July 24, 2015
TO: JPA Members
FROM: Patricia Faison
JPA Regulatory Update: FDA Publishes Supplemental Proposed Rule on Nutrition Facts Labeling
JPA has been providing updates regarding the Food and Drug Administration’s (FDA’s) efforts to update the nutrition labeling regulations, including the Nutrition Facts Panel. As you may recall, the Agency issued two proposed rules in 2014 regarding nutrition labeling.
Today, the FDA issued a press release announcing publication of a supplemental proposed rule that would require in part, (1) the declaration of the percent daily value (%DV) for added sugars; and (2) change the current footnote on the Nutrition Facts label. The pre-publication version of the Federal Register notice is available here, the Constituent Update is available here, and the Agency’s blog (FDAVoice) is available here. Details regarding the proposed rule follow.
As you may recall, the FDA earlier proposed requiring the declaration of “Added Sugars” underneath the declaration of “Sugars” on the Nutrition Facts label. According to the Federal Register notice, the Agency considered the recommendations in the 2015 Dietary Guidelines Advisory Committee’s (DGAC) scientific report, which recommended that Americans limit their added sugars intake to less than 10 percent of total calories. In addition, the DGAC recommended that the Nutrition Facts label should include added sugars and the declaration of a percent DV for added sugars. According to the Agency, evidence in the 2015 DGAC report related to dietary patterns intake that are associated with a reduced risk of chronic disease, specifically cardiovascular disease (CVD), as well evidence in the report regarding excess intake of added sugars in the U.S. supports the FDA’s proposal to require the declaration of added sugars. This evidence had not yet been published when the proposed rules were issued in 2014.
In the supplemental proposed rule issued today, the FDA is proposing to include the percent DV for added sugars on the Nutrition Facts label of packaged foods. FDA is also proposing that the Daily Reference Value (DRV), used to calculate the percent DV, would be 50 grams of added sugars for adults and children 4 years of age and older and 25 grams for children 1 through 3 years. The FDA provides insight regarding consumer research undertaken by the Agency related to the declaration of added sugars on the Nutrition Facts label. (See pages 12 – 14 for details.)
The FDA is also considering use of the term “Total Sugars” on the label in place of the current “Sugars” declaration. According to the Agency, comments were received in support of a “Total Sugars” declaration, and consumer research showed this declaration helped improve understanding that added sugars are part of the total amount of sugars in the product. The FDA is not proposing to establish a DRV for total sugars or require the mandatory declaration of a percent DV for total sugars as there is no quantitative intake level or other reference amount upon which to base a DRV for total sugars.
In 2014, Health Canada announced revisions to Canada’s nutrition labeling regulations. In June 2015, JPA members were notified that Health Canada had announced another consultation regarding its nutrition labeling proposals. The Agency had revised a number of provisions based on input received from stakeholders regarding the 2014 labeling proposals. Of particular note, JPA members were notified that Health Canada had not maintained the proposal to declare added sugars on the label. Health Canada also proposed use of the term “Sugars” rather than “Total Sugars.” In addition, Health Canada proposed to establish a Daily Value for “Sugars.” The FDA and Health Canada nutrition labeling proposals do not align in these three areas, among others.
JPA previously submitted comments to FDA and Health Canada regarding the nutrition labeling proposals. JPA's Nutrition Committee is currently drafting comments regarding Health Canada's June 2015 nutrition labeling proposal.
In 2014, the FDA proposed removing the requirement for the footnote listing the reference values for certain nutrients for 2,000 and 2,500 calorie diets. In the supplemental proposed rule, the FDA is proposing to shorten the current footnote to allow for more space on the label. The proposed footnote would state, “*The % Daily Value tells you how much a nutrient in a serving of food contributes to a daily diet. 2,000 calories a day is used for general nutrition advice.” The footnote would be preceded by an asterisk and placed beneath the list of vitamins and minerals, and separated from the list by a hairline.
The FDA also conducted consumer research regarding the footnote, which compared consumer reactions to seven footnote formats (five modified footnotes, the current footnote and no footnote) for explaining percent DVs and how to use them. According to the Agency, none of the modified footnotes significantly affected product perceptions or judgments of nutrient levels compared to the current footnote or the no-footnote control. However, the FDA stated the following footnote was perceived to be more believable than the current footnote: “2,000 calories a day is used for general nutrition advice. *The % Daily Value tells you how much a nutrient in a serving of food contributes to a daily diet.” The Agency subsequently reversed the order of the sentences, which now permits the first sentence to follow the asterisk in the “%DV column heading that leads to the footnote.
Currently, the footnote and footnote table listing nutrients and calories for a 2,000 and 2,500 calorie diet can be omitted from products that qualify for a simplified format and small or intermediate packages, provided that the following abbreviated footnote statement is used: “Percent Daily Values are based on a 2,000 calorie diet.” In the supplemental proposed rule, the Agency is proposing to allow the proposed footnote above to be omitted from products that qualify for a simplified format and from small or intermediate packages, provided the following statement is used on the label: “%DV=% Daily Value.” The proposed statement shortens the current footnote for these packages and allows for more label space.
The FDA is also proposing that the footnote be omitted from foods that can bear the following terms: “calorie free,” “free of calories,” “without calories,” ”trivial sources of calories,” “negligible source of calories,” or “dietary insignificant source of calories.” The FDA notes these products would have little to no impact on the average daily 2,000 calorie intake, which the footnote addresses, and omitting the footnote for these products would assure adequate space is still available for the required nutrient declarations.
Request for Comments
The FDA is requesting comments on a limited number of topics and will not consider comments outside of the scope of this supplemental proposed rule. The Agency is seeking comments on the following topics:
(1) The new information from the 2015 DGAC report 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) The exemptions from the proposed footnote requirement;
(6) Whether the FDA should make changes to the footnote used on the Dietary Supplement Facts label; and
(7) Whether the FDA should propose a footnote for foods other than infant formula, represented or purported to be specifically for infants 7 through 12 months or children 1 through 3 years of age.
The deadline to comment on the supplemental proposed rule will be 75-days following publication in the Federal Register. Additional details will be provided in the near future, including an opportunity for comment. JPA’s Nutrition Committee will be considering the supplemental proposed rule and possible comments to the Agency.
FDA Conference Call
Today, the FDA held a briefing via conference call to update interested stakeholders regarding the supplemental proposed rule. To access a replay of the conference call, dial 866 508 6481. The replay of the call will be available until August 24, 2015.
The proposed rule has received significant media coverage including the Associated Press, The Washington Post, and FoodNavigator-USA.com. The FoodNavigator article contains statements from the Sugar Association, the Grocery Manufacturers Association (GMA) and the Center for Science in the Public Interest (CSPI).
JPA will continue to monitor and provide updates, as information becomes available. As always, please contact me with questions or comments.
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