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Law firm K&L Gates says recent pronouncements by the FDA supporting an exemption for coffee from a Proposition 65 ruling highlight the need for science-based decision-making about nutritional information.

In a blog on its website, the law firm said recent action taken by the Food and Drug Administration (FDA), California Office of Environmental Health Hazard Assessment (OEHHA) and the US Congress illustrate “active resistance” to state labelling laws that conflict with science-based nutrition information, including California’s Safe Drinking Water and Toxic Enforcement Act, better known as Proposition 65.

Prop 65 allows private citizens, advocacy groups, and attorneys to sue on behalf of the state for failure to provide required warnings. “While the statute may have been viewed as well-intended and effective in certain instances, it is now regarded by many as lacking the necessary scientific support, and thus unnecessarily burdening businesses and confusing consumers,” the law firm said.

Coffee has been targeted by Prop 65 enforcers because of acrylamide, a chemical produced as a by-product of roasting. Very large doses of acrylamide have been linked to cancer in mice. However, the National Cancer Institute and the World Health Organization’s International Agency for Research on Cancer have concluded there is no consistent evidence that dietary acrylamide exposure is associated with the risk of any type of cancer in human beings. In fact, IARC found that coffee is associated with a reduced risk for certain types of cancer, including liver and uterine cancer, and there are additional health benefits due to the strong antioxidant effects.

Despite the scientific evidence, earlier this year, after eight years of litigation between numerous coffee companies against Council for Education and Research on Toxics, a California superior court ruled against the coffee companies. The Los Angeles court found that the defendants’ had failed to convince the court that coffee should be exempted from the statute and that warnings would be required.

“While the ruling itself did not mean coffee causes cancer, media reporting and a general lack of understanding of the statute contributed to further confusion over the safety of coffee,” said the law firm. “Much protest, debate and dispute followed, mainly centred around the strong and consistent scientific evidence disproving any link between coffee and cancer in humans.”

As reported by C&CI on 30 August 2018, the FDA made its position known when Commissioner Scott Gottlieb issued a detailed statement strongly supporting an exemption for coffee from the Prop 65 warning requirement.

This is not the first time the FDA has made its feelings regarding Prop 65 known. In 2003 and 2006, the FDA wrote to OEHHA, expressing concerns that labelling cereals and some other foods with Prop 65 warnings could confuse consumers and even lead to worse health outcomes.

“The FDA is not the only authority that wants to see Prop 65 enforcement changed,” said K&L Gates. “A bipartisan group of US Congress members have introduced bills in the Senate (S 3109) and House of Representatives (HR 6022), collectively dubbed the ‘Accurate Labels Act,’ that seek to ensure that Prop 65 and other warnings are based on sound, scientifically-based evidence and risk analyses.”

If the bills were to become law, said the law firm, Proposition 65 enforcement would change dramatically.

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