Summary
Scientific studies continue to establish a strong relationship between constituents in foods and dietary supplements and certain diseases. Not surprisingly, the food and dietary supplement industries are responding by developing new products and repositioning old products efforts to help consumers manage their health. Here, Hahn reviews the basic statutory and regulatory framework for products regulated by Food and Drug Administration then reviews the various claims that can be made for foods and dietary supplements, and explores the opportunities that exist for marketing functional foods.
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Extract
Functional Foods: What Are They? How Are They Regulated? What Claims Can Be Made?
I. INTRODUCTION
Scientific studies continue to establish a strong relationship between constituents in foods and dietary supplements and certain diseases.1 The general population is inundated on a seemingly daily basis by media reports of new studies showing that a food or dietary supplement is useful in treating particular diseases or reducing the likelihood that a consumer will develop particular diseases. With increasing frequency, consumers are looking for foods and supplements to help manage and prevent the onset of disease.2Not surprisingly, the food and dietary supplement industries are responding by developing new products and repositioning old products efforts to help consumers manage their health. For example, yogurt used to be positioned only as a delicious component of a meal but now is also promoted for use in weight loss programs after a study showed that the calcium in dairy products is effective in weight loss.3 Tomato products and ketchup are promoted for their lycopene content, which studies have shown to be effective in treating prostate cancer.4 Crystalline glucosamine sulfate dietary supplements are used by many people because numerous clinical studies have shown that the supplements are effective in treating the joint pain and reducing the progression of osteoarthritis.5 These and other products fall into the category of "functional foods."6The "functional food" terminology has been around for many years;7 however, Congress has never amended the Federal Food, Drug, and Cosmetic Act ("FFDCA") to establish unique requirements for functional foods, and the Food and Drug Administration ("FDA") has never established regulations unique to this product category. Although no statutory or regulatory definitions exist for functional foods, numerous commentators and expert bodies have attempted to define functional foods. The Food and Nutrition Board of the National Academy of Sciences has suggested that a "functional food" is "any modified food or food ingredient that may provide a health benefit beyond the traditional nutrients it contains."8 Others imply that a functional food is any food promoted or consumed for a specific health effect, regardless of whether the food has been modified in some fashion.9 A frequent criticism is that all foods are, in some sense, functional.10Because there are no unique statutes and regulations for functional foods, these products fall under the same general requirements that apply to foods, dietary supplements and other products FDA regulates.11 This means that a functional food product may be regulated as "conventional food," a "dietary supplement," a food for "special dietary use," a "medical food," or a "drug," depending on the claims made for the product and the product's positioning in the marketplace. This article explores how functional foods are regulated under federal laws governing food products. As discussed below, a product's intended use, primarily determined by the claims made on the label and in the labeling and advertising, will have a large impact on how FDA will regulate the product.12 This article, therefore, first reviews the basic statutory and regulatory framework for products regulated by FDA then reviews the various claims that can be made for foods and dietary supplements, and finally explores the opportunities that exist for marketing functional foods.II. STATUTORY AND REGULATORY REVIEW OF THE FEDERAL FOOD, DRUG, AND COSMETIC ACTFDA has primary regulatory authority over foods pursuant to the FFDCA.13 While FDA in theory has jurisdiction over all foods, FDA does not regulate meat and poultry products. These products are regulated primarily by the United States Department of Agriculture.14 This article focuses on the FDA regulatory scheme and does not explore the opportunities that may exist for meat and poultry products.A. STATUTORY FOUNDATION: "FOOD," "DRUG," AND "SPECIAL DIETARY USE FOODS"Congress enacted the FFDCA in 1938.15 Although the statute has been amended numerous times, the basic statutory framework created in 1938 still exists today. When originally enacted, the FFDCA established requirements for only three product categories relevant to functional foods-"foods," "drugs," and foods for "special dietary uses."16 Different premarket authorization, labeling, manufacturing and other requirements exist for drugs than for foods. Drugs generally are subject to much more onerous requirements than foods and dietary supplements.17A product's intended use will determine whether FDA will regulate the product as a food, a dietary supplement or a drug.18 Intended use is determined largely by the claims made on labels and in the labeling a...See the full content of this document
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