September 30, 2016

FDA to Redefine 'Healthy' Claim for Food Labeling

The U.S. Food and Drug Administration (FDA) announced this week that it has started the rulemaking process to redefine “healthy” for food labeling. FDA invites public comment on the use of the term “healthy” as a nutrient content claim in the labeling of human food products; and when, if ever, the use of the term “healthy” may be false or misleading.

According to FDA, “redefining ‘healthy’ is part of an overall plan to provide consumers with information and tools to enable them to easily and quickly make food choices consistent with public health recommendations and to encourage the development of healthier foods by the industry.” The announcement comes just two months after the new nutrition labeling rules went into effect. Those rules include new requirements for providing additional nutritional information such as added sugars, making “calories” more prominent on the label and changing some serving sizes.

How Does FDA Currently Define 'Healthy'?

In the context of food labeling, “healthy”—as well as related terms such as “healthful” or “health”—is an implied nutrient content claim with an existing regulatory definition. Under the definition, if the term is used to suggest that a food, because of its nutrient content, may be useful in creating a diet that is consistent with dietary recommendations, the food must meet certain nutrient conditions. Though they can vary for different food categories, the conditions include thresholds on certain nutrients (including total fat, saturated fat, cholesterol and sodium), and requirements for other “beneficial” nutrients (including vitamin A, vitamin C, calcium, iron, protein and fiber) to be present in the food at a stated level.

Of note, while the existing definition of “healthy” remains in effect for now, FDA published new guidance this week on the use of the term “healthy” that may provide companies with more leniency until the definition is formally amended. Specifically, the guidance offers two situations where FDA will exercise enforcement discretion. First, even if a food labeled “healthy” falls over the existing total fat threshold, FDA will exercise enforcement discretion if the fat content is predominantly mono and polyunsaturated fats. Second, if a food labeled “healthy” meets the other requirements for the claim, FDA will exercise enforcement discretion if the only “beneficial” nutrient it contains at ten percent of the Daily Value (DV) or more is either potassium or vitamin D. These changes are consistent with the new nutrition labeling rules. The guidance document is effective immediately.

What Prompted FDA's Decision to Reevaluate 'Healthy'?

Although perhaps made sooner than anticipated, FDA’s announcement does not come as a surprise to stakeholders. Last year, FDA indicated its intention to update the criteria for “healthy” after a warning letter it issued to KIND LLC received a fair amount of attention. The warning letter cited a number of technical labeling violations, including that some KIND bars labeled as “healthy” do not meet the regulatory definition of the term due to higher levels of saturated fat content. KIND filed a citizen petition with FDA on December 1, 2015 urging the agency to update “outdated” regulations governing the use of “healthy” on food labels. Following its closeout letter to KIND, in which FDA determined that KIND had satisfactorily addressed the violations contained in the warning letter, on May 10, 2016 FDA published a statement that “[i]n light of evolving nutrition research . . . and [KIND’s] citizen petition, . . . now is an opportune time to reevaluate regulations concerning nutrient content claims, generally, including the term ‘healthy.’” In its statement, FDA indicated that it would solicit comments on the term in the near future. FDA is following through on its statement with this week’s announcement.

In addition to KIND’s citizen petition, FDA is reevaluating the regulatory criteria for “healthy” in light of the latest nutrition science and the current dietary recommendations, including the science underlying the recently published 2015-2020 Dietary Guidelines for Americans. This action is part of FDA’s broader nutrition-related strategic goals for fiscal years 2016-2025. FDA states that “[a] key element in achieving these goals is the modernization of FDA’s regulations for nutrition-related labeling claims to reflect current science, provide information in ways that are understandable and useful to consumers, and reduce barriers and encourage industry efforts to develop and introduce healthier food products through innovation or reformulation.” 

Implications for Food Companies

FDA’s action on “healthy” may prove meaningful for food companies in a number of ways. For example, companies currently defending lawsuits challenging “healthy” on labels may consider seeking a stay of litigation pending FDA’s final action. Companies may also evaluate whether their products that have not met the definition for “healthy” due to mono or polyunsaturated fat content or missing beneficial nutrients now align with FDA’s new guidance document.  Brands with “healthy” labeling may generally want to consider whether continued use of the term makes sense with an FDA definition now a possibility, though likely years away.

In the long term, FDA’s announcement suggests that the agency will likely turn to reevaluating other nutrient content claims and health claims in the near future. As first revealed in its May 2016 statement, FDA has been planning to update nutrient content claims and health claims regulations to align with the updated nutrition facts label regulations. Douglas Balentine, director of the Office of Nutrition and Food Labeling at CFSAN, reinforced this possibility in his blog post yesterday, stating that the agency “will begin evaluating other label claims to determine how they might be modernized.”  Food companies will want to keep an eye on FDA action in this area, although other changes are likely years away.

Participating in the Comment Process

Industry stakeholders should take an active role in the comments process. FDA is now seeking information and comments on questions such as:

  • What types of food, if any, should be allowed to bear the term ‘‘healthy?”
  • What nutrient criteria should be considered for the definition of the term “healthy?”
  • If criteria other than nutrient content (e. g., amount of whole grain) are to be included in the definition of the term “healthy,” how might we determine whether foods labeled “healthy” comply with such other criteria for bearing the claim?

FDA also specifically invites public comment on KIND’s requests raised in its December 1, 2015 citizen petition.

FDA will accept comments until January 26, 2017.  To electronically submit comments to the docket, visit this page. More information about the announcement and the new guidance document are available on FDA’s website at Guidance for Industry: Use of the Term “Healthy” in the Labeling of Human Food Products.

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