In a pair of Proposed Rules set to be published in Monday's Federal Register, FDA proposes to significantly revamp how nutrition information is presented on packaged foods, including bolder calorie counts and a separate line item for the amount of sugar that is added to a product. FDA also proposes to change serving sizes to reflect updated data on what Americans actually eat, the practical effect of which would be increased amounts of calories, fat, sugar, and other nutrients—in some cases even doubling these amounts—on many product labels. 

More than 20 years ago, the Nutrition Labeling and Education Act introduced the requirement that all packaged foods bear standardized nutrition labeling and serving sizes. The principal rationale was that consumers should be given the information necessary to make informed choices about what they eat with the objective of encouraging consumers to eat more healthfully. Since then, there have been periodic revisions, but nothing on the scale of what FDA is currently proposing. These proposals are based on the familiar rationale of allowing consumers to make informed decisions, but FDA is now armed with more nutritional study data than has previously been available. 

Key provisions of the proposed rules are summarized below. 

Serving Sizes Generally Get Bigger, Although Some May Shrink  

FDA proposes to recalibrate serving sizes from their original calculations, which are more than 20 years old. FDA emphasizes that, by law, the serving size must reflect what people actually eat, not what they shouldeat. The agency's recommendations for updated serving sizes take into account updated consumption data and the 2003 FDA Obesity Working Group conclusions.

Under the proposed rule, some serving sizes would potentially increase, while others would potentially decrease, reflecting how FDA believes people actually eat. Serving sizes are based on reference amounts customarily consumed ("RACCs"). Changes to RACCs would be required if the National Health and Nutrition Examination Survey median consumption data have increased or decreased by at least 23 percent compared to the 1993 RACCs. Recent food consumption data indicate that 27 out of 158 (17 percent) of RACCs used to calculate serving sizes would be changed as a result of the proposed rule. The intended effect of the proposed rules is to provide consumers with more accurate and current information on serving sizes to "help them maintain healthy dietary practices."

FDA acknowledged in the preamble of the pre-publication release that changing the RACCs may have an impact on the health and nutrient content claims that can be made on certain products, adding that such changes may be appropriate in light of the changes in the amounts of food being customarily consumed.

"Single-Serving Container" Redefined 

The proposed rule would require that packaged foods and beverages typically consumed in one sitting be labeled as a single serving and that calorie and nutrient information be declared for the entire package. 

For example, a 20-ounce bottle of soda, typically consumed in a single sitting, would be labeled as one serving. Any container of product that holds less than 200 percent of the product's RACC would be labeled as a single-serving container. For packages that are larger and capable of consumption in one sitting or multiple sittings (containers that contain at least 200 percent and up to 400 percent of the RACC), manufacturers would have to provide "dual-column" labels to indicate both "per serving" and "per package" calories and nutrition information. 

FDA provided the following graphic to illustrate how different serving sizes for the same product may be reflected on different kinds of packaging, particularly on products that are usually consumed in a single sitting.

Click here to view image.

Calorie and Serving Size Declarations Get Bigger and Bolder 

The proposed rule would require that calories and serving size information be in bold print and be much larger than is the case under existing requirements. FDA proposes to double the current 8-point minimum for the word "Calories" and triple the minimum type size for the number of calories to 24 points. This would result in calories being by far the most prominent information on the nutrition facts panel, rivaled only by the prominence of serving size information. The proposed rule would require that "X Servings Per Container" be center justified and in at least 11-point type, three points larger than the type size currently required.  

Calories Will Also Get Bigger in Number on Certain Packages 

As a result of adjusting the serving size (see above), particularly for packaged foods that currently contain two servings but are more likely to be consumed in a single sitting, the proposed rules would also have the effect of increasing the actual numerical values of calories in a serving size, relative to what is now required on the same package. In the circumstance mentioned above, the number of calories on the package would actually double under the proposed rules. 

Added Sugars Get Their Own Line Item  

The proposed new format would require that a manufacturer measure and report the total grams of added sugars on a separate line, portrayed as a subset of total sugars. FDA does not provide a daily value for added sugars. Advocates have been calling for more awareness regarding added sugars based on the rationale that sugar is a main contributor to obesity and associated illnesses. However, many stakeholders take the position that the amount of added sugar is irrelevant; consumers need only evaluate the total amount of sugar in a product to make informed eating decisions. 

Updated Daily Values for Nutrients, Especially Sodium 

The proposed rule would adjust the daily values (DV)—which are used to calculate the percent DV in the nutrition facts panel—for several important nutrients, including calcium, vitamin D, and fiber. Most notably, FDA proposes to trim the DV for sodium from 2,400 mg to 2,300 mg. At the same time, the agency is requesting comments about whether 1,500 mg may be a more appropriate DV for sodium given the contended linkage between sodium intake and cardiovascular disease.

FDA is "separately developing a long-term strategy to reduce the sodium content in the food supply." This is seen by observers as a warning to industry that FDA plans to take action regarding salt in the near future.

Vitamin D and Potassium Declarations Trump Vitamins A and C

Under the rationale that many Americans are consuming insufficient amounts of vitamin D and potassium, which could result in higher risk of disease, the proposed rule would require that vitamin D and potassium levels be declared on all labels. Although manufacturers may continue to voluntarily declare vitamins A and C, FDA would no longer require them on the nutrition facts panel, due to its conclusion that deficiencies in these nutrients are no longer common.

No More "Calories from Fat" Declaration 

Noting that the type of fat in a product matters more than the amount of fat present, FDA proposes to remove the line for calories from fat, while maintaining line items for total fat, saturated fat, and trans fat. 

Other Formatting Changes

FDA is also proposing several other minor formatting changes (pictured below), including, among others, shifting the percent DV to the left side of the label, in closer proximity to the nutrient it describes; removing the  percent DV footnote; and declaring the actual amount, in addition to percent DV, of mandatory nutrients.

Click here to view image.

Comment and Compliance Deadlines 

Assuming the proposed rules are published as scheduled on March 3, comments would be due 90 days after publication, on June 2. If history is an indicator, given the controversial and far-reaching nature and scope of these proposed rules, there is at least a possibility that FDA would extend the comments deadline; however, stakeholders should be prepared to comment within the prescribed time period. 

Once the final rule is published in the Federal Register, the timing of which is unspecified, the rule would be effective 60 days later. FDA proposes a compliance date of two years after the effective date, essentially 26 months from the publication of the final rule.