Drug Firms Win Round on Labeling

California may not put stricter health warnings on over-the-counter drugs if the warnings conflict with labels approved by the federal government, the California Supreme Court ruled Thursday.

In a unanimous decision, the court held that manufacturers and distributors of nicotine-replacement products, including nicotine chewing gum and patches, may ignore a state law that requires a warning that the products may cause reproductive harm.

As a result of the ruling, nicotine-replacement products in California will carry only the federal warning, which says pregnant women should try to quit smoking without using nicotine. The warning says the replacement products are less harmful than smoking, but also notes that the products’ medical risks are not fully known.

“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,” Justice Joyce L. Kennard wrote for the court.

Thursday’s decision was the first by the state high court to put limitations on Proposition 65, a 1986 initiative that requires warnings on products that may cause cancer, birth defects or other reproductive harm.

Lawyers in the case said the decision might affect future Proposition 65 disputes over labels on a wide variety of consumer products.

The decision came in response to a lawsuit by a consumer who alleged that the federal warning on smoking cessation products was inadequate. The Food and Drug Administration countered that a stricter label that warned of birth defects might mislead pregnant women into thinking that smoking was a better alternative.

The court cited the potential for misunderstanding in siding with the federal government.

“The risk of harm may be so remote that it is outweighed by the greater risk that a warning will scare consumers into forgoing use of a product that in most cases will be to their benefit,” Kennard wrote.

But the court said the state may continue to post health warnings that are more extensive than federal labels.

“In most cases, FDA warnings and Proposition 65 warnings would serve the same purpose -- informing the consumer of the risks involved in use of the product -- and differences in wording would not call for federal preemption,” Kennard wrote in Dowhal vs. SmithKline, S109306.

A spokesman for Atty. Gen. Bill Lockyer, who also sought a tougher warning for nicotine products, said he was disappointed with the decision but relieved that the court had left Proposition 65 intact.

The ruling “leaves ample room for the state to use Proposition 65 to require more explicit warnings than the FDA calls for on over-the-counter drugs,” said Tom Dresslar, a spokesman for Lockyer. The federal warnings will prevail only if a state-proposed advisory runs counter to the federal objective, Dresslar said.

Paul Dowhal, 45, who brought the case, was unavailable for comment. His lawyer, Mark N. Todzo, credited Dowhal’s 1999 lawsuit with pushing the federal government to expand warnings on nicotine products.

Before the lawsuit was filed, Todzo said, nicotine gum and other such aids warned only that the nicotine could increase the heart rate of the fetus, Todzo said.

“It is better than what was there in 1999, but it is not as good as what we had hoped for,” Todzo said.

Michelle Corash, who represented GlaxoSmithKline Consumer Healthcare and other manufacturers and retailers of nicotine products, said the ruling recognized that narrow warnings may not serve public health needs.

“The court is saying a broader public health goal is going to trump a narrower one,” she said. “It has its eyes on the ball.”

Disputes over warnings on products arise continually under Proposition 65, she said.

“There will be differences between what the FDA has approved and what California requires, but sometimes when that happens, the state warning will have to yield,” Corash said.

A spokesman for the federal Department of Justice said the FDA was pleased that the court had vindicated its “authority to protect the public health.”