As we discussed in an August 11 post, a “supplementary proposed rule” from the Food and Drug Administration (FDA) has taken the federal government’s contrived campaign against “added sugars” to a new level. FDA not only cites a federal advisory committee’s report as retroactive justification for added-sugars disclosure on food labels, it also seeks to establish a Daily Reference Value (DRV) for added sugars. The DRV would be used to calculate a “%DV” that would appear in addition to the grams of added sugars on the Nutrition Facts label. Finally, FDA released results of a consumer survey, completed after its initial added-sugars labeling proposal in March 2014, in support of the Nutrition Facts mandate. The public comment period for these items ends on October 13.
In this two-part commentary, we discuss some of the federal statutory and administrative procedural problems with the supplementary proposed rule. These legal infirmities, which stakeholders will likely raise in their public comments, could expose the agency to court challenges.
FDA Waffles on Health Effects of Added Sugars
Over the past five years, FDA has been unable to settle on a definitive health reason for mandating the disclosure of added sugars—a threshold issue under federal law. Section 403 of the Food, Drug, and Cosmetic Act (FDCA) dictates that FDA must show that the information it requires on a food label “will assist consumers in maintaining healthy dietary practices.”
- In 2011, in a proposal to the Office of Management and Budget (OMB) to conduct research on how consumers would interpret such a disclosure, the agency argued that the study was needed because “added sugars have been linked to obesity.”
- In 2014, when the agency proposed its regulation to disclose added sugars on the Nutrition Facts label, it flip-flopped and stated, “U.S. consensus reports have determined that inadequate evidence exists to support the direct contribution of added sugars to obesity or heart disease.” FDA claimed instead that added sugars-labeling was important to inform consumers about the nutrient density of foods.
- In 2015, FDA flip-flopped yet again. Based on a controversial Dietary Guidelines Advisory Committee report (DGAC), it concluded that a “strong” association existed between added-sugars consumption and cardiovascular disease (CVD).
FDA Misleadingly Relies on Selective Portions of the DGAC Report
In its supplementary proposed rule, FDA relies on portions of the 2015 Dietary Guidelines Advisory Committee report dealing with general dietary patterns and ignores the specific portion of the DGAC report pertaining to the relationship of added-sugars consumption and cardiovascular disease. FDA relies on Part D, Chapter 2 of the DGAC Report entitled “Dietary Patterns, Foods and Nutrients and Health Outcomes.” The agency claims that Chapter 2 of the DGAC report supports its proposal because it shows, “there is evidence of a strong association between a dietary pattern of intake characterized, in part, by a reduced intake of sugar-sweetened foods and beverages and a reduced risk of CVD.” However, what Part D, Chapter 2 of the DGAC report actually says is:
. . . strong and consistent evidence demonstrates that dietary patterns associated with decreased risk of CVD are characterized by higher consumption of vegetables, fruits, whole grains, low-fat dairy, and seafood, (Part D, Chapter 2, DGAC Report, p. 8) and lower consumption of red and processed meat, and lower intakes of refined grains, and sugar-sweetened foods and beverages . . .
The part of the DGAC report that FDA cites does not focus specifically on scientific evidence related to the relationship between added sugars and CVD. Rather, it focuses on studies involving a combination of nine dietary factors and eating patterns, which, taken as a whole, constitute in the opinion of the DGAC, “strong” evidence. Added sugars is but one of the many factors named.
The section that focuses directly on scientific studies pertaining to the relationship between added-sugars consumption and CVD found only “moderate” (Part D, Chapter 6, DGAC Report p. 20) evidence linking primarily sugar-sweetened beverages (but not all foods with added sugars) with an increased risk of hypertension, stroke, and heart disease.
Thus, contrary to FDA’s most recent purported justification for its proposed rule, the evidence specifically pertaining to added sugars and CVD that the DGAC reviewed is not “strong.” Rather, the DGAC report characterizes the evidence as only “moderate.” The preamble to FDA’s proposed rule disingenuously implies otherwise. The agency’s attempt to mischaracterize a “moderate” finding in the DGAC report as a “strong” finding is arguably arbitrary and capricious, an abuse of discretion, and thus a violation of the Administrative Procedure Act (APA).
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Part II tomorrow will address FDA's unprecedented reliance on the DGAC report to establish a Daily Reference Value and the consumer survey it performed to retroactively support the added-sugars disclosure.
