California Supreme Court Limits Anti-Toxics Labeling Law in Nicotine Replacement Products Case
The state Supreme Court on Thursday unanimously ruled that federal warnings on nicotine replacement products, such as nicotine patches and gum, preempt the state's more stringent label requirements for the products, marking the first time the court has limited the scope of the state's anti-toxics law, the San Francisco Chronicle reports. Under Proposition 65, which voters approved in 1986, manufacturers are required to include warning labels on products containing ingredients that pose a risk of birth defects. In 1999, consumer advocate Paul Dowhal filed a lawsuit against 10 manufacturers and retailers of nicotine-replacement products, arguing that the over-the-counter products should be required to include a warning under Proposition 65. At the time, FDA required a warning label stating, "Nicotine can increase your baby's heart rate," and advising consumers to consult with a health professional about using the products (Chiang, San Francisco Chronicle, 4/16). Many products required to carry warning labels under the state law read, "This product contains a chemical known to the state of California to cause birth defects or other reproductive harm." Since the lawsuit was filed, FDA officials have changed the federal warnings on such products to say, "If you are pregnant or breastfeeding, only use this medicine on the advice of your health care provider. Smoking can seriously harm your child" (Curtis, AP/Contra Costa Times, 4/16). The new federal label also says that pregnant women should try to stop smoking without using nicotine and notes that the replacement products are "less harmful than smoking" but that their "medical risks are not fully known," the Los Angeles Times reports (Dolan, Los Angeles Times, 4/16). While ruling that federal law overrides the state law on nicotine replacement products, the court "appeared to restrict its ruling to the facts of the case before it, rejecting a more sweeping interpretation" proposed by U.S. Attorney General John Ashcroft that would allow federal law to override any state warning that was not identical to it, the Chronicle reports. The justices found that in this particular case, the state warning conflicted with FDA's aim of discouraging pregnant women from smoking because "consumers may give too much weight to the warnings and decide to continue smoking," Justice Joyce Kennard wrote in the court's opinion. The court concluded that whenever such warnings conflict, federal law prevails.
Justice Department spokesperson Charles Miller said federal officials were pleased with the ruling. Michele Corash, an attorney for the manufacturers and retailers, said she was satisfied with the ruling, adding, "FDA and the label recognize that the benefits of the product for the pregnant women are substantial and real and the risks remote." Tom Dressler, a spokesperson for Attorney General Bill Lockyer (D), said that while Lockyer was "disappointed" with the ruling, he also was "heartened by the fact that it was narrowly applied," according to the Chronicle. "The court leaves ample room for the state to continue using Proposition 65 to require more explicit warnings on over-the-counter products," Dressler said (San Francisco Chronicle, 4/16).This is part of the California Healthline Daily Edition, a summary of health policy coverage from major news organizations. Sign up for an email subscription.