Regulatory Comments to Docket No. FDA-2012-N-1210, RIN 0910-AF22: Food Labeling: Revision of the Nutrition and Supplement Label Facts
Date: October 13, 2015
The Food and Drug Administration (FDA) wanted to increase public knowledge and awareness of sugars and promote human health and nutrition. FDA therefore created an additional revision to the Nutrition and Supplement Facts label label update because they stated they had empirical evidence that such changes for consumers is warranted. Based on the evidence that was presented in the 2015 Dietary Guidelines Advisory Committee (DGAC), the FDA has proposed to establish a Daily Recommended Value (DRV) of 50g for added sugars and will mandate labeling of %DRV of added sugars on the Nutritional Facts label: “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 respondents in putting the amount of added sugars in a serving of a product into the context of their total daily diet.”
The NPA has an interest in changes and revisions made to the long-standing Nutritional and/or Supplement Facts labeling regulations. The NPA offers two points for consideration on the establishment of a DRV for added sugars. First and foremost, the FDA is setting an unprecedented standard by using only DAGC recommendations to develop the 50g DRV for added sugars. Previous changes made by the FDA to the DRV have been the result of recommendations made by several scientific and health organizations. In the past these have included but are not limited to the Institute of Medicine, National Cancer Institute, World Health Organization, American Heart Association and United States Department of Agricultural/Human Health Services (USDA/HHS). Second, by establishing DRV and % DRV value for added sugar without establishing recommendations for total sugars the Nutritional Facts label will mislead consumers. While the NPA recognizes the FDA is without the current means to support establishing a DRV for sugar consumption we believe, by singling out added sugars, it is implied that added sugars are somehow metabolically different than naturally occurring sugars in dietary ingredients and food additives. This is not the case. Furthermore, by including the added sugars to the Nutritional Facts label, consumers may base purchases solely on added sugars content while disregarding total sugars. Products containing no additional added sugar may still have exceptionally high levels of sugar and may not necessarily be the “healthier” option. The misconception among consumers has the potential to cause the added sugars label addition to completely miss the FDA’s original goals of the declaration of added sugars. The NPA agrees that moderate sugar consumption should be encouraged to promote healthier eating behaviors; however isolating added sugar from total sugars will lead to increased consumer confusion. The NPA would encourage the FDA to further explore consumer understanding regarding DRV, added sugars, and total sugars.
The FDA’s own consumer studies did not support the addition of added sugars to the Nutritional Facts label. The NPA would additionally like to address several points regarding the data published in the “Eye-tracking experimental study on consumer responses to modifications to the Nutrition Facts label outlined in the Food and Drug Administration’s proposed rulemaking”. These points include: (1) participant sample size, (2) participant sampling locations, and (3) lack of meaningful analysis between the Current, Alternative and Proposed Nutritional Facts labels concerning the added sugar proposals.
Using the FDA’s own empirical study data in addition to the much larger food industry consumer research study, it would suggest that mandating a label requirement to include added sugars in the declaration is not “material” and holds no added importance to a consumer’s decision to buy or use the product. FDA’s evidence to require such a change should be demonstrated to be “material” before adding this change to the regulations. In accordance with Central Hudson.