With industry struggling with changes to food labels to incorporate the listing of trans fat, the Food and Drug Administration (FDA) has announced a new initiative that may require changes to the food label. FDA’s actions come in direct response to the report of it’s Obesity Working Group entitled "Calories Count" which made recommendations in large part based on its finding that weight control is mainly a function of caloric balance. As a result, on April 4, 2005, FDA published two Advanced Notices of Proposed Rule Making (ANPRs) seeking input from industry and the public regarding possible alterations to the existing food label format. Comments are due by June 20, 2005.

Currently, FDA’s regulations require a food product to bear a Nutrition Facts Panel (NFP), which provides specific information on serving size, calories per serving, and other required nutrition information such as fat, cholesterol, sodium and carbohydrates. FDA’s regulations mandate the listing of total calories per serving in a standard format.

One ANPR is entitled "Food Labeling; Prominence of Calories", which is a request to industry for comments regarding whether and how FDA should alter the NFP or any other aspect of the nutrition label to highlight calorie information. In addition, in this ANPR FDA states that it is seeking information to help it develop a better understanding of how consumers currently use calorie information, to then assess whether the NFP needs modification in some other way to be an effective tool in facilitating positive dietary change.

FDA has already gathered information on these issues which indicated that consumers do use information provided on the NFP, and that they are interested in calories (although many are also interested in other aspects of the nutrition information such as saturated fat, cholesterol, carbohydrates and sodium). It was not clear to the agency, however, that highlighting the calorie amount, either through larger or bold type, or though a "starburst" with the information, would be value added to consumers.

Therefore, FDA is asking for comments to gather information from industry and other interested parties. Some of FDA’s specific questions follow:

  • Would consumer awareness of the caloric content of packaged foods be increased by amending nutrition labeling regulations to give more prominence to the declaration of calories per serving?
  • How would a more prominent listing of calorie information change the way consumers use the NFP in deciding what to eat?
  • What methods could be considered for increasing prominence?
  • How does the listing "Calories from fat" adjacent to "Calories" affect consumers’ focus on the total calories of a food?
  • Is calorie content used to determine how much of a given food to eat, or to determine which foods, out of a range of similar products, to eat? Why or why not?
  • What do consumers currently think the calories on packaged foods represent?
  • Would the display of caloric content per package on the front panel of a label encourage more competition based on the caloric content of packages and, if so, how?

In addition, FDA issued a second ANPR entitled: "Food Labeling: Serving Sizes of Products That Can Reasonably Be Consumed At One Eating Occasion; Updating of Reference Amounts Customarily Consumed; Approaches for Recommending Smaller Portion Sizes." Again, in light of recommendations by the Obesity Working Group, FDA is seeking comments on a number of issues directly related to how serving sizes are disclosed on product labeling.

As required by the Nutrition Labeling and Education Act, serving sizes are based upon standard "reference amounts customarily consumed"(RACC) developed in the 1970s and 1980s to establish standardized amounts upon which all nutrition information would be provided. The intention was to provide for easy food choice comparisons for consumers. FDA now questions whether there is a need to update the RACCs and if so, how to do that. In addition, FDA is requesting whether or not there should be new rules governing when a product can be labeled as a single serving container.

FDA has raised issues, including the following:

  • Should FDA initiate rulemaking to require packages that can reasonably be consumed at one eating occasion to provide the nutrition information for the entire package? If so, what criteria should FDA use to determine which multiserving products would require nutrition information for the entire package?
  • Should such products be required to include an additional column within the NFP to list quantitative amounts and % Daily Value for the entire package, as well as the preexisting columns listing the quantitative amounts and % Daily Value for a serving that is less than the entire package?
  • If the nutrient amount per serving size and the per package were listed side-by-side in separate columns, how would this affect consumers’ ability to understand the label?

Finally, the Federal Trade Commission submitted comments to FDA recommending that FDA permit truthful, nonmisleading claims which compare different portion sizes of foods. FDA’s current regulations regarding nutrient content claims, including comparative claims, require that all such comparisons be based on a uniform amount of food. FDA is revisiting this position, and requesting industry’s reaction to this suggestion by posing questions such as:

  • Will it be confusing to consumers to have claims made only on the basis of the difference in the amount of calories in two different labeled servings or two different portions of the same food?
  • What words should be used to ensure that consumers understand that comparisons are made only on this basis (i.e., the difference in the amount of product) and that there is not a difference based on product reformulation?
  • Should the size of the compared servings, portions, or packages be part of the claim?
  • Should these types of claims be limited to products that are identical except for the specified serving or portion size?
  • Should this claim be limited to single-serving containers, or is it appropriate on multi-serving packages?
  • If claims are permitted on multi-serving packages, should these claims be limited to products that have portioned pieces, such as cookies or slices of bread, or should the by allowed on products that are not portion controlled, such as pies or bulk sodas?
  • What comparative terms are appropriate?
  • Currently all comparative calorie claims are limited to reductions of at least 25 percent. Should these comparisons (e.g., reduced or fewer calories) continue to be limited to reductions of a at least 25 percent, and if not, what justification is there that a smaller reduction of calories would be meaningful and significant? Please provide data.

This article has been prepared by Sidley Austin Brown & Wood LLP for informational purposes only and does not constitute legal advice. This information is not intended to create, and receipt of it does not constitute, an attorney-client relationship. Readers should not act upon this without seeking professional counsel.