Federal law preempts Proposition 65 health warning requirements
Today the California Supreme Court issued its decision in Dowhal v. SmithKline Beecham Consumer Healthcare, ___ Cal.4th ___ (Apr. 15, 2004), holding that the federal Food, Drug and Cosmetic Act and relevant FDA regulations preempted California's Proposition 65, which required manufacturers of nicotine patches to give certain warnings about the risks to pregnant women. As reported here, a noted UCL commentator, William Stern, opined that Dowhal could resolve "whether the UCL's prohibition against false advertising can be used to force a manufacturer of nicotine patches to issue warnings about hazards posed to fetuses where the FDA approved the package label without such a warning." As it turns out, Dowhal mentioned the UCL only once, in passing, when it described the legal basis for the plaintiff's claims. The Dowhal court's conclusion that the claims were entirely preempted obviated any need to analyze the UCL and consider how far, absent conflict preemption, its liability provisions might be stretched.
- posted by Kim Kralowec @ 12:06 PM