July 29, 2015
TO: JPA Members
FROM: Patricia Faison
JPA Regulatory Update: FDA Issues Supplemental Proposed Rule on Nutrition Labeling and Re-opens Comment Period on Nutrition Labeling Consumer Studies (Input Requested by August 12)
FDA Publishes Supplemental Proposed Rule on Nutrition Facts Labeling
On Friday, July 24, JPA advised that the Food and Drug Administration (FDA) announced pre-publication of a supplemental proposed rule regarding Nutrition Facts labeling. The FDA recently issued the supplemental notice of proposed rulemaking (80 FR 44303; July 27, 2015), which can be found here.
JPA’s legal counsel, Hogan Lovells, has prepared a memorandum, available here, summarizing the key points related to the supplemental proposed rule.
As previously noted, the FDA is requesting comments on the following topics and will not consider comments outside of the scope of the supplemental proposed rule.
(1) The new information from the 2015 Dietary Guidelines Advisory Committee (DGAC) report regarding added sugars;
(2) The proposal to establish a Daily Reference Value (DRV) for added sugars and to require the declaration of the percent Daily Value (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 FDA is also requesting comments on the Preliminary Regulatory Impact Analysis (PRIA), which examines the economic impact of the proposed revisions (i.e., declaration of added sugars and the proposed footnote). A summary of the economic impact is included in the supplemental proposed rule on pages 44304 - 44305. The PRIA is available here.
The deadline to submit comments to the FDA is October 13, 2015. Please provide any comments related to the supplemental proposed rule to me by the close of business on August 12.
FDA Re-Opens Comment Period on the Revision of the Nutrition and Supplement Facts Labels as to Specific Documents
The FDA also re-opened the comment period for 60 days on specific documents regarding its proposed rule to revise the Nutrition Facts and Supplement Facts labels. According to the Federal Register notice (80 FR 44302; July 27, 2015), FDA is reopening the comment period “for the sole purpose of inviting public comments on two consumer studies being added to the administrative record.” When the FDA issued the nutrition labeling proposed rule in March 2014, the Agency noted plans to conduct consumer studies regarding the proposed changes to the Nutrition Facts label. The FDA also stated the Agency would publish the results, which might be used to inform future actions related to nutrition labeling. The two consumer studies being added to the record are noted below.
1. FDA, Eye-Tracking Experimental Study on Consumer Responses to Modifications to the Nutrition Facts Label Outlined in the Food and Drug Administration's Proposed Rulemaking, June 2015. This was a study in which 160 participants participated in a computer-based research of the potential effects of several possible changes to the label on consumer viewing and use of the label. The results of this consumer study may be accessed here. According to the FDA, “Within the context of the study, we found relatively few statistically significant differences between the three formats or between their variants that were substantive. Among these differences, no one single format or variant consistently stood our as the “best” format in terms of degree of participant attention to label information, level of effort in using label information, or accuracy of information search or dietary choices.”
2. FDA, Experimental Study of Proposed Changes to the Nutrition Facts Label Formats, June 2015. This was a Web-based experiment, involving more than 5,000 participants, designed to explore whether modifications to the format of the Nutrition Facts label would affect consumers' interpretation of information on the Nutrition Facts label. The results of this consumer study may be accessed here. According to the Agency, there were some statistically significant differences when comparing the single-column current label with the percent Daily Value (DV) on the right, the single-column proposed label with the percent DV on the left, and the single-column alternative label with the percent DV on the left. The test labels are presented on pages 28-30 of the study. The FDA notes respondents were more accurate in identifying:
(1) the grams of saturated fat and percent DV for sodium using the proposed single-column label (percent DV on the left),
(2) the grams of sugars per serving using the current single-column label (percent DV on the right),
(3) the grams of sugars per container using the current single-column label,
(4) the grams of added sugars with the single-column proposed label compared to the single-column alternative label (percent DV on the left). Of note, respondents viewing the current single-column label were not asked this question.
FDA notes that after reviewing the comments on the proposed rule, they have “tentatively concluded” that they do not intend to further consider the alternative format for the Nutrition Facts label. FDA further notes, “A review of the results of the consumer research made available in this [notice] has not provided information to change our planned approach.” FDA also advises that interested parties who intend to submit comments “may wish to focus on the study results relevant to the current and proposed formats.” Comments are due September 25, 2015. Please provide any comments to me regarding the consumer studies by the close of business on August 12.
Conference Call to Consider JPA Comments to FDA
JPA is planning a conference call with the Nutrition Committee and interested parties to consider possible comments to the FDA related to the supplemental proposed rule. If you are interested in joining the call, please advise of your availability using the Doodle Scheduling Tool, available here. Please enter your name in the designated area, select the dates you are available and click “Save.” The date, time and dialing instructions will be provided in the near future.
Please do not hesitate to contact me with questions or comments.
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