Nutrition Labeling and Education Act

The FDA has regulatory authority over the labeling of the majority of food and beverages for sale in the country. In 1990, Congress enacted the NLEA, which amended the Food, Drug and Cosmetic Act of 1938 (FDCA). By 1993, the FDA enacted most of the regulations carrying out the intent of the NLEA. These regulations expand and explain how the FDA will enforce NLEA requirements.

The NLEA authorized the FDA to regulate nutrition labeling and disclosure statements. The “label” is defined as “display of written, printed, or graphic matter upon the immediate container of any article,” and which must also appear or be easily legible from the outside container or wrapper.^[1] Labeling means all labels and other written, printed, or graphic matters upon or accompanying the article, container, or wrapper.^[2] Thus, labeling includes things like shelf tags accompanying the food.

Instead of directly requiring or prohibiting certain practices, the NLEA specifies that certain labeling practices or lapses in labeling would render a food misbranded. The regulation states that a food designed for sale to consumers is considered misbranded if: it has a false or misleading label; it is misnamed; is an imitation but does not so state; the container is misleading, or does not disclose the name and place of business of the manufacturer, packer, or distributor; it does not state the quantity of the contents; required information is not prominently displayed; it misrepresents to be a food with a standard of identity; it does not disclose the ingredient list using common usual names of ingredients; it does not meet standards of quality prescribed by regulations (e.g., pasteurization); it misrepresents that it is for special dietary use; it does not list artificial flavoring, coloring, or chemical preservatives; or it does not disclose the eight major food allergens, nutrition information, or health and nutrition-related claims according to regulations.^[3]

A few provisions are worth explaining. In terms of the major food allergens noted above, Congress passed the Food Allergen Labeling and Consumer Protection Act of 2004, which requires that the eight “major food allergens,” defined as milk, eggs, fish, crustacean shellfish, tree nuts, wheat, peanuts, and soybeans,^[4] must be explicitly disclosed on all food regulated by the FDA. The Act requires a statement that the product “Contains” the food source from which the allergen is derived to be printed immediately after or adjacent to the ingredient list, or the list of ingredients must include the common or usual name of the food allergen followed by the name of the food source in parentheses.^[5]

FDA regulations require the ingredient list to disclose ingredients in descending order of predominance by weight until the product contains 2% or less by weight of an ingredient, in which case the manufacturer may use a quantifying statement, such as “Contains _ percent or less of_.”^[6]

In terms of nutrition information, the product would be considered misbranded unless the Nutrition Facts Panel provides: the serving size based on the amount customarily consumed or common household measure; number of servings per container; total number of calories and total number of calories derived from the total fat; amount per serving of total fat, saturated fat, cholesterol, sodium, total carbohydrates, complex carbohydrates, sugars, dietary fiber, and total protein; and specific vitamins and minerals. The regulations permit the Secretary of Health and Human Services (HHS) (which by designation translates into the FDA) to specify other nutrients if such information “will assist consumers in maintaining healthy dietary practices.”^[7] The FDA is undertaking rulemaking, discussed below, that might amend some of these requirements.

When a food is misbranded the agency has limited recourse against the violator. Although it has the power to issue civil fines in the context of food safety (including missing allergen information), the FDA does not have the authority to issue fines in the context of false or misleading labels.^[8] The vast majority of misbranding violations are thus met with a Warning Letter putting the company on notice that its label violated the NLEA.^[9] Through Warning Letters, the FDA seeks voluntary compliance by the company to correct the labeling violation. The agency may alternatively hold a meeting with the violator to discuss the violation. After notice through a letter or meeting, the FDA may condemn and seize misbranded food if it is dangerous to health, or if the labeling is fraudulent, or materially misleading in a way that could injure or damage a purchaser or con- sumer.^[10] This is rare in the typical misbranding context.

A final and not highly utilized option of limited availability to the FDA is for it to work with the United States Department of Justice (DOJ) to seek an injunction or initiate a criminal prosecution after providing notice through the letter or meeting.^[11] The FDA is prohibited from reporting “minor violations” to the DOJ and it has little guidance to determine when a food-related violation rises to the level of criminality.^[9] The FDCA gives the FDA leeway to determine otherwise, but Congress stated that the FDA should not elevate a violation when the “public interest will be adequately served by a suitable written notice or warning.”^[13] Thus, for the vast majority of cases, the FDA responds to labeling violations by issuing Warning Letters.

It is important to note that the FDA lacks the authority to compel a company responsible for a misleading claim to disclose the research or scientific data that presumably served as the basis for the claim.^[14] These are called substantiation documents, and unlike other government entities such as the FTC and state attorneys general, the FDA cannot require companies to provide the agency with substantiation documents if the FDA questions a claim.^[15] Rather, the FDA has the burden of conducting its own research if it questions information on a company’s label. This is a very high burden and dissuades the FDA from addressing all potential labeling violations.

[1] 21 USCS § 321 (m)
[2] 21 USCS § 321(k)
[3] 21 USC 343.
[4] 21 USCS § 321(q)(q)(1).
[5] 21 USCS § 343(w).
[6] 21 CFR 101.4.
[7] 21 USC 343(q).
[8] 21 USC § 333.
[9] J. L. Pomeranz. A Comprehensive Strategy to Overhaul FDA Authority for Misleading FoodLabels. American Journal of Law & Medicine. 20i3;39(4):6i7-647.
[10] 21 U.S.C. § 334.
[11] 21 USC 335.
[12] J. L. Pomeranz. A Comprehensive Strategy to Overhaul FDA Authority for Misleading FoodLabels. American Journal of Law & Medicine. 20i3;39(4):6i7-647.
[13] 21 U.S.C. § 336.
[14] U.S. Government Accountability Office. GAO-11-102. Food Labeling: FDA Needs ToReassess Its Approach to Protecting Consumers From False or Misleading Claims. 2011.
[15] J. L. Pomeranz. A Comprehensive Strategy to Overhaul FDA Authority for Misleading FoodLabels. American Journal of Law & Medicine. 2013;39(4):617-647.