“A good example is Cream of Wheat. Expecting moms and nursing moms who cannot hold their iron can eat Cream of Wheat because it’s fortified [with iron], and that particular form is really gentle on your stomach,” Dr. Shelke says. “When they go for their next blood test, they can see it. And word has gotten around over the years, so people trust it.”
Another way to gauge the effect of a fortified food is in a product such as a fortified energy drink, where an effect is immediately palpable, she says. “People trust it, they have no doubt, and they buy it,” she says.
People have come to expect function from practically every food or drink, she says. She thinks the trend could continue. “Human beings are creatures of habit,” she says, noting that office workers who moved to working remotely during the pandemic may not have continued their habit of picking up coffee and a donut in the morning and may instead have formed new habits with food. “Some of the newer habits may stick.”
Valigra is a freelance writer based in Maine. Reach her at [email protected].
Regulating Functional Foods Internationally
While functional foods are not regulated separately by FDA in the United States, other countries have taken a more specific approach to the scientific merit of benefits listed on functional food labels.
In 1991, the Japanese Ministry of Health, Labour and Welfare set up a regulatory system for functional foods called “Foods for Specified Health Use,” or FOSHU, to evaluate foods for their effectiveness and safety. FOSHU also approved statements on food labels about how the food affects the human body, and qualifying foods could include the FOSHU seal on their labels.
In Europe, the International Life Sciences Institute initiated the Functional Food Science in Europe, or FUFOSE, project in 1995 to establish a science-based approach for assuring that specific nutrients and food components positively affected their targeted functions in the body. Over a period of three years, the effort involved about 100 European experts in nutrition and medicine who critically assessed the state of the art in functional foods.
The work by FUFOSE led to a project called PASSCLAIM, or Process for the Assessment of Scientific Support for Claims on Foods, in the early 2000s to produce a pan-European generic tool that could scientifically assess health-related claims on foods or drinks. In 2006, the European Union adopted a regulation on nutrition and health claims made on food.
The European Food Safety Authority is charged with verifying the scientific substantiation of submitted claims regarding general health, disease risk reduction, child development or health, and criteria for setting nutrient profiles.—LV
Defining Functional Foods
FDA doesn’t have a statutory definition for functional foods, so it does not regulate them, but industry groups have given some guidance with their own definitions.
The Academy of Nutrition and Dietetics defines functional foods as whole foods and fortified, enriched, or enhanced foods that have a potentially beneficial effect on health when consumed as part of a varied diet on a regular basis at effective levels.
The Institute of Food Technologists says they are foods and food components that provide a health benefit beyond basic nutrition (for the intended population). Examples may include conventional foods; fortified, enriched, or enhanced foods; and dietary supplements. Functional foods provide essential nutrients beyond quantities necessary for normal maintenance, growth, and development, and/or provide other biologically active components that impart health benefits or desirable physiological effects.
The International Life Sciences Institute defines them as foods and food components that have the ability to beneficially influence body functions to help improve the state of well-being and health and reduce the risk of diseases.—LV
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