A product given to American troops during wartime later evolved into a massive, lucrative industry. Although this product was unhealthy and physically addictive, the companies behind its manufacture attempted to downplay its health risks and place responsibility on consumers. Industry leaders ultimately succeeded in marketing this product to the American public and reaped substantial profits along the way.
Many readers might assume, correctly, that the allegations above point to the tobacco industry. According to a recent lawsuit brought by San Francisco City Attorney David Chiu ’95, though, they also apply to ultraprocessed foods. Defendants named in Chiu’s complaint include Kraft Heinz, Mondelez, Post, Coca-Cola, PepsiCo, General Mills, Nestle, Kellanova, Kellogg, Mars, and Conagra.
Lawsuits against the manufacturers of allegedly unsafe or unhealthy food are hardly a new concept. According to Harvard Law Clinical Professor Emily M. Broad Leib ’08, however, the San Francisco case is “unique” because “it’s the first case of its kind filed against ultraprocessed foods manufacturers by government, rather than by private individuals.”
On the heels of this new lawsuit, Harvard Law Today met with Broad Leib, an expert who serves as director of both the Harvard Law School Food Law and Policy Clinic and the Harvard Law School Center for Health Law and Policy Innovation, to discuss the latest legal challenge against companies that sell ultraprocessed foods and the urgent need for meaningful food policy changes.
Harvard Law Today: What are ultraprocessed foods? How do they impact human health?
Emily Broad Leib: Ultraprocessed foods, or “UPF,” are foods that use ingredients and methods that average people making food at home don’t use. They generally involve colorings, flavorings, and additives designed to improve texture and appearance. The definition many people use comes from a Brazilian scientist, Carlos Monteiro, who developed a categorization system from level 1 unprocessed food to level 4 ultraprocessed food. But the lack of a formal definition for “ultraprocessed” can make it tricky to regulate and tricky to prove impact, both in terms of scientific studies and legal claims. So, there are efforts at the state and federal level to establish consensus on what qualifies as “ultraprocessed.”
Definitional questions aside, there is a lot of evidence emerging about just how harmful these foods are to the human body. At this stage, most people in the public health sector agree ultraprocessed foods are causing health risks and diet-related diseases including Type 2 diabetes, obesity, various cancers, neurological issues, endocrine issues, etc. Research has also shown mental health risks and psychological harms associated with high UPF consumption. All this evidence is driving a growing demand for something to change.
HLT: San Francisco city attorney David Chiu ’95 recently filed a lawsuit against several corporations manufacturing and selling UPF. Have there been other cases against food companies for selling UPF? How have those gone?
Broad Leib: The recent lawsuit filed by the San Francisco city attorney is unique because it’s the first case of its kind filed against food manufacturers by government, rather than by private individuals. Until now, most cases we’ve seen brought against companies selling UPF has involved labeling. For example, plaintiffs have argued, “You market your product as ‘all-natural,’ but you’re using genetically modified ingredients or artificial flavorings.”
There have also been a small handful of cases alleging that foods produced either by one company or a group of companies have caused obesity or other diet-related diseases. The most famous one is Pelman v. McDonald’s, a 20-year-old case brought by a group of children against McDonald’s that primarily focused on negligence claims. In dismissing the case, the judge was unconvinced about causation. There wasn’t enough certainty about how much of the product these people ate or how other foods in their diet or other genetic factors could have contributed. The case also hinged on whether the foods were actually more harmful than consumers knew or should have known.
HLT: What about more recent cases?
Broad Leib: In a case brought about a year ago in Philadelphia, Martinez v. Kraft Heinz Co. et al., an individual sued the same 12 food businesses that San Francisco is now suing. It was an impressive complaint in terms of the detailed scientific data and evidence it marshaled to show that these foods cause harm, that the major food companies know their food is causing harm, and that they have had discussions about their food causing harm. That case was dismissed in the summer, although the plaintiff has petitioned the court to file an amended complaint.
Martinez was filed by a single plaintiff, rather than on behalf of a class. Individuals suing food companies as a class have had a tough hill to climb, in part because the past two decades, the courts have significantly narrowed the courthouse door for class litigation. In a case like this, a class plaintiff would have a difficult road to showing that members of the class shared enough facts in common to warrant class certification. This highlights the importance of government enforcement. California state law allows for city attorneys — like David Chiu — to bring statewide litigation on behalf of the people of California. This changes the scope of the action from an individual scale to a societal scale. That may provide new opportunities.
“Individuals suing food companies as a class have had a tough hill to climb, in part because the past two decades, the courts have significantly narrowed the courthouse door for class litigation.”
HLT: What is the legal basis or cause of action for the lawsuit?
Broad Leib: There are two distinct claims in the San Francisco case. The first alleges a violation of state unfair competition law. It alleges the defendants used unfair, fraudulent or deceptive practices; that they knew that the food that they’ve been selling is harmful to people, even as they have claimed it is safe and healthy. It’s an interesting approach because proving fraud can avoid some of the challenges you face in proving negligence. Fraud cases focus more on the internal knowledge and behavior of the defendants, whereas negligence cases more often focus on causation. You don’t have to answer the same questions about linking diseases to UPF consumption with so many other contributing factors in the mix. Instead, the plaintiffs’ injuries are tied to the harm associated with being misled. Plaintiffs must show the companies knew something to be true but said something else purposefully misleading or inaccurate, and that led people to purchase the product.
The second claim is for public nuisance, which is also a fascinating approach. Prior to the last 20 years or so, public nuisance was usually only seen in the context of property. Private nuisance, for instance, would historically come up during feuds between neighboring property owners. Public nuisance was applied in similar situations; for example, when one property was causing harms that impacted a whole neighborhood. The relief sought by the government in a public nuisance case would often be abatement of the nuisance — basically saying, “Stop doing what you’re doing or fix the problem that’s affecting all these people.” The abatement of a public nuisance has, in some cases, included the money needed to fix it.
But in recent years, public nuisance has evolved beyond the context of real property. It’s been increasingly used in tobacco cases, opioid cases, and lead paint cases. Using public nuisance outside of purely property matters has been more successful in some places than others, with California being a particularly amenable state. We’ve seen a trend where public nuisance can provide the basis for governments to sue when there’s a common threat harming the public and forcing governments to expend funds to remedy the damage. This is the first time we’re seeing this type of claim brought in the context of the food industry.
HLT: What do you think the defendant companies will likely argue?
Broad Leib: For the public nuisance claim, the city attorney will still have to establish causation. Proving causation in a public nuisance claim is probably easier than proving causation in a negligence claim. But they’ll still have to show that the health harms that California is expending resources to address are caused by the defendant companies’ food and not by other factors. That will be an opportunity for the defendants to argue that the health harms aren’t a product of the UPF they sell — it’s genetics, it’s stress, it’s lack of sleep, it’s lack of physical activity, etc.
Another key argument for the defense is going to be that they were following the law, which they were. The subject of UPF — and generally of chronic health conditions caused by food — still remains highly underregulated by the FDA. The companies will say this issue is clearly in the FDA’s jurisdiction. The FDA has created rules about how we approve additives and ingredients, what we’re allowed to do with them, and what we have to put on labels. Their argument here would basically be, “There’s a legal framework and we’re operating within that framework. What do you want us to do, if not follow the rules that are being given to us?” But, the response to this will be, even if FDA is regulating, industry knows much more about what is actually in their products and knows when they are harmful, and they still have a duty to sell things that are safe for the public.
HLT: What kind of relief is being sought here?
Broad Leib: The complaint filed by the city attorney is asking the court to enjoin the defendants from deceptive marketing and from “maintaining the public nuisance,” which could mean a lot of things. In addition, in this as in other public nuisance cases, the complaint is also asking for “costs to abate the public nuisance.” Abatement can include money to the city or state to remedy the problem. The idea is that California is currently shouldering a financial burden from all these health issues. The relief could include money to go towards treating the issue by providing public education or resources to the state to alleviate associated health costs.
As to the injunctive relief, this may prove to be a little challenging in the food context. It’s easier to apply an injunction to a product like, for instance, tobacco, where the court can order companies to stop selling to children under a certain age. With food, it’s a little trickier. Injunctive relief could involve improving warnings to consumers about certain foods that are really problematic. It could involve imposing a duty on the food companies to make sure the food they produce is not going to be addictive or cause people to keep eating it endlessly. There are a lot of directions it could go.
HLT: If the suit is ultimately unsuccessful, are there ancillary benefits to pursuing it anyway?
Broad Leib: There are several potential benefits to this suit. First, bringing suits against UPF manufacturers raises awareness of the health issues and their connection to diet. This also could lead to more litigation and state enforcement actions. Looking just at this and the Martinez case, there are similar defendants and a lot of cross-citing of facts between complaints. This is similar to what we saw in tobacco litigation, where coalitions of state attorneys general worked together on litigation, sometimes in concert with private litigants. If we start to see a bunch of these cases, another benefit could be companies deciding to settle and come to some sort of reasonable agreement instead of fighting, even if they think there is a chance that they could win. Even better, this could motivate them to sit down with FDA and say, “What do we need to do to have rules we can all agree to that are better suited to protect public health?”
HLT: Are there ancillary downsides to filing the case if the court dismisses it or finds for the defendant?
Broad Leib: One potential risk is that if this litigation is unsuccessful, it gives the public the perception that UPF are actually fine. Creating bad precedent is another obvious downside. But I’m not so worried about creating harmful precedent. For example, looking at the Martinez case, the dismissal doesn’t create bad case law; it just means that the complaint contained insufficient allegations. So, that would motivate future efforts to identify what information is needed to advance another case and get better access to that information. Also, state-based claims are often limited to their own jurisdictions. Overall, I think the pros outweigh the cons.
HLT: Should companies be allowed to manufacture and sell any products considered UPF?
Broad Leib: This is a tricky question facing these cases and the future direction of regulation. Where I struggle is that some of these foods are clearly dessert foods or treat foods. I think there should be better rules and regulations around UPF, but I don’t believe we should no longer have dessert. On the other hand, there are some foods that are UPF that people think they are eating as part of a healthy diet. For example, bread is a major part of the American diet, but much of the bread sold in our stores is actually UPF. You can get bread that is not UPF, but it takes a very knowledgeable consumer to make the distinction. To me, there is a line between UPF marketed as a small-quantity, occasional treat versus something that is supposed to be one of the building blocks of people’s everyday meals. Our rules ought to take that into account and treat these types of products differently.
“Federal statutes make it clear that the FDA’s job is to make sure food is safe, and the definition of ‘safe’ should include ‘safe, even if you eat it for a long period of time.’”
HLT: How would you characterize the FDA’s regulation of UPF thus far?
Broad Leib: The FDA has absolutely missed the boat here in a couple different ways. The FDA is responsible for regulating substances added to food, but it has basically delegated its power to industry. All food additives are supposed to go through pre-market review unless they are “generally recognized as safe” or “GRAS.” But, the FDA has decided to let industry determine if a substance is GRAS and has made it optional for them to even notify FDA before using that substance. That has opened the floodgates to many of these substances.
The FDA has also done a poor job on post-market regulation of these substances, which it has used as an excuse for not needing to regulate better up front. FDA says that it is okay to have industry self-designate substance as GRAS because the FDA can remove them from the food supply post-market if they are later found unsafe. But the FDA takes forever to act and has very rarely banned a substance that was initially approved. As an example, it took decades of data showing harm for the FDA to ban trans fat, or to prohibit the use of Red Dye No. 3 in foods.
Federal statutes make it clear that the FDA’s job is to make sure food is safe, and the definition of “safe” should include “safe, even if you eat it for a long period of time.” I’ve long written about this issue: The FDA historically has committed the majority of its resources to addressing acute food safety risks such as foodborne illness, and has greatly underregulated food causing chronic health conditions. Congress could certainly step in to require FDA to do more on this topic, but the bottom line is that the FDA has the authority and the responsibility to go beyond what it’s currently doing.
HLT: Do you see more stringent federal UPF rules and regulations coming anytime soon?
Broad Leib: In the past 12 months, we’ve seen a shocking increase in public agreement on the proposition that UPF is causing harm, and the current administration seems willing to do something. For example, the FDA has committed to propose new regulations on GRAS, which could increase oversight of substances in food. FDA and USDA started a process to formally define UPF, which is a critical underpinning of efforts to regulate these foods. And, the brand-new 2025 Dietary Guidelines for Americans encourages consumers to eat less “highly processed foods” for the first time. The key question is whether the FDA will actually take durable steps to address these issues through formal regulations, as opposed to just reaching agreements with companies as we saw, for example, in the case of removing synthetic color dyes. I’m also curious to see how strong the FDA’s proposals will be when it proposes regulations, as it will for GRAS substances. I want to see that it is willing to pursue standards that ensure food is safe and actually contributes to health, rather than inducing illness. I think the forces are aligned for a moment of change, but I’m waiting to see where it will go.
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