In an unexpected move, FDA this coming Monday, July 27th, will publish a supplemental proposed rule that would establish a Daily Reference Value (DRV) for added sugars. This DRV would be utilized in calculating the percent Daily Value (%DV) that would be required to accompany the quantitative amount when Added Sugars is declared in nutrition labeling a conventional food or dietary supplement. The requirement for an Added Sugars declaration was included in FDA’s March 3, 2014 proposed rule, and has been the most contested aspect of nutrition labeling reform. The supplemental proposed rule almost certainly will “add fuel to this fire.”
The supplemental proposed rule specifically includes provisions that would:
- Establish a DRV of 10 percent of total energy intake from added sugars (e.g., 50 grams, deriving from 10% of 2000 calories being 200 calories for the general population, and a gram of sugar providing 4 calories);
- Require the declaration of a %DV when Added Sugars is declared in Nutrition Facts and Supplement Facts; and
- Simplify the %DV footnote in the Nutrition Facts to read: *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.
Such provisions reasonably would not be proposed unless an Added Sugars declaration almost certainly was going to be required in nutrition labeling conventional foods and dietary supplements (when warranted).
The supplemental proposed rule asserts that evidence in the 2015 Dietary Guidelines Advisory Committee (DGAC) report supports inclusion of an Added Sugars declaration and the related information in Nutrition/Supplement Facts:
We have considered the evidence that the DGAC relied upon and have tentatively concluded that the new evidence provided in the 2015 DGAC report related to dietary patterns of intake that are associated with a reduced risk of chronic disease (specifically cardiovascular disease (CVD)) as well as the evidence provided in the report related to excess intake of added sugars in the U.S. supports our proposal to require the mandatory declaration of added sugars on the Nutrition and Supplement Facts labels. The DGAC report also provides evidence to support a reference amount for added sugars upon which we can establish a DRV for use in calculating a percent DV on the label. The percent DV is included to assist consumers in understanding the relative significance of the amount of added sugars in a serving of a product in the context of a total daily diet.
Nonetheless, this might be criticized as FDA “placing the cart before the horse,” inasmuch as HHS and USDA have not yet adopted the DGAC report recommendations into the 2015 Dietary Guidelines for Americans.
In addition to the supplemental proposed rule, FDA will publish a separate notice reopening the comment period on the proposed rule for the sole purpose of inviting public comments on two consumer studies being added to the administrative record. The consumer studies pertained to proposed changes to the Nutrition Facts label formats. FDA states that the results of the consumer studies have “not provided information to change our planned approach.” However, based on comments received on the proposed rule, FDA says it does not intend to further consider the “alternative format” for the Nutrition Facts label that was published in the proposed rule.
Comments on the supplemental proposed rule and on the label formats notice must be submitted to FDA by October 12, 2015, and September 25, 2015, respectively.