FDA Eyes "Functional Foods"

The US Food and Drug Administration (FDA) has announced plans to examine foods being marketed as functional foods--i.e., foods marketed with claims of providing added benefits such as health benefits, feelings of well-being or, in some cases, beauty effects. In a recent report featured in C&T Today, "Cosmetic Hybrids," the trend for innovations such as foods that bridge across the pharmaceutical (nutraceutical) or cosmetic (nutracosmetic) gap, or cosmetics that cross into pharmaceutical areas (cosmeceuticals) were explored, among others.

Thus, with attention drawn towards functional foods in particular, the FDA has taken notice of these synergistic claims being made insomuch as to call a public hearing to determine how these materials shoul be regulated.

The public hearing, scheduled for Dec. 5, 2006, at the Center for Food Safety and Applied Nutrition (CFSAN) Harvey W. Wiley Auditorium in College Park, Maryland, USA, will take a closer look at foods referred to as functional foods. According to the Federal Register Notice, although there is no formal definition of what the industry means by functional food, on March 24, 2005, the Institute of Food Technologists (IFT) issued a report entitled "Functional Foods: Opportunities and Challenges" in which the term was defined as "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.'' Examples of functional foods cited in the report include conventional foods, fortified, enriched or enhanced foods and dietary supplements.

According to the report, the agency's position has been that issues concerning substance/nutrient safety and label statements regarding nutrition can be appropriately handled under provisions of the Federal Food, Drug, and Cosmetic Act. This hearing will examine how foods currently marketed as functional foods fit into existing regulatory regimes and will solicit information and comments from interested persons regarding how the FDA should regulate these foods under the agency's existing legal authority.

The Hearing will include a series of prepared presentations by agency scientists and invited speakers and an FDA panel Q&A for the invited presenters. Members of the public will then have the opportunity to present their views. For additional information, see the Federal Register Notice.

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