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

The FDA advises pregnant women to try to give up cigarettes without using nicotine gum or patches, even though the agency says the products are safer than smoking. However, the FDA warns that the risks of nicotine-replacement products are unknown. Consumer advocate Paul Dowhal, a restaurant owner in Tahoe City, had sued GlaxoSmithKline Consumer Healthcare, which makes Nicorette gum and NicoDerm' CQ patches, and McNeil Consumer Products Co. and Pharmacia & Upjohn Inc., manufacturers of Nicotrol' patches. He claimed that the products' warnings — mandated by the FDA — were inadequate, and that California labels provided expectant mothers with enough information to make intelligent decisions.

Dowhal was backed by the California attorney general's office, which argued that the FDA advisory would withhold truthful information from pregnant women. But the manufacturers had the full support of the Justice Department, which said the Prop 65 warnings “overstated the known risks” of nicotine gums and patches.

The First District Court of Appeal had earlier ruled against Dowhal, noting that Congress expressly exempted Prop 65 from the labeling requirements of the FDA Modernization Act of 1997. The state's Supreme Court reversed, however, saying that Congress did not intend to exempt state warnings that are in direct conflict with the FDA's goal of uniform labeling nationwide. The justices also held that the mere existence of a risk falls short of justifying a warning that could create an overreaction by consumers. “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,” Justice Kennard wrote. “The FDA has so determined in this case, and we find no basis to question the FDA's expert determination.” In most cases, she continued, the FDA labels and Prop 65 warnings would serve the same purpose — informing consumers of the dangers of a given product. “Here, however,” she wrote, “the FDA warning serves a nuanced goal — to inform pregnant women of the risks of [nicotine-replacement] products, but in a way that will not lead women, overly concerned about those risks, to continue smoking.”

The Outcome

Oakland-based Deputy Attorney General Susan Fiering represented the state's interests, and Morrison & Foerster partner James Bennett represented the manufacturers. Charles Miller, a spokesman for the Justice Department in Washington, DC, would only say that the agency was “pleased that the court vindicated FDA's authority to protect the public health.” Several amici curiae, including the Pharmaceutical Research and Manufacturers Association and the Consumer Healthcare Products Association, had filed briefs supporting the manufacturers.

San Francisco lawyer Mark Todzo, who argued the case for Dowhal, said that he disagrees with the court's opinion, even though he felt it was narrowly focused on nicotine products and should not undermine any other Prop 65 warnings. Todzo, a partner in the Lexington Law Group, also noted that the FDA — which originally only warned that Nicorette and similar products could increase unborn children's heart rates — had strengthened its labels after Dowhal filed suit. “It ends up being this balance,” he said, “where Prop 65 did have some positive effect. However, the court goes on to say the FDA can shield some truthful information.”

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.

What It's About

The FDA advises pregnant women to try to give up cigarettes without using nicotine gum or patches, even though the agency says the products are safer than smoking. However, the FDA warns that the risks of nicotine-replacement products are unknown. Consumer advocate Paul Dowhal, a restaurant owner in Tahoe City, had sued GlaxoSmithKline Consumer Healthcare, which makes Nicorette gum and NicoDerm' CQ patches, and McNeil Consumer Products Co. and Pharmacia & Upjohn Inc., manufacturers of Nicotrol' patches. He claimed that the products' warnings — mandated by the FDA — were inadequate, and that California labels provided expectant mothers with enough information to make intelligent decisions.

Dowhal was backed by the California attorney general's office, which argued that the FDA advisory would withhold truthful information from pregnant women. But the manufacturers had the full support of the Justice Department, which said the Prop 65 warnings “overstated the known risks” of nicotine gums and patches.

The First District Court of Appeal had earlier ruled against Dowhal, noting that Congress expressly exempted Prop 65 from the labeling requirements of the FDA Modernization Act of 1997. The state's Supreme Court reversed, however, saying that Congress did not intend to exempt state warnings that are in direct conflict with the FDA's goal of uniform labeling nationwide. The justices also held that the mere existence of a risk falls short of justifying a warning that could create an overreaction by consumers. “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,” Justice Kennard wrote. “The FDA has so determined in this case, and we find no basis to question the FDA's expert determination.” In most cases, she continued, the FDA labels and Prop 65 warnings would serve the same purpose — informing consumers of the dangers of a given product. “Here, however,” she wrote, “the FDA warning serves a nuanced goal — to inform pregnant women of the risks of [nicotine-replacement] products, but in a way that will not lead women, overly concerned about those risks, to continue smoking.”

The Outcome

Oakland-based Deputy Attorney General Susan Fiering represented the state's interests, and Morrison & Foerster partner James Bennett represented the manufacturers. Charles Miller, a spokesman for the Justice Department in Washington, DC, would only say that the agency was “pleased that the court vindicated FDA's authority to protect the public health.” Several amici curiae, including the Pharmaceutical Research and Manufacturers Association and the Consumer Healthcare Products Association, had filed briefs supporting the manufacturers.

San Francisco lawyer Mark Todzo, who argued the case for Dowhal, said that he disagrees with the court's opinion, even though he felt it was narrowly focused on nicotine products and should not undermine any other Prop 65 warnings. Todzo, a partner in the Lexington Law Group, also noted that the FDA — which originally only warned that Nicorette and similar products could increase unborn children's heart rates — had strengthened its labels after Dowhal filed suit. “It ends up being this balance,” he said, “where Prop 65 did have some positive effect. However, the court goes on to say the FDA can shield some truthful information.”