The Short and Sweet of It: Key Insights for Manufacturers and Retailers on Recent Studies Assessing Artificial Sweeteners and Cardiovascular Events

A series of recent studies by the same group of researchers have raised concerns regarding the safety and health impacts of artificial sweeteners, specifically erythritol and xylitol. While these papers have weaknesses and suggest the need for further research, they nonetheless could increase the risk of potential litigation related to product safety, consumer protection, and regulatory compliance. This Advisory outlines key considerations and recommended actions for entities involved in the production, marketing, or distribution of these sweeteners and products containing these sweeteners.

The Recent Studies

• A 2023 study published in Nature Medicine, titled “The Artificial Sweetener Erythritol and Cardiovascular Event Risk,” investigated the potential link between erythritol and cardiovascular events. Researchers found that higher levels of erythritol in the blood were associated with an increased risk of heart attacks, strokes, and death. The study suggested that erythritol might contribute to the formation of blood clots by affecting platelet function, thus raising cardiovascular risk.
• In a follow-up study published in the September 2024 edition of Arteriosclerosis, Thrombosis, and Vascular Biology, titled “Ingestion of the Non-Nutritive Sweetener Erythritol, but Not Glucose, Enhances Platelet Reactivity and Thrombosis Potential in Healthy Volunteers,” the same researchers examined the effects of erythritol on platelet function and cardiovascular risk in a small number of healthy volunteers. Participants were given either erythritol or glucose solutions and blood samples were collected before and after ingestion to evaluate changes in platelet reactivity. The researchers observed increased platelet activity in the participants who ingested erythritol compared to baseline levels and glucose. The study concluded that erythritol consumption can enhance platelet reactivity, potentially enhancing thrombosis potential.
• The same researchers conducted a similar series of tests to examine the impact of xylitol on cardiovascular health. The study titled “Xylitol is Prothrombotic and Associated with Cardiovascular Risk,” published in the June 2024 edition of European Heart Journal, concluded there is a potential link between xylitol consumption and increased cardiovascular risk. The authors suggested that xylitol might contribute to adverse cardiovascular events through enhanced platelet reactivity.

These papers have limitations. For example, as the authors observed, the observational data in these studies do not establish causality. As noted by the authors themselves, the clinical cohort studies measured participants’ baseline fasting levels of xylitol and erythritol only once and did not examine the long-term effects of artificial sweetener consumption. Additionally, participants in two of the studies were already at high risk for cardiovascular disease. Finally, the study authors indicated the need for future research to understand the long-term effects and how these findings translate to the general population.

Major news agencies, including The New York Times, CNN, and The Guardian have covered these studies on erythritol and xylitol. And plaintiff lawyers are actively advertising and soliciting clients who consumed erythritol and later experienced a cardiovascular event.

Possible Litigation Risks

The recent focus on erythritol and xylitol raises the risk of both product liability litigation and consumer class actions against manufacturers and distributors of these sweeteners. Indeed, erythritol has already been the subject of consumer litigation claiming the inclusion of artificial sweeteners, such as erythritol, in various foods and beverages renders “all natural” product labels false and misleading.

In product liability litigation, plaintiffs must prove scientific causation (i.e., that the product can cause the alleged harm and that it caused or materially contributed to the plaintiff’s injury) to hold a defendant liable for the alleged harm. Jurisdictions employ different standards for establishing causation and the standard used can have a significant impact on the defendant’s exposure to liability. For example, some jurisdictions apply the “but-for” test, which is satisfied when a plaintiff establishes that, had the plaintiff not used the defective product, the plaintiff would not have sustained the injury. Other jurisdictions apply the “substantial factor” test which is satisfied when a plaintiff proves that the product was a significant factor in causing the plaintiff’s injury. Under the substantial factor test, the defendant’s product need not be the only cause of plaintiff’s injury. The substantial factor test can muddy the causation analysis and increase risk of liability, particularly when the alleged injury commonly occurs in the general population (e.g., heart attacks, strokes, cancer).

Regardless of the causation standard applied, defendants can defeat these claims by demonstrating there is no reliable scientific evidence that the product in question is capable of causing the alleged harm (i.e., general causation) or caused the plaintiff’s specific injury (i.e., specific causation). However, this process can be protracted, as it is often the case that challenges to the scientific validity of the claims cannot be properly raised until the summary judgment stage or on appeal after a trial, potentially years after litigation begins. Even when the science is questionable, the claims may not be dismissed immediately, and companies may face years of expensive and extensive litigation in the interim that includes discovery and even trials.

Class action lawsuits claiming deceptive marketing practices or failure to adequately disclose health risk are of particular concern, as these actions often involve large numbers of plaintiffs and requests for substantial damages. Additionally, class actions are particularly attractive to plaintiff lawyers where — as here — the science is still developing because plaintiffs need to show only an economic injury and not a physical injury. For example, plaintiffs may show economic injury by proving they would not have purchased the product had the company disclosed the alleged health risk.

Plaintiffs may also pursue medical monitoring claims if the plaintiffs were exposed to the product but have not yet experienced physical injuries. Plaintiffs may seek economic compensation for medical expenses incurred or expected to incur, such as diagnostic testing, as they are monitored for the injury without showing proof of a present injury.

Key Considerations and Recommended Action

The recent research into erythritol and xylitol, combined with advertising by plaintiff lawyers and the risk of consumer class actions, necessitates careful consideration of potential litigation risks and regulatory challenges. The limitations in the current studies highlight the importance of a nuanced approach to assessing the risks. Entities involved in the production, marketing, and distribution of these sweeteners and products containing the sweeteners should take proactive steps to mitigate these risks and ensure compliance with evolving scientific and regulatory standards:

• Companies should assess potential litigation risk by determining which of their products may contain erythritol, xylitol, or other artificial sweeteners. Part of this assessment should take into consideration the amount of artificial sweetener in their products and whether that can translate into a potential risk for consumers per the studies’ findings.
• After understanding which products may be at issue, companies should evaluate whether there is a need to revise product labels and marketing materials (sometimes in consultation with regulators), keeping in mind the limitations of recent research.
• It is important to stay current on scientific literature. Following the scientific landscape will help companies evaluate whether these studies or future studies present a real risk that is translatable to consumers. Companies may want to consider engaging with external scientific experts to help them interpret the scientific literature and its impact on their products. Additionally, developing internal experts can help with litigation defense down the road, both as possible witnesses and to show a jury that the company was following these issues in real time.
• As companies internally assess new science, make decisions about labeling and other consumer facing messaging, or communicate with regulators, it is important to consider the best way to properly memorialize important conclusions and the supporting analysis. These communications and decisions can become key points in litigation that plaintiff lawyers attempt to weave into an out-of-context narrative that a defendant does not prioritize safety. Having a contemporaneous memorandum detailing a company’s scientific assessments and guidance from regulators can help show a jury that decisions were based on a rigorous evaluation of the state of the science at the time.
• Companies should stay informed about changes in regulatory guidelines and industry standards related to these artificial sweeteners. It is important to be prepared for potential regulatory changes or increased scrutiny from agencies such as the Food and Drug Administration.

Arnold & Porter’s diverse group of attorneys specializing in areas such as product liability, consumer products, and food and beverage law have assisted companies with risk mitigation and navigating the complexities associated with new scientific literature claiming negative health implications associated with various consumer products. Arnold & Porter will continue to monitor scientific literature and regulatory agencies’ action pertaining to artificial sweeteners.

© Arnold & Porter Kaye Scholer LLP 2024 All Rights Reserved. This Advisory is intended to be a general summary of the law and does not constitute legal advice. You should consult with counsel to determine applicable legal requirements in a specific fact situation.