Mid-November brought more than consternation over the Presidential election to Washington D.C., it brought representatives from most of the groups invested in the emerging functional foods industry to a standing room only conference. More than 120 people actively participated in a spirited debate about the merits of a third party review system, first proposed by the Research-based Dietary Ingredient Association, Washington, D.C. This review would consist of an independent panel of experts evaluating the strength of the scientific substantiation supporting a structure/function claim.

During one of the most substantive meetings of the year, broad consensus emerged in support of an independent review of structure/function claims. Industry, government, academicians and consumer groups all spoke in favor of creating such a system. Brett Kay, program associate, National Consumers League, Washinton, D.C., stated "With independent third party scientific review, consumers can be assured that claims are substantiated." Paul Coates, Ph.D., director of the Office of Dietary Supplement Research at NIH, Bethesda, MD, also supported it. He said, "One of the government needs is information and an independent review system would help practitioners know what is evidence-backed."

There was active debate over how this system would be implemented. It was proposed that "Generally Recognized as Efficacious" (GRAE) should be modeled on the process for determining "Generally Recognized as Safe" (GRAS). At a minimum, a GRAE panel would need information on the safety profile of the ingredient or food under evaluation, at the doses to be recommended as well as efficacy studies.

Another area of active debate was the distinction between a health claim and structure/function claim. Scott Bass, Esq., Sidley & Austin, Washington, D.C., argued, "Drug testing endpoints do not support a structure/function claim." A health claim is the relationship between a dietary ingredient or food and the risk of a disease. On the other hand, a structure/function claim is limited to the relationship between a dietary ingredient or food and its effect on a structure or function of the body in maintaining health. However, scientists are not trained to measure the maintenance of health. They see the two issues as opposite sides of the coin-health on one side and disease on the other. They logically argue that the only way to measure health is in the absence of disease or disease biomarkers. There is wide disagreement on biomarkers for diseases and even less agreement about biomarkers for wellness. Placebo controlled, randomized clinical trials have long been the gold standard for pharmaceuticals, but "well-controlled" trials may be a better standard for substantiating structure/function claims.

Is there a meaningful difference between maintaining health, reducing the risk of disease and preventing disease? Under current legal definitions, there must be, as the first one define foods and supplements and the latter two define foods and supplements qualified to bear a health (drug) claim and drugs. However, as a practical matter, there is not an easy way to distinguish among the three. The regulatory premise that prevention defines a drug claim no longer fits what we know to be true about the role of nutrients in the emergence and management of disease. There is much we can do to maintain our health in the context of dietary intake that should not be linked with the treatment of disease.

Robert Hoerr, M.D., Ph.D., RDIA president and chairman and CTO of GalaGen, Minnetonka, MN, discussed the need for exclusivity as a means of giving companies incentives to invest in research. He proposed a seal of approval that would be linked to passing an independent review of substantiation. Some people asserted that consumers would compare two products, one bearing a seal and the other without, and be unable to determine the difference and purchase the cheapest one. Ian Newton, director of business development and regulatory affairs, Roche Vitamins, Parsippany, NJ, suggested that an extensive campaign to educate consumers about the meaning of this mark or seal would be necessary. Gilbert Leveille, Ph.D., worldwide vice president, scientific and regulatory affairs, McNeil Consumer Healthcare, Fort Washington, PA, summarized the debate on exclusivity. He said. "Obviously every manufacturer would love to have a position that would keep competitors away. It is not likely to happen. What could happen is some degree of exclusivity." He continued, "This could range from congressional action that would give exclusivity over a period of time to manufacturers willing to spend resources to get the claim approved, to some other ways of getting data reviewed but kept confidential in a way that only the group generating the data would have access to the data for some period of time. Exclusivity for two to three years would allow you to establish a brand in the marketplace that would make investment worthwhile."

The Life Science Research Office, Washington, D.C., co-sponsor of the meeting along with RDIA, also held a workshop of participating academic scientists after the meeting to address practical issues and guidelines for reviews. LSRO hopes to have a model review process operational by early 2001.
One clear conclusion of this meeting is that we need a new paradigm of thinking about how we study and quantify the maintenance of health. As much effort will be invested in creating the rules of this new paradigm as are spent in developing the scientific data supporting claims. The Research-based Dietary Ingredients Association will continue to champion these issues and welcomes discussion and input from all interested parties. NW

About the author:
Rhonda S. Witwer is director of business development at GalaGen, a nutritional ingredients company developing health promoting ingredients, including Proventra™ colostrum protein concentrates. GalaGen is a founding company of the Research-based Dietary Ingredients Association. She can be reached at 301 Carlson Parkway, Suite 301, Minnetonka, MN 55305; 952-258-5508; Fax: 952-258-5608; E-mail: rwitwer@galagen.com; Website: www.galagen.com.