Should FDA Define Functional Foods?

Food companies would love to capitalize on consumer interest in functional foods. Before they can, however, someone has to figure out exactly what functional foods are. 

FDA currently does not have an official definition, nor does it plan to create one. The Institute of Food Technologists Expert Panel on Functional Foods created the most widely accepted definition in 2005. Functional foods, said the panel, are "foods and food components that provide a health benefit beyond basic nutrition (for the intended population). These substances provide essential nutrients often beyond quantities necessary for normal maintenance, growth, and development, and/or other biologically active components that impart health benefits or desirable physiological effects." 

The statement creates wriggle room for enterprising marketers. Is a fiber-enriched cereal a functional food? Is a vitamin-fortified mineral water? A protein-enriched candy bar? 

The FDA hasn't acted on functional foods because it feels all foods are regulated under the Food, Drug, and Cosmetic Act. But new technologies and ingredients have the agency taking a fresh look at what it means to be functional. 

Should an official definition follow? No, says the National Association for the Specialty Food Trade. "Food" is "food", commented NASFT, the current regulatory system is adequate at this time, and there is no need for a new notification process or a changed (and probably more complex) system of committees and reviews. NASFT would support harmonized federal-state food labeling. Barriers and burdens created by differing rules among the states impact the small companies that make up NASFT's membership. 

The Natural Products Association (formerly National Nutritional Foods Association) agrees. According to NPA (Washington, DC), the current food safety regime works, and has allowed Americans safe access to the greatest food supply in the world. Both FDA and the Federal Trade Commission (FTC) have increased enforcement action against false claims and unsafe products, thus, demonstrating that the current system provides these agencies with adequate authority to take action when and where necessary. Additional regulation would simply be over regulation and result in limited access to products that may provide a health benefit beyond the nutritive value. The solution is not more regulation, but rather stronger enforcement of current food safety and fraud laws (i.e. 403(a) FTC section 5, and FDA misbranding provisions) to address problems that may exist in the current marketplace. 

The American Medical Association (AMA) also agrees. The AMA recommended:

1. A class of foods called "functional foods" should not be established.
2. Ingredients that are added to conventional foods must be proven – unequivocally – to be safe prior to marketing of the food product.
3. Health claims for conventional foods should be required to satisfy the "significant scientific agreement" standard.
4. Structure/function claims for conventional foods should be limited to those that are based on taste, aroma, or nutritive value.
5. Conventional foods that contain amounts of ingredients that increase the risk of a disease should be required to contain precautionary information.

AMA does not believe a functional food designation is necessary because conventional foods could be considered "functional." For example, fruits and vegetables are associated with a reduced risk of chronic diseases, such as stroke, type 2 diabetes, and certain cancers; fat-free and low-fat milk products are rich in calcium and can reduce the risk of low bone mass; whole grain food products are rich in fiber that can reduce the risk of coronary artery disease; and foods fortified with folic acid can reduce neural tube defects in the offspring of pregnant women. Although none of these conventional foods are designated by label as "functional foods," most Americans understand the valuable health benefits of these foods. 

Additionally, consumers could easily be confused and misled into believing such food products are better than conventional foods lacking such a designation.

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