Popularity brings attention, not all of it welcome. Functional foods, fast becoming market favorites, are attracting federal attention as well, according to speakers at the Food and Drug Law Institute's 45th Annual Education Conference and the 25th National Food Policy Conference held in Washington, D.C., April 16-17 and 22-23.

Functional foods—widely defined as foods that provide benefits beyond basic nutrition—are a $20 billion market growing at 24 percent to 39 percent annually. The rapid market growth is fueled by consumers' desire to take control of their well-being, said Cheryl Toner, associate director, health communications, International Food Information Council in Washington, D.C. "Consumers believe nutrition plays a great role in maintaining or improving health," she said, "and strongly believe in the benefits of functional foods."

According to IFIC surveys, 94 percent of consumers questioned believe functional foods may reduce disease risk, particularly heart disease, and nearly one third said they add particular foods or food ingredients to their meals to keep healthy. Sixty-three percent reported eating functional foods in 2002, up from 53 percent in 1998. The most popular food choices were broccoli, carrots, fiber, fish, fish oil, garlic, green/leafy vegetables, milk, oats, oranges/orange juice and tomatoes. People older than 55 were more likely to buy functional foods for a specific health concern than those aged 18-34.

Although most consumers have heard of functional foods, some population segments remain largely unaware of their health benefits, said Toner. For instance, IFIC found only 39 percent of people with a high-school education and 42 percent of men knew antioxidants may ward off cancer, and only 40 percent of women knew calcium reduces osteoporosis risk. The message for manufacturers and retailers, according to Toner, is it's time to start educating consumers. On the bright side, "85 percent of consumers want to learn more about functional foods and their health benefits," she said.

Recent research findings on the health benefits of specific nutrients are adding to consumer curiosity. Several studies link carotenoids in fruits and vegetables—such as anthocyanins found in cherries and blackberries, and lycopene found in tomato and tomato-based products—with a reduced risk of prostate cancer and heart disease in men, according to Beverly Clevidence, Ph.D., Phytonutrients Laboratory, Beltsville Human Nutrition Research Center, Agricultural Research Center, U.S. Department of Agriculture.

Such new findings are also creating opportunities for manufacturers, especially the soy foods industry, said Nancy L. Chapman, executive director, Soy Foods Association of North America in San Francisco. Soy foods sales grew by 21 percent from 1999 to $2.77 billion in 2000, due in part to a U.S. Food and Drug Administration-approved health claim that soy may reduce heart disease risk.

Soy milk remains the most popular soy product, with sales of nearly $500 million in 2000, up from $100 million in 1995. It's followed by soy meat alternatives, which rose 14.5 percent in 2000 to $390.5 million, and tofu, up 7.3 percent in 2000 to $240.5 million.

Other soy products have seen sharp growth as well. Soy yogurt grew by 55.3 percent in 2000 to $15.8 million, soy-based cheese alternatives increased 26.9 percent to $52.7 million, and nondairy frozen desserts rose 36.4 percent to $31.6 million.

The soy foods market is largely driven by "baby boomers who seek foods that promote longevity and good health," Chapman said, adding that soy is increasingly being added to breads, cereals, bars and juice blends.

The Price Of Popularity
Popularity has its pitfalls. The surge in functional foods caught the attention of the Federal Trade Commission, and health claims, particularly those on Web sites, are regulators' new favorite target. Functional foods health claims are judged by the same standards that apply to all FTC-regulated products, said FTC staff attorney Leslie Fair. "We ask two basic questions," she said. "What claims, expressed or implied, do consumers take from an ad, and does the company have solid, competent, reliable scientific evidence to support the claim?"

Companies that make dubious or misleading claims online are feeling federal heat and Fair advised food makers "heed the lessons" of the past. Last year, the agency—along with FDA, Health Canada and the attorneys general—pursued dietary supplements that alleged, without proof, to cure various ills. Claims made by Arkansas-based ForMor Inc. that its St. John's wort herbal blend successfully treated HIV/AIDS, cold, syphilis, tuberculosis, dysentery, whooping cough, mania, hypochondria, fatigue and hysteria were considered fraudulent by FTC. The agency also charged the company with failing to disclose that the product could have potentially serious adverse interactions with some prescription drugs.

Most recently, FTC targeted an Interstate Bakeries' Wonder Bread ad stating added calcium improved children's brain functioning. "Of course calcium is an essential element for brain functioning," Fair said. "But the company did not have substantiation to prove that adding Wonder Bread to a child's diet would improve brain functioning."

The FDA—which only permits agency-approved health claims, namely those backed by "significant scientific agreement"—is also focusing on Internet health claims. "What that means for all of us is that Web content could be subject to regulatory action by the FDA if it finds the information on the site violates [the Federal Food, Drug and Cosmetic Act]," said Cate McGinn, senior attorney, Kellogg Co., Battle Creek, Mich. "The bottom line is to make sure that all advertising, labeling and Web site materials comply with all applicable regulatory requirements."

According to the FDA, if a company promotes or sells its products on the Web, any accompanying information may be considered "labeling" and subject to labeling requirements. Last year, the FDA sent letters reminding companies of their regulatory obligations, and warning letters to firms that made questionable online health claims. In one case, the agency cautioned Lakeville-Middleboro, Mass.-based Ocean Spray Cranberries Inc. that its Web site contained "unauthorized" health claims linking its juice line to a reduced risk of chronic diseases such as cancer, cardiovascular disease and cataracts.

Nevertheless, unsubstantiated health claims continue to thrive, said Ilene Ringel-Heller, senior staff attorney, Center for Science in the Public Interest in Washington, D.C., who called on FDA to strengthen functional foods regulations.

The potential for some functional foods ingredients to trigger allergic reactions only heightens the need for stronger rules, she said, citing a 2000 General Accounting Office report that concluded current FDA oversight may allow unsafe products to reach the market. "FDA and federal law give limited assurances of safety," Ringel-Heller said.

Germán Muñoz is associate editor of Food Nutrition Health News Service in Washington, D.C.

Natural Foods Merchandiser volume XXIII/number 6/p. 14, 16