Can you name the nutrient claim that likely generates the highest level of consumer interest but is not yet defined by the Food and Drug Administration (FDA)? If you guessed “low-carb” and “reduced-carb” you are correct. But what nutrient did the government recently announce is the key to educating consumers about diet, health and weight management? Calories.

Indeed, the nutrient that launched diet and weight control products in the early 1980s is back in vogue. While consumers should not forget about fat and other nutrients, recent FDA recommendations on combating obesity suggest it's all about calories. At the same time, new rules authorizing carb claims are on the horizon, as FDA faces the challenge of keeping pace with a dynamic marketplace.

The report, “Calories Count: Report of the Working Group on Obesity,” was issued a few months ago by the Obesity Working Group (OWG), appointed from within the FDA by then-commissioner of food and drugs, Mark McClellan. It offers important insights into federal regulatory policy, and foreshadows changes that may be on the horizon.

As fads and trends challenge longstanding federal dietary recommendations, the Food Guide Pyramid may one day bear some resemblance to a kaleidoscope rather than a triangle. Regulatory developments inevitably influence new product development—here is a look at what's coming our way.

Living in a Low-carb World

One cannot discuss dieting, weight maintenance and obesity rates without talking about carbohydrates. Although carbohydrates are not yet specifically part of the Food Guide Pyramid, earlier this year, the FDA received no less than three industry petitions, each seeking definition of “low-” and “reduced-” carbohydrate claims. Suggestions for a “low-carb” claim range from six to nine grams carbohydrates per serving, and the reduced claim would require a 25% reduction in comparison to an appropriate reference food. Agency action, in the form of a proposed rule, is expected by summer.

The current state of affairs in communicating carbohydrate content to consumers is tricky. The Nutrition Labeling and Education Act expressly prohibits a claim that characterizes the level of a nutrient, unless defined by FDA. Indeed, over the past several years, FDA has issued a series of warning letters to food companies, challenging “low-carb” and related claims. FDA's initial focus was on sports nutrition bars, but others—for example, in the baking industry—also have been the subject of FDA enforcement activities.

Current labeling regulations authorize a company to declare the amount of carbohydrates, or any other nutrient, on a food label. Simple factual statements not presented in a fashion that characterizes the level of a nutrient are lawful. Of course, food marketers seek other means by which labels can communicate carbohydrate messages. Because the rules in this area are not well-settled, developing labeling and marketing strategies is a risky undertaking, as the regulatory environment may well change. Yet, faced with extraordinary consumer interest, food companies increasingly must look to all options, recognizing that the uncertainty of the direction of federal policy creates an inherent level of regulatory risk.

While FDA has taken the lead in informally crafting interim policies, their counterparts at USDA's Food Safety and Inspection Service (FSIS) have developed a written interim policy on carbohydrate labeling statements. FSIS regulates the labeling of meat and poultry products. While technically inapplicable to FDA-regulated products, the interim policy closely tracks FDA views and practices over the past year or more. FSIS offers the following guidance.

  • Because no regulations permit “low-carb,” “lower-carb” or “carb-free,” these claims are not permitted.

  • Statements that do not imply a specific level of carbohydrates in a product, such as “carb-conscious” and “carb-wise,” are permitted.

  • Additional terms such as “net carb” are allowed, provided they are adequately explained on the label.

    FDA similarly has not objected to product claims that highlight a food as being of interest to consumers who are interested in limiting their carb intake. The agency also has promised some form of informal guidance on use of “net carb” statements. Some argue that such guidance is unnecessary, and that any such statement that is adequately explained should be permitted, provided it is not otherwise false or misleading. Others have expressed concern that different uses of common terms will create consumer confusion.

    Carb-conscious consumers have spawned an unprecedented surge in demand for new types of food products. This market trend underscores the challenge regulators face in keeping pace with a dynamic marketplace. FDA will take an important step forward with publication of a proposed rule on “low-carb” and related claims. In addition, closely monitoring agency statements and enforcement actions will continue to provide key insight into how food marketers can communicate carbohydrate-related information to consumers.

    Calories: The Sign of the Times

    A principle charge of the FDA Obesity Working Group was to develop new and innovative ways to address the obesity issue and to encourage healthier eating habits. Recognizing that there is not a single cause of rising obesity rates, the report makes a series of recommendations relating to strengthening food labeling, educating consumers about maintaining a healthy diet and weight, encouraging restaurants to provide calorie and nutrition information, increasing enforcement, updating guidelines regarding the development of obesity drugs, and strengthening coordinated scientific research to reduce obesity, including developing foods that are healthful and low in calories.

    The report provides an invaluable blueprint for FDA regulatory developments over the next several years. While the recommendations will not result in any immediate changes to the food label, the document provides insight into the future direction of federal food labeling regulatory activities. An appreciation of where the federal government is headed, in turn, will benefit planned and future new product development and marketing.

    Consider first the new rulemakings that likely will be initiated over the next year or more. They could include recommendations on the following subjects: how calories are presented in the Nutrition Facts panel; a health claim related to lower-calorie diets and obesity; carbohydrate content claims (discussed above); issues relating to changes in serving sizes, as well as a focus on smaller portion sizes. The need for greater attention to calories ties into the report's recurrent theme that “calories count.” FDA certainly is open to changing its rules to allow for greater prominence of calorie information. The idea of linking reduced-calorie intake to a specific health- or disease-related condition would certainly be a change from current health claims that focus largely on specific types of foods or substances (e.g., fruits and vegetables, fiber, soy).

    Do not expect many of these recommendations to be implemented any time soon, however. The recommendations require rulemaking that can easily take from one to two years. One area where companies might act now is to provide information to consumers in the form of dietary guidance. The report encourages companies to make immediate use of statements such as “to manage your weight, balance the calories you eat with your physical activity; have a carrot, not the carrot cake; and, as a snack, have an apple rather than a serving of potato chips.”

    FDA's renewed focus on calories should prompt companies to undertake a review of existing and planned food labels and marketing. In particular, companies should focus on products labeled as two or three servings of food that may routinely be consumed at one eating occasion (e.g., a 20oz. soft drink). A review of all serving sizes is appropriate, recognizing that such label statements, based on regulations published in 1993, may not have been reviewed for many years.

    Companies also should examine marketing practices through the “calories count” prism. When current regulations were written over a decade ago, the focus was primarily on fat. Many nutrient content claims are, in some fashion, restricted by the amount of fat per serving. While similar restrictions are not in place, based on calorie content, companies should consider whether nutrition-related positioning of foods is consistent with the caloric content of the food promoted.

    Restaurant/Foodservice Innovation

    The OWG was also charged with developing an approach for working with the restaurant industry to “create an environment conducive to better informed consumers.” The Nutrition Facts panel information on nearly all packaged foods does not apply to restaurant foods, owing to the practical differences between the way that packaged and restaurant foods are prepared and served. The report urges this segment of the industry to launch a nationwide, voluntary and point-of-sale nutrition information campaign for consumers.

    Suggestions for increasing consumer access to nutrition information included segregating “healthier” menu items with simple nutrition information in a separate portion of the menu, and providing information in an accessible fashion at point-of-sale. The great diversity in restaurant formats arguably necessitates a flexible approach. Longer-term recommendations encompassed a possible pilot program to study various in-store labeling options to evaluate which methods for providing consumers information is most useful to them. The foodservice industry is well on its way to advancing the OWG report goals.

    Beyond trans fat labeling and a few other specific issues, very little has changed at FDA with respect to nutrition labeling and related regulations. The OWG provides many recommendations that will serve as FDA's roadmap for new regulatory initiatives. Anticipating these changes is important. Understanding how such reform would best facilitate the practical challenge of communicating with consumers enables firms to positively influence the regulatory process. In practical terms, understanding and responding to regulatory developments in the area of carbohydrates and calories will provide insight to companies long before new federal rules are finalized.

    First Hand with Steinborn

    Want to hear more on upcoming regulations impacting how products will be formulated and marketed? Would you perhaps personally like to ask this author, Steven Steinborn, a question or two? Attend this year's New Products Conference on October 10-13, 2004 in Scottsdale, Ariz., and hear Steinborn provide updates on regulatory initiatives guiding how new products will be developed in the coming years. See page 118.