Will the heavy metals issue ever come to an end? Just as the US Pharmacopeia is finalizing its revisions to the new chapters on elemental impurities, and just as the ICH expert working group on heavy metals is preparing to start its proceedings on harmonizing metal limits, concern over the level of heavy metals present in dietary supplements is gaining traction.

Last month, FDA issued a warning to consumers not to use Vita Breath (American Herbal Lab, Rosemead, CA) because it may contain hazardous levels of lead. The dietary supplement had, in fact, 1,100 parts per million of lead—that’s 10,000 times greater than FDA’s maximum recommended level for lead in candy, according to the agency—and was recalled by the manufacturer. Last year, the agency warned the public about the presence of heavy metals in Ayurvedic products, traditional medicines largely sold on the Internet or in Indian and South Asian stores.

In fact, the presence of heavy metals in supplements has been a concern for years, but with growing reports of contamination, it seems high time to increase enforcement of the quality and safety of these products. Although FDA has cracked down on misleading supplement labels—which often make broad claims such as being able to prevent cancer, the agency does not approve dietary supplements before they reach the consumer. As a result, the products may be more susceptible to this type of contamination.

Principal Deputy Commissioner Joshua Sharfstein testified before the US Senate Special Committee on Aging on May 26, 2010 about the agency’s oversight of dietary supplements. He pointed to a recent GAO report that analyzed 40 dietary supplements for heavy metal contaminants. Although levels of lead, cadmium, arsenic, and mercury (the “big four”) in the products were not found to be at dangerous levels, he did note that, if consumers are taking such products daily, they are digesting a “significant fraction” of the metals. In fact, according to a recent New York Times article, “Half of the nation’s adult population takes vitamin supplements regularly, and about a quarter take herbal supplements at least occasionally.”
Sharfstein urged the Senate committee that, “preventive standards of the type authorized by pending food safety legislation could help FDA reduce lead levels in dietary supplements as much as feasible.”

Such a move could give the agency the authority it needs to control the quality and safety of dietary supplements just as it does for food and drugs.

The Senate is expected to review and debate pending food-safety legislation (S. 510) in the coming weeks. The current S. 510 document exempts dietary supplements from the proposed regulations. It’s unclear, however, whether FDA’s oversight of dietary supplements—and thus their heavy metal limits—will make it into the final bill once it’s merged with the House version (H.R. 1332).

Meanwhile, public comments on USP’s new elemental impurities general chapters, which update testing methods and limits for the big four metals, were due April 15. And ICH’s harmonization work on the issue is getting underway this month in Estonia. Let’s hope that between USP, ICH, and Congress, some progress can be made to keep consumer products—supplements, drugs, and food—free of dangerous levels of heavy metals in the long term.

For those interested in learning more about heavy metals, Pharmaceutical Technology is hosting a free webinar on heavy metals on Monday, June 14, 2010 and June 17, 2010. Be sure to listen in.

[orig. published June 4, 2010]