Proposition 65 Advisory

April 26, 2001

Proposition 65 Advisory 01-V

Proposition 65 Preempted by FDA-Approved Warning
for Over-The-Counter Nicotine Patches and Gum

San Francisco Superior Court Judge David A. Garcia ruled that federal regulations promulgated by the U.S. Food and Drug Administration ("FDA") preempt the application of Proposition 65 to over-the-counter ("OTC") nicotine patches and gum. The ruling was issued on March 9, 2001, in response to cross-motions for summary adjudication in the case Dowhal v. SmithKline Beecham, et al. Defendant SmithKline successfully pointed to the conflict between Proposition 65 and product-specific warning language required under FDA regulations as the reason to invoke preemption.

Judge Garcia found that FDA regulations explicitly prohibit the defendants from including Proposition 65 warnings on the labels for their products. Since the inception of this case, and as recently as March 2, 2001, FDA has insisted that manufacturers and distributors use only the warnings prescribed by the federal regulations, without any additional or modified warning language. Garcia recognized the supremacy of the federal requirements. "Where, as here, a federal agency requires one thing in accordance with its statutory authority, and a state statute requires another, and where both requirements cannot be satisfied simultaneously, conflict preemption exists and the state requirement must yield." Garcia further ruled that defendants could not be required to distribute warning statements in their advertising that FDA has expressly prohibited them from including on their labels. Such warnings still would be inconsistent with the federal warnings, and would frustrate the purpose of the federal requirements.

Garcia was unimpressed with Dowhal's argument that a "savings clause" in the FDA Modernization Act of 1997 exempts Proposition 65 from the preemptive effects of the federal statute. This "exemption from preemption" has no effect where there is an actual conflict between Proposition 65 and a specific FDA requirement.

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