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FDA Will Reconsider Meaning of “Healthy”

On May 10, FDA announced that it will reevaluate regulations concerning nutrient content claims (NCCs), including the definition of “healthy.”

An NCC is a claim on a food product label that directly or by implication characterizes the level of a nutrient in a food (e.g., “low fat,” “high in fiber,” “healthy”). A food with a “healthy” NCC claim must contain specific low levels of total fat, saturated fat, cholesterol, and other nutrients. However, members of the food industry have pointed to current nutrition guidance that state that a healthy diet includes foods that are high in certain fats, such as almonds, avocados, and salmon.

FDA’s decision to reevaluate the NCC regulations was largely prompted by KIND LLC’s use of NCCs on the labels of its fruit and nut bars.1 In a March 2015 Warning Letter, FDA alleged that some of the company’s snack bars were misbranded because they bore NCCs that did not comply with the relevant regulations. Among other things, FDA stated that the “products [did] not meet the requirements for use of the nutrient content claim ‘healthy’ on a food label” because the bars exceeded the threshold amount of saturated fat set forth in the regulations.

In December 2015, KIND submitted a Citizen Petition that challenged those regulations, which stated that “[m]any current federal labeling regulations are based upon…past thinking” that focused on total fat intake “despite the fact that current science no longer supports those standards.”2 KIND specifically questioned whether a “healthy” claim should be based on the levels of specific nutrients in a food rather than the overall nutritive value of a food. KIND stated that FDA’s focus on specific nutrients is inconsistent with the current understanding of nutrition and healthy eating habits. For example, the company stated that the US Department of Health and Human Services’ 2010 Dietary Guidelines for Americans emphasizes the nutritive quality of whole foods and dietary patterns rather than individual nutrients like fat.3

Despite its Citizen Petition, KIND subsequently took corrective action to remove and amend certain NCCs on its product labels.

On April 20, FDA issued a close out letter for the KIND case.4 After receiving the close out letter, KIND requested confirmation as to whether it could use the phrase “healthy and tasty” on its snack bar labels to describe its corporate philosophy, and not as an NCC. The company stated that the phrase would appear “only in text clearly presented as its corporate philosophy, where it isn’t represented as a nutrient content claim, and does not appear on the same display panel as nutrient content claims or nutrition information.” On May 10, FDA announced that it evaluates the label as a whole and in this instance did not object to KIND’s use of the phrase “healthy and tasty.”

Notably, FDA further stated that, in light of evolving nutrition research and KIND’s Citizen Petition, it would reevalute regulations concerning NCCs generally, and the term “healthy” in particular. The Agency stated that it plans to solicit public and expert comment in the near future.

1William A. Correll, Jr., Director, Center for Food Safety and Applied Nutrition, Food and Drug Administration Warning Letter to Daniel Lubetsky, CEO, KIND, LLC (Mar. 17, 2015), http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2015/ucm440942.htm?source=govdelivery&utm_medium=email&utm_source=govdelivery.

2KIND Citizen Petition (Dec. 1, 2015), https://s3.amazonaws.com/kind-docs/citizen-petition.pdf.

32010 Dietary Guidelines for Americans, US Dept. of Agric. and US Dept. of Health & Human Services, http://health.gov/dietaryguidelines/dga2010/dietaryguidelines2010.pdf.

4Latasha A. Robinson, Branch Chief, Center for Food Safety and Applied Nutrition, Food and Drug Administration Warning Letter to Daniel Lubetsky, CEO, KIND, LLC (Apr. 20, 2016), http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2016/ucm497335.htm.

Copyright © 2020 by Morgan, Lewis & Bockius LLP. All Rights Reserved.National Law Review, Volume VI, Number 133



About this Author

Hilary Lewis, Morganlewis, FDA lawyer, consumer product attorney, medical device

Hilary L. Lewis counsels clients on US Food and Drug Administration (FDA), US Department of Agriculture (USDA), Federal Trade Commission (FTC), and state regulatory compliance issues involving food and dietary supplements, over-the-counter and prescription drug products, and cosmetics. Hilary applies her background litigating on behalf of FDA-regulated companies to assist clients in their defense against FDA, USDA, and Consumer Product Safety Commission (CPSC) enforcement actions, and has helped companies resolve import detentions, manage product recalls...