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FDA Commissioner Gottlieb Launches FDA’s New Nutrition Strategy

Yesterday (March 29), FDA Commissioner Scott Gottlieb kicked off the agency’s Nutrition Innovation Strategy in his keynote address, “Reducing the Burden of Chronic Disease,” delivered at the National Food Policy forum. The Strategy is intended to promote public health through improved nutrition, encourage industry innovation to create more healthful products, and help consumers identify such products.

Commissioner Gottlieb characterized the Strategy as a critical investment in public health, stating “[t]he public health gains of [improved nutrition and diet] would almost certainly dwarf any single medical innovation or intervention we could discover.” FDA’s Strategy is intended “to assist the American public with creating healthier diets for themselves and their families.”

In his address, Commissioner Gottlieb highlighted the modern consumer’s demand for more healthful options and transparency in the food s/he consumes. He commended industry for “innovating to give people more of what they want”--foods with fiber and potassium and less sodium and sugar.

FDA’s Nutrition Innovation Strategy focuses on five key areas: (1) reducing sodium, (2) modernizing claims, (3) modernizing ingredient labels, (4) modernizing standards of identity, and (5) implementing the nutrition facts label and menu labeling. Throughout the speech, Gottlieb promised to ensure that all stakeholders would have ample opportunities to provide input and feedback as the agency rolls out its plan.

Reducing Sodium

According to Gottlieb, reducing sodium in foods is pivotal to a meaningful nutrition initiative, as “[t]here remains no single more effective public health action related to nutrition than the reduction of sodium in the diet.” Gottlieb notes the agency’s short-term, voluntary draft targets for sodium reduction, which support reducing sodium intake to 3,000 mg per day from the current average of over 3,400 mg per day. Going forward, FDA intends to align its approach with the Dietary Reference Intake being conducted by the National Academies and plans to release updated short-term targets in 2019.

Modernizing claims, including “healthy” and “natural”

Gottlieb highlighted the importance of science-based food claims and consumers’ interests in finding easier ways to identify healthful foods by looking at labels. Because label claims act as “quick signals on food packages . . . about what benefits a food or beverage they choose might have,” the Strategy will look for ways to “encourage the food industry to introduce new products or reformulate existing products to improve their healthy qualities.” In turn, FDA intends to streamline its process for reviewing qualified health claims and will consider how to enhance the efficiency of this review process

Gottlieb specifically addressed the agency’s activities to redefine the regulatory definition of a “healthy” food, indicating the possibility of a definition that moves away from the nutrient focus to a definition that better reflects dietary patterns and food groups, like whole grains, low fat dairy, fruits and vegetables and healthy oils.

Gottlieb also specifically addressed the agency’s activities to define “natural,” recognizing that “consumers increasingly want to know what is in the food they eat and whether it is ‘natural.’” While Gottlieb acknowledged the wide differences that exist regarding “natural” foods, he promised that the agency will have “more to say on the issue soon.”

Modernizing Ingredients Labels

Gottlieb announced the agency’s intent to take a “fresh look” at standards of identity, given today’s marketing trends and advances in technology and nutritional science. For example, there is a need to modernize the yogurt standard of identity, the standards of identity for certain cheeses do not permit the use of salt substitutes that could result in lower sodium content, and some standards are no longer in use. Gottlieb reiterated that the Strategy’s priority is public health and that “flexibility is key.”

Implementing the nutrition facts label and menu labeling

Gottlieb stated that FDA needs to finish its work on menu labeling and will soon finalize its guidance document on the menu labeling requirements. With respect to the new nutrition facts label, Gottlieb was keenly aware that this rule presented a unique challenge for FDA in creating a set of rules with a broader range of stakeholders than the other areas that the agency regulates. Gottlieb acknowledged that “this is something we need to remain cognizant of, and it’s why our public engagement needs to be robust.” With respect to nutrition labeling, Gottlieb promised to provide clear expectations “so that industry can meet them.”

To support its Strategy, Gottlieb described the upcoming launch of a major educational campaign directed at educating consumers about the new nutrition information. The campaign will include educational videos, social media campaigns, and user-friendly websites. Among other things, the campaign will provide “actionable tips,” such as “simple swaps” for healthier food choices. Where possible, FDA will target its efforts toward certain subgroups at greater risk for nutrition-related chronic disease.

© 2018 Covington & Burling LLP

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About this Author

Miriam Guggenheim, Covington, Food regulation attorney
Partner

Miriam Guggenheim, co-chair of Covington’s Food, Drug & Device Practice Group, assists a broad range of major food and dietary supplement companies in achieving their marketing goals while minimizing regulatory and litigation risks. She also helps clients successfully navigate crises such as recalls and unwanted Congressional or regulatory attention. In addition to her work for individual clients, Ms. Guggenheim serves as outside counsel to a number of key trade associations, helping them accomplish broad industry objectives by engaging with the FDA, FTC, and...

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Jessica O'Connell, Food and drug lawyer, Covington
Special Counsel

Jessica O’Connell provides strategic advice to a broad range of companies and trade associations in engaging with food and drug regulatory bodies and Congress. She assists clients in complying with U.S. regulatory requirements for the manufacture and sale of foods, dietary supplements, cosmetics, OTC drugs, and animal products, and the import and export of FDA-regulated products. In addition, she counsels clients regarding potential crises, such as recalls and unanticipated regulatory attention.​ 

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MaryJoy Ballantyne, Food and Drug lawyer, Covington Burling law firm
Special Counsel

MaryJoy Ballantyne combines a technical and policy background with expertise in all aspects of food (human and animal), cosmetic, and OTC law at both the state and federal level to help companies and trade associations navigate ever-changing regulatory and litigation risks.

Ms. Ballantyne helps clients assess and obtain authorizations of food and dietary ingredients, create competitive yet low-risk labeling and marketing strategies, and respond strategically to regulatory and competitor challenges. Ms. Ballantyne helps clients understand the nuances of clean label...

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Stephanie Resnik, Covington, food and drug attorney
Associate

Stephanie Resnik is an associate in the firm’s Washington, DC office, where she is a member of the Food, Drug, and Device practice group. She advises food, pharmaceutical, biotechnology, and tobacco companies on a variety of regulatory and compliance issues.

Ms. Resnik advises major food companies on a broad range of U.S. regulatory and compliance issues, including labeling, advertising, facility registration, ingredient status, CGMP compliance, and reporting requirements. This advice also includes strategies for minimizing the risk of consumer fraud or class action litigation....

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