FDAThis is the second part of a two-part commentary on FDA’s requirements that added sugars be listed on the food Nutrition Facts panel, and that a Daily Reference Value (DRV) be set for added sugars and included in the panel footnote. For part I, click here.

 FDA’s Reliance Solely on a DGAC Report to Establish a DRV is Unprecedented

When implementing the Nutrition Labeling and Education Act, FDA first set daily reference values in 1993 based on “sufficient scientific consensus,” a standard established by the agency under that law. FDA did not rely on a federal advisory committee’s report. Moreover, it relied only minimally on the Dietary Guidelines for Americans itself. Instead, FDA cited numerous consensus reports which, taken together, constituted “sufficient scientific consensus.”

For example:

For the added-sugars DRV, the agency provides no justification other than a single DGAC report and fails to explain why it  abandoned its “sufficient scientific consensus” standard for setting DRVs.

FDA’s Consumer Survey Shows that Added-Sugars Labeling Could Mislead Consumers

In 2011, FDA first sought Office of Management and Budget (OMB) approval to conduct research on how consumers would interpret an added-sugars disclosure on the Nutrition Facts label. OMB did not give FDA permission to proceed with the study, until after it already proposed a regulation mandating the requirement.

After the study was finally completed, FDA initially denied the public an opportunity to comment on the results. It also refused to release the underlying raw data that would allow stakeholders to scrutinize and replicate the study results. Under public pressure, the agency just recently opened the study results to public comment, and finally released the underlying data. It also agreed to extend the comment period on the studies, but only by a mere 19 calendar days.

In the Federal Register notice, FDA declared that its survey on the added-sugars labeling reflected consumer understanding and thus supported its proposal. In other documents related to the survey, however, FDA was more circumspect about the survey’s conclusions. An FDA Memorandum summing up the study results stated:

The study showed that while added sugars declarations increased the ability of some participants to identify those products with less added sugars, and to determine the quantity of added sugar in a food, the declarations decreased the ability of some participants to correctly identify the quantity of total sugars in a food.

FDA Memorandum to the File, Page 1, Page 11 Table 3a—Experimental Study on Consumer Responses to the Nutrition Facts Labels with Declaration of Amount of Added Sugars (OMB, Control No. 0910-0764), cited as Reference No. 1, 80 Fed. Reg. at 44,311.

Furthermore, the agency’s Memorandum reflects that added-sugars labeling, even when listed along with a “Total” sugars disclosure, led survey subjects to identify more nutritious foods as less healthy when they contained greater amounts of added sugars than less nutritious foods:

Results showed that when the more nutritious (i.e. lower-calorie, lower-fat, higher-fiber, and higher-vitamin) product has less added sugars, label format had no statistically significant effect on the likelihood of respondent identifying that product as healthier [parenthetical omitted]. In contrast, when the more nutritious product had more added sugars, the percentage of respondents identifying that product as healthier decreased.

FDA Memorandum to the File, id. at 17, Judgments: Two-product tasks, cited as Reference No. 1, 80 Fed. Reg. at 44,311 (emphasis added). This perverse result hardly helps the agency achieve its objectives, and significantly undermines its ability to meet the FDCA’s standard that new labeling mandates “will assist consumers in maintaining healthy dietary practices.”

FDA Should Rescind the Proposal

The concerns discussed above are but a small sampling of the legal and constitutional challenges FDA will face if the redesigned Nutrition Facts label includes a listing of grams of added sugars and a recommended Daily Value for added sugars. FDA is so determined to be the pointy end of the spear in the federal government’s fight against disfavored foods and beverages that it has recklessly ignored its own enabling statute and the due process rights of regulated entities protected by the Administrative Procedure Act.

The added-sugars labeling proposal also distracts regulators and other policy makers from measures that are more likely to actually help consumers make informed decisions about their diets. FDA needs to stop campaigning and reestablish its credibility as a science-based regulatory agency. Rescinding this proposal is an essential first step.

Also published by Forbes.com at WLF’s contributor site.