For decades, health-conscious consumers have argued about what it really means for a food to be “healthy.” Is dark chocolate “healthy”? How about breakfast cereal, coffee, or fruit gummies? At the same time, class action litigants have seized on ever-evolving and subjective definitions of “healthy,” pursuing claims against food manufacturers based on allegations that consumers were misled by a product’s marketing into believing that the product was more “healthy” than it really is.
But as of this week, the U.S. Food and Drug Administration might finally have an answer to the age-old question of what “healthy” means. On September 28, 2022, the FDA released its new proposed criteria for when foods can be labelled “healthy.” Under the FDA’s new proposed definition, in order to make a “healthy” claim, a product must:
- Contain a certain meaningful amount of food from at least one of the food groups or subgroups (such as fruit, vegetable, dairy, etc.) recommended by the Dietary Guidelines.
- Adhere to specific limits for certain nutrients, such as saturated fat, sodium, and added sugars. The threshold for the limits is based on a percent of the Daily Value (DV) for the nutrient and varies depending on the food and food group.
The History of “Healthy”
The FDA first defined “healthy” for label claims in 1994, and most recently updated its guidance in 2016, when the agency advised manufacturers that it would allow “healthy” labels on food products that contain at least ten percent of the Daily Value of potassium or vitamin D, or products that have a fat profile makeup of predominantly mono- and polyunsaturated fats.
Under the FDA’s current definition, a food qualifies for the “healthy” label if it has limited amounts of certain fats, cholesterol, and sodium, and provides at least ten percent of the Daily Value of certain nutrients. Notably, there are no limits on added sugars.
Digesting the New Proposed Criteria
The FDA’s new criteria, announced this week, seeks to reduce added sugar consumption by limiting added sugar in products labeled “healthy” to generally no more than 2.5 grams per serving, but there are exceptions based on the exact category of food product.
As part of the FDA’s new proposed definition, foods can be slotted into one of four categories: (1) raw whole fruits and vegetables; (2) individual food products (like plain yogurt or brown rice); (3) combination foods, like mixed products (like granola or yogurt with fruit chunks), main dish products (like frozen entrees intended to be eaten with sides to form a full meal), and meal products (like frozen dinners); and (4) plain water.
Raw whole fruits and vegetables and plain water automatically qualify for the “healthy” label.
The other categories are judged based on (1) meeting certain nutritional requirements and (2) if the product contains a certain amount of food from at least one of the food groups or subgroups (e.g., fruit, vegetables, grains, dairy, and protein foods) recommended by the 2020–2025 Dietary Guidelines for Americans.
To understand the FDA’s new proposed criteria, it is important to understand that the FDA measures quantity in “food group equivalents” (FGE). One FGE is based on the FDA’s understanding of how much of that food group a healthy person should consume on a 2,000-calorie daily diet.
Mixed Product Requirements
“Mixed products” are food products that contain small amounts of multiple components. Imagine a trail mix with fruits and nuts, where there are not enough fruits in the package to equal a full FGE’s amount of fruit, and there are also not enough nuts to qualify as a full serving of nuts. Under the FDA’s new proposed rule, a mixed food is “healthy” if it contains at least half an FGE each of two different food groups. So the trail mix would qualify for the “healthy” label if it has half an FGE’s worth of nuts per serving (1/2 ounce-equivalent of nuts) and half an FGE’s worth of fruit per serving (1/4 cup-equivalent of fruit). The trail mix would not qualify as “healthy” if it had the same amount of nuts but a miniscule amount of fruit, because it would then be a mixed product with half an FGE’s worth of only one food group, not the required two.
Main Dish and Complete Meal Product Requirements
Under the FDA’s new proposed rule, “Main dish products” must contain at least one full FGE’s worth of two different food groups per labelled serving. For example, a vegetarian lasagna containing a ½ cup-equivalent of mixed vegetables per serving (one vegetable FGE) and ¾ ounce-equivalent of whole grains per serving (one whole-grain FGE) would qualify as “healthy.”
Similarly, under the FDA’s new proposed rule, “Complete meal products” must contain at least one full FGE of three different food groups per labelled serving. A frozen salmon dinner would meet the “healthy” criteria if it contains at least one FGE each of salmon, green beans, and brown rice. That would be a large enough amount of three different food groups: seafood (protein food), vegetables, and whole grains.
Combination foods have yet further complexities under the FDA’s new proposed rule. For example, beans, peas, and lentils may be counted as either a protein or as a vegetable in a combination food.
One Day You’re Healthy, the Next Day You’re Not
Under the FDA’s new proposed definition, some foods that currently qualify as “healthy” will no longer meet the criteria to use the label. These products include white bread, some yogurts, and cereals that exceed the FDA’s new limits on added sugar per serving.
But other products that currently fail to qualify as “healthy” would qualify under the FDA’s new proposed definition. These products include avocados, nuts and seeds, higher-fat fish such as salmon, water, and certain oils (such as oil-based spreads or dressings). Water previously failed to qualify as healthy because it did not meet the existing nutrient-related criteria—another oversight that the FDA is seeking to close with this update.
While the new contours of “healthy” will get all of the media (and potentially litigation) attention in coming months, the FDA’s proposed new definition of “healthy” comes with additional recordkeeping requirements that are likely to be important to food manufacturers. Manufacturers that want to use the “healthy” label on their products may be required to keep records proving their products meet the FDA’s requirements. The FDA may require companies to maintain records such as recipes or formulations, batch records, or certificates of analysis from ingredient suppliers.
Exact recordkeeping requirements depend on the type of food product, and if the ingredient statement on the product’s information panel makes it facially apparent that the product meets the “healthy” requirements. Manufacturers subject to the FDA’s new proposed definition would be required to keep records for a period of two years after rolling out the product, and would be required to make the records available to the FDA for examination or copying upon request.
The Future of “Healthy”
As part of its effort to improve the nation’s health, the FDA is also developing a front-of-package symbol indicating that a product meets the FDA’s “healthy” criteria. The FDA understands that consumers are busier than ever and wants to enable consumers to make healthy decisions more easily. The FDA is accepting public comment on its proposed rule for “healthy” labeling until December 28, 2022.
Morrison & Foerster will continue to monitor the FDA’s rulemaking on “healthy” claims and is available to provide legal guidance to its clients on regulatory and class action litigation matters pertaining to the “healthy” label.