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F. B. SATCHELL, Food Labeling and Standards, Center for Food Safety and Applied Nutrition, U.S. Food and Drug Administration, HFS-820, 5100 Paint Branch Parkway, College Park, MD 20740 What ingredients does this food contain? Can I use this new product like the regular version? Does this product have special handling requirements? How is this food processed? Does this food contain meat? These are only a few of the questions consumers have indicated must be answered by food labels for them to make informed purchase decisions. But is all of this information really needed to make a purchase decision? Is all of it material? The Federal Food, Drug and Cosmetic Act (the Act) specifically requires food labels to disclose basic information about the food; for example, name, ingredients, nutritional profile. For FDA to determine what is material beyond the basic required information, it must first determine what is false or misleading. The Act directs FDA to ensure that food labels are not false or misleading. Section 201(n) of the Act informs us that labeling is misleading if it fails to reveal all facts that are material in light of representations made or suggested in the labeling, or material with respect to consequences that may result from the use of the food under typical conditions of use. FDA has interpreted the scope of the materiality concept to mean information about the attributes of the food itself, and has required special labeling on the basis of it being "material information" in cases where the absence of such information may: (1) pose a special health risk (for example, a safe handling statement on shell eggs); (2) mislead the consumer in light of other statements on the label (for example, a vitamin asterisk statement "dietarily insignificant" on products containing olestra); or (3) suggest that a food, because of its similarity to another food, has nutritional, organoleptic, or functional characteristics of the food it resembles when in fact it does not.
Session 46, Rationalizing food product labeling: Comparative needs and requirements
2005 IFT Annual Meeting, July 15-20 - New Orleans, Louisiana |