The FDA recently released a “2018 Strategic Policy Roadmap” outlining (among other things) its nutrition-related policy priorities for the coming year.
In the Roadmap, FDA lists nutrition as one of its four top issues for this year. The Agency aims to: “Empower consumers to make better and more informed decisions about their diets and health and expand the opportunities to use nutrition to reduce morbidity and mortality from disease.” The Agency’s “Nutrition Action Plan” aims to: “Reduce preventable death and disease caused by poor nutrition by ensuring that consumers have access to accurate, useful information to make healthy food choices; foster development of healthier food options.”
The document (see page 15) lists numerous specific actions that will be part of the Agency’s plan. In this memorandum, we provide background, commentary, and analysis on the specific elements of the FDA’s planned actions. The elements of the Nutrition Action Plan are as follows:
- Issue practical, substantive guidance to advance implementation of the menu labeling regulation
After some initial hesitation, the Trump Administration surprised many parties by deciding to move ahead with FDA’s calorie labeling and other labeling requirements of the menu labeling final rule, which implements a requirement in the Obama era Affordable Care Act. See Menu Labeling Requirements. The final rule is now scheduled to take effect on May 7, 2018. The planned “substantive guidance” hopefully will address questions of the food industry about how to comply, in a practical manner, with the new regulation. It might also explicitly highlight the preemptive effect of the regulation on unidentical State and municipal laws.
- Provide guidance for industry to implement the new requirements for updating the Nutrition Facts label
FDA Commissioner Gottlieb made clear in Senate Appropriation’s Committee testimony last year that the Agency is “not reopening” its new Nutrition Facts label rules. FDA, however, has proposed to delay the compliance date of the regulations and, until that decision is finalized, will exercise enforcement discretion and extend the enforcement dates to January. 1, 2020, for manufacturers with $10 million or more in annual food sales, and to January 1, 2021 for manufacturers with less than $10 million in annual food sales. See Changes to the Nutrition Facts Label.
The Agency is using the extra time to develop further guidance documents on the labeling of added sugars and dietary fiber on the Nutrition Facts panel.
Food manufacturers with products containing added sugars and/or dietary fiber might consider delaying reprinting labels until FDA releases new guidance documents on the labeling of these nutrients.
- Launch a new public education campaign to help consumers maximize the public health benefits of the Nutrition Facts label and new menu labeling provisions
The Agency has long promised a consumer education campaign. The FDA’s initial efforts under the Obama administration emphasized added sugars content and ignored other nutrients about which FDA said it had concerns, including saturated fat and sodium, and vitamin D and potassium. Hopefully the Agency’s new efforts will take a more balanced approach.
- Initiate a new, comprehensive action plan encompassing steps to advance policies that better leverage nutrition and diet as ways to reduce morbidity and mortality from disease. Among steps FDA will consider, as part of this plan, include:
– Revising requirements for certain existing food label claims, such as “healthy”
The Agency began re-examining its official definition of the implied nutrient content claim “healthy” under the previous administration. See “Healthy” on Food Labeling. The project will apparently continue under the Trump Administration. One critical question will be how the Agency addresses the added sugars content of foods aiming to make a “healthy” claim. Presently, sugar content is not considered under the Agency’s definition, 21 C.F.R. § 101.65(d)(2).
– Creating a more efficient review system for evaluating health claims on food labels
This planned initiative may be one of the most interesting in the Agency’s 2018 Roadmap. FDA already has an expedited process for health claims based on “authoritative statements” of U.S. government agencies and the National Academy of Sciences, and allows qualified health claims with disclaimers authorized by letters of enforcement discretion, See Label Claims for Conventional Foods and Dietary Supplements.
Look for additional FDA efforts to authorize dietary guidance claims without triggering the Agency’s rulemaking requirements for health claims supported by “significant scientific agreement,” Id.
– Modernizing certain standards of identity to address current barriers to the development of healthier products while making sure consumers have accurate information about the foods they eat. Among other steps, FDA intends to issue a request for information to identify and help prioritize which potential standards of identity should be modernized based on their public health value
FDA and USDA’s Food Safety and Inspection Service (FSIS) have previously examined this issue. On May 20, 2005, the Agencies published a proposed rule to establish a set of general principles for food standards. See Food Standards; General Principles and Food Standards Modernization. Adherence to these principles was intended to result in standards that would better promote honesty and fair dealing in the interest of consumers and protect the public; allow for technological advances in food production; be consistent with international food standards (to the extent feasible); and be clear, simple, and easy to use for both manufacturers and the Agencies that enforce compliance with the standards. The proposed general principles would establish the criteria that the Agencies would use in considering whether a petition to establish, revise, or eliminate a food standard would be the basis for a proposed rule. In addition, each Agency permissibly could propose to establish, revise, or eliminate a food standard on its own initiative or permissibly could propose revisions to a food standard in addition to those a petitioner had requested. These proposed general principles were the Agencies’ first step in instituting a process to modernize their standards of identity (and any accompanying standards of quality and fill of container) and standards of composition. The matter needs a renewed look.
– Providing new opportunities to make ingredient information more helpful to consumers
This item is one of the newest (and most mysterious) issues in the FDA’s 2018 Roadmap. Ingredient labeling, as a general matter, previously has not been on the Agency’s update agenda. Consumer groups, however, particularly the Center for Science in the Public Interest (CSPI), have been vocal and are sure to let the Agency know their views. CSPI has recommended reforms of FDA’s ingredient labeling regulations. See Food Labeling Chaos: The case for reform at chapter IX.
– Advancing guidance on dietary sodium reduction
It is unclear what FDA precisely means by “advancing” guidance on sodium reduction.” This item may mean a continuation of the Agency’s voluntary sodium reduction initiative (see Draft Guidance for Industry: Voluntary Sodium Reduction Goals: Target Mean and Upper Bound Concentrations for Sodium in Commercially Processed, Packaged, and Prepared Foods) much in the same way the Agency has continued the Obama era menu labeling regulation. On the other hand, it might foreshadow a rollback in the Agency’s effort to reduce sodium levels in favor of a consumer education program. The Agency’s intentions remain to be seen.