FDA Issues Proposed Rule Updating "Healthy" Food Claim Definition

Alerts / October 17, 2022
Key Takeaways
  • On September 28, 2022, the FDA issued a proposed rule to update the criteria for which foods can be labeled as “healthy” to align the definition with current nutrition science.
  • For the first time, there will be proposed limits on three specific nutrients – sodium, saturated fat and added sugar.
  • The proposed rule will pave the way for many more foods to use the “healthy” claim on their labeling, and manufacturers should ensure that claims are substantiated.

On September 28, 2022, the U.S. Food and Drug Administration (FDA or Agency) issued a proposed rule to update the criteria for when foods can be labeled with the nutrient content claim “healthy” on their packaging. The proposed change aims to modernize and align the definition with current nutrition science; the Dietary Guidelines, 2020-2025; and the updated Nutrition Facts label. The FDA first established a definition for “healthy” in 1994, and at that time nutrition science and federal dietary guidance focused more on the individual nutrients contained in food. In 1994, the Agency amended Section 101.65(d) to define the term “healthy” as an implied nutrient content claim under Section 403(r) of the Federal Food, Drug, and Cosmetic Act. The definition in Section 101.65(d) establishes parameters for use of the implied nutrient content claim “healthy” or related terms (such as “health,” “healthful,” “healthfully,” “healthfulness,” “healthier,” “healthiest,” “healthily” and “healthiness”) on the label or in the labeling of a food that was useful in creating a diet that is consistent with dietary recommendations, if the food meets certain nutrient conditions. Under the existing regulation, these conditions include specific criteria for nutrients that must be met in the food for it to bear such claims.

The FDA believes that the proposed rule will help resolve situations where the current definition permits manufacturers to use the “healthy” claim on some foods that, based on the most up-to-date nutrition science and federal dietary guidance, contain levels of nutrients that would not help consumers maintain healthy dietary practices. Under the proposed updated definition, more foods that are a part of a healthy dietary pattern would be eligible to use the “healthy” claim on labeling, including nuts and seeds, higher-fat fish – like salmon – certain oils, and water.

Under the proposed regulation, foods would have to contain a certain meaningful amount of food from at least one of the food groups or subgroups (e.g., fruit, vegetable, dairy) recommended by the Dietary Guidelines to be labeled “healthy.” The proposed nutrient criteria are specific for the different food groups and reflect the most contemporary nutritional science. For example, there must be at least 0.5 cups of fruits or vegetables, 0.75 cups of dairy, 1-1.5 ounces of protein (depending on the type), or no less than 0.75 ounces of whole grain to be considered “healthy.” Additionally, there are proposed limits on three specific nutrients – sodium, saturated fat and added sugar. The threshold for the limits is based on a percentage of the Daily Value for the nutrient and varies depending on the food and food group. The limit for sodium is 10% of the Daily Value per serving (i.e., 230 milligrams per serving).

The Agency is also in the process of studying and developing a symbol that manufacturers could display on products to indicate the products meet the definition of “healthy.” The FDA believes that consumers have long been interested in finding ways to easily identify healthy foods and that a potential standardized graphic together with the updated “healthy” claim would act as quick signals to help consumers identify healthier food choices and practice healthy eating habits.

The FDA believes that updating the term “healthy” to reflect the significant advancements that have been made in nutritional science in the past two decades is necessary to promote public health. The proposed rule is another step in the Agency’s ongoing efforts to help consumers build a nutrient-dense diet, thereby reducing diet-related chronic diseases and advancing health equity.

The proposed rule would revise Section 101.65(d) to require manufacturers using the “healthy” implied nutrient content claim on their products to make and keep written records to verify that the products comply with this requirement. Examples of these records would include analyses of databases, recipes, formulations, information from recipes or formulations, or batch records. Manufacturers would be required to provide these records upon request from the FDA during an inspection for official review and photocopying or other means of reproduction.

The proposed rule would also require some manufacturers to relabel products to comply with the criteria for the “healthy” implied nutrient content claim. A product that does not meet the criteria would need to have the term removed from its label, and a product that became eligible would be permitted to use the term in its label.

While the proposed rule will pave the way for many more foods to use the “healthy” claim on their labeling, manufacturers know all too well from the flood of class-action lawsuits that FDA compliance does not shield a company from complaints that its advertising or labeling is false or misleading. Companies should thus continue to ensure that any health-related claims are properly supported and do not exaggerate the benefits of the product.

Comments on the proposed rule in either electronic or written form must be submitted by December 28, 2022. The FDA intends that any final rule resulting from this rulemaking will become effective 60 days after the date of the final rule’s publication in the Federal Register, with a compliance date of three years after the effective date.

Authorship credit: Winston S. Kirton, Linda A. Goldstein and Laura E. Macherelli

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