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St. John’s Wort and Cheerios. Ginkgo biloba and Coca-Cola. Odd dietary choices, for sure, but the pairings actually represent a powerful new alliance pushing up against the Food and Drug Administration. For years, the dietary supplement industry has been arguing that the FDA should loosen its regulatory grip on the industry’s products. Makers of supplements want free rein to make health claims on package labels — something the FDA has resisted. Now the industry has a new ally in its fight. The Grocery Manufacturers of America — an alliance of corporate interests in the food, beverage, and packaged goods industries — submitted a petition April 28 to the FDA supporting the dietary supplement industry’s argument. It’s a case of overlapping interests: The GMA says it wants the same rights sought by the dietary supplements’ advocates. And some observers say there’s strength in numbers. “It might help us to have someone of their stature, with all their companies, on this issue,” says Candace Campbell, executive director of the American Preventive Medical Association, a doctor-focused group that supports supplements. “They are big, and they have money, and they have clout,” she says. “The supplement industry has been afraid to challenge the FDA because of retributions.” What the GMA has is power. The association represents the companies behind some famous brand names, including the Dole Food Co., Campbell Soup Co., and Hershey Food Corp. And the group is represented by some of D.C.’s most prestigious and powerful law firms — Hogan & Hartson, Kirkpatrick & Lockhart, and Covington & Burling. “People are not going to sit around forever and allow their constitutional rights to be trampled on,” says Peter Barton Hutt, a partner at Covington who has worked with the GMA on this issue. But even with its pull, the GMA still has to convince the FDA that it is right. And that could be a difficult proposition. TOUGH ON HEALTH CLAIMS For years, the FDA and the dietary supplement industry have fought over labeling and packages. Dietary supplement makers want to market their products with the strongest health claims possible for increased consumer appeal. The FDA has continually rejected those claims, arguing that supplements are untested and lack scientific proof to back their claims. The FDA allows three types of claims on supplement and food labels: nutrient-content claims, which tout an ingredient (“high in calcium”); structure-function claims, which refer to a positive effect on a body function or organ (“calcium builds strong bones”); and health claims, which explain the impact on a disease or health condition (“calcium reduces the risk of osteoporosis”). The FDA has historically been the toughest on the third type — health claims. The agency has reasoned that health should be more strictly regulated because they can sound similar to claims made by pharmaceutical companies on drug packages. The agency traditionally required “significant scientific agreement” before approving a health claim. The FDA’s position took a hit last year in court. In Pearson v. Shalala, the U.S. Court of Appeals for the D.C. Circuit ruled that health claims are commercial speech and deserve constitutional protection. The upshot: The FDA should not reject health claims outright but instead should consider allowing stronger claims with disclaimers such as “The evidence in support of this claim is inconclusive.” It was an unadulterated victory for the dietary supplement industry — and a blow to the agency’s regulatory power. “Typically, the FDA doesn’t get slammed quite so badly,” says Daniel Kracov, a partner at Patton Boggs in Washington, D.C., who works on food and drug issues on behalf of producers but was not involved in the Pearson case. “It’s lessened their ability to regulate health claims.” Since the decision last year, the FDA has been wrestling with how to establish new health claim regulations. Last month, the agency held a meeting on the post- Pearson options that grew contentious and difficult — and the issue is growing more complicated. The dietary supplement industry complains the agency is dragging its feet in establishing new regulations. Jonathan Emord, who represented the lead plaintiffs in the Pearson case, has filed several lawsuits to prod the agency into action. “We are long past the point where this issue could be characterized as open to public debate,” says Emord, a partner at D.C.’s Emord & Associates. “The [FDA] should now accept what is the law of the land.” And this Pearson discussion has opened the door to the food industry, which is now jumping in with its own request for new health claim standards. “We want to make more health claims, as well as more structure-function claims, on our labels,” says Stacey Zawel, GMA vice president for scientific and regulatory affairs. “There is a need for the food industry to take advantage of that labeling.” Consumer groups are not happy with the new push, saying it will lead to grandiose statements on cereal boxes and soda bottles and more consumer confusion. “When you start being able to make claims left, right, and center, there is a danger that almost any food can make almost any claim,” says Brett Kay, program associate for health policy with the nonprofit National Consumers League. The FDA will now have to make a decision. Agency-watchers say it will probably be reluctant to extend those looser health claim regulations to food products without another legal battle. FDA officials did not comment on GMA’s petition. But the agency’s reading of Pearson is not very sympathetic. “At this point, unless the petition convinces us that their legal interpretation is appropriate, clearly Pearson applies to dietary supplements,” said Christine Lewis, director of the dietary supplement and labeling office. Brewing on the horizon could be a food version of the Pearson case, or a congressional battle that could open up a whole host of related issues. But the GMA, for one, is confident it will eventually win out and is marrying its fate to the success of the dietary supplement industry. “It will be very difficult to justify under the First Amendment different rules for food than for supplements,” says William MacLeod, a senior partner at Collier Shannon Scott who represents the GMA.

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