Notice & Comment

FDA Seeks Comment on Changes to Food Labeling, by Elisabeth Ulmer

Since the original serving size regulations passed in 1993, the size of food portions noticeably increased.  The Food and Drug Administration’s proposed rule will revise serving sizes to reflect current consumption data and offer serving size information on nutrition facts labels “that will help [consumers] maintain healthy dietary practices.”

This proposed rule has three main objectives:

  1. Amend the definition of a single-serving container;
  2. Require dual-column labeling for certain containers; and
  3. Update and modify several reference amounts customarily consumed (RACCs)

The Nutrition Labeling and Education Act of 1990 (NLEA) updated the Federal Food, Drug, and Cosmetic Act (the FD&C Act) of 1938 by adding section 403(q), which authorizes the FDA to require nutrition labeling on most of the packaged foods that it regulates.  Section 403(q)(1)(A)(i) states that “a food intended for human consumption and is offered for sale” must, with some exceptions, carry nutrition information that provides “the serving size which is an amount customarily consumed and which is expressed in a common household measure that is appropriate to the food.”  This section defines a serving size as an amount customarily consumed, instead of as a recommended amount of food.  Thus, RACCs are the “reference amounts customarily consumed” that are used to determine serving sizes.

First, the FDA proposes to change the definition of single-serving containers.  They are now defined as products “that [are] packaged and sold individually and that [contain] less than 200 percent of the RACC.”  Products that have “large” (greater than or equal to 100 g or 100 mL) RACCs may currently be labeled as containers with either one or two servings.  However, the FDA proposes to categorize all products with less than 200 percent of the RACC as single-serving containers.

The FDA’s second preposition relates to dual-column labels for containers of products with at least 200 percent and up to and including 400 percent of the RACC.  One column that lists nutrition information for the serving size derived from the RACC is already required.  For this category of containers, the FDA is proposing the addition of a second column to the label that would list nutrition information for the container as a whole.

Third, the FDA proposes to update, modify, or establish RACCs for various product categories.  If the median consumption data from the National Health and Nutrition Examination Surveys “have increased or decreased by at least 25 percent compared to the 1993 RACCs,” the FDA will consider updating the RACCs.  On the other hand, if this data has not shown such an increase or decrease in consumption, the FDA will consider modifying the RACCs.  The FDA seeks comment on whether it should update the RACCs and serving sizes for the products that were identified as products of concern in the comments on the Advanced Notice of Proposed Rulemaking.  The FDA also invites comment on whether other product categories that the FDA did not address in this proposed rule should be amended.

Comments are due on June 2, 2014.  Interested parties are invited to submit comments by any of the following methods:

  • Federal eRulemaking Portal: or
  • Mail/Hand delivery/Courier: Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852

All comments must include the Agency name, Docket No. FDA-2004-N-0258, and Regulatory Information Number 0910-AF23.

This post was originally published on the legacy ABA Section of Administrative Law and Regulatory Practice Notice and Comment blog, which merged with the Yale Journal on Regulation Notice and Comment blog in 2015.

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