ARTICLE
20 January 2025

Healthy For The New Year: FDA Updates Requirements For 'Healthy' Claims

DL
Davis+Gilbert LLP

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Davis+Gilbert LLP is a strategically focused, full-service mid-sized law firm of more than 130 lawyers. Founded over a century ago and located in New York City, the firm represents a wide array of clients – ranging from start-ups to some of the world's largest public companies and financial institutions.
The Food and Drug Administration (FDA) recently updated the requirements to make a nutrient content claim of "healthy," in order to reflect modern understandings of nutrition science.
United States Food, Drugs, Healthcare, Life Sciences

The Bottom Line

  • For the first time since the 1990s, the FDA updated the nutritional requirements that a food must meet to use the claim "healthy."
  • Companies can voluntarily make "healthy" claims using the new standards starting on February 25, 2025.
  • Companies making "healthy" claims must comply with the new standards by February 25, 2028.

The Food and Drug Administration (FDA) recently updated the requirements to make a nutrient content claim of "healthy," in order to reflect modern understandings of nutrition science. These requirements specifically apply to claims made on food packaging and labeling – but companies should keep in mind that the FDA construes "labeling" broadly (to include, for example, website and social media claims) and the Federal Trade Commission (FTC) generally harmonizes its enforcement efforts with the FDA's labeling regulations.

Background: Prior Criteria for "Healthy" Claims

The prior criteria for a "healthy" claim was developed in 1994, and solely focused on individual nutrients. The criteria included limits for saturated fat, total fat, cholesterol, and sodium and required a certain amount of beneficial nutrients like certain vitamins, minerals, fiber, and protein. Accordingly, foods such as nuts and seeds, olive oils, eggs and higher-fat fish like salmon did not qualify as "healthy" under the prior standard because of their nutrient profile. However, foods such as fortified white bread, highly sweetened yogurt and highly sweetened cereal did qualify as "healthy."

Requirements Updated for Modern Nutrition

Since 1994, nutrition science has evolved and the definition of "healthy" has altered. As a result, the FDA has revised the criteria for "healthy" claims to reflect modern understandings. Now, to qualify as "healthy," a food must:

  • contain a certain amount of food from at least one of the food groups or subgroups (such as fruit, vegetables, grains, fat-free and low-fat dairy and protein foods) recommended by the Dietary Guidelines for Americans, and
  • adhere to specified limits for added sugars, saturated fat and sodium.

In addition, food groups and subgroups such as vegetables, fruits, whole grains, fat-free and low-fat dairy, lean game meat, seafood, eggs, beans, peas, lentils, nuts, and seeds automatically satisfy the updated criteria. While water isn't part of a food group, it now also qualifies as "healthy."

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As seen in the FDA's "Use of the Term Healthy on Food Labeling," December 2024.

Healthy Claims in Advertising

Be prepared for brands now on the "winning" side of "healthy" to be more aggressive in making health-related advertising and marketing claims. Those on the "losing" side will be devising new creative strategies to protect its historical advantage. For example, we may see companies position "healthy" statements as reflections of corporate culture and philosophy, rather than as a nutritional claim. In fact, several years back, the FDA sent a warning letter to KIND objecting to their use of the term "healthy" for snack bars that failed to meet FDA requirements. The FDA eventually, however, allowed KIND to use of the term "healthy" in the context of its corporate philosophy, rather than as a nutrition claim.

The heightened focus on "healthy" claims may lead to increased focus by state and federal regulators, as well as the National Advertising Division. Competitors, consumers, and industry/interest groups may also challenge these claims – for example, there has been a wave of consumer class action lawsuits alleging that food and beverage products that are high in sugar are misleadingly advertised as "healthy."

Compliance With "Healthy" Claims

Companies that choose to place a "healthy" claim on a food package or label can use the new criteria starting on February 25, 2025. Companies making "healthy" claims must comply with the new criteria by February 25, 2028.

Failure to comply could result in regulatory enforcement actions, such as FDA warning letters or product recalls.

The content of this article is intended to provide a general guide to the subject matter. Specialist advice should be sought about your specific circumstances.

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