Institute for Food Laws and Regulations

Currently, approximately 5% of all food packages purport that the food inside is “healthy.”  However, many of the products that are currently using the term, or similar words such as health, healthful, and healthier, will soon either need to drop the term on the package or significantly change the formulation. The products haven’t changed so, what happened?

Until last month’s FDA revision to guidelines regarding the use of the term "healthy" on foood labels, the use of the term on a package meant that the food inside met the definition of “healthy” established in 1994, thirty years ago! The prior rule placed limits, based on the nutrition facts label and serving size, on such components as total fat, saturated fat, cholesterol, and sodium. They also required a minimum of at least 10% of the daily value (DV) minimum amounts of at least one desirable nutrient such as vitamin A, vitamin C, calcium, iron, protein, or dietary fiber based on the type of food and serving size. Moreover, the “healthy” distinction also required either an explicit or implicit claim or statement about a nutrient, such as “healthy, contains zero grams of cholesterol.”

Over time, scientific advances in nutrition science, the Nutrition Facts Label, and the serving-size recommendations changed. These changes necessitated a change in the definition. Moreover, under the prior rule, foods such as traditional yogurt with a large amount of added sugar, fortified sugary cereal, and fortified white bread could be labeled “healthy.”  

On December 19, 2024, the FDA released a revised final rule regarding use of the term “healthy” on food labels to make the term consistent with nutrition science and federal dietary guidelines. This is important because when consumers see this term on food packages, they naturally believe that the food is advantageous and beneficial to their diet. Therefore, it is important to ensure that foods with this label meet the current scientific definition with respect to minimum amounts of important nutrients while limiting too much of the current evils of added sugar, sodium, and saturated fat. But this will have industry members scrambling because many foods currently using the term on packaging will no longer meet the definition.

First, in order to use the term "healthy" or a derivative term under the new rule, the product must contain enough of a particular food group or subgroup as recommended by the Dietary Guidelines. Examples of food groups or subgroups include fruit, vegetables, whole grains, fat-free dairy, low-fat dairy, and protein foods (such as seafood, egg, beans/peas/ and lentils, nuts/seeds, soy products, and game meat). In addition, the new rule focuses on “food group equivalent (FGE).” An FGE establishes a level of food that meets the requisite nutritional content. For example, if using a healthy claim on a “grain” product, the food must contain at least ¾ ounce (oz) equivalent of whole grain. If the food is a fruit product, the food must contain at least ½ cup equivalent fruit. These requirements are based on the serving size. There are no FGEs for oils or oi-based spreads whose fats come solely from oil, or oil-based dressings.

Second, if a food meets the positive criteria, it must also not contain too much added sugar, sodium, or saturated fat. For example, a vegetable product may not be labeled healthy if it contains more than 2% DV of added sugars, more than 10% DV of sodium, or more than 5% DV of saturated fat. The new rule also adds flexibility for mixed food products with multiple food groups. Take a product such as granola with grains, fruits, and nuts. In this case, the product must first contain at least one total FGE with no less than ¼ FGE from at least two food groups. If the granola contained ¼ FGE of whole grain, ¼ FGE of fruit, and ½ FGE of nuts and did not contain more than 10% DV of added sugar, no more than 15% DV sodium, and no more than 10% DV saturated fats not counting saturated fats that are inherent in nuts, seeds, and soybeans in any soy product, it could be labeled as “healthy.”  With this new rule, some granola will meet the standard, others will not. There is similar flexibility in meeting the minimum 2 FGEs for main product dishes and 3 FGE minimum for meal products. Overall, the necessary changes will better inform the public about foods that meet the definition of “healthy” that is based on updated science.

Food manufacturers may start to use these new criteria beginning February 25, 2025, and must meet the new requirements to use the terms as of February 25, 2028. For more information, see https://www.regulations.gov/document/FDA-2016-D-2335-1702.

Disclaimer. 

Learn more about U.S. food laws and regulations with MSU's online graduate courses, particularly:

• Food Laws and Regulations in the United States (fall and spring semesters)