Regulatory Issues: Meal Replacements -- Convenience or Compromise?

By Leslie Krasny, Contributing EditorThe term “meal replacement” is not defined in federal Food and Drug Administration regulations, but generally refers to a calorie-controlled, prepackaged product in the form of a bar or beverage (ready to drink or powder), that replaces a regular meal. Meal-replacement products usually provide 200 to 250 calories per serving, are fortified with more than 20 vitamins and minerals at “good” or “excellent source” levels and often bear nutrient content claims, such as percent fat free and reduced sugar. Some meal replacement products use the term “meal” in the statement of identity, while others use the term only in romance copy and advertising to recommend uses: “occasional meal replacement,” “meal supplement” or “snack.”Initially, meal replacement products were consumed mainly by elderly or ill adults, frequently with nutritional deficiencies. In recent years, however, the marketing of meal replacements has increasingly targeted healthy adults. Such products are presented as a convenient source of balanced nutrition or for specific purposes including weight loss, maintenance and gain. Proponents tout the nutritional advantages of meal replacements over “empty” calorie alternatives and believe the calorie-controlled portions can be beneficial for weight loss and maintenance. Critics discourage reliance on meal replacements, other than on an occasional basis, because such usage may decrease the servings of so-called “real food” like fruits and vegetables. Studies by the American Institute for Cancer Research and similar groups show fruits and vegetables are a greater source of antioxidant protection than supplements alone, as well as providing the additional health benefits of phytochemicals.Another concern raised by critics is that consumers using meal replacements as a main source of nutrition, unless supervised by a medical professional, may not consume sufficient calories or nutrients, depending on the formulation.Regulation of meal replacementsMeal replacement products can be regulated as conventional/functional foods. Those represented as weight-loss products sometimes include warnings, particularly if the product is specifically labeled as a “meal.” The packaging may also suggest a weight control plan, with meal replacements substituting for one meal per day (for weight maintenance) or two meals per day (for weight loss), in addition to snacks. Meal replacement products can also be regulated as foods for special dietary use. Section 411(c)(3) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) defines "special dietary use" as a particular use for which a food is represented to be used, including supplying a special dietary need that exists by reason of a physical, physiological, pathological or other condition, including but not limited to the conditions of disease, convalescence, pregnancy, lactation, infancy, allergic hypersensitivity to food, underweight, overweight or the need to control the intake of sodium or supplying a special dietary need by reason of being a food for use as the sole item of the diet. Any such particular use of a food is a special dietary use, regardless of whether such food is also marketed for general use.Regulations also mandate information and statements that must be given on the labels of foods for special dietary use. The label of a product represented to be for special dietary use with respect to reducing or maintaining weight must bear a conspicuous statement of the basis upon which the food claims to be of special dietary usefulness. Foods for special dietary use are subject to nutrition labeling and health claim requirements, like conventional/functional foods.Another regulatory category covering meal replacements is medical foods. These are foods specially formulated to be consumed or administered enterally under active, ongoing medical supervision, and intended for the dietary management of a specific disease or condition for which distinctive nutritional requirements are established by medical evaluation. Medical foods are not intended for use by the general public, and are primarily available through hospitals, clinics and other medical facilities. Medical foods are exempt from nutrition labeling and health claim requirements.Meal replacement products may not, however, be marketed as dietary supplements. The Dietary Supplement Health and Education Act of 1994 defines a dietary supplement as a product (other than tobacco) that (1) contains specified dietary ingredients and is intended to supplement the diet, (2) is intended for ingestion in pill, capsule, tablet or liquid form, (3) is labeled as a dietary supplement, and (4) is not represented for use as a conventional food or as the sole item of a meal or diet.Marketing challengesChallenges to the marketing of meal replacements over the past decade have been brought primarily by the Federal Trade Commission (FTC) or by the National Advertising Division (NAD) of the Council of Better Business Bureaus.The FTC, pursuant to the FTC Act, may challenge an advertisement on the grounds that it is false or deceptive and likely to mislead a consumer acting reasonably under the circumstances, to influence consumer purchasing decisions or to otherwise affect important consumer actions. The NAD handles challenges from competitors alleging that advertising is false, deceptive or misleading. Participation in NAD proceedings is voluntary, but refusal to participate may result in an NAD referral to the FTC or a state agency.In 1997, for example, Abbott Laboratories settled a highly publicized FTC case charging deceptive advertising claims for Ensure nutritional products. The FTC alleged Abbott represented, without adequate substantiation, that many doctors recommended Ensure as a meal supplement and replacement for healthy, active adults, in order to remain healthy and active. The survey relied upon had merely asked doctors to assume they would recommend a supplement for adults who were not ill, and then to select the brand they would most recommend.The FTC issued a statement at the time acknowledging that nutritional beverage products may provide a benefit if you have a medical condition that makes it difficult to eat, or if you are using them in place of an occasional skipped meal, but warning that “before consumers spend their money to use such products as a regular supplement to their diet, they should check with a doctor or nutritionist.”Claims regarding the safety, success and rate of weight loss for meal replacements have been subject to particular scrutiny. Other issues that have been raised in challenges are “healthy” claims for meal replacements that are not low in fat, lack of directions for use (such as the recommended number of servings per day) on products labeled as meal replacements and infomercials presented in news program formats.Assuming labeling and advertising comply with applicable regulatory requirements, and consumers make informed decisions regarding the consumption of meal replacements as part of the diet, the convenience, nutritional choices, and portion control for such products can provide significant benefits.Leslie T. Krasny is a partner at the law firm of Keller and Heckman LLP, San Francisco office. She specializes in food and drug law, with emphasis on food safety, food labeling, ingredient evaluation, organics, biotechnology and advertising. She is a member of the California Bar and holds a master’s degree in cell and molecular biology. For more information about Keller and Heckman, visit the firm’s web site at www.khlaw.com.