"Nutraceutical" is the term coined by Dr. Stephen DeFelice to describe a food, or part of a food, with medical or health benefits, including the prevention, treatment or cure of disease. Other terms, such as "functional foods" and "designer foods," are used elsewhere to describe the same categories.
Food ingredient companies care little about the choice of terminology, but almost without exception they share the same strategy: to provide value-added ingredients that are useful in the formulation of healthy foods. However, industries other than the traditional food industry may realize earlier benefits from the health and nutrition boom. The dietary supplement industry is one of these. Depending on the outcome of the current debate about the nutritional labeling of dietary supplements compared with that of foods, ingredient companies also may find it worthwhile to consider redefining their healthy food ingredient strategies to include the arena of dietary supplements.
As most of us know, the passage of the Nutrition Labeling and Education Act in 1990 required the Food and Drug Administration to issue revised standards for the nutritional labeling of foods. FDA regulations, finalized in early 1993, govern the nutritional information required on food labels, the use of descriptors such as "light" and "fat-free," and the ability to make health claims on food labels.
As currently written, these regulations generally constrain -- rather than enhance -- the opportunities for new value-added food ingredients.
For example, the new regulations require that emulsifiers be counted when one tallies up the fat content of a food. The definition of "sugar" also has been broadened, making it more difficult to use descriptors such as "low sugar" or "sugar free." Options that existed for the ingredient company in the past -- to develop improved emulsifiers for fat-free products, or to provide food enzymes that break down carbohydrates into sugar in situ -- have been eliminated. Further, current food-additive regulations allow the use of additives only when they provide technical benefits -- not health benefits -- to foods. While supplementing a breakfast bar with vitamins up to 100% of recommended daily allowances is permitted, adding higher amounts for purposes of disease prevention is not. If Sen. Orrin Hatch, R-Utah, and Rep. Bill Richardson, D-N.M., have their way, the arena of dietary supplements will be much less restrictive. The original NLEA required FDA to regulate dietary supplements as well as food products. However, legislative action sponsored by Hatch and Richardson resulted in passage of the Dietary Supplement Act in October 1992, which placed a moratorium on the regulation of dietary supplements by FDA until Dec. 15, 1993.
FDA responded strongly, filing dietary supplement labeling regulations with the Federal Register on Dec. 29, 1993. In the new regulations, FDA has generally applied the same principles to dietary supplements as it does to food products, while recognizing that supplements contain much higher levels of nutrients and may therefore become eligible for additional types of health claims in the future.
The battle is by no means over. In April 1993, Hatch and Richardson introduced their Dietary Supplement Health and Education Act, which would permit the dietary supplement industry to operate in a much less restrictive regulatory arena. If passed, the legislation would also permit health claims for dietary supplements with much less in the way of scientific consensus than that required for health claims on foods.
C. Gail Greenwald is vice president and managing director of technology consulting for Arthur D. Little Inc., Cambridge, Mass.
