Proposition 65 and California

Acetaminophen has been available in the U.S. without a prescription since 1955. Concerns about its potential link to cancer come from its relationship to another drug: phenacetin. That drug, once a common treatment for headaches and other ailments, was banned by the FDA in 1983 because it caused cancer.

State regulators have reviewed 133 studies about acetaminophen, all of which were published in peer-reviewed journals. Some studies reported an increased risk of some types of cancers, while others did not. Overall, the review noted acetaminophen has been difficult to examine because it is hard to isolate it from other variables that could contribute to cancer, such as smoking.

A state law known as Proposition 65 says California must warn people of any chemical known to cause cancer or reproductive toxicity. The state's list has grown to about 900 chemicals, including toxic pesticides and flame retardants, and is more extensive than any in the U.S. Some critics say California regulators have been overzealous, requiring warning labels for countless products that confuse instead of inform consumers when the risk of cancer is disputed.

Evidence for acetaminophen's link to cancer has been weak enough that the International Agency for Research on Cancer declined to list it as a possible carcinogen following reviews in 1990 and 1999. The U.S. Food and Drug Administration has warned state officials that labeling acetaminophen as cancer-causing would be “false and misleading” and also illegal under federal law.

A panel of scientists appointed by the governor can add chemicals to this list. In 2011, the panel voted to make acetaminophen a “high priority” for consideration because it believed there was relevant evidence to consider, according to Sam Delson, spokesman for the California Office of Environmental Health Hazard Assessment.

The review process has been slow, but the panel is scheduled to have a public hearing on the listing this spring after the public comment period closes on Jan. 27.

That's one reason why the industry is pushing back on a potential listing. The Consumer Healthcare Products Association...

 

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• cancer

• pain policy