FDA Weighs Labeling Changes

The Food and Drug Administration (FDA) recently published two Advance Notices of Proposed Rule Making (ANPRMs) that seek public comment on possible changes to the familiar nutrition facts panels on food labels. The changes under consideration are aimed at helping consumers prevent weight gain and reduce obesity, and their consideration has been recommended by FDA’s Obesity Working Group.One of the notices invites comment on the amount of prominence given to the declaration of total calories in the Nutrition Facts panel. The calorie content of a food currently appears on the first line of the nutrition facts panel, just below the stated serving size and the number of servings per container. By virtue of its appearance at the top of the table, the total calorie statement is probably the most prominent piece of nutrition information currently included in the table.There are a few ways in which the total calorie statement could be given more prominence. It could appear in a larger or bolder font, or the calorie declaration could appear on the principal display panel (the front) instead of, or in addition to, its appearance in the Nutrition Facts panel. Removing the separate listing for “total calories from fat” or adding a percent daily value for total calories might also provide more emphasis. FDA seeks comments on these options generally and also presents a set of specific questions. For example, how would a more prominent listing of calorie information change the way consumers use the Nutrition Facts panel in deciding what to eat?FDA’s desire to give more prominence to the total calorie declaration is based on the simple idea that weight management requires that calories consumed not exceed calories expended. This basic message is featured prominently in the 2005 Dietary Guidelines for Americans and in the recommendations of the Obesity Working Group. It seems to represent a return to basics and a turn away from popular diets that focus on certain foods to eat or not eat, rather than portion control.The second notice deals with three separate topics:

1. Whether to require food packages containing food that can be reasonably consumed at one time to declare the whole package as a single serving;
   
   
2. Which, if any, “reference amounts customarily consumed” (RACCs) for food categories need to be updated in FDA’s regulations to account for heavier consumption patterns today; and
   
   
3. Whether food labels should be able to make truthful, non-misleading claims comparing foods of different portion sizes – for example, a claim that a product contains one-third fewer calories than a competing brand based only on a reduced portion size.

As you know, the Nutrition Facts panel lists nutrients (fat, carbohydrates, total calories, etc.) in terms of the quantity present in a single serving of the food. The stated serving sizes for some packaged foods recently have been criticized as unrealistic. Soft drinks sold in 20-oz. bottles are often cited as an example of this. Under FDA’s current regulations, a 20-oz soft drink bottle may be labeled as containing about 2 ½ servings. The Nutrition Facts panel then indicates the amount of sugar present per serving. A consumer who only glances at the Nutrition Facts panel may not realize that if he or she drinks the entire 20-oz. container, the amount of sugar ingested will be 2 ½ times the declared amount per serving.As FDA acknowledges, this is not a straightforward issue. According to focus group studies carried out by the agency, most participants incorrectly thought the labeled serving size was a recommended portion size rather than a standardized unit of measure. If this is true, increasing the labeled serving sizes to account for foreseeable heavy consumption will not have a favorable impact on obesity.The issues presented in the two ANPRMs deserve careful consideration. On the one hand, there is a temptation to dismiss modifications to the Nutrition Facts panel as not likely to impact consumer behavior. Are there really consumers who are trying hard to improve their diets but cannot do so because they find the Nutrition Facts panel confusing? On the other hand, the food industry should support efforts to provide factual, easily understood information to consumers. Certainly, the proposals included in the ANPRMs are more reasonable than many suggestions put forward by food industry critics. David Joy is a partner at the Washington, D.C. law firm of Keller and Heckman LLP. He specializes in food and drug law with emphasis on the domestic and international regulation of food, food additives, food labeling, antimicrobial pesticides, and medical devices. He is a member of the District of Columbia Bar and holds a bachelor’s degree in chemistry. For more information about Keller and Heckman, visit the firm’s web site at www.khlaw.com.