Prop 65 pushback: Landmark ruling curbs cancer warnings for dietary acrylamide

Cancer warnings for dietary acrylamide are no longer enforceable under Prop 65 court decision.
Cancer warnings for dietary acrylamide are no longer enforceable under Prop 65 court decision. (Getty Images)

A landmark federal court decision to block mandatory cancer warnings for dietary acrylamide under California’s controversial Prop 65 is a major win for food manufacturers – and could offer protective precedence for compelling warnings based on shaky science in violation of First Amendment rights

A recent and rare legal victory limiting the application of California’s notorious Prop 65 cancer warnings for acrylamide in foods could be the first of several this summer that reinforce manufactures’ First Amendment rights and allows them to forgo cautionary statements that could scare away consumers or demonize food at a time when additives, chemicals and ingredients are being scrutinized and evaluated on political versus scientific grounds.

Earlier this month, the Eastern District of California deemed it unconstitutional to require cancer warnings on foods and beverages with dietary acrylamide, which is created during some cooking processes, under California’s Safe Drinking Water and Toxic Enforcement Act of 1986, better known as Prop 65. The legislation requires businesses to warn of the presence of hundreds of chemicals that may cause cancer or reproductive toxicity.

The decision has widespread implications for the food and beverage industry, according to Trent Norris, a partner with the law firm Hogan Lovells who helped make the winning argument in the case brought by the California Chamber of Commerce against the state. He explains in this episode of FoodNavigator-USA’s Soup-To-Nuts podcast, the significance of the landmark victory, including for food manufacturers and restaurants. He explains the technicalities of the arguments for dropping the warning and the practical implications for businesses, including potential formulation cost-savings and protection against so-called bounty hunters who sue businesses for perceived Prop 65 failures. He also shares how the precedent dovetail with other cases against other high profile chemicals currently under Prop 65, including titanium dioxide.

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Prop 65: ‘The food industry has been a major target’

As Norris explains, Prop 65 may have begun as a well-intentioned mechanism to help consumers understand potential risks posed by consuming foods and beverages or using products made with specific chemicals, but because of how it is applied and enforced it has become a thorn in the side of industry.

“Prop 65 was adopted by California voters back in 1986 and it requires warnings for consumers in California of exposure to any of about 1,000 chemicals, and often at exposure levels that are extremely low compared to other regulatory regimes,” such as FDA or EU requirements, Norris explained.

The law also is unique in that it is enforced primarily by private parties, resulting in – at times – a flood of cases that were never intended to go to court, but filed with hopes of settlements.

“The food industry has been a major target of these cases,” with most cases centered on three types of chemicals: naturally occurring chemicals, which are exempt but difficult to prove, ‘true contaminates,’ which are rare, and chemicals created in heating or cooking food, Norris said.

Acrylamide falls into the third category and is created when foods are cooked at high temperatures or through the Maillard reaction, which is the primary way in which food is browned or cooked.

“It is found in a majority of the foods that form our diets,” including coffee, cookies, bread, toast, potato chips, French fries and grilled asparagus, he added.

Until recently, the presence of dietary acrylamide in food from this process was unknown, but as soon as it was discovered the Prop 65 cases began.

The first round occurred in the 2008 timeframe and primarily focused on French fries and potato chips and results in a “great deal of money that changed hands and agreements by these companies to either put warnings on their products or to reduce the level acrylamide in their products” by adopting different preparation methods, adding an enzyme that blocks the formation of acrylamide or other steps, Norris said.

The second round of cases hit around 2015 and focused on smaller companies, many of which could not afford to reformulate and so opted to add warnings.

Norris explains the second round of litigation created “a lot of consternation” among food companies and public health advocates who worried if everything in the snack aisle bore a cancer warning then consumers would just ignore the caution and it would become essentially meaningless.

The case against cancer warnings for acrylamide

At the same time, evolving science suggested the warning was meaningless for dietary acrylamide because the mechanism of action that caused cancer in lab animals did not exist in humans – or if it did, it required much, much higher doses in humans than they were exposed to in food. Respected regulatory bodies and authoritative bodies also cast doubt on the link between dietary acrylamide and cancer in humans.

“All of that indicated the basis for the warning was really quite weak,” and suggested that companies were being compelled to include false and misleading information on their labels in violation of federal food laws, said Norris.

“This formed the background for Cal Chamber to say we should challenge Prop 65 as it is applied to acrylamide warning in food” on the grounds of First Amendment violations, Norris explained.

After several years of litigation and appeals, the California Chamber of Commerce won – meaning private enforcers cannot bring any new cases and consent judgements from earlier cases are no longer enforceable.

For companies that adopted expensive measures to reduce acrylamide, they are now able to reformulate again to potentially save money without fear of litigation or including a warning.

The case provides a blueprint for potentially blocking warnings for other chemicals

This case also could offer protective precedence for other chemicals found in food currently targeted by Prop 65 but for which the science connecting them to cancer in humans is shaky – including a pending case examining titanium dioxide. It also builds on another case regarding the application of Prop 65 on glyphosate in food.

Norris said his goal is not to dismantle Prop 65 but rather encourage authorities to apply it more carefully so as to save food and beverage companies from an expensive and resource intensive barrage of cases when the threat of cancer is not scientifically supported.

“We think the state agency, which has a duty to adhere to the US Constitution, has a duty to go through that list and to cull it essentially and to identify those chemicals for which Prop 65 enforcement actions should not take place” because they are based on shaky science, said Norris. “It would be quite an undertaking, but we think it is the only way that the state can actually comply with these rulings.”