To employ an oft-used quote, “the devil is in the details.” The use of certain words and phrases could result in a company making certain claims it does not realize it is making and did not intend to make. If the criteria for such claims are not met, the Food and Drug Administration (FDA) may consider such products to be misbranded. To avoid being overrun by “labeling demons,” companies must be well-versed in the linguistics of labeling laws.
Many companies craft marketing messages designed to tout the existence of “trendy” ingredients, using descriptive phrases such as “rich in calcium,” “packed with green tea” or “high in vitamin C.” Other companies use seemingly benign words such as “contains” or “provides” to indicate the existence of an ingredient, without necessarily intending to imply a particular level of that ingredient. However, claims in labeling that characterize a level of a particular nutrient in a product are nutrient content claims and must comply with the applicable regulations addressing such claims.
Claims such as “rich in calcium” or “high in vitamin C,” pursuant to 21 CFR 101.54(b), indicate the food contains at least 20% of the Recommended Daily Intake (RDI) or Daily Recommend Value (DRV) of the described nutrient in each serving. Meanwhile, 21 CFR 101.54(c) indicates the use of “contains” or “provides”—which may not seem to imply any particular level of a nutrient—but actually means there is at least 10% of the RDI or DRV of the referenced ingredient in each serving. Words and phrases that are not specifically identified in 21 CFR 101.54, such as “packed,” “overflowing” or “teeming,” are not authorized for use in a nutrient content claim.
While the FDA has, in some warning letters, recognized such phrases to be synonymous with claims like “high in” or “rich in” and has exercised enforcement discretion to allow their use, companies still must comply with the requirements for such claims—most notably, that at least 20% of the RDI or DRV of the ingredient is contained in the product. Finally, it is important to note that such nutrient content claims are only permitted to describe nutrients for which RDIs or DRVs have been established. If there is no established RDI or DRV for a particular ingredient, no claim may be made that either expressly or implicitly describes the amount of the ingredient in the product. So, a company seeking to promote the hottest new ingredients must take special care to ensure its word choices are in line with nutrient content regulations.
“Healthy” is another word used ubiquitously in the labeling and advertising of food products. The desire of companies to have their products thought of as “healthy” has steadily increased as consumers continue to be more conscious of their overall health. However, the inclusion of “healthy” in labeling messages often occurs without the realization by the company of what is implied by its use. The context in which “healthy” is used in labeling will be determinative of its regulatory status as a structure-function claim, a health claim or a nutrient content claim. Unless the claim complies with the criteria for such claims, the product is legally misbranded.
“Supports a healthy immune system” or “helps maintain a healthy circulatory system” are examples of legally permissible structure-function statements using the word “healthy.” But, the company must have sufficient substantiation for such claims. However, a claim of “heart healthy” is a statement the FDA indicated is likely to be considered an implied health claim. A health claim may be used on a label or in labeling, if the claim has been authorized by the FDA, via regulation; meets the requirements for the particular health claim; and contains the specific language necessary to legally convey that claim.
Any references using the word “healthy” (or derivatives, such as “health” or “healthiness”), in association with a claim about a nutrient to suggest the food, because of its nutrient content, may be useful in maintaining healthy dietary practices, are considered implied nutrient content claims. These claims must comply with the requirements of 21 CFR 101.65(d); such foods must meet certain requirements for limited amounts of fat, saturated fat, sodium or cholesterol, and have at least 10% of the RDI or DRV for vitamin A, vitamin C, calcium, iron, protein or fiber. Thus, “healthy” often implies more than just a sought-after product category for companies looking to market products to health-conscious consumers.
Using the word “only” or “just” to promote a low level of a particular nutrient also is common in food labeling. For example, “just 5 grams of fat” or “only 5g of sugar” are phrases often seen on labels. While they might not appear to be express nutrient content claims, the FDA considers words like “only” or “just” to imply that the food meets the requirements for low-nutrient content claims. Companies must ensure the use of those words is consistent with the claims such statements imply. Pursuant to 21 CFR 101.13(i), if a statement implicitly characterizes the level of a nutrient and is not consistent with the defined claim, the label must carry a disclaimer adjacent to the claim. One example is, “only 200mg of sodium, not a low sodium food.”
There are many other specific words frequently used in labeling foods that a company must ensure are accurate and not misleading. The regulatory and litigation issues around use of the terms “natural” and “all natural” have been reported ad nauseum in articles and publications. Without a formal definition contained in laws or regulations enforced by the FDA, the use of “natural” and “all natural” in labeling food, beverages and supplements carries significant risks of civil litigation from zealous plaintiffs’ lawyers, as shown by the frequent cases filed over the last several years.
“Organic” has been defined by the U.S. Department of Agriculture (USDA) as part of its National Organic Program. Ingredients and products must meet the specific criteria in order to legally use “100% organic” or “organic” on labels or in the labeling of food products—or companies may face action from the USDA.
The choice of words can shape a company’s compliance obligations and, possibly, lead to unwanted federal enforcement action or civil litigation. So, for food, beverage and supplement makers, that “magical” phrase or tagline created by the marketing department needs to not only be persuasive, it must also comply with the applicable labeling regulations that govern the type of claim implicated by the word selection. By ensuring the language of labeling claims is compliant with applicable labeling regulations, companies can focus on making and moving product—and avoid running afoul of the various labeling demons. pf
|Class (Action) Wars|
In the past two years, the food and beverage, dietary supplement and cosmetics industries have seen a flood of consumer class action litigation targeting advertising and health claims. In just the past year, more than 150 class actions have been filed in state and federal court focusing on health claims—from “all natural” representations, to advertising that suggests a product is healthy or contains beneficial ingredients, to litigation challenging the failure to disclose that a product may have adverse health benefits. Recent FDA and FTC activity suggests regulators also are paying more attention to this area, which could lead to more enforcement actions and more class action litigation.
Class action plaintiffs’ lawyers claim consumers are misled by these advertising tactics and often seek to recover the entire purchase price paid by each member of the putative class—amounts that often reach into the hundreds of millions. Many of these lawsuits have drawn media attention, increasing the pressure on companies targeted. Businesses often must spend millions to defend the lawsuits, and settlements often are in eight figures. pf