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FDA Announces ‘Healthy’ Definition

Dec. 20, 2024
Voluntary label claim seeks limits on saturated fat, sodium and added sugars and suggests more fruits and vegetables and lowfat dairy.

The FDA yesterday (Dec. 19) issued a voluntary final rule to update and define the use of the term “healthy” on food & beverage packaging. There are just two components to it; to use the “healthy” claim, a food product needs to:

  • Contain a “certain amount” of food from at least one of the food groups or subgroups (such as fruits, vegetables, fat-free and low-fat dairy etc.) recommended by the Dietary Guidelines.
  • Adhere to specified limits for saturated fat, sodium and added sugars.

Those "certain amounts" and limits, in terms of "food group equivalents" include:

  • 1/2 cup of vegetables or fruits (with less than 2% of the daily value [DV] of added sugar, 10% of the DV of sodium and 5% of the DV of saturated fats.
  • 2/3 cup of dairy (with less than 5% of the DV of added sugar, 10% of the DV of sodium and 10% of the DV of saturated fats).
  • 3/4 oz. of grains (with less than 10% of DV of added sugar, 10% of the DV of sodium and 5% of the DV of saturated fats). Servings of meat, seafood, eggs, legumes and nuts or seeds also are recommended. 

There are many more specific foods and limits in the draft Federal Register notice.

“Manufacturers can voluntarily use the claim on a food package if the product meets the updated criteria,” the FDA statement said. As for enforcement: "The FDA is committed to doing everything within its resources and authorities to identify products with inaccurate and misleading labeling. If the FDA determines that an FDA-regulated product violates the law, the agency takes action, as appropriate, based on public health priorities and available resources."

The Dec. 19 announcement acknowledges that “foods that did not qualify for the ‘healthy’ claim before but are foundational to a healthy eating pattern” can use the term. Meaning foods that had “good” fats (monounsaturated), such as “nuts and seeds, higher fat fish such as salmon [and] certain oils. … Many foods that fit into a range of budgets such as some peanut butters and canned fruits and vegetables also qualify.”

The FDA gave some specific examples of foods that cannot use the healthy claim: fortified white bread, highly sweetened yogurt and highly sweetened cereal.

Manufacturers who choose to use the claim have three years to conform but can use the new criteria starting on Feb. 25, 2025.

“On a separate but related track, the FDA is also continuing to explore development of a symbol that manufacturers could use on food labeling to show that a product meets the criteria for the healthy claim,” the agency continued.

The FDA said it will host a stakeholder webinar to provide an overview of the final rule and address questions, with details to be released shortly.

The last time “healthy” was defined on packaging was in the 1990s. Based on the nutrition science and federal dietary guidelines at that time, the definition was solely focused on individual nutrients; for example, it 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.

“Today, we have a greater understanding of dietary patterns and their effects on health, and we recognize that foods are made up of a variety of nutrients that work together as part of a healthy dietary pattern.”

The agency’s constituent update is here.

And the draft Federal Register notice is here.

About the Author

Dave Fusaro | Editor in Chief

Dave Fusaro has served as editor in chief of Food Processing magazine since 2003. Dave has 30 years experience in food & beverage industry journalism and has won several national ASBPE writing awards for his Food Processing stories. Dave has been interviewed on CNN, quoted in national newspapers and he authored a 200-page market research report on the milk industry. Formerly an award-winning newspaper reporter who specialized in business writing, he holds a BA in journalism from Marquette University. Prior to joining Food Processing, Dave was Editor-In-Chief of Dairy Foods and was Managing Editor of Prepared Foods.

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