Since 1990, FDA has permitted food companies to make “nutrient content claims.” Nutrient content claims are voluntary marketing claims about the amount of a recognized nutrient (including macronutrients such as fats and protein, and micronutrients such as vitamins and minerals) in a given serving of food. Food manufacturers are permitted to characterize their products as “high in,” “low in,” or “free” of various nutrients based on levels established by FDA with reference to levels of daily consumption (“daily values” or “DVs”). A nutrient content claim may be express (e.g., “low fat”) or implied, for example by claiming that a food contains an ingredient known to contain a particular nutrient (e.g., “high in oat bran” is an implied “good source of dietary fiber” claim).
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Explore This IssueJune/July 2019
FDA regards “healthy” as a special case of an “implied nutrient content claim”—one that simultaneously makes multiple implied claims about specific nutrients that are present or absent in significant quantities. That very fact is at the heart of the main regulatory problem with “healthy.” Most people regard the term “healthy” holistically—as, indeed, current nutritional science indicates that they should. Considering the sum total of a food’s ingredients and nutrients, what is its likely overall impact on the health of a normal person? FDA’s historical conception of “healthy” does not address this question directly, and as nutritional science evolves, may have fallen out of step with Americans’ health needs.
What Constitutes “Healthy”?
In all, FDA’s criterion for “healthy” (prior to modified guidance issued in 2016, discussed below) addresses four different nutrients to be limited: Having more than the specified amount of any one of 1) total fat, 2) saturated fat, 3) sodium, or 4) cholesterol rules out a “healthy” claim for a food.
Besides these four ceilings, there is one floor, and several ways to reach it. To qualify as “healthy,” a food must contain at least 10 percent daily value per serving of any one of six nutrients:
- Vitamin A,
- Vitamin C,
- Protein, and/or
(Note that this is the rule for an individual food other than a fresh fruit or vegetable, meat, or a whole meal; those food types have related but different requirements.) So “healthy” to FDA means “containing at least one of six specific good things, and not too much of any of four specific things we already eat too much of.” It’s not a very holistic definition. Most Americans couldn’t guess it, and we don’t use “healthy” in this way in our daily lives.
The non-holistic, nutrient-by-nutrient focus of FDA’s “healthy” definition has made it a target of criticism, and even outright mockery, in some of the counterintuitive results that it produces in terms of which foods can be called “healthy” and not. Thus, non-lowfat nutritious foods such as avocados, nuts, and fatty fish cannot be called “healthy” even though, really, they’re better for you than a lot of common alternatives. However, heavily sugared breakfast cereals may qualify as “healthy” provided they are fortified with one or two of the encouraged nutrients. Similar complaints have been lodged against the ability of food manufacturers to make specific nutrient content claims through the fortification of a basically unhealthy food with some added substance such as a vitamin or dietary fiber.
Many experts and commentators regard the FDA criteria for both specific nutrient content claims and “healthy” claims as broken, or at least out of step with modern dietary thinking. In March of this year, snack company KIND LLC said as much in a citizen petition submitted to FDA together with a group of health scientists. One of the subtitles in KIND’s position puts it succinctly: “FDA’s Existing Nutrient Content Claim Framework Allows Claims that Mislead Consumers Regarding Quality of 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.
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.
Ultimately, the task faced by FDA in resolving the issues with “healthy” claims is formidable. Perhaps the ultimate source of the problem is that “healthy” is a descriptor best applied to an entire diet, not to an individual nutrient or even really to an individual food. No one food provides complete, balanced nutrition. Almost any food, other than the most nutritionally horrendous, can find a place somewhere in a healthy dietary plan, if only as an indulgence.
And yet, a sentence like, “If you are considering a snack, an apple is healthier than a candy bar,” is not absurd or meaningless. To the extent “healthier” means anything in that sentence, it ultimately must reduce to what nutrients (albeit in a broader sense than FDA’s limited list) are present, and in what quantities, in the foods. But it reduces to all the nutrients in the foods, in the context of everything else their consumers eat. Reduce it any further and, while the healthiness decision between an apple and a candy bar may still be fairly easy, the choice between an apple and a protein bar—let alone between two different protein bars—can’t be predetermined. There may even be no general solution to the equation; too many of the variables are specific to the consumer.
The one thing that can be asserted confidently about nutrient content claims, and especially express or implied “healthy” messaging, is that we have not seen the end of either regulatory evolution or legal activity around them.
Horvath is a partner at Foley Hoag’s Advertising & Marketing practice. Reach him at firstname.lastname@example.org.