my_plate_dinnerThe term “healthy” as commonly used is quite subjective—meaning different things to different types of consumers. Culturally, there are sometimes fast-changing trends about what is healthy—foods rejected by consumers a few years ago are now regaining popularity and vice versa. Nevertheless, the FDA defines “healthy” and regulates how the term may be used on product labels. Until now, that regulatory definition was based on science from the 1990s, when low-fat foods were all the rage, and products made from avocados, nuts, and fatty fish could not be labeled as “healthy.”

However, following an active summer of policymaking, the FDA announced on Monday, September 26, that it is redefining “healthy.” This move is likely the result of a December 2015 petition to the FDA by KIND Bar, in response to an FDA warning letter challenging its use of the term on its nut bars. The FDA also noted that the move reflects updated nutrition science and dietary recommendations contained in the 2015-2020 Dietary Guidelines for Americans and its recently revised Nutrition Facts panel and serving size regulations.

Under existing regulations, in order for a food to be labeled as “healthy,” it must contain limited amounts of total fat, saturated fat, cholesterol, and sodium, and higher amounts of other nutrients, including vitamin A, vitamin C, calcium, iron, protein, and fiber. 21 C.F.R. § 101.65(d). Foods higher in fat (even if “beneficial” fat) are not “healthy,” while foods that are low in fat but high in sugar are “healthy.”

The FDA recognized that much of these regulations derive from relics of a prior era of health science. FDA is taking steps to bring its regulations into alignment with more modern nutrition perspectives. As the first step in its process to define the term, it is seeking information and comment on issues such as:

  • What types of food, if any, should be allowed to bear the term “healthy”?
  • 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”)?
  • What is consumers’ understanding of the meaning of the term “healthy” as it relates to food? What are consumers’ expectations of foods that carry a “healthy” claim?
  • How will the food industry and consumers regard a change in the definition of “healthy”?
  • What would be the costs to the industry of the change?

Comments responding to the FDA’s questions are due to the FDA on January 26, 2017.

In the meantime, the FDA’s recently published guidance reflects the agency’s intent “to exercise enforcement discretion with respect to [use of] the implied nutrient content claim ‘healthy’ on foods that have a fat profile of predominantly mono and polyunsaturated fats, but do not meet the regulatory definition of ‘low fat’, or that contain at least 10 percent of the Daily Value per reference amount customarily consumed of potassium or vitamin D.”

Two cautions before relying on this enforcement discretion:

First, remember that guidance documents are not binding on the agency. The FDA can change its mind about this enforcement discretion at any point.

Second, and more noteworthy, the FDA’s exercise of enforcement discretion may not deter plaintiff’s attorneys from bringing suit alleging that labels are misleading. This is not just speculation. Recently, General Mills, Kellogg, and Post Foods were each sued in California on similar grounds—the complaint filed in the General Mills case asserts that “statements that these products are ‘healthy,’ ‘nutritious,’ or ‘wholesome’ are false, or at least highly misleading, because, due to their high sugar content, consumption of these products is decidedly unhealthy.”

The FDA’s request and guidance may give food companies some idea of where the new regulations are likely headed. In the request for comment, the FDA noted KIND Bar’s suggestion that the FDA “emphasize whole foods and dietary patterns rather than specific nutrients” in amending the regulations. In addition, we also expect the FDA to limit sugar (or at least “added sugar”) content in foods that make a “healthy” claim.

Food companies that would like to make “healthy” claims on their labels should consider submitting comments to the FDA. The opportunity to shape a regulation with this much impact in the food industry does not come around very often and making sure the FDA hears from as many perspectives as possible will help them draft a better-informed rule that the food industry will have to operate under for a long time.