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.”