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FDA Life News and Trends Impacting the FDA and Life Science Industry


Posted in Advertising and Promotion, Beverages, Foods, Labeling, Regulation

Food and BeverageOn March 9, 2017, the U.S. Food and Drug Administration (“FDA”) held a public meeting to invite public comments on the possibility of redefining use of the term “healthy” in the labeling of human food products.  The FDA’s reconsideration of the “healthy” claim criteria follows recent FDA guidance on this issue, and is related to a broader set of recent regulatory actions that are designed to update FDA regulations to more accurately reflect current nutritional science.

  The public meeting was attended by hundreds of stakeholders from across the food and beverage industry, and included general informational presentations and “breakout” sessions that focused, among other things, on consumer perceptions of “healthy” claims and whether “healthy” should be defined as a “nutrient-based” claim, a “food-component” claim, or both.  The FDA is accepting written comments on a potential new definition of “healthy” until April 26, 2017.

  Here’s a quick review of the issue and where things stand after the public meeting:

   Why is the FDA reconsidering the definition of “healthy” claims?

                Current FDA regulations allow for the use of “healthy” and similar terms (e.g., “health,” “healthful,” “healthier,” etc.) as implied nutrient-content claims on food labeling subject to two conditions that relate to nutrients that should be limited or encouraged in the diet.  You might think of it this way: the FDA does not permit you to make “healthy” claims on foods that contain too much potentially bad stuff (total fat, saturated fat, cholesterol or sodium), or too little of certain good stuff (vitamin A, vitamin C, calcium, iron, protein and fiber).  The specific criteria vary for different food categories, and the criteria are generally linked to elements in the Nutrition Facts panel and serving size regulations.  All of these regulations, however, were implemented in the early 1990s, when nutrient science focused on limiting total fat intake and remedying certain nutritional deficiencies that were identified as public health concerns.  As science and nutrient intakes have evolved over time, the focus has shifted from total fat reduction to encouraging certain types of fats (e.g., mono and polyunsaturated fats), and deficiencies in vitamins A and C are no longer public health concerns but have given way to new concerns about deficiencies in vitamin D and potassium intake.  As FDA’s recent changes to the Nutrition Facts panel and serving size regulations reflect this new science, FDA plans to update its other nutrition labeling regulations, including those for “healthy” nutrient-content claims, to align with the other recent changes.  

  What different approaches to a new definition are currently being discussed?

 The primary discussion at the recent public meeting focused on consumer perception of “healthy” claims, as well as on whether “healthy” claims should remain nutrient-based claims or instead should be redefined in terms of specific food groups or overall healthy dietary patterns. 

  With respect to consumer perception, there was general acknowledgement that consumer attitudes vary widely and can be hard to determine, although there is a growing trend with many consumers to look to “whole” foods or less processed and nutrient-dense options (e.g., natural sugars versus “added” artificial sugars), even when such foods have higher levels of nutrients that should be limited.  Although concerns were expressed about whether an adequate definition of “healthy” is realistic given the diversity of consumer behaviors, and some encouraged deleting the regulatory definition altogether, others emphasized the need for the industry to define “healthy” claims to avoid the ambiguity and litigation that has arisen over unregulated terms like “natural.” 

Discussion regarding whether “healthy” claims should be nutrient-based claims or based on specific food groups generally converged on the potential need for a definition that incorporates the benefits of both types of approaches.  There was acknowledgement that certain nutrient limitations were appropriate, that some deficiencies remain public health concerns, and that the current list of nutrients for which limits are prescribed should be revised (e.g., to add sugar, remove cholesterol, etc.).  Others emphasized that maintaining “healthy” as a nutrient based claim was particularly important for certain types of foods (e.g., processed foods), but less important for others (e.g., raw fruits and vegetables), and so a dual paradigm or one that focused nutrient criteria on specific categories of foods might be more appropriate.  Other comments focused on how to define or address nutrient density, the role of fortification, and defining “healthy” in terms that allow consumers to connect entire foods, not specific nutrients, to overall healthy dietary patterns.

 How can industry provide comments and what should we expect next from the FDA?

The public comment period on a new definition of “healthy” ends April 26, 2017.  The agency’s request for comments, which also sets forth the types of issues on which the agency is soliciting information, is available here and provides instructions for submitting handwritten or electronic submissions.  After the comment period closes, the FDA will review the public comments and make a determination on whether and how to revise the “healthy” definition.  Although the FDA has provided no specific timeline for when this might occur, the revision to the definition of “healthy” is partly driven by changes to the Nutrition Facts Panel, and industry must begin to comply with those new requirements as early as July 26, 2018.

Will there be changes in enforcement as the FDA considers a new “healthy” definition?  

Yes.  The FDA has issued guidance to notify manufacturers of its intent to exercise enforcement discretion in relation to “healthy” claims when they are made on two types of foods.  First, the FDA will exercise enforcement discretion with respect to the current requirement that “healthy” foods meet a low fat requirement, provided that the foods have a fat profile makeup of predominantly mono and polyunsaturated fats.  Second, the FDA will also exercise enforcement discretion with respect to the current requirement that “healthy” foods contain at least ten percent of the Daily Value (DV) per reference amount customarily consumed (RACC) of vitamin A, vitamin C, calcium, iron, protein, or fiber, so long as the food instead contains at least ten percent of the DV per RACC of potassium or vitamin D.  A copy of the enforcement guidance is here.


The FDA is revisiting its definition of “healthy” for the first time in nearly twenty-five years.  As evidenced by the large attendance at the recent public meeting and the nearly 900 comments submitted on the docket to date, the comment period is an important opportunity for clients in the food and beverage industry to shape the policy on this important issue.   The Food and Beverage Industry Team at McGuireWoods LLP has extensive experience advising clients on regulatory issues, and is available to respond to your questions about the public comment process.