Avoid Claims Court
The FDA is the federal regulatory agency charged with regulating the labeling of food, beverage and supplement products. The FDA has issued regulations which implement various provisions of the Federal Food, Drug and Cosmetic Act (FFDCA) regarding labeling; those regulations are set forth in the Code of Federal Regulations (CFR) at 21 CFR Part 101. More specifically, 21 CFR 101.13 sets forth the general requirements and parameters for nutrient-content claims.
What is a “nutrient-content claim?” A nutrient-content claim is defined in FDA 21 CFR 101.13(b) as “a claim that expressly or implicitly characterizes the level of a nutrient” in a food. Thus, companies may not use phrases such as “low in calories,” “rich in calcium” or “fat free” with impunity. Nutrient-content claims may not be legally made unless they are made in accordance with one of the regulations found at 21 CFR 101.54 to 21 CFR 101.67. The following are a few of those types of claims.
Levels of Nutrients in Foods
Some of the most common nutrient-content claims are those that expressly or implicitly make a claim about the level of a nutrient in a food in relation to the Reference Daily Intake (RDI) or Daily Reference Value (DRV). Displayed on many labels, these are claims such as “rich in potassium,” “good source of calcium” or “high potency.” Such claims must meet the requirements set forth in 21 CFR 101.54. Claims using the words “rich,” “high” or “excellent source of” are authorized by 21 CFR 101.54(b), as long as the food contains at least 20% of RDI or DRV of the specified nutrient in each serving. (Serving sizes or Recommended Amount Customarily Consumed [RACCs] are prescribed at 21 CFR 101.12.)
Meanwhile, 21 CFR 101.54(c) allows for the use of “contains,” “provides” or “good source of” to describe nutrients for which there is between 10-19% of the RDI or DRV in each serving of a food. “High potency” may be used when individual vitamins and minerals are present at 100% or more of the RDI per serving. Such claims may only be made for the nutrients, vitamins and minerals for which an RDI or DRV has been established.
Statements describing ingredients without an established RDI or DRV must be crafted to ensure there is no express or implied claim about the level of the ingredients in the food product. Additionally, words and phrases that aren’t specifically provided for in 21 CFR 101.54, such as “full of,” “packed with” or “loaded with,” are not authorized to describe a particular level of a nutrient.
Claims referencing the level of antioxidants in foods have become increasingly popular in promoting food products. Marketers have determined that the presence of “antioxidants” in foods, beverages and dietary supplements is an attractive buying point for consumers. While antioxidant claims are popular, they often are improperly phrased and not in compliance with the regulation permitting such claims. Claims indicating the level of antioxidants in a product must meet the parameters set forth in 21 CFR 101.54(g).
A claim that references a particular level of antioxidants must identify one or more specific nutrients that are the source of the antioxidants, and said nutrient or nutrients must be referenced in the claim. A claim such as “rich in antioxidants” is not a legally permissible claim, because the source of the antioxidants is not identified. Additionally, the nutrient or nutrients identified as the source of the antioxidants must have an established RDI or DRV. A claim such as “high in antioxidants from açai berries” also is not a legally permissible claim, because açai berries do not have an established RDI or DRV. Finally, the level of the nutrient or nutrients that are the source of the antioxidants must be sufficient to qualify for the claim. For example, if the claim is “high in antioxidant vitamin C,” there must be at least 20% or more of the RDI for vitamin C in each serving of the food for the claim to be a legally permissible claim.
“Free of” or “Low” Claims
Nutrient-content claims may also be used to tout the presence of certain nutrients on the other end of the spectrum. Claims using “free of” or “low” appear with ever-increasing frequency, and 21 CFR 101.60 provides the requirements for claims touting products as “calorie free” or “low in calories.” Pursuant to subsection (b)(1), a claim of “no calories” or “calorie free” may be made if a food contains fewer than 5 calories per serving, while “low calorie” may be used if a food contains no more than 40 calories per serving. Similar claims for sodium content can be made if the food and the sodium content meet the requirements set forth in 21 CFR 101.61. Claims regarding low levels of fat, fatty acids and cholesterol must be made pursuant to 21 CFR 101.62.
Comparison Claims—“Light” and “More”
Comparison claims are another oft-utilized form of nutrient-content claims. Claims using relative terms like “more,” enriched,” added,” “extra” or “plus” must meet the requirements of 21 CFR 101.54(e). Such claims may be made as long as the food for which the claim is made contains at least 10% more of the RDI or DRV of the specified nutrient than an appropriate reference food. Pursuant to 21 CFR 101.56, claims using the terms “light” or “lite” may be used on a food if the food derives 50% or more of its calories from fat, and its fat content is reduced by 50% or more per serving than an appropriate reference food.
Alternatively, if a food derives less than 50% of its calories from fat, a “light” or “lite” claim may be made, if the number of calories is reduced by one third compared to an appropriate reference food. Both types of comparative claims require additional disclosures, set forth in the respective regulations, regarding the identity of the reference foods and quantitative information comparing the levels of nutrients between the two products.
The Importance of Compliance
There are highly specific regulations pertaining to nutrient-content claims. But, are they closely regulated? Improper nutrient-content claims have been a consistent component of Warning Letters issued by the FDA over the last several years.
Recently, the FDA issued a number of Warning Letters identifying improper antioxidant nutrient-content claims. In 2012, Warning Letters were issued by the FDA to companies for statements such as: “tart cherries are a rich source of antioxidants…” and “loaded with protective antioxidant polyphenols.” In each of those letters, the FDA asserted that neither cherries nor polyphenols have an established RDI or DRV, thereby making the claims noncompliant. Other Warning Letters in 2012 cited claims such as “contains…protein” and “rich mineral content,” with the FDA alleging that the products did not contain the requisite levels of the nutrients to make such claims.
While such claims have traditionally been regulated almost exclusively by the FDA, the tide has turned in the past year or two to private litigation over such claims.
Class actions filed in 2012 against food, beverage and supplement companies included allegations over the improper use of nutrient-content claims for antioxidants and green tea, as well as specific claims, such as “excellent source of omega-3s,” “potassium-rich” and “good source of electrolytes.” In many instances, the FDA’s opinion that companies have violated federal labeling regulations regarding nutrient-content claims, as expressed in various Warning Letters, was utilized as the main “proof” for allegations of misleading labeling and advertising.
While companies have defenses available to them, including preemption arguments and the lack of actual damages suffered by alleged plaintiffs, it is unquestioned that it will cost companies a good deal of time and money to address alleged improper nutrient-content claims. The best plan of action for companies wanting to use nutrient-content claims to attract consumers is to ensure that claims are compliant at the production stage, as opposed to down the road when a challenge is made.