What Constitutes ‘Healthy’ Claims for Foods?

KIND’s criticisms of FDA’s existing nutrient content claim guidelines boil down to two points: 1) The particular nutrients featured in the guidelines were based on now-outdated nutrition science, and 2) There should be a focus on healthfulness at the level of the food, not the nutrient. KIND addressed the first point by proposing changes in the nutrients and that would qualify for a nutrient content claim.

The second point is demonstrated by KIND’s proposal that any nutrient content claim—not just “healthy,” but even any truthful claim about the amount of a specific nutrient—should be permitted “only if the food contains a meaningful amount of at least one health-promoting food, such as: vegetables, fruits (especially whole fruits), whole grains, legumes, nuts, and seeds.” KIND’s reasoning is that any specific nutrient content claim is also, in part, an implied general “healthy” claim, a position supported by academic research cited in the petition. This research found that specific nutrient content claims increase consumers’ perceptions of the overall healthfulness of a food, and that consumers can be induced to switch to less healthy foods that promote their fortification with specific nutrients.

Relatively little private litigation has explicitly attacked “healthy” labeling or advertising claims as its primary theory. This is partly because “healthy” is viewed by FDA as an implied nutrient content claim. But some class-action complaints point to more concrete marketing claims that they allege to be false, and secondarily allege that the claim amounts to an implied “healthy” claim.

For example, the use of words like “wholesome” and “lightly sweetened” on sugared cereals and snacks has been challenged as an implied “healthy” claim in cases like Hadley v. Kellogg Sales Company in California, which was class-action certified last year. This legal theory echoes the position reflected in the KIND petition and other commentary that a specific nutrient content claim implies a general “healthy” claim at the level of the entire food. It is also the most practical way to attack “healthy” claims in a class action.

Food manufacturers generally are pretty scrupulous in explicitly claiming “healthy” for their foods only if their foods meet FDA’s clear parameters for a general “healthy” claim. A lawsuit under a state’s deceptive practices law challenging such a “healthy” claim on the grounds that the food is unhealthy notwithstanding its compliance with FDA guidelines would be preempted. However, if a food does not meet FDA’s guidelines for a general “healthy” claim and does not make a claim explicitly, but arguably implies such a claim, either through a truthful specific nutrient content claim or some other marketing pitch, a lawsuit might be able to go forward.

There is some evidence that “healthy” is the real meaning lurking behind several of the food advertising and marketing claims most commonly challenged by competitors and consumers. Why do consumers care, for example, whether a product contains artificial flavorings? Most likely because they believe artificial flavors are less healthy. Why do consumers care whether products are “all-natural” or organic? Environmental and sustainability concerns may play a role, but a major reason is likely that consumers consider natural ingredients and organic products healthier. Why do consumers care whether a food contains bioengineered or genetically modified organisms? The public comments received by the USDA in response to its proposed bioengineered food labeling requirements in 2018 (since finalized, in modified form) indicated that many consumers doubted the healthiness of these ingredients.

Future Uncertainty

In September 2016, FDA issued new guidance on the use of “healthy” as a food marketing claim. Nothing in the law or regulations was changed, but the move signaled a shift in FDA’s enforcement intentions. Producers could now call their foods “healthy” if they are not low in total fat but have a fat composition of mostly monounsaturated and polyunsaturated fats, thus relaxing the “total fat” ceiling. FDA also added potassium and vitamin D to the list of desirable nutrients that can support a “healthy” claim if present in at least 10 percent of daily value per serving. Nobody, including FDA, viewed this new guidance as anything more than a bandage on the existing policy, pending a review and overhaul of at least “healthy” claims, if not all nutrient content claims.