We’re all familiar with nutrient-content claims, even if we’ve never heard that name. Terms like high, low, good source, added, enriched, more, and fewer, when paired with a particular nutrient, signal to the consumer that a product is healthy. For many consumers, the nutrient-content claim may be the only information they read, so adding one to the product label can pack a significant punch.
The FDA regulates nutrient-content claims, with some general rules set forth in 21 CFR § 101.13, and more detailed requirements laid out in sections 101.54-69, these latter provisions being commonly referred to as Subpart D. Subpart D provides the maximum and minimum amounts of each regulated substance that would allow the product to qualify for a nutrient-content claim about that substance. This article summarizes the general rules for nutrient-content claims. But anyone wanting to make such a claim should also follow the detailed requirements in Subpart D before sending any label to the printer.
FDA defines a nutrient-content claim as a claim that expressly or impliedly characterizes the level of a nutrient of the type that is required to be listed on the label’s nutrition-information panel (the information required to be on the nutrition-information panel itself is not considered to be a nutrient-content claim).
An express claim is one that directly states the amount of the nutrient. Examples of express claims are “100 calories” or “low fat.” An implied claim suggests the presence of a nutrient at a certain level, or suggests that the food may be useful for maintaining healthy dietary practices and also makes an explicit claim about a nutrient. The claim “high in oat bran” is an example of the former; the statement “healthy, 3 grams of fat” is an example of the latter.
FDA provides some broad general principles for nutrient-content claims. When making a statement about the amount or percentage of a nutrient, the manufacturer has three options:
It can simply state an amount that is not false or misleading, such as “100 calories.”
It can make a statement that suggests that the amount of the nutrient meets Subpart D’s requirements for the particular claim, in which case it must in fact comply with Subpart D (e.g., “less than 3 g fat per serving,” implying that the product is low in fat, so the product must meet Subpart D’s requirements).
It can make a statement that suggests the product meets Subpart D’s requirements when in fact it does not, in which case it must include a disclaimer (e.g., “only 200 mg sodium, not a low-sodium food.” The use of the word “only” indicates that the product is low in sodium, but the product does not meet Subpart D’s definition of low sodium (only products with 140 mg or less of sodium qualify as low-sodium foods). This statement is useful if a product is significantly “healthier” than competing products but not quite “healthy” enough to qualify under Subpart D.
What about relative claims, those claims that a food has fewer, less, or more of something, or that a food contains added or reduced amounts of a nutrient? First, you must be comparing the amount of the particular nutrient in the product to an amount of that nutrient in an appropriate reference food. That makes sense; the fact that celery sticks have more fiber than a serving of ice cream is hardly deserving of recognition.
For “less” and “fewer” or “more” claims, the comparison food may be a similar food or a dissimilar food within the product category. If your product is a bag of potato chips, you might compare it to another brand of chips, or to another similar snack food such as pretzels. If your product is orange juice, you could compare it to another brand of juice or to vitamin C tablets.
For claims that a product is “light,” “reduced,” “added,” “extra,” “plus,” “fortified,” or “enriched,” the comparison food must be a similar food (e.g., chips for chips). For “light” claims, the reference food must be representative of the type of food that includes your particular product making the claim. For all other claims, you may simply use your regular product, or a product that another manufacturer has regularly offered for sale to the public for a substantial amount of time. Absent these restrictions, a manufacturer could create an experimental product with, say, 20,000 mg of sodium, and then, using that product as the reference food, claim that all of its products were reduced sodium. Of course, none of you would do that, but who’s to say what your competitor might try?
The product label must identify the reference food and the percentage or fraction of the amount of the nutrient in the reference food by which the labeled product differs; this must be immediately adjacent to the claim. For example, “1/3 fewer calories than” or “30% less fat than.” Finally, you may not make a “relative” claim if the reference food would itself already qualify for its own nutrient-content claim.
While these regulations are complex and require careful attention to detail, they are also quite simple; their purpose is to prevent manufacturers from confusing consumers or misleading them into believing a product is healthier than it really is, or that the consumer ought to purchase one product over another for health reasons when the product lacks any real health benefit. When viewed through this lens, the regulations are in fact much easier to follow. By giving the consumer a product label that is low in misleading claims and high in informative facts, both FDA and the consumer will be happy.Jennifer Allen, Partner, Stinson LLP