FDA Seeks to Redefine the Term “Healthy” and Questions Whether this Could Help Consumers Make Better Food Choices

Getting consumers to make informed food choices and encouraging the food industry to develop healthier foods continues to be a priority for the Food and Drug Administration (FDA) as the Obama administration comes to an end. After publishing a Final Rule updating the Nutrition Facts panel and serving sizes for some foods for the first time in over 20 years in May[1] of this year, FDA is now turning to redefining the term “healthy” as a nutrient content claim.

Currently, FDA regulations (21 C.F.R. § 101.65(d)) establish parameters for the use of the implied nutrient content claim “healthy” on the labeling of a food to suggest that the food, because of its nutrient content, may be useful in creating a diet that is consistent with dietary recommendations.[2]  The parameters include (1) specific criteria for nutrients to limit in the diet, such as total fat, saturated fat, cholesterol, and sodium; and (2) requirements for nutrients to encourage in the diet, including vitamin A, vitamin C, calcium, iron, protein, and fiber.[3]  While the nutrient criteria for using the term “healthy” can vary for different food categories, they are specifically linked to the elements in the Nutrition Facts panel and serving size regulations.[4]

healthy11On September 28, 2016, FDA issued a Federal Register Notice entitled “Use of the Term ‘Healthy’ in the Labeling of Human Foods; Request for Information and Comments,” inviting public comment “on the term ‘healthy’ generally, and as a nutrient content claim in the context of food labeling,” as well as on specific questions set forth in the federal register notice.[5]  FDA’s request for comments is partly intended to further the Agency’s nutrition-related strategic goals which include “[p]roviding and supporting accurate and useful information to consumers so they can choose healthier diets consistent with the Dietary Guidelines for Americans . . . . and encouraging and facilitating new products and product reformulation to promote a healthier food supply.”[6]  FDA also noted it had been planning to update these regulations to “align with the updated Nutrition Facts label regulations.”[7]

Overall, FDA is inviting comments on the use of the term “healthy,” as a nutrient content claim in the labeling of human food products and on when, if ever, the term may be false or misleading.  To that end, FDA is seeking answers to the following questions, as well as supporting data, consumer research, and any other supportive information:

  • Is the term “healthy” most appropriately categorized as a claim based only on nutrient content? If not, what are other criteria (e.g., inclusion of foods from specific food categories) would be appropriate to consider in defining the term “healthy” for use in food labeling?

  • If criteria other than nutrient content (e.g., amount of whole grain) are to be included in the definition of the term “healthy,” how might we determine whether foods labeled “healthy” comply with such other criteria for bearing the claim?

  • What types of foods, if any, should be allowed to bear the term “healthy?” Should all food categories be subject to the same criteria? Detailed reasoning is requested.

  • Is “healthy” the best term to characterize foods that should be encouraged to build healthy dietary practices or patterns? What other words or terms might be more appropriate (e.g., “nutritious”)? Submission of any studies or data related to descriptors used to communicate the overall healthfulness of a food product is encouraged.

  • What nutrient criteria should be considered for the definition of the term “healthy?” Should nutrients for which intake is recommended to be limited be included? Should nutrients for which intake is encouraged be included?

  • If nutrients for which intake is encouraged are included in the definition, should these nutrients be restricted to those nutrients whose recommended intakes are not met by the general population, or should they include those nutrients that contribute to general overall health? Should the nutrients be intrinsic to the foods, or could they be provided in part – or in total – via fortification? Detailed reasoning and any supportive data or information is requested.

  • Are there current dietary recommendations that should be reflected in criteria for use of the term “healthy?”

  • What are the public health benefits, if any, of defining the term “healthy” or other similar terms in food labeling? Any data or research related to public health benefits should be included in reasoning.

  • What is consumers’ understanding of the meaning of the term “healthy” as it relates to food? What are consumers’ expectations of food that carry a “healthy” claim? FDA is particularly interested in any data or other information that evaluates whether or not consumers associate, confuse, or compare the term “healthy” with other descriptive terms and claims.

  • Would this change in the term “healthy” cause a shift in consumer behavior in terms of dietary choices? For example, would it cause a shift away from purchasing or consuming fruits and vegetables that do not contain a “healthy” claim and towards purchasing or consuming processed foods that bear this new “healthy” claim?

  • How will the food industry and consumers regard a change in the definition of “healthy”?

  • What would be the costs to industry to change?

Comments should be submitted to FDA either electronically (www.regulations.gov) or in writing by January 26, 2017.  While working on the use of the term “healthy,” the Agency will also start to evaluate other label claims to determine how they can be “modernized.”[8]

* * * * * * *

On September 28, 2016, FDA also issued a Notice of Availability announcing a Guidance for Industry entitled “Use of the Term ‘Healthy’ in the Labeling of Human Food Products.”  The Guidance’s purpose is to advise manufacturers of [the Agency’s] intent to exercise enforcement discretion [i.e., not to take enforcement action] with respect to the implied nutrient content claim “healthy” on foods that:

  1. are not low in fat, but have a fat profile makeup of predominantly mono and polyunsaturated fats; or

  2. contain at least ten (10) percent of the Daily Value (DV) per reference amount customarily consumed (RACC) of potassium or vitamin C.

A copy of the Guidance document is available here.

Download Copy

[1] See our prior blog post ,“Today is the Day – Final Regulations on Nutrition and Supplement Facts Labels and Serving Sizes Officially Publish in the Federal Register,” available here.  

[2] See Federal Register Notice entitled, Use of the Term ‘‘Healthy’’ in the Labeling of Human Food Products; Request for Information and Comments, 81 Fed. Reg. 66,562 (September 28, 2016).

[3] Id. at 66,563.

[4]Moreover, under Section 403(a)(1) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) a food is deemed misbranded if its labeling is false or misleading in any particular.

[5] 81 Fed. Reg. 66,562 at 66,563.

[6] Id.

[7] Id. at 66,564.

[8] See FDA’s Blog Post “Making Sure ‘Healthy’ Means What it Says on Food Packages.” Available at http://blogs.fda.gov/fdavoice/index.php/2016/09/making-sure-healthy-means-what-it-says-on-food-packages/.

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