A Government Accountability Office investigation intended to shed light on whether senior citizens are at risk when buying herbal supplements has refueled debate on the effectiveness of both FDA enforcement and industry self-regulation.

A May 26 Senate Special Committee on Aging hearing on GAO's investigation also underscored for supplement manufacturers the importance of outreach to retailers to manage claims being made about products.

FDA Principal Deputy Commissioner Josh Sharfstein said at the hearing the Dietary Supplement Health and Education Act gives the agency sufficient authority to remove from the market contaminated products, including herbals, and enforce against firms that make violative claims.

"I think it's obvious. With more resources we could do more," he said. "But I think we're on the right track."

Sharfstein explained FDA plans good manufacturing practice inspections of at least 250 supplement manufacturers in 2010, but some 1,500 U.S. companies are in the business.

GAO queried herbal supplement firms about their ingredients and made undercover purchases of products online and at stores in an investigation committee Chairman Herb Kohl requested (¹ Also see "GAO New Dietary Ingredient Probe Has Puzzled Firms Seeking Legal Advice" - Pink Sheet, 1 February, 2010.).

According to a ² statement submitted to the committee, GAO found examples of firms using illegal claims to market supplements.

GAO said the "most egregious practices" included claims that a supplement prevented or cured cancer and cardiovascular disease, and mitigated age-related medical conditions such as Alzheimer's disease and diverticular disorder.

Gregory Kutz, GAO's managing director for forensic audits and special investigations, testified about the investigation, presenting examples of violative claims on labels for garlic and ginkgo biloba products and in retail clerks' sales pitches captured in undercover recordings.

"You will be amazed to know [garlic] prevents and cures cancer," Kutz said, referring to a product claim.

The investigation also found retail clerks recommended ill-advised product usage - such as the combination of ginkgo biloba and aspirin, which FDA warns can increase risk of bleeding - to elderly consumers.

"In making these claims, sellers put the health of consumers at risk," according to the GAO statement.

Industry Or FDA Responsible?

Kohl questioned whether industry self-regulation combined with FDA's current enforcement authorities are sufficient.

"These are employees in your industry who are saying things that are just flat untrue," the Wisconsin Democrat told Council for Responsible Nutrition President and CEO Steve Mister, who testified at the hearing.

Minnesota Democrat Sen. Al Franken echoed Kohl's concerns about industry's capability to regulate itself. While retail clerks might not be expected to understand supplement marketing regulations, manufacturers should know to not include unsubstantiated claims on their products, the freshman senator said.

"If these are on the products, I'm not sure how robust the voluntary, self-regulation regimen could be," Franken said.

Ranking member Sen. Bob Corker, R-Tenn., also asked industry to do more, but did not suggest additional regulations are needed. He said in addition to FDA's authority over product quality and claims, the Federal Trade Commission must enforce against false or misleading advertising.

"That's not really [industry's] responsibility," Corker said.

The day before the hearing, Senate supplement industry allies Sens. Tom Harkin, D-Iowa, and Orrin Hatch, R-Utah - a committee member - introduced a bill to fund fully DSHEA (see ³ Also see "Harkin, Hatch Reload In Hunt For Full DSHEA Funding, Implementation" - Pink Sheet, 31 May, 2010. ).

Hatch and Corker repeatedly referred to the bill as an answer to concerns that the supplement industry is not sufficiently regulated.

"We should not be focused on changing current law, but instead on enforcing current law," Hatch said.

While FDA expects supplement firms to comply with manufacturing and marketing regulations, the agency does not anticipate self-regulation will keep so-called supplements adulterated with Rx pharmaceutical ingredients off the market.

Drug-tainted products sold as supplements are "the area that gives the FDA the most concern," Sharfstein said.

While keeping spiked supplements off the market vexes the agency - particularly due to online sales - enforcement against violative claims is "relatively easy," he added. Once FDA determines a firm is making an inappropriate claim, "Boom, you're not allowed to do that."

Heavy Metals In Trace Amounts

The GAO investigation found 37 of 40 herbal products it tested contained at least one potentially hazardous contaminant, though none reached levels high enough to pose a toxicity hazard to humans.

While all 37 tested positive for trace amounts of lead, 32 of those also contained mercury, 28 cadmium, 21 arsenic and 18 residues from at least one pesticide, according to GAO's statement.

The statement adds that manufacturers GAO spoke with "were concerned about finding" contaminants in their supplements, but "they noted that the levels identified were too low to raise any issues internal product testing."

Kutz also pointed out that FDA and the Environmental Protection Agency do not consider trace amounts of the substances in the products a health risk.

Supplement industry stakeholders contacted outside the hearing pointed out herbal products are vegetable matter, which absorb substances including heavy metals from soil as they grow. Trace amounts sometimes remain in the finished product even though the ingredients meet purity specifications.

Further, trace amounts of potentially hazardous contaminants can be found in many consumer products other than supplements, stakeholders say.

GAO selected the types of herbs purchased in its investigation based on surveys about supplement usage by elderly consumers. The surveys identified chamomile, echinacea, garlic, ginkgo biloba, ginseng, peppermint, saw palmetto and St. John's wort as most commonly used.

Kutz added that GAO forwarded to FDA and FTC information on the deceptive claims found in the investigation, but the office has not learned whether either agency will act on the referrals.

Hatch observed that it is not for lack of regulations that deceptive claims are made for supplements. "The trouble is FDA doesn't have the money to do its job," the senator said.

NPA Launches Retail Education Program

CRN's Mister described the self-regulatory work of trade groups and the National Advertising Division's CRN-supported reviews of supplement ads in response to questions about whether the industry can do more to police itself.

"We do as much as we can as a trade association," he said. "At some point we have to rely on enforcement agencies, such as FDA and FTC, to do their job, too."

Industry is expanding its education outreach by providing information to retail chains about supplement marketing regulations.

The Natural Productions Association said it will distribute materials to train retailers on what can and cannot be said to customers.

The group will provide training at trade shows and via online and conference-call presentations and develop a dedicated Web page with materials for salespeople, retailers and customers.

NPA also will seek partnerships with media to broaden the publication of educational materials and more frequently provide content for salespeople.

- Malcolm Spicer ( ⁴ m.spicer@elsevier.com )

Senate Supplement Hearing Spotlights Self-Regulation, FDA Enforcement

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