On 29 March 2021 the United States District Court for the Eastern District of California entered a significant ruling temporarily halting the filing of new lawsuits by the California Attorney General and anyone else related to the enforcement of California’s Proposition 65 against businesses that do not display Proposition 65 acrylamide warnings for food and beverage products. While the ruling bars the filing of new lawsuits, it does not alter any existing consent decrees, settlements, or other agreements related to Proposition 65 warning requirements. The ruling also does not prevent private enforcers from sending demand letters or notices of violation (60-day notice). It also remains unclear at this point whether the preliminary injunction will be appealed by the State. Food and beverage businesses with active Proposition 65 matters related to acrylamide should consult with their legal counsel and carefully assess whether and to what extent the ruling applies to them.
California’s Proposition 65 requires the Governor of California to publish, at least annually, a list of chemicals “known” to the state to cause cancer or reproductive toxicity.1 Businesses are required to provide a “clear and reasonable” warning before knowingly and intentionally exposing anyone in California to a listed chemical. Acrylamide is a chemical that can naturally form in some foods during the Maillard reaction that takes place in high-temperature cooking processes, such as frying, roasting, and baking. Acrylamide has been listed as a carcinogen under Proposition 65 since 1990.
Proposition 65 does not specify what warning is necessary for chemicals “known” to cause cancer. Regulations promulgated by the California Office of Environmental Health Hazards Assessment (OEHHA) offers a model warning that serves as a safe harbor against liability for food warnings:
“WARNING: Consuming this product can expose you to [name of one or more chemicals], which is [are] known to the State of California to cause cancer. For more information go to www.P65warnings.ca.gov/food.”2
Proposition 65 warning requirements can be enforced by the California Attorney General (California AG), as well as private enforcers using lawsuits to enforce the warning requirements on behalf of the State of California. Private enforcers, however, must notify the potential defendant and state prosecutors of the alleged violation and of the intent to sue 60 days (60-day notices) before a lawsuit may be filed. Since 2016, private enforcers have issued more than 900 60-day notices of violation regarding acrylamide in foods to food companies and their retailers, with the total settlement payments for these acrylamide notices totaling over US$9.6 million.
The California Chamber of Commerce (CalChamber) filed a lawsuit against the California AG in December 2019 challenging that the Proposition 65 warning requirement for acrylamide containing foods, as it is currently being enforced by the State and private litigants, is unconstitutional as a violation of the First Amendment.3 CalChamber takes issue with the fact that Proposition 65 requires warnings related to chemicals “known” to cause cancer or reproductive harm, but the scientific evidence that consumption of acrylamide containing foods causes cancer in humans is unclear. Further, the safe harbor warning language, as discussed above, states without qualification that the acrylamide in a particular food is “known to cause cancer,” and does not permit businesses to add language explaining their views on the dangers of acrylamide in food. Thus, contends CalChamber, acrylamide is not “known” to cause cancer and the warning requirement as exercised using the safe harbor language is an unconstitutional infringement on commercial speech because it compels speech that may not be true.
On 29 March 2021, Chief Judge Kimberly Mueller granted CalChamber’s motion for a preliminary injunction in the case barring the California AG and any other person from filing new lawsuits against businesses to enforce the Proposition 65 warning requirement for cancer as applied to acrylamide in food and beverage products while the CalChamber case is ongoing.4 In the order, Chief Judge Mueller explains that “the safe harbor warning is controversial because it elevates one side of a legitimately unresolved scientific debate about whether eating foods and drinks containing acrylamide increases the risk of cancer.”5 Further, explains Chief Judge Mueller, “the State has not shown that the safe-harbor acrylamide warning is purely factual and uncontroversial, and Proposition 65’s enforcement system can impose a heavy litigation burden on those who use alternative warnings.”6
Chief Judge Mueller granted the preliminary injunction after finding that CalChamber’s members are likely to succeed on the merits of their argument – that the State has unconstitutionally compelled speech which is not purely factual and uncontroversial – and would suffer irreparable harm if new lawsuits were permitted to be filed while the CalChamber case is ongoing. The thoughtfully written opinion considered the various factors that must be considered in a First Amendment challenge. The opinion recognizes the delicate balance that must be met in these First Amendment challenges and recognized the United States Court of Appeals for the Ninth Circuit opinion supporting the required warning for cell phones:
“To assure safety, the Federal Government requires that cell phones meet radio frequency (RF) exposure guidelines. If you carry or use your phone in a pants or shirt pocket or tucked into a bra when the phone is ON and connected to a wireless network, you may exceed the federal guidelines for exposure to RF radiation. Refer to the instructions in your phone or user manual for information about how to use your phone safely.”
The court distinguished the cell phone warning from the acrylamide warning in that the former “was a purely factual summary of federal regulation about radio frequency radiation,” federal regulations already required disclosure of the same or similar information, and businesses were permitted to add information to the warning at their discretion.7 Chief Judge Mueller noted various ways in which the acrylamide warning could be written to remove the false or misleading language that currently conveys acrylamide in the food and beverage is known to cause cancer. For example “allow[ing] businesses to explain that acrylamide forms naturally when some foods are prepared,” or “list[ing] acryalmide as a chemical that ‘probably’ causes cancer or is a ‘likely’ carcinogen or that the chemical causes cancer in laboratory animals,” among other ways.8
Food and beverage businesses who receive new demand letters or 60-day notices, or with otherwise active Proposition 65 matters related to acrylamide, should consult with counsel and carefully assess whether and to what extent the ruling applies to them.
Hogan Lovells will continue to closely follow the CalChamber lawsuit and other Proposition 65 developments related to food and beverages.
1 Cal. Health & Safety Code § 25249.8(a).
2 Cal. Code Regs. tit. 27, § 25607.2(a).
3 California Chamber of Commerce v. Xavier Becerra, No. 2:19-cv-02019-KJM-JDP (E.D.C.A.).
4 California Chamber of Commerce v. Xavier Becerra, No. 2:19-cv-02019-KJM-JDP, Doc. 114 (E.D.C.A. 30 Mar. 2021).
5 Order at 23.
6 Order at 25.
7 Order at 26.
8 Order at 24.