Regulatory Issues: Marketing Products Using the Dietary Guidelines
Companies must ensure that any marketing use of the guidelines is truthful and not misleading within the total context.
By Leslie Krasny, Contributing Editor | 04/04/2006
The Dietary Guidelines for Americans — the foundation for the Federal food and nutrition policy — provides recommendations to advance health and reduce the risks of major chronic diseases through diet and physical activity. The U.S. Dept. of Health and Human Services (HHS) and the USDA jointly issue a revised edition every five years.
The 2005 edition was a significant departure from previous editions because it is based on a more comprehensive, scientific analysis of diet and health data, including the Dietary Reference Intake (DRI) reports (published since 2000 by the Institute of Medicine). This latest Dietary Guidelines contains 41 detailed recommendations within nine general areas, and presents marketing opportunities for the food industry, particularly in conjunction with appropriate nutrient content, health, and structure/function claims.
The guidelines may be the source of authoritative statements for purposes of Food and Drug Administration Modernization Act (FDAMA), notifications to the FDA for nutrient content and health claims, although only statements in the Executive Summary and Key Recommendations sections of the Dietary Guidelines, which reflect a preponderance of the scientific evidence, may be used for FDAMA notifications.
One way the guidelines may be used in marketing is to reference recommendations for daily consumption. For example, 2 cups of fruit and 2½ cups of vegetables (an average of 9 servings), 3 cups of dairy (preferably fat-free or low-fat), and at least 3 ounce-equivalents of whole grains are recommended. Note: Equivalent amounts of products within food groups are identified; thus, an ounce-equivalent of grains is 1 slice of bread, 1 cup of dry cereal, or ½ cup of cooked rice, pasta or cereal. And a “serving” under the Dietary Guidelines may differ from the required reference amount/serving size for nutrition labeling purposes, which may also be advantageous as a marketing tool if stated in a manner that is not confusing.
Another opportunity is to highlight differences between daily intakes recommended under the Dietary Guidelines for specific nutrients and Daily Values used in nutrition labeling. The guidelines recommend 4,700 mg of potassium — far greater than the Daily Value of 3,500 mg — and 28g of fiber (14g per 1,000 calories), as compared with the Daily Value of 25g.
In addition, the guidelines state that intake levels of calcium, potassium, fiber, magnesium, and vitamins A (as carotenoids), C, and E may be insufficient in the diets of adults, a finding that can be effectively used to promote products.
With respect to overweight and obesity, the emphasis is that consuming more calories than are expended is a key factor contributing to the obesity epidemic. It’s noted that if only nutrient-dense foods are selected from each food group in amounts recommended, a small amount of calories can be consumed as added fats or sugars, alcohol, or other foods (“the discretionary calorie allowance”). The trend is to market snack foods in relatively small single-serving units to assist consumers in controlling their intake of discretionary calories.
The Dietary Guidelines also includes statements that identify dietary patterns or nutrients with health or disease prevention. Such statements may be dietary guidance, approved health claims, unapproved health claims, structure/function claims or may fall in an unsettled area of the law. The FDA has not fully clarified the distinctions among food categories, ingredients and nutrients, making it a challenge to properly identify the classifications in order to comply with requirements.
Companies must ensure that any marketing use of the guidelines is truthful and not misleading within the total context. It is unclear under what circumstances “disclosures” may be indicated in the event that products meet referenced recommendations of the Dietary Guidelines, yet are not consistent with overall recommendations.
About the Author
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.