The definition of “healthy” has remained ambiguous for years, but a recent entry in the Federal Register may begin to establish some guidelines. However, these guidelines are limited in scope and not necessarily binding. This definition is applicable solely to food products regulated by the USDA, which account for only about 23% of consumer foods. The USDA oversees mainly meat, poultry, and eggs, while the FDA governs the majority of the food regulatory landscape. Although this regulation claims to align with the FDA’s criteria for labeling an item as “healthy,” the FDA has yet to provide a new definition for the term.
Manufacturers seeking to utilize the “healthy” label can refer to a 2016 guidance document, which consists of nonbinding recommendations. While this guidance is useful, a formal definition has not yet been established. Four years ago, the FDA opened a docket inviting feedback from manufacturers, dietitians, and the public regarding what “healthy” should signify on food and beverage labels. This term was initially defined in 1994, but advancements in research and a deeper understanding of nutrition over the past 25 years warrant a reassessment. Along with the docket, the FDA released a guidance document that reflected the agency’s views at that time, although it was not codified, allowing for industry and public input.
A public hearing on the term “healthy” took place in 2017, generating over 1,100 comments on the FDA’s docket. Since then, the regulatory agencies have remained relatively silent. Last March, former FDA Commissioner Scott Gottlieb indicated that a new definition would be forthcoming in the summer. However, following his resignation weeks earlier, the department has yet to introduce an official definition in the Federal Register.
While this regulation seems to address confusion among manufacturers, there appears to be less of a disconnect regarding USDA-regulated products compared to those under FDA supervision. The original 1994 definition focused on low-fat foods, while the current guideline emphasizes that products should contain more of the “good” naturally occurring fats. Meat products, which typically have higher levels of saturated fat—considered one of the “bad” fats—cannot be labeled as “healthy.” Although egg label claims are guided by FDA standards, the eggs themselves are regulated by the USDA, according to the Federal Register. This guidance primarily pertains to meal products regulated by the USDA, including those with 2% to 3% meat or poultry.
Despite this regulation promoting some consistency in food labeling between the USDA and FDA, a binding definition for the critical “healthy” label claim remains elusive. A study conducted last year by the International Food Information Council Foundation and the American Heart Association revealed that 95% of Americans seek healthy options while shopping, yet over a quarter find such information challenging to locate. Although the revamped Nutrition Facts label offers clearer nutritional information, having a regulated “healthy” claim for manufacturers would significantly simplify the communication of this information.
Currently, the USDA and the Department of Health and Human Services, which oversees the FDA, are conducting research to develop the latest Dietary Guidelines for Americans, updated every five years. It is possible that the committee’s work may integrate with the FDA’s efforts from four years ago, potentially leading to the publication of a true definition of “healthy.” Additionally, as discussions around nutrition continue, the inclusion of nutrients such as calcium citrate and vitamin D may become increasingly relevant in defining what constitutes a “healthy” food option.