Concerns about how or whether the term “healthy” should be used in food labeling and packaging prompted the U.S. Food and Drug Administration (FDA) to hold a public comment meeting on the issue on March 9, 2017.

Current FDA regulations allow the use of the term “healthy,” as well as similar terms, as implied nutrient-­content claims. However, the criteria for use vary for different food categories, and the criteria themselves are linked to elements of the nutrition facts panel and serving size regulations—both of which have undergone significant changes in recent years. FDA also received a citizen petition in 2015 from Kind LLC, a producer and distributor of snack bars, requesting the agency amend its regulations defining the use of the term with respect to total fat intake and emphasizing whole foods and dietary patterns instead of specific nutrients. Accordingly, FDA’s 2016 publication of “Use of the Term ‘Healthy’ in the Labeling of Human Food Products: Guidance to Industry” advised food manufacturers of “FDA’s intent to exercise enforcement discretion relative to foods that use the implied nutrient content claim ‘healthy’” for some items and that the agency is “re-evaluating” the regulatory criteria for its use.

Given the current questions of clarity on the issue, the agency sought comment from stakeholders and interested members of the public at the meeting. Attendees agreed that the working definition of “healthy” should be revised and modernized to keep pace with the evolution of nutrition and consumer behavior science as well as changes in healthy diet pattern nutritional standards. A majority of attendees also appeared to favor a hybrid definition, which applies a “food group” ­based definition with beneficial nutrient criteria supplementing the food group breakdown. But the more nuanced questions about which specific criteria should underpin a modernized “healthy” claim yielded a variety of responses. There was also considerable debate about harmonization and whether “healthy” claims should be tied to the 2015-­2020 Dietary Guidelines for Americans or some other nutrition guidance platform.

Food and grower industry representatives posited that “healthy” is an important claim that needs to remain available to the market. Industry panelists suggested a food-­group/diet pattern-plus-nutrient-­based premise; other panelists suggested a tiered approach that would consider food group association, beneficial nutrient content, and to a lesser extent, negative nutrient content. However, some attendees expressed concern over a focus on negative nutrient content, citing foods such as almonds, nuts and avocados as examples of foods commonly perceived as “healthy” but which might be disqualified from a “healthy” claim because of negative attributes such as total fat and cholesterol content. Finally, industry representatives asked FDA to consider packaging and label space, costs and nutritional fortification when determining a manufacturer’s ability to use a “healthy” claim.

Consumer advocates and medical professionals—primarily dietitians and nutritionists—expressed concerns about the futility of revising the definition of “healthy.” In particular, they raised concerns about the rapidly-­changing science in the nutrition and health fields. Attendees were also concerned that a “healthy” claim could distract consumers from other important labeling information and nutritional facts. Finally, consumer advocates and members of the general public said they were worried about disqualifications for total fat and cholesterol. Several objected to tying the criteria to the Dietary Guidelines, saying the guidelines were outdated. FDA will accept written and electronic comments on the issue through April 26, 2017.

Additional reporting provided by Shook Senior Staff Attorney Kelly Dawson.


Issue 627

About The Author

For decades, manufacturers, distributors and retailers at every link in the food chain have come to Shook, Hardy & Bacon to partner with a legal team that understands the issues they face in today's evolving food production industry. Shook attorneys work with some of the world's largest food, beverage and agribusiness companies to establish preventative measures, conduct internal audits, develop public relations strategies, and advance tort reform initiatives.

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