In a move that could signal widespread use of "seals of approval" for dietary supplements, labels of many Nature Made products -- starting with bottles of vitamin E -- will prominently feature a "USP Verified Dietary Supplement" mark by the end of January. The symbol asserts that the product is free of contaminants, accurate in its ingredient labeling and manufactured using sound practices.
Officials at Pharmavite, which makes Nature Made products, predict that the new mark from USP -- U.S. Pharmacopeia, a Rockville-based nonprofit organization that already sets standards for U.S. drug makers -- will become the "gold standard" for recognizing quality among dietary supplements.
But there are other options. In a month or so, Perrigo, which calls itself the nation's largest maker of store-brand nutritional products and nonprescription drugs, expects to start using a quality symbol from NSF International on some of its supplement labels.
"We've done some market research which showed very clearly [that] a consumer given the choice between two products, all other things being equal, is going to pick up the one that has a credible third-party certification," said Ray Jaglowski, vice president of new business development for NSF, which is based in Ann Arbor, Mich.
Industry spokesman John Cardellina cites a "steady stream" but "not a stampede" of supplement companies signing up for such certification. "I think the interest is there and the sense that there is value from the NSF and USP programs is there. But cost is clearly a factor," says Cardellina, vice president for botanical science and regulatory affairs at the Council for Responsible Nutrition, a dietary supplement trade group.
While neither USP nor NSF would discuss what it charges companies to verify the basic contents of their supplements, Cardellina estimates it could cost anywhere from $12,000 to $25,000 for a basic manufacturing audit and analyses of multiple products. He notes that NSF's program is cheaper than USP's, because USP charges both a "hefty" base fee and another fee for every package carrying the new USP symbol. "That's a killer for a huge manufacturer," Cardellina says.
A less expensive path would involve a company's using ConsumerLab.com, which founder and president Tod Cooperman said charges on average $3,000 for a product's testing. Unlike USP and NSF, his company does not conduct a manufacturing audit, and he usually doesn't wait for companies to make requests. Instead, he pulls products off retailers' shelves as he did for his latest report, on garlic supplements. Then he tests them according to his own standards for therapeutic doses of active ingredients and the like. He offers general findings online free to the public.
ConsumerLab.com is for-profit, unlike USP and NSF, and makes money through company-requested product testing and by selling detailed test information on product categories to subscribers, including health plans and public libraries. The company also offers its seal of approval for the labels of products that meet its standards, but so far no supplement makers have paid for that privilege. Cooperman, a medical doctor, says they likely have been frightened off by his requirement that they must remove products that carry his seal from the market immediately if subsequent testing revealed problems.
Even as the supplements industry may be starting to embrace voluntary certification by private testers, the federal government is taking some modest action. After several years of review, the Food and Drug Administration (FDA) expects soon to publish a rule on how companies must manufacture dietary supplements. An FDA rule on the controversial supplement ephedra may also be released soon. And the FDA has asked the Institute of Medicine to help figure out how to evaluate the safety of supplement ingredients without spending a great deal of taxpayer money.
In the absence of federal mandates, the nascent certification programs seem likely to succeed only if manufacturers decide that such labeling marks could serve as powerful marketing tools.
Consumer advocates differ in their assessments of the fledgling efforts. Some groups praise the initiatives as a good first step. But other groups, along with the American Medical Association and some members of Congress, insist that more needs to be done to help the American public make informed choices about potentially dangerous products.
"It's an industry based on deceit, so the industry is trying very hard to put on the veneer of respectability," said Larry D. Sasich, a pharmacist/researcher at Public Citizen. "It's all voluntary. There is no oversight with any regulatory authority. . . . I would say that the use of dietary supplements is risky, and it's 'Let the buyer beware.' Consumers are basically on their own. Does the public really know what [labeling seals] mean? I would say no. There is no safe substitute for FDA regulation of these products."
Further complicating the picture: Manufacturers are free to use USP's initials -- but not its new symbol -- on products without undergoing any review. Unlike the new USP mark, the initials mean only that a company claims its product meets USP's written standards -- for proper dissolution and disintegration in the body, for example.
Sen. Richard Durbin, D-Ill., who chaired recent hearings questioning the safety of ephedra-containing products, agrees on the need for strong FDA oversight of dietary supplements. "You need the independence and professionalism of a federal agency to establish consumer confidence," he said. "We cannot go at this half-heartedly. . . . It is an unregulated industry and many of the players are unscrupulous, and those that are honest should invite oversight and regulation."
Durbin has been an outspoken critic of the FDA, and last week he again referred to its oversight efforts on dietary supplements as "half-hearted and at times pathetic." Durbin said an FDA rule on ephedra -- which he said accounted for 42 percent of all supplement-related adverse event reports to the FDA in 2001 -- has been in the works for five years, and the agency has worked about seven years on a good manufacturing practices rule for supplement makers.
Last week FDA's top official on dietary supplements, Christine Taylor, said the manufacturing rule is expected out "very, very shortly," though she said it could easily take two years to become finalized.
Durbin describes the Dietary Supplement Health and Education Act of 1994 (DSHEA) -- which defines supplements as equivalent to foods and assumes them to be safe unless the FDA has evidence to the contrary -- as "an invitation to deceive," and he insists that many dietary supplement companies "have gladly accepted that invitation." Under federal law, products defined as drugs and food additives -- unlike items categorized as foods -- must undergo extensive safety evaluations prior to their marketing.
Cardellina responds that the industry has worked with USP and NSF to build support for voluntary certification programs, sees them as credible and anticipates that consumers will find them a trustworthy attempt at industry self-regulation.
Yet Durbin doubts the value of the labeling marks. "We're going to provide pieces of information to consumers which have no meaning to them. If you can't speak to the safety of the product, then of what value is this?"
USP and NSF acknowledge that their programs don't solve the entire question of supplement benefits. They anticipate that the National Center for Complementary and Alternative Medicine will continue to fund clinical studies of supplements' safety and efficacy. And the FDA and the Federal Trade Commission will continue to provide oversight and watch for product mislabeling.
V. Srini Srinivasan, vice president of USP's verification program, said his organization "is trying to bring some clarity to a confusing market" by using a comprehensive auditing and product testing process that takes on average five months. He said it involves not only culling through thousands of pages of company documents, but also on-site inspection of manufacturing plants and lab tests that ensure, for example, that products can dissolve and disintegrate properly in the body.
David Schardt, senior nutritionist at the Center for Science in the Public Interest, praises USP for its effort to help identify high-quality dietary supplements. He sees "a clear need" for some kind of consumer assistance, given documented quality control problems within the industry. Recently, for example, scientists have reported wide variability in commercially available saw palmetto and ginkgo biloba, for example, finding virtually no active ingredients in some products.
But Schardt worries that the USP mark is too vague about what is being certified and what is not, and could lead some people to think that the product is safe and beneficial for any claim that may be written on its label. In fact, the USP says its mark means only that it has not found contamination, that the product contains basically what the label says it contains and that proper manufacturing practices were used. The mark does not mean a product's claims -- enhancing memory or boosting energy, for example -- have been evaluated in any way.
Schardt sees shortcomings in other certification efforts, too. He notes that ConsumerLab.com tests only one sample of each product, which "gives you more information that you'd have otherwise, but products can vary from lot to lot," and that the names of products that flunk its tests aren't publicized.
ConsumerLab's Cooperman responds that it has not been financially feasible for his company to test more than one lot and that listing "flunking" products turned into a "legal nightmare." As a result, the company has focused its efforts on listing products that have passed muster.
Where does all of this leave consumers? "Realistically," says Schardt, the consumer advocate, "it is unlikely that the government will get involved" in quality control for dietary supplements. With an understaffed FDA and a Congress controlled by Republicans generally skeptical of regulation, he says, the federal government likely will continue to feel that such an "expensive and extensive effort' should be handled by private industry.
Judy Packer-Tursman is a Washington area freelance writer.