orange splashWhich foods deserve to be labeled as “healthy?” The FDA considered this question at a public meeting on March 9th.

This public meeting was the latest stop on the FDA’s journey to redefine the term “healthy” in food labeling. The journey started almost 2 years ago in March 2015 when KIND received a warning letter from the FDA stating that many of its products labeled “healthy” were misbranded. KIND’s products, of which nuts are a primary ingredient, exceeded the “low saturated fat” threshold required to make the nutrient content claim “healthy” under FDA regulations.

Subsequent to receiving the warning letter, KIND petitioned the FDA to redefine “healthy” since the administration’s current definition of the term excludes many whole ingredients—like nuts, avocados, and salmon—that are recommended for consumption.

Then in September 2016, the FDA announced the start of the public process to redefine the term. At the same time, the administration announced that it would be exercising enforcement discretion against manufacturers that use the claim “healthy” on their labels if the food is (1) not low in total fat, but has a fat profile makeup of predominantly mono and polyunsaturated fat; or (2) contains at least 10 percent of the Daily Value (DV) per reference amount customarily consumed (RACC) of potassium or vitamin D.

Last week’s public meeting gave industry stakeholders and consumers an opportunity to provide the FDA with their input on how to redefine “healthy.” During the meeting, the FDA only moderated and answered questions—the administration did not weight in on the policies that were proposed. While there was a wide array of ideas presented during the all-day event, there were a few general takeaways that are listed below.

  • Everyone dislikes the current definition. No one at the public meeting supported keeping the FDA’s current definition of “healthy” in place. Many supported the FDA’s efforts to revise the definition, suggesting that the current definition keeps products that are widely regarded as healthy from making “healthy” claims. Other stakeholders suggested that the FDA abandon any effort to redefine “healthy” and, instead, forbid the term from being used on labeling.
  • The definition of “healthy” should consider both food components and nutrient content. Stakeholders largely agreed that any new definition of “healthy” must be approached in a way that considers both the food group/component and nutrient content. For example, one stakeholder proposed an approach that combines the current nutrient-content focus with an emphasis on the Dietary Guidelines for Americans’ recommended foods. In their proposal, as the presence of food encouraged in the Guidelines increases in a product, flexibility for the number of nutrients to limit also increases.
  • There is general agreement regarding some disqualifications. Most stakeholders agreed that presence of certain—or certain amounts—of nutrients should disqualify a product from making “healthy” claims. Stakeholders suggested that there should be thresholds for added sugar, sodium, and non-naturally occurring cholesterol and saturated fat. Stakeholders also discussed whether a calorie limit should be required in the absence of a total fat threshold.
  • Ideas vary on how “healthy” can be a beneficial claim to consumers. Stakeholders provided a number of ideas about how the term “healthy” could be a benefit or burden to consumers. Stakeholders agreed that the term likely has a wide range of perception from consumer to consumer, with some associating the term with other claims (g., organic, gluten-free) and others associating it with negative connotations (e.g., less tasty, high cost). In order to provide more information to consumers, stakeholders also suggested combining “healthy” claims with the USDA’s MyPlate icon or requiring a statement to accompany each claim that identifies why a product is “healthy.”

Following the meeting, the FDA informed stakeholders that the docket for comment would remain open through April 26, 2017. The administration suggested that there was no timeline for moving forward, other than that it would examine the information from the public meeting and review comments submitted to the docket in the coming months.

Although the FDA provided little information about if and when the FDA will propose a new definition, it is likely that the journey to redefine the nutrient content claim “healthy” is far from over.