In October 2010, the Institute of Medicine (IOM) Committee on Front-of-Package Nutrition Rating Systems and Symbols (front-of-package or “FOP” labeling) issued a report examining the advantages and disadvantages of current FOP labeling. The committee found that FOP labeling would be most useful to consumers if it highlighted the amounts of nutrients of greatest health concern -- calories, saturated fat, trans fat and sodium. The report does not include recommendations for a specific FOP system, but instead focuses on key features for such a system with the aim of using FOP labeling to increase the focus on nutrients of public health concern.

The report reaches six conclusions as follows.
1. FOP labeling is best geared toward the general population. The committee concluded that this audience is appropriate because a majority of the U.S. population is overweight or obese and, thus, at greater risk for chronic diseases.

However, the committee recognized that an appropriately designed system may be useful for determining products that may be marketed to children and may revisit this issue during Phase II of the study.

2. The most useful primary purpose of FOP labeling would be to help consumers identify and select foods based on the nutrients most strongly linked to public health concerns for Americans. The committee believes that an ideal FOP system would allow consumers to identify the amount of calories per serving and the serving size, as well as to compare and evaluate the amounts of targeted nutrients present in products both within and across food categories. The committee is hopeful that such a system would encourage reformulation by manufacturers.

3. Regardless of the type of FOP system, it would be useful to declare calorie and serving size information prominently in FOP labeling. The committee also expects that a more prominent display of calories on packaged foods could complement the new menu and vending machine nutrition labeling requirements.

4. The most critical nutritional components to include in FOP labeling are calories, saturated fat, trans fat and sodium. The committee considers it essential that FOP labeling focus on the nutritional components that are most strongly associated with diet related health risks affecting the greatest number of Americans, such as obesity and type 2 diabetes. These four nutrients are featured because they are the most critical nutritional components affecting these health risks and are also over-consumed in the American diet.

5. There is insufficient evidence at this time to suggest that including the following nutrients would be useful in all types of FOP labeling: total fat, cholesterol, total carbohydrate, total or added sugars, protein, fiber, vitamins and minerals other than sodium. Exclusion of these nutrients is based upon several considerations, such as the relative importance of these nutrients to the most pressing diet-related public health concerns, the potential for some nutrients to track with other nutrients that are considered important to include in FOP labeling, and challenges in measuring compliance for some nutrients, such as added sugars.

6. Several options exist for setting criteria for two types of rating systems, nutrient-specific information (i.e., systems displaying guideline daily amounts) and summary indicators based on nutrient thresholds (i.e., systems with a single icon), but further testing of consumer use and understanding is required to assess their overall viability. The committee identified multiple options for setting criteria for different types of FOP systems. For nutrient-specific information systems, the committee identified four options for displaying calories, saturated fat, trans fat, sodium and serving size. The options are to include (1) amount per serving, (2) amount within the context of a daily diet, (3) characterization of the amount of nutrients in foods with “low” levels only and (4) characterization of the amount of nutrients in foods with “high,” “medium” and “low” levels.

For summary indicators based on nutrient thresholds, the committee concluded that two options may be reasonable. The options would be either to (1) set the same criteria across all foods or (2) develop different criteria across food categories to make the criteria more or less stringent based on the characteristic attributes of the food category. For either system, the setting of criteria would benefit from modeling studies to ensure that an adequate number of foods qualify within each category and that the resulting ratings make sense.

The committee also concluded that algorithm-based ratings (e.g., NuVal) and food group information systems (e.g., Whole Grain Stamp) are not ideal. Algorithms were considered less effective for the purposes of characterizing or rating only calories, saturated fat, trans fat and sodium. Food group information systems were considered to provide insufficient information about nutrients of concern.

Phase II of the study will focus on issues related to consumer understanding and use of FOP systems. The committee will consider (1) which icons are most effective with consumers, (2) systems and icons that best promote health and how to maximize their use and (3) potential benefits of a single, standardized front-label food guidance system regulated by FDA.

Steven Steinborn, Hogan & Hartson LLP, represents food and dietary supplement companies on a range of product development, marketing and regulatory compliance and enforcement issues involving the FDA, the USDA, the FTC and the Consumer Product Safety Commission; steven.steinborn@hoganlovells.com.

From the December 20, 2010,E-dition