The restaurant industry was bracing for FDA’s menu labeling regulation, requiring mandatory calorie disclosure on menus at chains that have 20 or more locations. The final compliance date was coming up next week on May 5, 2017. However, in a last minute change, FDA submitted an interim final rule to the White House Office of Management and Budget (OMB) that would delay compliance with the final rule and open it again for public comment. The move was taken after a recent petition was filed with the FDA by the National Association of Convenience Stores and the National Grocers Association asking for a delay and substantive changes in the final regulation.
The interim final rule approach, which delays the final menu labeling regulation and opens it again for public comment, provides a blueprint for a similar delay and substantive changes in FDA’s final rules updating the Nutrition Facts label. Those rules were finalized in the Federal Register on May 27, 2016. The compliance date currently is July 26, 2018 (manufacturers with less than $10 million in annual food sales have until July 26, 2019 to comply). However, major segments of the food industry have asked for an extension of time while others have also filed petitions for substantive changes in the final regulations.
In a March 14, 2017, letter to the Honorable Thomas E. Price, MD, Secretary, U.S. Department of Health and Human Services, the Grocery Manufacturers Association and major food industry trade groups representing bakers, confectioners, millers, corn refiners and dairy producers among others, asked that the FDA rules be delayed until May 2021. Doing so would align the compliance deadline for the FDA rules with other labeling changes to be required by the U.S. Department of Agriculture (USDA) involving the labeling of foods with ingredients derived from bioengineering. The latter USDA requirement is required by an act of Congress. Under the Bioengineered Ingredient Disclosure Law, USDA is mandated to finish the biotechnology disclosure rule by July 29, 2018. That means that just three days after more than 700,000 food and beverage products are required to comply with FDA’s new Nutrition Facts rules, industry must start again and begin the expensive and time-consuming process to relabel their products to come into compliance with the USDA biotechnology disclosure rule. Each label change can cost the food industry well over $1 billion dollars.
FDA’s action on menu labeling provides a way out of this quandary. As with the menu labeling regulation, FDA can issue an interim final rule delaying the compliance date with the agency’s new nutrition labeling rules until the USDA bioengineering labeling rule takes effect. Furthermore, as with the interim final rule on menu labeling, the agency should use the extra time to reopen the comment period and reexamine portions of its final nutrition labeling rules that are in need of review.
For example, the American Bakers Association has petitioned FDA to revoke the agency’s controversial definition of fiber. Under the new definition, companies can count a synthetic substance as a dietary fiber only if the FDA has determined that it has “physiological effects that are beneficial to human health.” The provision would prevent many synthetic fibers from being counted as fiber on the Nutrition Facts label.
The FDA’s added sugars labeling requirement should be another candidate for review. Under the Obama administration, FDA mistakenly singled sugar out as the primary driver for the increase in U.S. obesity rates and incidence of a variety of diseases. As part of this effort, new FDA rules require that the amount of added sugars be listed on the Nutrition Facts label together with the percentage Daily Value (DV) that a customary serving of the food contributes to the maximum amount (50 g) FDA says can healthfully be consumed in a day.
FDA’s DV for added sugars is largely based on a U.S. Dietary Guidelines Advisory Committee (DGAC) report that was heavily influenced by political appointments made by the Obama team. The decision making process was rushed -- the process did not include a scientific review by the National Academy of Medicine (NAM). In taking this short cut, FDA lowered the scientific standard for adding new nutrients and DVs to the Nutrition Facts label. All previous DVs have been based on findings by the NAM (formerly know as the Institute of Medicine). Instead of relying on such indirect and questionable evidence, NAM should conduct a study of sugars and all carbohydrates to determine recommended intakes, as has been the case for every nutrient found on the Nutrition Facts label other than added sugars.
Further, some specifics of FDA’s added sugars labeling requirement make no sense. A packet of sugar would list the contents on the Nutrition Facts as entirely “added sugars” when common sense dictates otherwise. A serving of honey from a honey jar would be listed on the Nutrition Facts label as entirely “added sugars” raising similar confusion. As with menu labeling, the current compliance deadline should be stayed to give the agency an opportunity to review the regulation and make appropriate adjustments.
The Trump administration appears receptive. Ray Starling, special assistant to the president for agriculture, trade and food assistance, told a group of journalists on April 24, 2017 that there was “a real active conversation” about delaying the label compliance date, according to a report in Politico.
President Trump’s pick for FDA commissioner, Scott Gottlieb, also stated during his confirmation hearing, that he would be open to adjusting food and nutrition rules that passed under the Obama administration.
The FDA’s interim final rule approach to menu labeling paves the way for this process to take place with FDA’s Nutrition Facts labeling regulations. Doing so will save money and ensure that deficiencies in the final regulations can be reexamined and corrected.