FDA recently tested more than 300 multivitamins for lead and will publish the results in response to pressure from Capitol Hill to follow up on a 2007 report that at least one multivitamin marketed in the U.S. contained "dangerous levels" of lead.

While the report could trigger problems for individual products, it is not likely to damage the supplement industry's overall reputation, according to Bill Frankos, director of the dietary supplement programs division at the Center for Food Safety and Applied Nutrition.

Frankos presented on FDA's top compliance concerns April 30 at the Supply Side East trade show in Secaucus, N.J.

"I can't give you specifics, but I am not seeing anything that is suggesting a big problem in the industry," he said.

FDA purchased multivitamins targeted to women and children through stores and online, and then compared the levels of lead in the products to tolerable levels based on different populations.

Frankos said the report will include the individual names of the products tested along with their lead value and the daily dose of lead consumers would receive based on the products' labels.

"Congressional discussions" prompted the agency's study, he said.

In an April 2007 letter, Rep. Henry Waxman, D-Calif., told FDA he was "disturbed" the agency did not immediately investigate reports that the Vitamin Shoppe's Especially for Women multivitamins contained "dangerous levels" of lead (¹ Also see "Waxman Seeks FDA Action Following ConsumerLab Vitamin Lead Testing" - Pink Sheet, 9 April, 2007., p. 6).

Vitamin Shoppe voluntarily recalled the product from store shelves in January 2007 after Consumer Lab.com tests found a daily dose of the product had 13.5 mcg of lead (² 'The Tan Sheet' Jan. 29, 2007, In Brief).

FDA continues to look for other contaminants and undeclared drugs in dietary supplements, such as undeclared prescription erectile dysfunction ingredients in products labeled as male potency dietary supplements, Frankos added.

Frankos reiterated other major compliance concerns previously highlighted by former CFSAN Director Robert Brackett.

These include a lack of industry compliance with the new dietary ingredient notification system, the blurring line between conventional foods and dietary supplements and illegal drug claims (³ Also see "NDI Notification Failures Concern FDA; Complete Submissions Urged" - Pink Sheet, 15 October, 2007., p. 8).

"It appears to us that companies that should be providing us with new dietary ingredient notification are not submitting NDIs," Frankos said.

"We see a paltry number of NDIs come in" - less than 100 per year - "and we are wondering how they are justifying calling themselves old dietary supplement ingredients versus new dietary supplement ingredients given that the number of products that are being sold is growing exponentially," he added.

Firms must notify the agency 75 days before marketing an NDI, which FDA characterizes as an ingredient not marketed before the Dietary Supplement Health and Education Act was enacted in 1994.

Frankos reminded the industry that NDI notifications allow FDA to verify the safety of an ingredient and are not an evaluation of efficacy.

He explained that whether an ingredient is clearly identified as "old" or "new" with a valid NDI notification will become more important with FDA tightening its import food and drug safety enforcement and inspectors looking more closely at ingredients at ports of entry.

"The dietary supplement ingredient notification is the gatekeeper," and if an ingredient is not clearly labeled as old and does not have an approved NDI, FDA inspectors will block it at the point of entry, he said.

He also echoed previous FDA complaints that many NDIs the agency receives currently are incomplete.

"We have many cases where they don't give us the genus/species," the part of the plant the ingredient comes from or how the ingredient is processed, extracted or manufactured, he explained.

FDA To Inspect More Foreign Companies

Also high on FDA's to-do list is to ensure the safety of imported ingredients from China, India and other countries, Frankos said.

"We are having significant congressional oversight" in this area, and the "movement with the food safety bills proposed in Congress [is] trying to address this," he said.

The bills would require FDA to collect user fees on food imported into the U.S. in order to conduct more import inspections, test samples and could require label-of-origin on products, among other provisions ("⁴ Also see "Congressional Supplement Scrutiny Won’t Take Front Seat ... Yet" - Pink Sheet, 24 September, 2007., p. 14).

Further, the House Energy and Commerce Committee is discussing draft legislation for sweeping reforms of FDA's import safety work (⁵ Also see "FDA Failures During Heparin Crisis Drive Congress’ Stronger Drug Safety Push" - Pink Sheet, 5 May, 2008., p. 8).

In addition, FDA will conduct "more specific inspections of dietary ingredient companies in foreign countries," Frankos said. He added, FDA's "compliance staff is targeting many more foreign inspections both for GMPs and agreement quality."

FDA Analyzes Line Between Foods, Supplements

FDA is also investigating products that inappropriately cross the line from conventional food to dietary supplement, Frankos said.

In particular, the agency is looking at products labeled as drinks that really are dietary supplements, he said.

DSHEA does not allow the sale of dietary supplements "in a conventional food form," Frankos explained.

Before leaving FDA in November 2007, Brackett said the agency would make a decision on how to more clearly define conventional food products versus dietary supplements. So far, though, the agency has not issued a guidance or additional regulations ("⁶ Also see "FDA Lawyers Working To Defog “Clouding” Of Food/Supplement Boundary" - Pink Sheet, 22 October, 2007. p. 6).

- Elizabeth Crawford (e.crawford@elsevier.com)

FDA Analyzing Lead Levels In Multivitamins, Concerned About NDIs

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