Nutrient content claim

A nutrient content claim is a claim that characterizes, either expressly or implicitly, the level of a nutrient in a dietary supplement.1 Source: Dietary Supplement Labeling: Overview, Labeling Claims for Dietary Supplements: Nutrient Content Claims (summarizing 21 C.F.R. §§ 101.13, 101.54–101.67; 21 U.S.C. § 343(r)) The FDA's regulations define many of the terms used to make these claims, including "high in," "contains," "light," and "more." 2 Source: Dietary Supplement Labeling: Overview, Labeling Claims for Dietary Supplements: Nutrient Content Claims (summarizing 21 C.F.R. §§ 101.13, 101.54–101.67; 21 U.S.C. § 343(r)) Wording such as "excellent source of calcium" is typical of the claims that foods and dietary supplements may be eligible to bear on their labels and in labeling. 3 Source: Product Labeling, Foods, Drugs, Medical Devices, and Cosmetics: Food (citing 21 C.F.R. §§ 101.3–101.7, 101.9, 101.13, 101.14, 101.36)

The FDA's dietary supplement labeling regulations exist to help inform consumers about the supplements they buy and use, to prevent consumer deception, and to aid the comparison of nutrition information between products. 11 Source: Dietary Supplement Labeling: Overview (summarizing 21 U.S.C. § 331(a), (c))Defined terms make that comparison possible. When "high in" or "light" has a fixed meaning, and other terms count as misbranding, a shopper can compare two products' claims on the same scale instead of guessing what each seller meant. 12 Source: Dietary Supplement Labeling: Overview, Labeling Claims for Dietary Supplements: Nutrient Content Claims (summarizing 21 C.F.R. §§ 101.13, 101.54–101.67; 21 U.S.C. § 343(r))

The stakes of a level-of-nutrient claim go beyond the number itself. A study cited in FTC staff's comment on a draft report on dietary supplement labels stated that 90% of consumers interpreted a nutrient content claim as a claim about the food's health benefits. 13 Source: FTC Division of Advertising Practices, Staff Comment on Draft Report of the Commission on Dietary Supplement Labels, n.2If shoppers hear a health message in "low in fat," an inaccurate or unauthorized claim misleads them about what the product does for them, which is why the term draws scrutiny.

Two agencies are involved. The FDA regulates the labeling of dietary supplements, while the advertising of conventional foods and dietary supplements is regulated by the Federal Trade Commission. 14 Source: Dietary Supplement Labeling: Overview (summarizing 21 U.S.C. § 331(a), (c))The FTC's food-claim orders connect the two regimes. In the Uno Restaurant order, a representation that conveys a nutrient content claim defined by an FDA labeling regulation is measured against that regulation's qualifying amount, and nothing in the order prohibited a representation that FDA regulations under the Nutrition Labeling and Education Act of 1990 specifically permit in labeling. 15 Source: In re Uno Restaurant Corporation, Pizzeria Uno Corporation, and Uno Restaurants, Inc., Agreement Containing Consent Order, Order Part IIBorrowing the FDA's threshold means an advertiser covered by such an order judges an ad by the same standard the label uses, rather than facing a second, different test.

A nutrient content claim that uses a term the FDA has not authorized makes a dietary supplement misbranded. 37 Source: Dietary Supplement Labeling: Overview, Labeling Claims for Dietary Supplements: Nutrient Content Claims (summarizing 21 C.F.R. §§ 101.13, 101.54–101.67; 21 U.S.C. § 343(r))The consequence reaches the sale itself, because the law prohibits the introduction, delivery for introduction, and receipt of misbranded dietary supplements in interstate commerce (21 U.S.C. § 331(a), (c)). 38 Source: Dietary Supplement Labeling: Overview (summarizing 21 U.S.C. § 331(a), (c))

On the advertising side, FTC orders over nutrient claims have carried money and long-running obligations. Under its order, The Dannon Company was required to pay $150,000 on or before the tenth day following entry of the order. 39 Source: In re The Dannon Company, Inc., Final Decision and Order (Mar. 18, 1996)That order also required Dannon to keep, for three years after the last dissemination of a covered representation, the materials relied on to substantiate it and any evidence that contradicts or calls it into question. 40 Source: In re The Dannon Company, Inc., Final Decision and Order (Mar. 18, 1996)The order was set to terminate on March 18, 2016, or twenty years from the most recent federal-court complaint alleging a violation, whichever comes later. 41 Source: In re The Dannon Company, Inc., Final Decision and Order (Mar. 18, 1996)In Dannon's consent agreement, the proposed respondent acknowledged that it may be liable for civil penalties in the amount provided by law for each violation of the order after it becomes final. 42 Source: In re The Dannon Company, Inc., Agreement Containing Consent Order (signed Aug. 31, 1995)

The orders also reach past the one product or nutrient that triggered them. Dannon's order covers any frozen food product and the amounts of fat, saturated fat, cholesterol, or calories in it. 43 Source: In re The Dannon Company, Inc., Final Decision and Order (Mar. 18, 1996)Uno's order covers any food product containing a baked crust and any other nutrient or substance, not only total fat in Thinzettas. 44 Source: In re Uno Restaurant Corporation, Pizzeria Uno Corporation, and Uno Restaurants, Inc., Decision and Order, Order Part IA closed investigation does not settle the question either. When the FTC closed its Catfish Institute investigation, it stated that the closing was not a determination that a violation may not have occurred and that it reserved the right to take further action. 45 Source: Letter from Phoebe D. Morse, Regional Director, FTC Boston Regional Office, to William Allen, Jr., President, The Catfish Institute (May 16, 1996)