Dietary supplement, food health claims exclusivity suggested at nutraceuticals conference.

DIETARY SUPPLEMENT, FOOD HEALTH CLAIM EXCLUSIVITY SUGGESTED by members of a panel convened May 9 by The Foundation for Innovation in Medicine and chaired by the foundation's Stephen DeFelice, MD. In a "legislative concept document," the foundation proposed that "the sponsor of...research shall have the exclusive right to convey the information for commercial purposes, for a limited period of time." The panel addressed the issue at the foundation's Nutraceuticals Conference in Washington, D.C.

Exclusivity was discussed as a way of encouraging research to support health claims for supplements and foods. DeFelice asserted that "legislative reforms like the Nutrition Labeling and Education Act and the Dietary Supplement Health & Education Act...have fallen short of the goal of creating...infrastructure for the development of nutraceuticals."

The panelists agreed that market protection should be available to companies that sponsor research to support claims. However, they disagreed about how exclusivity should be applied. The consensus of the industry reps on the panel was that, though more research on botanicals is necessary in order to bring them into mainstream use, there is currently no incentive to conduct research that would lead to use of "hard" claims for the products.

Panelist Lyn Ciocca, president and general manager of IntraCellular Health, Inc., suggested that exclusivity for herbal products should be limited to scientifically proven "novel positions" -- claims such as "a better/improved valerian." Ciocca suggested an exclusivity period of two to four years, depending "on the work" the company has expended on its research. Generally, she noted, the industry is in favor of category claims -- not brand claims -- for herbals.

Panel member Robert Donovan, consultant and former head of Sandoz' OTC business, suggested that the OTC industry would settle for a "three-to-seven year time frame" for exclusivity of supplement and food claims. Donovan stressed the need for an "economic incentive" for OTC industry investment in supplement research.

In an "executive summary" assembled by DeFelice at the end of the conference, the foundation urges that dietary supplements and conventional foods be given "the same opportunities and standards for bearing claims." D.C. attorney Stephen McNamara (Hyman, Phelps and McNamara), suggested that food companies might not want to place established brand names at risk by carrying claims that have not been evaluated by FDA. However, Robert Smith, PhD, senior VP-research for Nabisco, countered by stating that the food industry "would see no downside" to being able to bear claims equal in strength to those made by dietary supplements.

The panelists also discussed the possibility of providing to "licensed health care professionals" data supporting an herbal product's ability to prevent, manage, or treat illness -- with the intention of "learned intermediaries" reviewing the data and deciding whether to disseminate information about herbal products to the public. David Collins, consultant and former president of Schering-Plough Healthcare, concurred, asserting that "a learned intermediary...is in a better position to make a...judgement as to the validity and the substantiation of the data" collected by the manufacturer.

The foundation also stated in its summary that "given completely independent, respected peer review of the quality" of clinical data gathered, a company should "have the right to provide the information to the public" via claims on product labels.

An approval process for exclusive claims is, according to Donovan, "begrudgingly admitted" by the OTC industry, to prevent companies that are "out on the fringes" and "willing to push the envelope" from competing with companies that are "closer to the OTC and pharmaceutical model." Ciocca likewise supported, "with caution," the claim approval process, although she added that the herbal industry views the process with skepticism.

The foundation's recommendations were presented at the conference to Sen. Tom Harkin (D-Iowa) a co-sponsor of the DSHEA legislation. Harkin, who sponsored legislation to create the Office of Alternative Medicine at the National Institutes of Health, suggested that OAM is actually the "office of complementary medicine," because, he said, alternative medicines complement the use of OTC and Rx drugs, rather than serve as alternatives.

Also addressing the conference, Patricia Knight, health policy advisor to Sen. Orrin Hatch (R-Utah), said that, in her view, exclusivity on health claims would conflict with NLEA's goal of providing more information to consumers. She added, however, that if the information conveyed to consumers is restricted by exclusivity, the result might be higher quality information overall on dietary supplements.