On February 27, the FDA proposed two rules to amend, among other things, nutrition labeling requirements for conventional foods and dietary supplements; reference amounts customarily consumed (RACCs); and the definition of what constitutes a single serving container. If the proposed rules are finalized without significant changes, nearly every food label that requires a nutrition facts box – which includes most processed foods – will need to be revised to remain compliant with FDA regulations.
Both rules propose regulatory changes too numerous to list here, but here are some highlights.
The impetus behind FDA’s proposals is that Americans have changed: They have become significantly more obese and the diseases related to obesity have become much more prevalent. FDA believes its proposals will help Americans understand how their diets contribute to these negative trends.
The most noticeable proposed revision is to the format and substance of the nutrition facts box. For instance, FDA proposes that the declaration of calories and servings per container be much more prominent. The minimum type size for the declaration of calories, for example, will go from 8 to 16 points for the “calories” heading and to 24 points for the number of calories.
Another proposed format change is the listing of Daily Values for each nutrient on the left side of the nutrition facts box. FDA is also proposing to change the nutrients that are declared in the nutrition facts box. Calories from fat and vitamins A and C will no longer be mandatory to declare, but potassium, vitamin D and added sugars will become mandatory.
FDA is also proposing to change the Daily Recommended Values (DRVs) and Reference Daily Intakes (RDIs) for certain nutrients. RDIs and DRVs form the basis of the Daily Values declared for nutrients listed in the nutrition facts box.
Eric Lindstrom is counsel with law firm Keller and Heckman LLP. Contact him at 415-948-2811 or [email protected].
While these values for phosphorus, potassium, calcium, and vitamins C and K, among others, will rise significantly, the values for molybdenum, chloride, selenium, zinc, chromium, copper and most of the B vitamins will drop significantly. FDA is also proposing to change the definition of dietary fiber, which will likely exclude substances currently declared on nutrition labels as fiber.
The second rule proposed by FDA also introduces significant changes, including (1) revising the RACCs for certain foods; (2) creating new RACC categories and RACCs; (3) amending the definition of a single-serving container; and (4) requiring dual-column nutrition labeling for certain food containers.
FDA’s proposed revisions to the RACCs are significant. RACCs are not recommendations, but are instead intended to reflect Americans' eating habits with respect to amounts typically consumed for various foods. The present RACCs were originally issued in 1993, and were based on information dating back to the 1970's and 1990's, when portion sizes and eating habits may have been very different from current practices. FDA proposes to substantially increase to the RACCs for coffees, teas and many beverages; ice cream and other frozen desserts; seafood and game meats; sugar; and bagels, among others. FDA has also proposed to reduce certain RACCs, including those for fruitcake, yogurt, and certain candies, among others. These changes are significant because serving sizes – which are the basis for the information declared in the nutrition facts box – and many nutrient content claims are derived from RACCs.
FDA is also proposing to change the definition of what constitutes a single-serving container so that all foods that are packaged and sold individually that hold less than 200% of the applicable RACC must be labeled as a single serving – regardless of the size of the RACC. FDA is also proposing to delete the option of labeling packages sold individually containing 200% or more of the RACC as a single serving if it could reasonably be consumed at a single-eating occasion.
FDA additionally proposes to make similar changes to the serving size rules for foods sold in discrete units (e.g., muffins, sliced products, such as sliced bread, or individually packaged products within a multiserving package), i.e., discrete units that are less than 200% of the applicable RACC must be labeled as a single serving.
Dual-column nutrition labeling will be required for foods packaged and sold individually and foods sold in discrete units in multiserve containers, if the container or unit is at least 200 percent and up to and including 400 percent of the applicable RACC. One column will contain nutrition information based on the serving size and the second will contain information for the individual container or unit, as appropriate.
Final rules will likely become effective in three to four years. However, unless an extension is granted, the time to submit comments to FDA closes on June 2. Thus, the time to make an impact on the rulemaking process is now.