and his staff, or the media who so widely report the findings of ConsumerLab as if they were infallible, have the knowledge to understand that supplement testing is not an exact science in general," says Suzanne Shelton, president of Shelton Group public relations.

"ConsumberLab's testing in particular is often disputed by the real experts," she adds.

Ullman agreed, noting, "I'm not always prepared to accept ConsumerLab's tests at face value. I think there are frequently issues with proper identification of the test methodologies they've used, whether those tests are appropriate for the specific class of goods that they've looked at."

"I think when it comes to citing ConsumerLab reports for the purpose of finger-pointing at specific companies, I question whether those reports are really reliable," he adds. Ullman said he questions the reports because ConsumerLab takes money both from consumers and from the industry.

Mister says this is indicative of a much broader issue on testing.

"As opposed to the approach of recognized standard-setting bodies such as AOAC and USP who seek consensus on testing methods, ConsumerLab.com unilaterally determines the techniques and assays it uses to test supplements, and these methods may not always be appropriate," he says.

Shelton says, "This underscores the need for a broadly supported and funded, and well thought out testing program that is focused on fully investigating test results and utilizing workable and agreed upon standards."

ConsumerLab's business practices have been the subject of criticism by members of the supplement industry in the past. CRN raised questions about company payments for the test and suppression of negative results. The allegations culminated in a lawsuit that was eventually dropped (² (Also see "ConsumerLab “Unfair,” “Deceptive” Practices Warrant FTC Action – CRN" - Pink Sheet, 17 Jan, 2005.), p. 17 and ³ 'The Tan Sheet' Nov. 20, 2006, In Brief).

Waxman notes in this letter he learned during a staff briefing FDA officials "appeared to be unfamiliar with the details of the ConsumerLab.com findings" and had not seen the full report because the company would not provide it without charge. However, he adds, the report is available online for $10.

"It also appears that FDA has taken no steps to independently investigate the Vitamin Shoppe product and to determine whether there was contamination, whether any contamination was limited to that product, and, perhaps most important, the source of the contamination," Waxman says.

Waxman says FDA's inaction is "even more alarming" given lead contamination in dietary supplements has "been a serious issue for at least a decade."

The dialogue sparked by Waxman could be a reflection of recent political changes in Washington, NPA Executive Director and CEO David Seckman says in an e-mail. "With long-time critics of DSHEA now in leadership positions in Congress, this type of communication is not unexpected," he notes.

Seckman notes Waxman has asked similar questions before, but as chairman "he is now in a position to push this agenda."

Further, American Herbal Products Association President Michael McGuffin notes, it "may be useful for FDA to initiate a dialogue to determine what levels of heavy metals are accepted in supplement products."

"The only thing that is surprising about the letter is the timing," Seckman says. "With all the other pressing issues that Congress has on its plate at the moment, to be focusing on a somewhat dated - and resolved - issue with dietary supplements is not a positive sign for the industry."

The FDA spokesperson says the agency will review the letter and respond to the representative.

Waxman requests a response from FDA by April 18.

- Rebekah Moan ([email protected])