Purpose of the Regulatory Action
FDA is revising certain provisions of the proposed rule that published in the Federal Register on March 3, 2014 (79 FR 11879), that would amend FDA's labeling regulations for conventional foods and dietary supplements to provide updated nutrition information on the NFL/SFL proposed rule.
In the NFL/SFL proposed rule, we proposed to remove the requirement for the footnote listing the reference values for certain nutrients for 2,000 and 2,500 calorie diets and reserved space to provide a proposed footnote. We stated in the preamble of the NFL/SFL proposed rule that we would continue to perform research during this rulemaking process to evaluate how variations in label format may affect consumer understanding and use of the Nutrition Facts label. We also stated that we would publish the results of our research for public review and comment. We are making results of our research available in this document. We are also proposing text for the footnotes to be used on the Nutrition Facts label. We are taking this action after completing our consumer research in which we tested various footnote text options for the label. We are also providing an exemption from the footnote requirement for certain foods.
In addition, the NFL/SFL proposed rule would require the declaration of added sugars as an indented line item underneath the declaration of “Sugars” on the Nutrition Facts label. We discussed in the NFL/SFL proposed rule that we were considering whether to use the term “Total Sugars” instead of “Sugars” on the label if we finalize a declaration of added sugars.
We stated in the NFL/SFL proposed rule that we were planning to conduct a consumer study that would include, among other things, questions regarding the declaration of added sugars on the Nutrition Facts label in order to help enhance our understanding of how consumers would comprehend and use this new information. We also stated that we would publish the results of the study when they become available.
As we prepared to make the consumer study results for the footnote and added sugars declaration available, new information emerged from the “Scientific Report of the 2015 Dietary Guidelines Advisory Committee” (the 2015 DGAC report) regarding added sugars. The new information on added sugars led us to reconsider our thinking for not establishing a DRV or requiring the declaration of a percent DV for added sugars on the Nutrition Facts and Supplement Facts labels. Specifically, the 2015 DGAC report provided evidence suggesting a strong association between a dietary pattern of intake characterized, in part, by a reduced intake of added sugars and a reduced risk of cardiovascular disease. The evidence also suggested an applicablereference amount for added sugars, i.e., limiting added sugars intake to no more than 10 percent of total daily caloric intake. As a result of our review of the science underlying the 2015 DGAC report, we are proposing to establish a DRV for added sugars and to require the percent DV declaration of added sugars on the Nutrition Facts and Supplement Facts labels. We are not proposing to establish a DRV for total sugars or to require the mandatory declaration of a percent DV for total sugars because there is no quantitative intake level or other reference amount for which there is sufficient scientific evidence upon which we can base a DRV for total sugars. We are proposing to establish a DRV for added sugars because science underlying the 2015 DGAC report provided a scientific basis for a reference amount for added sugars upon which we can propose a DRV (a recommended maximum of 10 percent of total energy intake). We also received many comments suggesting that, if added sugars are declared on the label, a percent DV declaration would assist consumers in putting the amount of added sugars in a serving of a product into the context of their total daily diet.Show citation box.
A summary of the results of FDA's consumer research on footnote text options and on the added sugars declaration is available in section I.C., and a detailed description of the results is available in the docket.
Summary of the Major Provisions of the Regulatory Action in Question
We are proposing to establish a DRV for added sugars of 50 grams (g) for children 4 years of age and older and adults, and of 25 g for children 1 through 3 years of age. We are also proposing to require the declaration of the percent DV for added sugars on Nutrition and Supplement Facts labels, and have proposed revisions to the NFL/SFL proposed rule codified to reflect these changes. These proposed revisions are outlined in section III. We are also proposing footnote text for the space reserved in § 101.9(d)(9) (21 CFR 101.9(d)(9)) of the NFL/SFL proposed rule. The footnote text would explain that the % Daily Value tells you how much a nutrient in a serving of food contributes to a daily diet and that 2,000 calories a day is used for general nutrition advice. The language in this footnote is similar to the wording of one of the options tested in our study (as described in section I.C.), except that the sentences have been reversed. We believe this footnote explains the %DV in the most concise manner by providing a brief description of “% Daily Value,” which is lacking in the current footnote. While the consumer research study did not suggest strong support for a particular footnote, the language in this footnote was perceived by study participants to be more useful than the current footnote. We consider that switching the order of the sentences is important because it allows the first sentence to clearly follow the asterisk in the “%DV” column heading that leads to the footnote. When consumers look down to the footnote to see what additional information is linked to the asterisk that they see after the “%DV” column heading, they may expect to find the sentence that explains percent daily value first, rather than a sentence about calories. This supplemental notice of proposed rulemaking would also allow the footnote proposed in § 101.9(d) to be omitted from products that qualify for a simplified format (§ 101.9(f)), and on small or intermediate packages (§ 101.9(j)(13)(ii)(A)(1); § 101.9(j)(13)(ii)(A)(2)), provided that the following abbreviated statement is used: “%DV = % Daily Value.”
The proposed statement is shorter than the current statement to allow for more space on the label. In addition, we realize that the standard format in the NFL/SFL proposed rule for the Nutrition Facts label had a placeholder for the footnote and did not explain the “%DV.” It is important for consumers to know what “%DV” on the label means. Consequently, we are proposing a statement that spells out “%DV” for products that qualify for a simplified format and on small or intermediate packages.
This supplemental notice of proposed rulemaking also proposes an exemption to the proposed footnote requirement in section § 101.9(d)(9) for the foods that can use the terms “calorie free,” “free of calories,” “no calories,” “zero calories,” “without calories,” “trivial source of calories,” “negligible source of calories,” or “dietary insignificant source of calories” on the label or in the labeling of foods as defined in 21 CFR 101.60(b). Such products would have little to no impact on the average daily 2,000 calorie intake, which the footnote addresses. Exempting the footnote for these packages is a practical solution that would assure adequate space is still available for the required nutrient declarations.
We are inviting comment only with respect to the following issues discussed in greater detail later in this document: (1) New information from the 2015 DGAC report and the science upon which that report is based regarding added sugars; (2) the proposal to establish a DRV for added sugars and to require the declaration of the percent DV for added sugars on the Nutrition and Supplement Facts labels; (3) using the term “Total Sugars” instead of “Sugars” on the label (4) the proposed text for the footnotes to be used on the Nutrition Facts label; (5) exemptions from the proposed footnote requirement; (6) whether we should make changes to the footnote used on the Supplement Facts label; and (7) whether there should be a footnote on labels of food represented for infants 7 through 12 months of age or children 1 through 3 years of age, and, if so, what that footnote should say. We will not consider comments outside the scope of these issues.
Costs and Benefits
In the NFL/SFL proposed rule we stated that we have developed one comprehensive Preliminary Regulatory Impact Analysis (PRIA) that presents the benefits and costs of this proposed rule as well as the proposed rule entitled “Food Labeling: Serving Sizes of Foods That Can Reasonably Be Consumed at One Eating Occasion; Dual Column Labeling; Updating, Modifying, and Establishing Certain Reference Amounts Customarily Consumed; Serving Size for Breath Mints; and Technical Amendments” (the original PRIA). As stated earlier, we are proposing revisions to the NFL/SFL proposed rule. We are proposing footnote text and an exemption to that text for certain foods, and we are proposing that manufacturers declare the percent DV for added sugars on the Nutrition Facts and Supplement Facts labels. We estimate that just the changes specified in this supplemental notice of proposed rulemaking, if finalized, will generate annualized costs of $10 million (at 7 percent discount rate) and $8 million (at 3 percent discount rate), annualized benefits of $200 million (at 7 percent) and $300 million (at 3 percent), and annualized net benefits of $190 million (at 7 percent) and $292 million (at 3 percent) on top of those estimated in the previous proposed rules. In total, we estimate that these rules, including the changes outlined in this proposal, if finalized, will generate annualized costs of $200 million (at both 3 and 7 percent), annualized benefits of $2.1 billion (at 7 percent) and $2.3 billion (at 3 percent), and annualized net benefits of $1.9 billion (at 7 percent) and $2.1 billion (at 3 percent). This represents an annual increase in net benefits from the original PRIA's estimates of approximately $200 million per year.Show citation box.
We summarize the annualized costs and benefits (over a 20-year period discounted at both 3 percent and 7percent) of the previous and revised proposed rules in the following table.
