Regulatory Report
By Adrian C. Azer, J.D., Managing Partner, Washington D.C. Office, Haynes Boone; Barry I. Buchman, J.D., Partner, Haynes Boone; Suzie Trigg, J.D., Partner and Chair of the FDA Regulatory and Compliance Group, Haynes Boone; Reese Letourneau, J.D., Associate, Haynes Boone; and Luke Nguyen, J.D., Associate, Haynes Boone
Ultra-Processed Foods—Running for Cover(age)
A review of developments and strategies to seek potential insurance coverage

Image credit: beats3/iStock/Getty Images Plus via Getty Images
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Barely two months after an American teenager filed a first-of-its-kind lawsuit against major food manufacturers arguing that such manufacturers should be liable for decades worth of development, marketing, and sale of ultra-processed foods (UPFs) that harm children, President Trump released an Executive Order (EO)1 establishing the President's Make America Healthy Again (MAHA) Commission.
Within days of the EO establishing the MAHA Commission, Deputy Commissioner for Human Foods Jim Jones announced his departure from the U.S. Food and Drug Administration (FDA), creating additional uncertainty for industry. Such actions also followed the 2025 scientific report,2 which was released on December 10, 2024 by the Dietary Guidelines Advisory Committee (DGAC). The 2025 report included a new question regarding the effects of UPF on growth, body composition, and risk of obesity, but failed to recommend a reduction in UPF consumption. Companies that have long marketed processed foods must now navigate a rapidly changing landscape.
The EO to Establish the MAHA Commission
The EO establishing the MAHA Commission cites an increase in the diagnoses of diseases such as autism, fatty liver disease, and Attention Deficit Hyperactivity Disorder (ADHD) among young people. The EO calls upon the MAHA Commission to develop a federal policy to "…aggressively combat challenges facing our citizens, including the rising rates of mental health disorders, obesity, diabetes, and other chronic diseases."1
Under this policy, among other efforts, "…agencies shall work with farmers to ensure that United States food is the healthiest, most abundant, and most affordable in the world."1 The MAHA Commission is led by the Secretary of the Department of Health and Human Services (DHHS), Robert F. Kennedy Jr. In addition to Kennedy, the Commission will consist of leaders from several other federal agencies, including the Food and Drug Administration (FDA), the National Institutes of Health (NIH), the Centers for Disease Control and Prevention (CDC), and the Environmental Protection Agency (EPA). The Director of the Office of Management and Budget (OMB) will also sit on the MAHA Commission.
The EO states, "[t]he initial mission of the Commission shall be to advise and assist the President on how best to exercise his authority to address the childhood chronic disease crisis."1 In particular, the Commission will study "potential contributing causes" to chronic diseases, ranging from "the American diet" and "food production techniques" to "government policies" and "corporate influence."1 Further, the MAHA Commission is tasked with assessing the impact of certain food ingredients and chemicals on childhood health. In advising the President, the MAHA Commission is given authority to consider a wide range of sources, such as conducting public hearings, roundtables, and meetings; evaluating current methodologies and data on childhood health in the U.S.; and comparing policies and data from other countries.1
The EO sets a 100-day deadline for the MAHA Commission to submit an initial assessment to the President. Based on this assessment, the Commission must finalize a strategy and present it to the President within 180 days of the EO's date of February 13, 2025.
On February 17, 2025, Jim Jones, Deputy Commissioner for Human Foods at FDA, resigned. As rationale, Deputy Commissioner Jones communicated to the Acting FDA Commissioner that significant losses of personnel—including ten personnel who were recently hired to strengthen food chemical oversight—would make it "fruitless" for him to continue in his role. While Kyle Diamantas was recently announced as Acting Deputy Commissioner for Human Foods, it is expected that Dr. Marty Makary, if confirmed, will represent FDA on the MAHA Commission.
The DGAC's Scientific Report
The Dietary Guidelines Advisory Committee releases a scientific report every five years to assist the U.S. Department of Agriculture (USDA), now led by Brooke Rollins, and the HHS in developing the Dietary Guidelines for Americans. The referenced 2025 report2 was issued in preparation for Dietary Guidelines for Americans, 2025–2030, set to be published in late 2025. The 2025 report answers certain scientific questions developed because of federal and public interest, and because of their importance to public health. The 2025 report was the first report to consider a question solely related to UPFs.
Ultra-Processed Food Scientific Question and Results
The UPF question posed in the 2025 report is, "What is the relationship between consumption of dietary patterns with varying amounts of UPF and growth, body composition, and risk of obesity?"
The UPF question was answered via a systematic review3 released by the DGAC. The articles considered in the review were published between January 2000 and January 2024. In answering the question, the DGAC focused on five categories of people:
- Infants and young children
- Children and adolescents (up to 19 years)
- Adults and older adults
- Individuals during pregnancy
- Individuals during postpartum.
Based on the systematic review, the DGAC did not include recommendations relating directly to limiting UPF consumption in its 2025 report.2 The conclusions drawn from the review3 are listed below:
- Infants and young children: A conclusion statement cannot be drawn about the relationship between dietary patterns of infants and young children up to age 24 months with varying amounts of ultra-processed food and growth, body composition, and risk of obesity because of substantial concerns with consistency and directness in the body of evidence.3
- Children and adolescents (up to age 19): Dietary patterns of children with higher amounts of food classified as UPF are associated with greater adiposity [fat mass, waist circumference, body mass index (BMI)] and greater risk of overweight. Conclusion statement is based on evidence graded as limited.3
- Adults and older adults: Dietary patterns of adults and older adults with higher amounts of food classified as UPF are associated with greater adiposity (fat mass, waist circumference, BMI) and greater risk of obesity and/or overweight. Conclusion statement is based on evidence graded as limited.3
- Individuals during pregnancy: A conclusion statement cannot be drawn about the relationship between dietary patterns during pregnancy with varying amounts of UPF and gestational weight gain because there is not enough evidence available.3
- Individuals during postpartum: A conclusion statement cannot be drawn about the relationship between dietary patterns during postpartum with varying amounts of UPF and postpartum weight change because there is not enough evidence available.3
“…while UPFs are typically higher in added sugars, saturated fats, and sodium, the characterization of UPFs has been primarily based on the use of colorants, emulsifiers, and other additives.”

Despite the new question, the DGAC did not include a reduction in UPF consumption in its recommendations. Likely playing a role in the DGAC's omission was the well-documented concern with the articles available that met their research question. "Because several methods have been developed to characterize ultra-processed foods, the foods and dietary patterns included in the articles were not consistent,"2 the DGAC stated in its 2025 report. Additionally, at a May 2024 meeting4 in which the DGAC discussed the results, they asserted that since many papers contained studies from outside of the U.S., there was concern that the same findings would not be applicable to the U.S. food supply and population.
In the same meeting, DGAC members noted that while UPFs are typically higher in added sugars, saturated fats, and sodium, the characterization of UPFs has been primarily based on the use of colorants, emulsifiers, and other additives.4 Furthermore, the DGAC noted there is minimal data on emulsifiers, colorants, and additives in its current database. Thus, DGAC members called for industry collaboration to ensure that data on these ingredients is obtained accurately.
The Martinez Lawsuit
On December 10, 2024—the same day as the release of the DGAC's 2025 report—Bryce Martinez, a 16-year-old from Pennsylvania who developed type 2 diabetes and non-alcoholic fatty liver disease, filed suit against multiple food manufacturers in the Court of Common Pleas of Philadelphia County.5 Morgan & Morgan, a well-known plaintiff's firm, filed suit on behalf of Martinez. The complaint filed in the lawsuit, which is nearly 150 pages long, makes several state law claims, including:
- Negligence
- Failure to warn
- Breach of implied warranty
- Breach of express warranty
- Negligent misrepresentation
- Fraudulent misrepresentation
- Fraudulent concealment
- Violation of Pennsylvania's Unfair Trade Practices and Consumer Protection Law
- Unjust enrichment
- Conspiracy
- Concerted action.
Based on the alleged actions of the defendants, the plaintiff seeks compensatory damages, economic damages, punitive damages, statutory damages, and "all other relief the court deems just and proper."5
The most recent update on the case occurred on January 22, 2025, when the Kraft-Heinz Company filed a motion to remove the case from the Court of Common Pleas of Philadelphia County to the U.S. District Court for the Eastern District of Pennsylvania.6
Statement of Facts
The complaint alleges that UPFs—and their marketing claims targeted toward children—are the cause of a recent increase in chronic illnesses among young people. For example, the complaint alleges that, because of UPFs, obesity has doubled among adults and tripled among children; the number of Americans living with type 2 diabetes has tripled since 1980; and non-alcoholic fatty liver disease in children is now as common as asthma.6 Although UPFs often consist of high saturated fat, sodium, carbohydrates, or sugar, the complaint argues that UPFs have increased the prevalence of chronic illness because they are ultra-processed, not because of certain nutrients. Therefore, the plaintiff argues, "One cannot evade the risks caused by UPFs simply by selecting UPFs with lower calories, fat, salt, sugar, carbohydrates, or other nutrients."6 In other words, choosing "healthier" UPFs does not remove the risk.
Additionally, now-former FDA Commissioner Dr. Robert Califf recently testified before the Senate Committee on Health, Education, Labor, and Pensions, stating that UPFs are "probably addictive," and that the industry has found "a combination of sweet, carbohydrate, and salt that goes to our brains," which Dr. Califf considers to be addictive.6 This combination, the complaint highlights, has led to "international consensus" that UPFs are dangerous.6
The plaintiff also argues that the defendants' marketing campaigns that allegedly target children magnify the dangers. Citing a 2006 report by the Institute of Medicine (IoM, known as the National Academy of Medicine since 2015), which found that television advertisements "influence children to prefer and request high-calorie and low-nutrient food and beverages," the complaint alleges that the defendants make a concerted effort to target young children and adolescents in marketing campaigns for UPFs.6 Such concerted effort, the IoM report argues, is "a direct threat to the health of the next generation."6 As a result, the IoM recommended changes for UPF manufacturers to improve their "child marketing behaviors."6
However, despite industry claims of self-regulation regarding marketing behaviors, as the complaint points out, follow-up studies conducted by the IoM and the Federal Trade Commission (FTC) found that marketing practices of UPF manufacturers did not "significantly change."6 Instead, the plaintiff argues, the defendants continue to aggressively target children with marketing campaigns in the U.S.6 Notably, according to the complaint, the prevalence and alleged dangers of UPF marketing have resulted in policies and recommendations made by the French, Brazilian, Israeli, and Australian governments, among others, aimed at reducing consumption of UPFs and restricting the marketing of UPFs to children.6 As illustrated by the DGAC's 2025 report, however, the U.S. has not followed suit.
Due to the alleged dangers of UPFs and their marketing, the complaint attributes Martinez's chronic illnesses to the defendants, explaining that Martinez was targeted with "marketing campaigns intended to increase consumption of UPF" and, as a result, "regularly, frequently, and chronically ingested UPF, which caused him to contract type 2 diabetes and non-alcoholic fatty liver disease" at age 16.6
Causes of Action
As previewed above, the lawsuit lists multiple causes of action related to the defendants' development, marketing, and sale of UPFs. These arguments include:
- Negligence: The complaint alleges that the defendants breached a duty of care by manufacturing, researching, testing, producing, supplying, marketing, selling, and distributing UPFs. Furthermore, the complaint argues, the defendants' actions showed a "total lack of care" and an "extreme departure from what a reasonably careful company" would do in a similar position. Such failure occurred when the defendants failed to warn that UPFs are addictive, dangerous, and designed to be overconsumed.6
- Breach of implied warranty: Prior to the plaintiff purchasing and ingesting the defendants' UPF, the complaint alleges that the defendants knew of the uses for which their UPFs were intended and impliedly warranted to the plaintiff that their products were of merchantable quality, and safe and fit for such intended and ordinary uses. Allegedly, when used as intended or reasonably foreseeable, UPFs increase the risk of type 2 diabetes, fatty liver disease, and other chronic illnesses.6
- Pennsylvania Unfair Trade Practices and Consumer Protection Law: The complaint argues that the defendants engaged in unfair competition or unfair, unconscionable, deceptive, or fraudulent acts when they misled consumers regarding the safety risks associated with use of their UPF. Such deceptive acts are said to have occurred when defendants misled consumers—and children in particular—by portraying UPFs as "cool, fun, and safe food substances" while omitting concerns regarding their safety and addictiveness.6
- Conspiracy: The Complaint alleges that defendants entered into an agreement and/or combined to advance their financial interests, as well as worked in concert to maintain and expand the UPF market and ensure a steady and growing customer base. Furthermore, the defendants supposedly had actual knowledge that UPFs were causing severe injuries but continued to withhold the truth.6 The complaint exhaustively details a 1999 meeting with industry leaders, where the defendants' CEOs were warned that the advertising of UPFs to children and young adults was directly contributing to chronic illness, but they did not change their ways.6
“Martinez, while unique, is not the first case brought against major food corporations for allegedly causing chronic illnesses.”

Similarities with Pelman v. McDonald's Corporation (2003)
If you have been watching for a while, you will notice that Martinez, while unique, is not the first case brought against major food corporations for allegedly causing chronic illnesses. In 2003, a class action was filed in the Southern District of New York against McDonald's.7 In the case, Pelman v. McDonald's, the plaintiffs brought suit against McDonald's claiming, among other things, that selling and manufacturing their food was negligent because the defendants failed to warn of the potential hazards of consuming the food, such as a risk of obesity and other chronic health problems.7 Furthermore, the plaintiffs also brought action against McDonald's because they sold addictive products without additional warnings.7 Such claims largely mirror the negligence claims listed in Martinez.
The court, however, dismissed all claims against McDonald's. The court emphasized that, while McDonald's may have played some role in the plaintiffs' health problems, proximate cause requires the defendant to be a substantial cause of the injury.7 Thus, given that there are a significant number of factors that play a role in contributing to obesity, proximate cause could not be proven.
Certainly, Martinez and Pelman have differences that may change the outcome of the current case. For example, UPFs have faced increased public scrutiny in recent years and are facing even more scrutiny at present, and Martinez offers different causes of action (i.e., unjust enrichment, conspiracy, and breach of implied warranty). However, the negligence and failure to warn causes of action alleged in Martinez are likely to encounter the same question as in Pelman: Is the complaint sufficient to establish UPFs as a proximate cause of the plaintiff's chronic illnesses?
If Pelman is any indication, this may prove to be a high hurdle for Martinez to clear.
Finding Insurance Coverage for UPF Claims
If faced with the current Martinez suit and/or potential future claims because of the use or sale of UPFs, companies may look to their insurance programs to offset the costs of such claims and thereby minimize their financial impact. UPF claims may follow a mass-tort model akin to substances that, once ingested, cause damage but are ultimately expelled from the body. Thus, as with other mass torts, companies should evaluate their occurrence-based policies for potential coverage, including evaluating prior policies that may cover such claims.
A first step is for companies to gather their occurrence-based insurance policies. Given that UPFs have been in use since the 1980s, policies going back that far may respond to UPF claims, and the earliest of those policies may provide the broadest coverage. Thus, gathering and evaluating all of those policies is critical.
Once companies have gathered all potentially applicable insurance policies, it is important to analyze both the policies and the law that may govern them, with a focus on potential coverage issues that likely will arise. Such issues include, without limitation, the following two issues:
- Trigger of coverage: Policyholders need to evaluate what is the "occurrence" that implicates a policy and when that occurrence began. Trigger of coverage is a highly contested issue in the world of mass torts. Policyholders typically want to trigger as many policies as possible in order to maximize the insurance available.
- Number of occurrences: Determining the number of occurrences is critical to policyholders in evaluating how to maximize coverage. For example, when insurance policies have significant "per occurrence" deductibles or self-insured retentions (SIRs), insurers often argue that each individual claim (or even each individual exposure to the allegedly harmful substance) constitutes its own occurrence and is subject to its own deductible or SIR. Depending on the size of the deductible or SIR and the average cost of each claim, such an approach could effectively eviscerate coverage. Conversely, if there are no such deductibles or SIRs, then policyholders may want a "multiple occurrences" approach if their policies have only "per occurrence" limits or have aggregate limits that exceed the "per occurrence" limits.
The coverage provided by occurrence-based insurance policies can be an extremely valuable business asset. Companies facing current and/or potential future UPF claims can maximize the benefits of that asset, and minimize the chances of protracted disputes later, by acting proactively now to assess and preserve their rights under those policies.
Taking Precautions
The harsh spotlight on processed foods may be just beginning to shine if the newly established MAHA Commission fulfills its charge, or if the Martinez case moves forward. In launching products, or in relabeling or creating advertising for existing products, food manufacturers and marketers should take careful note of the current climate and emerging state laws, as states are increasingly seeking to ban specific food chemicals. Marketers should also take notice of the need to carefully examine formulations, processing, and claims made on labeling and in advertising—especially advertising that may be viewed by children.
Note
The views expressed in this article are solely those of the authors, and do not necessarily reflect the views of Haynes Boone LLP or any of its clients. This article also does not constitute or provide legal advice, which should be based upon a company's individual circumstances.
“Each step in the 'rings of defense' must be used consciously and with proper consideration, as it may be obvious what caused the noncompliance, and its resolution may be straightforward, simple, and not costly.”


References
- The White House. "Establishing the President's Make America Healthy Again Commission." Executive Order. February 13, 2025. https://www.whitehouse.gov/presidential-actions/2025/02/establishing-the-presidents-make-america-healthy-again-commission/.
- U.S. Department of Agriculture (USDA). "Scientific Report of the 2025 Dietary Guidelines Advisory Committee." December 10, 2024. https://www.dietaryguidelines.gov/sites/default/files/2024-12/Scientific_Report_of_the_2025_Dietary_Guidelines_Advisory_Committee_508c.pdf.
- Stanford, F.C., Taylor, C., Booth, S., et al. "Dietary Patterns with Ultra-Processed Foods and Growth, Body Composition, and Risk of Obesity: A Systematic Review." USDA. November 2024. https://nesr.usda.gov/sites/default/files/2024-12/Dietary-patterns-ultraprocessed_growth-obesity2025DGACSystematicReview.pdf.
- National Institutes of Health (NIH). "2025 Dietary Guidelines Advisory Committee: Meeting 5 (Day 2)." May 30, 2024. https://videocast.nih.gov/watch=54603.
- Martinez v. Kraft Heinz Company, Inc., No. 241201154 (Phila. Ct. C.P. Feb. 10, 2024).
- Martinez v. Kraft Heinz Company, Inc., No. 2:2025cv0037 (E.D. Pa. Jan. 22, 2025).
- Pelman v. McDonald's Corp., 237 F. Supp. 2d 512, 530 (S.D.N.Y. 2003).
Adrian C. Azer, J.D. is Managing Partner of Haynes Boone's Washington D.C. office. He represents corporate policyholders in a variety of complex insurance coverage matters. Clients seek Adrian's representation in connection with insurance recovery for mass tort claims and contamination claims.
Barry I. Buchman, J.D. is a Partner in the Insurance Recovery Practice group at Haynes Boone. He represents policyholders in a wide variety of complex insurance coverage matters. Among many other types of coverage matters, he has handled disputes over general liability coverage for various toxic tort and environmental claims, including "medical monitoring" claims and claims by governmental entities related to public health.
Suzie Trigg, J.D. is Chair of the Haynes Boone FDA Regulatory and Compliance Group. She develops practical strategies and solutions for companies that produce or sell FDA-regulated products to assess and respond to evolving regulatory requirements, risks associated with their products, and FDA actions.
Reese Letourneau, J.D. is an Associate in the Insurance Recovery practice group. Her practice focuses on corporate insurance recovery in a wide array of industries, exclusively representing policyholders in insurance coverage disputes and aiming to maximize recoveries under various insurance policies.
Luke Nguyen, J.D. is an Associate in the FDA Regulatory practice group. His practice focuses on assessing and solving FDA regulatory compliance issues for companies developing, manufacturing, or marketing FDA-regulated products.