In conjunction with the proposed changes to the nutrition labeling requirements, the FDA is separately issuing a proposed rule that would make significant changes to “reference amounts customarily consumed” (“RACCs”) for certain foods, and existing requirements governing the declaration of serving sizes for nutrition labeling purposes.
Existing FDA regulations prescribe the “RACC” for foods on a category basis. The RACC that applies to a food is the unit amount of a food that must be used by companies to determine the amount of food that constitutes a “serving.” The Nutrition Facts box must declare the “serving size” and the calories and nutrient amounts are provided based on a “serving” of the food. In addition, under existing FDA regulations, for a food to qualify for nutrient content claims (e.g., “high in fiber,” “low in saturated fat”), nutrient levels in the food must meet criteria that are specified on the basis of the RACC.
Specifically, the FDA is proposing major changes to the following areas:
- Single-Serving Containers: FDA is proposing to revise the definition of a single-serving container so that a product that is packaged and sold individually and contains less than 200% of the applicable RACC must be considered a single-serving container, and the entire content be labeled as one serving. In doing so, FDA removes the current exception for foods that have “large” RACCs (i.e., products that have reference amounts of 100 g (or mL) or larger), which currently provides that a package containing more than 150% but less that 200% of the applicable RACC, can be labeled as having one or two servings. This change reflects FDA’s belief that packages which can be consumed, or are typically consumed, in one sitting should be labeled as a single-serving.
- Dual-Column Labeling: For food products that contain between 200% and 400% of the applicable RACC, FDA is proposing to require the use of dual-column labeling that provides nutrition information on a “per serving” and “per container” basis. The purpose is to provide nutrition information for those who may consume the entire container in one-sitting, as well as for those who consume the container over multiple-sittings or share the container with others. FDA’s proposal is based on the results of a consumer study, which suggests that dual-column labeling can lead to reduction in the total amount consumed. FDA is also proposing two alternatives for comment that would require dual-column labeling for only certain nutrition facts (as opposed to all nutrition facts). FDA proposes to include a few exemptions from the dual-column labeling requirement, including for products that are primarily used as ingredients (e.g., flour) or bulk products typically used for multi-purposes (e.g., eggs).
- Changes to RACCs: FDA is proposing to amend existing regulations governing the RACCs that must be used for purposes of nutrition labeling and nutrient content claims. In short, the proposed regulations would make significant changes to the established RACCs for a wide variety foods, including foods in the following food categories: “Bakery Products,” “Dairy Products and Substitutes,” “Desserts,” “Dessert Toppings and Fillings,” “Egg and Egg Substitutes,” “Fish, Shellfish, Game Meats, and Meat or Poultry Substitutes,” “Miscellaneous Category,” “Mixed Dishes,” “Sauces, Dips, Gravies and Condiments,” “Soups,” “Sugars and Sweets,” and “Vegetables.
For example, the proposed rule would increase the current RACCs for the following products or product categories:
- Beverages (which include “carbonated and noncarbonated beverages, wine coolers and water” and “coffee or tea, flavored and sweetened”) would be increased from 8 fl. oz. (240 mL) to 12 fl. oz. (360 mL).
- “Bagels, toaster pastries, and muffins” (which are being removed from their current product categories, to create a new product category for “Bagels, toaster pastries, muffins (excluding English muffins)”) would be increased from 55 g to 110 g.
- “Ice cream” (in the general category of “Desserts”) would be increased from 1/2 cup to 1 cup.
- “Sugar” (in the general category of “Sugars and Sweets”) would be increased from 4 g to 8 g.
- “All other candies” (in the general category of “Sugars and Sweets”) would be increased from 30 g to 40 g.
According to FDA, the proposed changes are necessary “to ensure that the Nutrition Facts label meets its intended goal of helping consumers maintain healthy dietary practices.” FDA recognizes that “changing the RACCs may have an impact on the health and nutrient content claims that can be made on certain products.” FDA states, however, that “such changes may be appropriate in light of the changes in the amounts of food being customarily consumed.” By way of an example, FDA illustrates that a product might currently qualify to bear a “low fat” nutrient content claim, but is actually being customarily consumed in amounts that contain more fat than would qualify for such a claim.
The FDA proposed regulation has far-reaching implications with respect to RACCs and requirements governing the declaration of serving sizes for nutrition labeling purposes, which merit careful consideration by affected companies. The FDA proposed regulations are open for public comment for 90 days – until June 2, 2014.