The Sugar Association is raising serious concerns about the Food and Drug Administration's (FDA) proposal to require an "added sugars" declaration and daily reference value (DRV) on the Nutrition Facts Label (NFL).

"FDA has not provided the scientific evidence to uphold its own statutory requirement that 'added sugars' labeling and a DRV for 'added sugars' is 'necessary to assist consumers in maintaining healthy dietary practices,'" The Sugar Association stated in its comment provided to FDA this week.

The Sugar Association notes that in this rulemaking effort, FDA has openly admitted it has deviated from "factors traditionally considered for mandatory declaration" of nutrients on the NFL. The record shows that FDA has arbitrarily selected from general dietary guidance, science of low evidentiary value and unofficial, controversial reports like the 2015 Dietary Guidelines Advisory Committee (DGAC) Report to support its proposal for "added sugars" labeling and to set a DRV.

In addition, FDA's own consumer research shows that should the Agency move forward with its "added sugars" labeling proposal it will mislead and confuse consumers.

The extraordinary contradictions and irregularities in this rulemaking process coupled with the use of scientific evidence of extremely low evidentiary value to propose "added sugars" labeling and a DRV is unprecedented for the FDA.

The Sugar Association points to the following specific concerns with the quality of scientific evidence and the irregularities in this rulemaking process used by the Agency to support its proposal:

In its proposal to set a DRV for "added sugars," FDA is bypassing its traditional reliance on the Institute of Medicine's Dietary Reference Intakes (DRI) to determine DRVs. DRIs provide the scientific basis for the development of food guidelines and labeling in the United States and Canada.

The mathematical construct of USDA Food Pattern modeling does not have the scientific underpinning to support "added sugars" intake recommendations, or to serve as a basis for setting a DRV.

FDA asserts that a public health endpoint now exists for the Agency to be able to require an "added sugars" declaration and to set a DRV. The evidence for this public health endpoint comes from the 2015 DGAC conclusion of a strong association between dietary patterns and increased risk of cardiovascular disease. FDA has failed to acknowledge that the majority of studies cited by the DGAC to reach this conclusion did not even assess "added sugars" intake.

FDA links "added sugars" to serious disease outcomes without scientific evidence of verifiable biological mechanisms that show causation to support this assertion.

FDA cited the World Health Organization (WHO) commissioned meta-analysis as a basis for the 10% DRV despite the fact WHO grades its own evidence for free sugars (added sugars) intake and body weight for both adults and children to be of moderate quality, at best.

"FDA has not provided evidence that, under section 403(q)(2)(A) of the Act, there is sufficient scientific evidence of a compelling public health reason to modify the current 'Sugars' category to include 'added sugars' labeling and a set DRV for 'added sugars.' To reiterate, the Agency has not provided evidence that 'added sugars' labeling is necessary 'to assist consumers in maintaining healthy dietary practices,'" The Sugar Association states.

"For the reasons outlined above, we ask FDA to withdraw its proposals to include 'added sugars' on the NFL and to set a DRV for 'added sugars.' Should FDA believe that 'added sugars' labeling is important, the Agency should follow its standard of sufficient scientific agreement and ask the Institute of Medicine to do a thorough review of the full body of scientific evidence (at the highest level of evidence available) on 'added sugars' intake," The Sugar Association concludes.