Many of us think of coffee as a morning essential, however, there has been a long running debate between California regulators, courts, business, and consumer advocates regarding whether coffee must have a Proposition 65 (“Prop 65”) warning for cancer. The debate stems from the fact that roasted coffee beans, and coffee brewed from those beans, contain acrylamide – a chemical of concern under Prop 65 because of potential cancer risks. This article discusses the opinions of various research groups regarding the noncarcinogenic nature of acrylamide, as well as a recent lawsuit initiated by the California Chamber of Commerce against the California Attorney General to end the need to warn for acrylamide.
What is Prop 65?
Prop 65 is a California law that requires California consumers receive warnings regarding the presence of chemicals known to cause cancer or reproductive toxicity. The law is highly technical, constantly evolving, and actively enforced by the government and private enforcers.
What Is Acrylamide?
When sugars and proteins are cooked at high temperatures, a chemical reaction, called the Maillard reaction, occurs. This reaction contributes to the aroma, taste, and color of cooked foods, including coffee, which is roasted at temperatures ranging from 180-250°C. A by-product of this reaction is acrylamide. Acrylamide can be found in a wide variety of foods we consume, including French fries, breakfast cereal, crackers, bread crusts, roasted asparagus, and even potato chips and nuts.
The safety of acrylamide has been tested in multiple ways. One method has been to dose laboratory animals with very high doses of acrylamide – magnitudes higher than people consume through coffee and cooked foods. These very high doses of acrylamide have been observed to cause cancer in some animal studies. In contrast, dozens of epidemiology studies in hundreds of thousands of people have not shown any association between coffee consumption and cancer; these epidemiology studies indicate that high-dose findings in animal laboratory studies are not relevant to people. In addition, in June 2016, IARC downgraded their original 1991 classification of coffee from Group 2B (‘possibly carcinogenic to humans’) to Group 3: ‘Not classifiable as to carcinogenicity’. This means that after reviewing over 1,000 studies, IARC has judged that the extensive scientific literature does not show evidence of an association between coffee consumption and cancer. Not only did IARC find no clear association between coffee intake and cancer at any body site, it also found that in some cases, there is evidence that coffee drinking may actually help reduce occurrence of certain cancers; specifically, cancers of the liver and uterine endometrium.
OEHHA Response to Litigation & Determination That Coffee Does Not Require An Acrylamide Warning
In 2010, a lawsuit was filed in California alleging that acrylamide in coffee posed a “significant” cancer risk to consumers and, thus, required a Prop 65 warning. Rather than rely on the findings of epidemiology studies, the claim was based on an assessment of animal studies. However, the acrylamide doses in these studies were magnitudes higher than the amount of acrylamide to which an average coffee drinker is exposed. Thus, cancer risks in humans were estimated by assuming one could accurately calculate the dose in humans that would be associated with an increased cancer risk based on the dose that caused effects in animals. This approach was used even though the existing epidemiology studies, which consider actual exposures in people, demonstrated that cancer was not associated with average, or even above average, coffee consumption.
Still, based on this, in 2014, a judge ruled coffee companies failed to prove that acrylamide in coffee posed “no significant risk” to consumers, and required coffee roasters and retailers to provide Prop 65 warnings on coffee sold in California. This ruling was maintained in March 2018 after a second phase of the trial. However, in June 2019, California’s Office of Environmental Health Hazard Assessment (OEHHA) evaluated all the science as a whole (including the epidemiology studies) and disagreed with the judge’s 2014 and 2018 decisions. OEHHA then determined that companies would be exempt from including cancer warnings on coffee based on existing epidemiology evidence.
Cal Chamber of Commerce Lawsuit To End Prop 65 Warnings for Acrylamide in Food Just Took A Major Hit.
In October 2019, the California Chamber of Commerce (“Cal Chamber”) filed suit against California Attorney General Xavier Becerra in federal court in the Eastern District of California, seeking to enjoin California and private enforcers from requiring Prop 65 warnings on foods that contain acrylamide. The suit was based on the idea that acrylamide is not an ingredient added to food products, but rather, formed naturally when cooked at high temperatures.
Cal Chamber relied on the conclusions of authoritative bodies, such as OEHHA, FDA, the National Cancer Institute, and the American Cancer Society to point out that there are currently no scientific studies showing that exposure to acrylamide in food increases the risk of cancer in humans, and that no governmental entity has made that determination or acknowledged such a causal connection. Specifically, the complaint references that epidemiologic studies in humans actually demonstrate acrylamide from food does not increase the risk of cancer in humans.
Further, the suit raises the concern that forcing companies to place Prop 65 warnings for food items without reliable scientific evidence results in over-warning and dilutes the effectiveness of Prop 65 warnings in other products that actually do pose a risk to consumers. The complaint notes that more than five hundred 60-day notices have been filed under Prop 65 related to acrylamide in various food products, and that businesses are caught between taking action to defend themselves against bounty hunters or placing controversial warnings on their products. Interestingly, Cal Chamber argues this is a violation of the First Amendment because it compels manufacturers to make false and misleading statements about their products.
The Attorney General filed a motion to dismiss Cal Chambers’ suit arguing that the claims are duplicative of defenses asserted in other Prop 65 lawsuits against manufacturers and that the suit promotes forum shopping. Additionally, defendant intervenor Council for Education and Research on Toxics (CERT) also filed a motion to dismiss on the grounds that the Anti Injunction Act prohibits the Court from staying any state proceedings. The motions were heard on January 17, 2020. The Court issued a written order on March 3, 2020, granting the Attorney General’s motion to dismiss. In its order, the Court reasoned that Cal Chamber’s complaint did not bring any claims independent of its declaratory relief claim, and that the Court may decline to hear the declaratory relief claim in its discretion under the Declaratory Judgments Act (28 U.S.C. § 2201). Specifically, the Court found that declining to hear Cal Chambers’ claim was appropriate because Cal Chambers appeared to be seeking to avoid an unfavorable decision in a state case (CERT v. Starbucks), and because Cal Chambers’ claim is duplicative of 38 other ongoing state court proceedings involving acrylamide and Prop 65. In also granting CERT’s motion to dismiss, the Court reasoned that Cal Chambers’ request for injunctive relief violated the Anti Injunction Act because it seeks to prohibit defendants from enforcing the Prop 65 warning requirement for acrylamide. The Court permitted Cal Chamber to file an amended complaint within 14 days of its order.
We will continue to monitor this litigation.