Welcome to the United States (“U.S.”), one of the wealthiest nations in the world but far from the healthiest. With an astounding 40% of adults having obesity, the U.S. has the highest obesity rate among high-income countries and also leads the way in prevalence for diabetes and high plasma glucose levels.[i] One in five children in the U.S. are obese.[ii]Additionally, U.S. adults over the age of fifty are more likely to die from heart disease than much older adults in other high-income countries.[iii]
U.S. adults consume 50% more sodium, 40% more added sugars, and 30% more saturated fat per day than recommended, contributing to preventable chronic diseases like type two diabetes and heart disease.[iv] The U.S. packaged food supply is a huge piece of this problem, as ultra-processed foods (“UPF”) make up 73% of the U.S. food supply.[v] UPFs are industrially formulated products made out of substances extracted from sugars, salts, hydrogenated fats, bulking agents, and starches.[vi]
In response to a rise in UPFs, President Bush signed the Nutrition Labeling and Education Act (“NLEA”) into law in 1990, requiring food companies to print nutrition facts on their packages.[vii] Under the NLEA, the Food & Drug Administration (“FDA”) deems a food to be misbranded unless its label provides a series of information, including the serving size, caloric information, and macronutrient requirements.[viii] Specifically, nutrition labels must display the amount of fat, sodium, carbohydrates, sugars, protein, and dietary fiber within the food and allow the Secretary of Health and Human Services to require certain information to be highlighted on the label if doing so would assist consumers in maintaining healthy dietary habits.[ix]
In 2016, the FDA made its first major update to nutrition labels in over twenty years, requiring the serving size and calories to be in large, bold font.[x] This update received little pushback, as companies were still permitted to display the nutritional information on the back, side, or even bottom of the product.[xi] Recent action has led to an uproar, as the FDA made its official proposal to require front-of-package (“FOP”) labeling, pursuant to the Secretary’s highlighting power under the NLEA.[xii]
Under the proposed rule, packaged food must explicitly display whether its contents are “High,” “Medium,” or “Low” in fat, sodium, and added sugars.[xiii] The proposal aims to make nutrient content more readily available to consumers who have been unable to ascertain the hidden, unclear content on the back of products.[xiv] Health advocacy groups are overjoyed with this significant step towards promoting health and wellness in the U.S. However, the food industry is a far cry from such excitement, giving the FDA immense pushback.
Food companies criticize the science behind FOP labeling. Specifically, the seafood industry is alarmed at the implications that FOP labels will have on their product, claiming such labeling could deliver an inaccurate message to consumers who include healthy seafood in their diets. The National Fisheries Institute President Lisa Picard (“Picard”) says the proposal is misleading because it does not distinguish nutrient components of the product. Picard particularly worries that FOP labeling provides no way to highlight nutritious components of the product, such as fish, which is high in unsaturated essential and healthy fats.[xv]
Further pushback stems from the statutory language itself, as critics contend that the proposal overextends the NLEA’s scope. The NLEA mandates a specific complete set of information to appear on the label, consisting of serving size, number of servings per container, calories, total fat, saturated fat, cholesterol, sodium, total carbohydrates, complex carbohydrates, sugars, dietary fiber, total protein, and vitamins and minerals.[xvi] Critics argue that the NLEA does not authorize any additional mandatory nutrition beyond this list.[xvii] Rather, such additional information qualifies as a “nutrient content claim”—a voluntary statement manufacturers use to describe the nutrient levels in a product.[xviii] If FOP labeling requirement is a nutrient content claim, then the FDA’s entire proposal is outside of the specific and limited authority granted by Congress.[xix]
Per its official proposal, the FDA acknowledged this discrepancy, claiming that the “High,” “Medium,” and “Low” scheme is not a nutrient content claim:[xx]
Some of the information that would appear in the Nutrition Info box would be a nutrient content claim if a manufacturer chose to voluntarily include it elsewhere on a food label. But we have determined that the proposed information in the Nutrition Info box, when it appears in the Nutrition Info box, is not a nutrient content claim and would not be subject to the requirements for nutrient content claims.[xxi]
By carving out this exception, the FDA is potentially disregarding legislative intent and attempting to codify law on its own volition.
Constitutional concerns also arise, as compelled commercial speech is protected under the First Amendment.[xxii] Courts use the Zauderer test as a framework for evaluating the constitutionality of compelled commercial disclosures, which is less stringent than other First Amendment protections.[xxiii] This test allows the government to mandate disclosures if they are (1) factual and uncontroversial; (2) reasonably related to a substantial government interest; and (3) not unduly burdensome to companies’ ability to market their products.[xxiv]
First, the FDA’s “High,” “Medium,” and “Low” scheme, while factual, is potentially controversial, as such labeling could be subjective and overly simplistic. Nonetheless, the FDA is likely to prevail, as the scheme is based on long-accepted Daily Values outlined in FDA regulations. Second, the proposal clearly has a substantial government interest, aiming to reduce consumer deception and promote public health by encouraging healthier food choices. Third, the proposal is not unduly burdensome. The content required on FOP labels is already available to companies, as it simply highlights information found on current labels. The FDA is also providing a fair and familiar timeline for the industry to comply, requiring acquiescence three years after the final rule’s effective date for businesses with $10 million or more in annual food sales and four years for businesses with less than $10 million in annual food sales.[xxv]
In the end, this proposal represents a significant shift in the agency’s approach to nutritional transparency, aiming to combat the alarming rates of health concern in the U.S. Despite statutory and constitutional challenges, the proposal is likely to succeed, as similar efforts by the FDA in the past—though slightly less extreme—have come into fruition.[xxvi]The FDA currently seeks feedback on the proposal, welcoming comments until May 16, 2025.[xxvii]
[i] See Samuel D. Emmerich et al., Obesity and Severe Obesity Prevalence in Adults: United States, August 2021–August 2023, Nat. Ctr. for Health Stat. (Sept. 2024), https://www.cdc.gov/nchs/products/databriefs/db508.htm; see also Steven H. Woolf & Lauren Aron, U.S. Health in International Perspective: Shorter Lives, Poorer Health, Nat. Libr. of Med. (2013), https://www.ncbi.nlm.nih.gov/books/NBK115854/pdf/Bookshelf_NBK115854.pdf.
[ii] See Childhood Obesity Facts, Nat. Ctr. for Health Stat., https://www.cdc.gov/obesity/childhood-obesity-facts/childhood-obesity-facts.html (last visited Mar. 3, 2025).
[iii] See id.
[iv] See Peter Lurie, CSPI Celebrates GFA Front-Of-Package Nutrition Labeling Proposal, Ctr. for the Sci. in the Pub. Int. (Jan. 14, 2025), https://www.cspinet.org/statement/cspi-celebrates-fda-front-package-nutrition-labeling-proposal.
[v] See Cecilia Nowell, The US Food Industry Has Long Buried the Truth About Their Products. Is That Coming to an End?, The Guardian (May 20, 2024), https://www.theguardian.com/environment/article/2024/may/20/food-companies-nutrition-labels-truth.
[vi] See id.
[vii] See Marcia Clemmitt, Report Says Congress Needs Better Science Analysis, The Scientist (Nov. 10, 1991), https://www.the-scientist.com/report-says-congress-needs-better-science-analysis-60380.
[viii] See Nutrition Labeling and Education Act 21 U.S.C. § 2(a) (1990).
[ix] See id.
[x] See What’s On The Nutrition Facts Label, Food & Drug Admin. (Mar. 5, 2024), https://www.fda.gov/food/nutrition-facts-label/whats-nutrition-facts-label.
[xi] See Understanding Food Labels, The Nutrition Source (June 2021), https://nutritionsource.hsph.harvard.edu/food-label-guide.
[xii] See Food Labeling: Front-of-Package Nutrition Information, 90 Fed. Reg. 5426 (proposed Jan. 15, 2025) (to be codified at 21 C.F.R. pt. 101).
[xiii] Food Labeling: Front-of-Package Nutrition Information, 90 Fed. Reg. at 5427.
[xiv] See Nowell, supra note v.
[xv] See Christine Blank, NFI, FMI Push Back Against US FDA’S “Unnecessary” New Food Labeling Proposal, Seafood Source (Jan. 16, 2025), https://www.seafoodsource.com/news/food-safety-health/nfi-fmi-push-back-against-us-fda-s-unnecessary-new-food-labeling-proposal.
[xvi] See Marin J. Hahn et al., FDA Lacks Statutory Authority to Mandate Front-of-Pack Nutrition Labeling, Wash. Legal Found. (Apr. 5, 2024), https://www.wlf.org/2024/04/05/publishing/fda-lacks-statutory-authority-to-mandate-front-of-pack-nutrition-labeling/.
[xvii] See id.
[xviii] See Food Labeling: Front-of-Package Nutrition Information, 90 Fed. Reg. 5426, 5437–38 (proposed Jan. 15, 2025) (to be codified at 21 C.F.R. pt. 101).
[xix] See Hahn et al., supra note xvi (“Congress provided very specific and limited authority when it comes to mandatory nutrition information [within the NLEA].”); see also Nutrition Labeling and Education Act 21 U.S.C. § 2(a) (1990) (listing the mandatory information required for nutrition labels).
[xx] Food Labeling: Front-of-Package Nutrition Information, 90 Fed. Reg. at 5457–38.
[xxi] See id.
[xxii] See Zauderer v. Office of Disciplinary Counsel of Supreme Court, 471 U.S. 626, 650 (1985).
[xxiii] See id. at 637.
[xxiv] See id. at 651.
[xxv] Food Labeling: Front-of-Package Nutrition Information, 90 Fed. Reg. at 5455.
[xxvi] See Food & Drug Admin., supra note x (requiring food companies to reformat the nutrition label’s appearance to display the serving size and calories in bold font).
[xxvii] Food Labeling: Front-of-Package Nutrition Information, 90 Fed. Reg. at 5426.
