A new era in the labeling of dietary supplement products is dawning, and packaging changes, imposed by the Food and Drug Administration, may be just over the horizon. Both developments stem from the 1994 Dietary Supplement Health and Education Act of 1994 (DSHEA), passed by Congress last October. That law allows supplement manufacturers to make "structure/function" claims for ingredients on the product label. It's also likely to force manufacturers to adhere to good manufacturing practices, once the FDA finalizes a rule on that subject. Bob Dunn, director of regulatory and legislative affairs for General Nutrition Corp., Pittsburgh, PA, one of the heavyweights of the supplement business, says his company expects to advertise on its product labels that garlic "helps lower cholesterol." Currently, garlic-based supplements simply state that the product delivers all the benefits of natural garlic, without specifying them. Dunn points out that companies must have substantiation of such claims before they put them on product labels. Companies must accompany any structure/function claim with a disclaimer that says: "This statement has not been evaluated by the FDA. This product is not intended to diagnose, treat, cure or prevent any disease." GNC is in the process of assembling that data. The FDA can examine that data and disallow the claim if it proves it is not justified by the facts. Other supplement manufacturers are already claiming that some products "strengthen the immune system," according to Dunn. The DSHEA is required to issue a rule dictating the format of supplement labels, how they are organized, and what they say. The first step in that rulemaking is expected any day, according to Virginia Wilkening, the FDA official who is in charge of it. She has been consulting with industry groups such as the Council for Responsible Nutrition (CRN) on the contents of that proposed rule. That proposal will also contain the first draft of good manufacturing practices (GMPs) which supplement manufacturers will have to abide by. "There is certainly some reason to believe that the FDA will extend those GMPs to packaging in some instances," Dunn of GNC says. The FDA has already proposed, under authority from an earlier dietary supplement law, that supplements with more than 30 mg of elemental iron be packaged in single-dose units (see sidebar, p. 27). The agency cited GMPs as the rationale for that proposed rule. Trade groups for GNC, Excel Energy, Nature's Way, Twinlab Co., and many others have been working closely with the FDA on the development of those proposed rules. John Cordaro, the president of the CRN, says his group has given the FDA a copy of its GMPs, and it hopes the agency adopts them. "They agreed to look at our proposal," he explains. But even while the CRN and other mainline trade associations try to maintain a semblance of comity with the FDA, another dietary supplements group, the Nutritional Health Alliance (NHA), is turning up the heat on FDA. The NHA is considered a "grassroots" group, composed mostly of consumers of nutritional products, although some members are manufacturers. The NHA has a more radical agenda. It has convinced Democrats and Republicans on the House Commerce Committee to introduce H.R. 1951, which jettisons key parts of the DSHEA. A key provision of H.R. 1951 would cancel the restrictive "function/structure" claims language in DSHEA, and would allow dietary supplements to make claims linking products to disease prevention as long as those claims are "truthful and nonmisleading." The bill would also prohibit the FDA from regulating supplements as drugs. On the floor of the House June 29, Rep. Frank Pallone, Jr., (D-NJ), the prime sponsor of H.R. 1951, alluded to a recent article in the Journal of the American Medical Assn. that presented "compelling evidence" of Vitamin E's role in warding off heart disease. He noted that scientists have established that selenium, an antioxidant mineral, has the ability to protect the human immune system and minimize damage from viral infections. "These studies promise innovation and cost-effective treatments for people with viral diseases," Pallone stated. "But such information will never reach the consumer in time under current FDA policies." Assertions on labels that link foods or ingredients to protection against diseases such as cancer or heart disease are considered "health" claims. They can only be made if the FDA specifically approves them. Thus far, the FDA has approved only three health claims: calcium prevents osteoporosis, folic acid prevents neural tube birth defects for women of child-bearing age, and antioxidant- and fiber-rich foods like fruits and vegetables could help prevent heart disease and cancer. The FDA has refused to approve the same claims for supplement versions of those nutrients. To do so, the FDA must find there is "significant scientific agreement" on the truthfulness of a health claim. Tony Martinez, a spokesman for the NHA, says that Rep. Thomas Bliley, Jr. (R-VA), chairman of the House Commerce Committee, has agreed to support H.R. 1951 as part of a larger legislative effort to reform the FDA. Chances for H.R. 1951 are significantly enhanced because many food and grocery trade associations are supporting it. GNC's Dunn says his company is not lobbying on behalf of the Pallone bill. The same is true of the CRN. "But we'd be tickled to death if it passes," Dunn adds. While the NHA wants to eliminate the "function/structure" restriction in DSHEA, in the meantime it will push for as broad a definition as possible as part of the FDA rulemaking that will get underway any day. Martinez says, for example, that the notion of a "function/structure" claim is not clear-cut. The FDA might consider a claim that garlic lowers blood serum cholesterol levels as a health claim. The NHA would disagree. But Cordaro of the CRN calls the function/structure provisions of DSHEA "self-implementing"; he says there is no need for rule-making on that issue. Everyone agrees that ingredient listings on the label will be a part of the rulemaking. The DSHEA lays out specifications for the order in which ingredients have to be listed in the nutrition box, with those having reference daily intakes (RDIs) and daily recommended values (DRVs) coming first. Dietary supplements present in "significant" quantities have to be listed, and the company has to make it clear that those ingredients do not have RDIs and DRVs.
