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California's Prop 65 Trumped By FDA, But On Narrow Grounds

The truth is apparently no defense for the state when it comes to issuing warning labels for nicotine gums and patches. Recently, the California Supreme Court unanimously ruled in Dowhal v. SmithKline Beecham Consumer Healthcare, 04 C.D.O.S. 3259 that federal regulations trump state statutes when it comes to putting pregnant women on alert about the possible dangers of Nicorette' and other nicotine-replacement therapies — even if the state warnings are legitimate. “Whether a label is potentially misleading or incomprehensible is essentially a judgment of how the consumer will respond to the language of the label,” Justice Joyce Kennard wrote. “A truthful warning of an uncertain or remote danger may mislead the consumer into misjudging the dangers stemming from the use of the product, and consequently making a medically unwise decision.”

The decision represents a victory for the federal Food and Drug Administration, which had argued that California went too far by identifying the nicotine in smoking-reduction gums and patches as a chemical known to “cause birth defects or other reproductive harm.” State regulators were complying with Proposition 65, the 18-year-old Safe Drinking Water and Toxic Substances Act now codified as Health and Safety Code Section 25249.6.

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