In the past decade, food and dietary-supplement manufacturers have created a new niche industry—one in which their goods do more than provide nutrition or gustatory pleasure. Designed to promote optimal health and reduce risk of disease, such products have come to be known as functional foods or nutraceuticals. Examples include St. John's wort tablets reputed to fight mild depression, calcium-fortified orange juice, and margarines made with cholesterol-lowering stanol esters. Even oatmeal and cranberry juice might be considered functional foods, in that they contain dietary agents that can cut disease risk.
Last week, the Chicago-based Institute of Food Technologists (IFT)—a scientific society of researchers in industry, universities, and government—released a report on this nascent industry and concluded that it is "at the threshold of unprecedented influence on public health and disease prevention." However, IFT added, the industry's growth, while rapid, faces major roadblocks to expansion unless the federal government institutes new regulations to streamline the Food and Drug Administration's evaluation of candidates for this novel class of products.
Currently, rules for conventional foods and food additives govern the production and sale of nutraceuticals. Generally, these rules prohibit manufacturers from making an explicit health claim for such products: Foods and additives can't be advertised as preventing, treating, or curing a disease. As such, producers of functional foods have had to walk on one side of a fine line between inferring health benefits and making solid claims.
For instance, science has shown that calcium builds bone, and doctors prescribe it for some postmenopausal women trying to avoid osteoporosis. However, manufacturers may not advertise calcium-fortified foods as helping to stave off osteoporosis, because that would link them to disease prevention, and only drugs can be marketed for such purposes. However, manufacturers can describe fortified orange juice as being a good source of calcium. The distinction? Beneficial nutrients, such as vitamins and minerals, can be marketed as dietary supplements or food ingredients.
If there were only a few dozen functional foods, manufacturers would probably be content to continue finessing the food-and-supplement regulations. However, the new IFT report notes, waves of these products are about to flood the U.S. market. In addition, the report predicted that the U.S. medical community will become more accepting of functional foods and begin recommending them as adjuncts to conventional medicines, approaching the current attitude of the European medical community.
The report predicts that many of the coming functional foods will be designed for people with special needs, such as women of childbearing age, adolescents, athletes, military personnel, the elderly, and people with heart disease or other chronic conditions.
IFT advocates not only streamlined regulations for nutraceutical candidates, but also leeway for manufacturers to make a broader variety of claims about the health benefits of their products. Some labels might list proven benefits, while others might note advantages that have been suggested by data. A new range of labeling terms might indicate the strength and quality of the data supporting a functional food's benefit.
"The concept of functional foods as a new product category is in the relatively early stages of development from a number of perspectives—including scientific, research, regulatory oversight, and consumer acceptance," notes C. Ann Hollingsworth, IFT's past president. Her organization convened an 18-member expert panel to investigate the challenges to and opportunities for new products in this sector.
"The impact of diet on health has become much broader than basic nutrition," explains Fergus Clydesdale, who chaired the panel and is head of the University of Massachusetts' food science department. Because science has identified food components that can prevent and fight various diseases, consumers can select foods to work in conjunction with conventional medicine in disease management.
If manufacturers are to continue developing effective functional foods, the IFT report argues, they need government rules with standard criteria for measuring safety and efficacy of such products. In addition, the report recommends that companies receive some compensation for the investment in research that's necessary to bring such products to market. That compensation might take the form of tax breaks or several years' exclusive rights to market a pioneering product—similar to the right that a pharmaceutical company receives upon FDA approval of a drug.
Designing for genes
The report points to three new research disciplines that underlie efforts to develop functional foods.
The first is the study of the interaction of dietary components with genes, a field called nutrigenomics. The dietary agents may be vitamins, fats, types of fiber, amino acids, certain plant pigments, or other compounds. Some of these agents may offer benefits to everyone. Others may benefit just some segments of society—for example, people undergoing growth spurts, people with genetically limited ability to absorb certain nutrients from the diet, people at risk of diseases that might be prevented with dietary supplements, or those with or at risk of specific chronic diseases.
The second discipline that's affecting nutraceuticals' development, proteomics, is the study of all proteins that can be produced by a person's genes. Scientists are attempting not only to identify those proteins, but also to trace their interactions with other body chemicals to better understand their ultimate effects on the body.
The last field that's boosting interest in functional foods is metabolomics (sometimes called metabonomics), which focuses on cells. Researchers examine how inputs of food, drugs, or potential toxicants affect the health of cells and particular tissues.
Making investments worthwhile
Research-oriented makers of foods and dietary supplements have been exploring these disciplines for data to support claims of health benefits for functional foods. That's expensive, because the Food and Drug Administration has required a mountain of evidence before allowing any of the few health claims that are now on foods such as oats and ingredients such as omega-3 fats (see Omega-3's May Hit Food Labels).
Currently, once the federal government accepts that a company has garnered sufficient data to establish a qualified health claim, then that company—and any other, including its competitors—can label its product as offering the benefit.
For instance, Quaker Oats established such a health benefit for the soluble fiber in oats. FDA now permits all products made from whole oats, oat bran, or oat flour to say that they, "as part of a low-saturated-fat, low-cholesterol diet, may reduce the risk of heart disease" (see FDA Helps You Identify Heart-Y Oats).
One company shouldn't have to pay for establishing a claim that its competitors can instantly exploit at no cost, the IFT report suggests. One possible solution to this inequity, it says, would be to offer to the company or firms establishing a health claim an exclusive right to market goods with that claim for several years. The policy would be akin to laws that grant patent holders sole rights to novel technologies for a given period.
At a news briefing last week, IFT-panel member Diane Birt, director of research on dietary supplements at Iowa State University, advocated a science-driven process for bringing functional foods to market. Key would be a determination of both the efficacy of a prospective product and its safety, says Birt. She noted that the panel recommends that FDA set up a committee to identify which nutraceuticals have already been proven safe.
That action would mirror FDA's current designation of food ingredients as "generally recognized as safe" (GRAS) if a wealth of data or longstanding use of a product has confirmed its safety in moderate doses. Manufacturers can add GRAS substances to foods without first requesting federal regulatory approval to do so. GRAS ingredients include salt, the food preservative BHT, and flavorings such as vanilla.
The report suggests development of a designation "generally recognized as efficacious" (GRAE) for nutraceuticals supported by a strong body of scientific evidence. The category might include foods such as oats and ingredients such as fish oil or the plant pigment lutein.
The panel recommended that FDA enlist outside experts to evaluate prospective candidates for a GRAE designation. Their independence from the regulatory process and commercial development of prospective products "would encourage public confidence while conserving government resources," says Birt.
Manufacturers aren't the only ones that stand to benefit from an overhauling of how FDA regulates functional foods, the report says. Consumers want to eat healthier but often don't know what health-promoting ingredients to look for or what quantities to eat for optimum benefits. Food labels carrying functional-food claims could become "the foundation for consumer education regarding dietary components for health," the report argues.
Diane F. Birt
Department of Food Science and Human Nutrition
224A Food Science
Iowa State University
Ames, IA 50011
Fergus M. Clydesdale
Department of Food Science
University of Massachusetts
Amherst, MA 01003
C. Ann Hollingsworth
Better Built Foods
160 Star Point Road
Carrolton, GA 30116
Institute of Food Technologists
525 W. Van Buren, Suite 1000
Chicago, IL 60607
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