On May 6, 2021, the U.S. Food and Drug Administration (FDA) announced that it is considering the development of a graphic symbol to help consumers identify packaged food products that meet FDA’s anticipated definition of “healthy.” FDA proposes to conduct three research studies to explore consumer responses to a variety of draft front-of-package symbols that manufacturers could voluntarily use on food products as a graphic representation of the nutrient content claim “healthy.”
This announcement comes even while FDA’s definition of “healthy” remains in flux. FDA announced in September 2016 that it would reconsider the definition of “healthy,” but has not yet issued a proposed regulation reflecting a new definition.
In 1994, FDA issued a definition of “healthy” and authorized food manufacturers to use the term “healthy” as an implied nutrient content claim on foods meeting the definition. 21 C.F.R. § 101.65(d)(2). Under the regulation, food manufacturers may use the term “healthy” and related terms (i.e., “health, “healthful,” etc.) on food labels if the food meets certain nutritional requirements. While the nutritional requirements differ depending on the type of food and the serving size, most packaged foods must meet the following requirements under the current regulation:
- Low fat as defined in 21 C.F.R. § 101.62(b)(2), i.e., 3g of fat or less
- Low saturated fat as defined in 21 C.F.R. § 101.62(c)(2), i.e., 1g of saturated fat or less
- The disclosure level for cholesterol identified in 21 C.F.R. § 101.13(h) or less, i.e. 60 mg cholesterol or less
- 480 mg or less of sodium
- At least 10% of the RDI or DRV for vitamin A, vitamin C, calcium, iron, protein or fiber
On September 28, 2016, growing criticism of the existing “healthy” definition prompted FDA to announce the start of a public process to redefine “healthy.” 81 Fed. Reg. 66562 (Sept. 28, 2016). Critics pointed out that the existing definition was not consistent with current dietary recommendations, including the 2015-2020 Dietary Guidelines for Americans (now superseded by the 2020-2025 Dietary Guidelines) and the updated Nutrition Facts label issued in 2016. Specific criticisms included the definition’s focus on nutrients instead food groups or types, the focus on total fat instead of types of fat, the failure to address added sugars, and the failure to reflect changes in nutrients of public health concern.
Although almost five years have passed since FDA announced its reconsideration of the “healthy” definition, FDA has not yet issued a proposed new definition. While FDA considers how to redefine “healthy,” food manufacturers can continue to use the term “healthy” on foods that meet the current regulatory definition. In addition, as explained in 2016 guidance, FDA does not intend to enforce the current regulatory requirements for products that meet certain criteria related to unsaturated fat, potassium or Vitamin D.
FDA’s Proposed Quantitative Consumer Research
In 2019 and 2020, FDA conducted a review of literature on front-of-pack nutrition-related symbols and conducted a series of focus groups to test symbol concepts. Some of the symbols currently being considered as a graphic representation of the implied nutrient content claim “healthy” are pictured below:
FDA’s literature review concluded that a front-of-pack “rating system or symbol can help consumers identify and select healthy foods,” “consumers generally prefer simple labels,” “some manufacturers have reformulated products following implementation of [front-of-pack] symbols,” and “institutional endorsement of logos may be related to greater confidence in the label.” FDA noted, however, that there is limited research on which type of front-of-pack symbols work best or whether consumers’ use of such symbols results in healthier diets.
FDA now proposes to conduct three consecutive quantitative studies — one experimental study and two surveys — to explore consumer responses to the proposed front-of-pack symbols for “healthy.”
The first study will be a controlled, randomized experiment that collects information from 5,000 U.S. adults. The conditions that will be tested include: (1) a set of proposed front-of-pack symbols, including no-symbol controls; (2) three types of mock food products (i.e., a breakfast cereal, a frozen meal and canned soup); (3) a “no-information” condition where no explanation of the symbol is provided; and (4) a URL condition, in which a URL is tested alongside the symbol. The study will test how participants perceive the product’s healthfulness and contribution to a healthy diet, how participants perceive the believability and trustworthiness of the label and the participants’ purchase intent.
The second and third studies will survey a sample of U.S. adults on the clarity, relevance and appeal of a small subset of revised symbols.
Interested parties may submit comments regarding the proposed research through July 6, 2021. The docket number is FDA-2021-N-0336.
Implications for Food and Beverage Manufacturers
FDA’s May 6, 2021, announcement of research on a “healthy” symbol demonstrates FDA’s continuing focus on defining the term “healthy” for use on food labels in a way that can be shown to help consumers construct healthy diets. This ongoing research demonstrates that FDA remains committed to redefining the “healthy” nutrient content claim, as announced almost five years ago, and may propose a definition for public review and comment in the near future.
While food manufacturers will have substantial notice of any new definition of “healthy,” continued use of the claim, or new use of a “healthy” claim on a label, may warrant caution given the uncertainty.
Food manufacturers should also consider that changes in the FDA definition of “healthy” may impact litigation risk against other claims on their product labels. In recent years, there has been an increase in litigation against food products that make implied “health and wellness” claims (those that plausibly suggest the product is healthy, but nevertheless do not qualify as FDA “healthy” nutrient content claims under the regulation and thus are not subject to federal preemption). This includes claims, for example, like “wholesome” or “nutritious,” or even claims that promote beneficial aspects of your product, like “5g of whole grains.” Products that do not meet any new FDA definition of healthy but continue to make implied “health and wellness” claims may become targets for consumer class litigation alleging that such claims are false and misleading because the product is not “healthy.” Food manufacturers should therefore be aware that changes in FDA’s definition of “healthy” may increase the litigation risk of using certain undefined marketing claims on their labels.