No Need for Coffee Cancer Warning, Says FDA

Nick Mulcahy

August 30, 2018

US Food and Drug Administration (FDA) Commissioner Scott Gottlieb, MD, said yesterday that requiring a cancer warning on coffee, as proposed in the state of California, "would be more likely to mislead consumers than to inform them."

Gottlieb further said that "current science indicates that consuming coffee poses no significant risk of cancer." As support, he referred to a report from the International Agency for Research on Cancer of the World Health Organization.

These declarations were made in a statement that "strongly" supports exempting coffee from California's cancer warning law.

As part of that law, known as Proposition 65, a cancer warning may be required on coffee products sold in the state. The proposed warning made headlines in April and May when a Los Angeles judge ruled that coffee companies such as Starbucks failed to show that coffee did not present a cancer risk, setting the stage for the cancer coffee warnings to be enforced.

The chemical acrylamide, which forms during the roasting of coffee beans, is the source of the cancer concern, according to California health authorities, who have deemed it possibly carcinogenic to humans.

But the FDA does not agree with that assessment, saying that acrylamide forms in many foods during high-temperature cooking. "Acrylamide in food forms from sugars and an amino acid that are naturally present in food," said the FDA in their statement.

Gottlieb and the FDA acknowledge that acrylamide "at high doses has been linked to cancer in animals" but say it is not a large risk for humans.

Consumer Choice

The FDA "may decide to step in" if California requires such a cancer warning on coffee products, said Gottlieb.

That would be justified because part of the mission of the FDA is to ensure food labeling "doesn't contain false or misleading statements about safety or nutrition."

In a tweet, Gottlieb positioned the FDA's take as a matter of consumer choice and protection.

"We know Californians enjoy their coffee. In fact, there are more coffee shops and cafes per resident in San Francisco than any other city in the US. My statement is in support of their choices — unhindered by warnings that are inaccurate or misleading," he wrote, and provided a link to the FDA statement.

Previous research is on the side of the FDA, Gottlieb also said in the statement: "Strong and consistent evidence shows that in healthy adults moderate coffee consumption is not associated with an increased risk of major chronic diseases, such as cancer, or premature death." Further, "some evidence suggests that coffee consumption may decrease the risk of certain cancers."

Since the discovery of acrylamide in foods in 2002, the FDA has performed toxicology research, conducted food surveys and exposure assessments, and issued guidance for industry on mitigating the formation of acrylamide during food production. "Given the widespread presence of acrylamide in foods, it isn't feasible to completely eliminate acrylamide exposure," says Gottlieb.

According to the new statement, with regard to acrylamide, the FDA's "best advice" is to adopt a healthy diet that emphasizes fruits, vegetables, whole grains, fat-free or low-fat milk and milk products, that includes lean meats, poultry, fish, beans, eggs, nuts, and healthy oils, and that limits saturated fats, trans fats, sodium, and added sugars.

Moderate coffee consumption (three to five cups a day or up to 400 mg/day of caffeine), on the other hand, can be part of a "healthy eating pattern," as indicated in the current dietary guidelines published by the US Department of Health and Human Services and the US Department of Agriculture.

Follow Medscape senior journalist Nick Mulcahy on Twitter: @MulcahyNick

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