Metropolitan News-Enterprise


Monday, July 15, 2002


Page 1


C.A. Rejects Preemption Challenge to Warnings on Nicotine Patches


By ROBERT GREENE, Staff Writer


Nicotine gum, patches and other over-the-counter products meant to help smokers kick their habit must carry the same kind of warnings that cigarettes do when sold in California even though federal law exempts them in other states, a state appeals court ruled Friday.

California’s Proposition 65, which requires health warnings on dangerous substances, is the only state law in the nation that is “saved” from preemption by federal drug laws, the First District Court of Appeal said.

Congress carefully crafted the Federal Food, Drug, and Cosmetic Act to make sure the labeling did not apply to certain nicotine products, because members wanted to be sure new regulatory barriers would come between smokers and products that would help them quit.

But the court said another federal law—the Food and Drug Administration Modernization Act of 1997, which was to assure that states didn’t pile their own regulations on top of federal food and drug laws—carved out a special exception for Proposition 65.

Congress’ Intent

Key provisions of the Modernization Act “clearly articulate Congress’ intent,” the opinion by Presiding Justice Barbara J.R. Jones of Div. Five said. “While state laws governing nonprescription drugs are generally preempted by the FDCA, Proposition 65 is not preempted,” Jones said.

If it stands, the ruling likely means makers of medicinal nicotine products, like lead defendant SmithKline Beecham Consumer Healthcare, will likely have to choose between adding the warning to every gum and patch package they sell nationwide or creating different packaging for the California market.

Proposition 65 was a statewide initiative approved by California voters in 1986. It mandates a host of warnings, not limited to consumer products. Warnings of asbestos posted in office buildings, petroleum products at gas stations, and other familiar signs are directly mandated by the initiative.

Proposition 65 also requires warnings on consumer products, including cigarettes. But the surgeon general’s package warning familiar to smokers is a result of federal law, which has been found by courts to preempt state law.

Jones said the Modernization Act was meant to establish national uniformity for nonprescription drugs, and to accomplish that expressly barred states and local governments from adding requirements that are different from those listed in federal law.

Express preemption is only the most obvious form of federal preemption. State laws also can be preempted when they regulate conduct in a field Congress intended only the federal government to occupy, or to the extent that there is an actual conflict between a state and federal law.

Jones said that a San Francisco Superior Court judge who originally rejected the suit against SmithKline and other drug-makers incorrectly ruled that federal law preempted Proposition 65’s application to all nicotine products, including those meant to help smokers quit.

She noted that the Modernization Act included a “savings clause” that preemption would “not apply to a State requirement adopted by a State public initiative or referendum enacted prior to September 1, 1997.”

Proposition 65 apparently is the only state law in the nation that fits that description.

In support of her interpretation of preemption law, Jones cited floor debates on the Modernization Act in which Sen. Barbara Boxer of California thanked the authors “for working with me to ensure that California’s proposition 65 will not be preempted by the uniformity provisions of this bill.”

No Conflict

But Jones went further, saying not only that the initiative is not expressly preempted, but that there is also no implied or actual conflict arising from the Constitution’s Supremacy Clause.

“Respondents have not cited, and we are not aware of, any case that holds a court can ignire Congress’s clearly articulated abd directly applicable express intent to preempt…based on an analysis of what Congress impliedly intended to do,” Jones said. “We will not be the first.”

The opinion drew a separate concurrence from Justice Mark B. Simons, who agreed that Proposition 65 mandates warnings on nicotine products but said it was only because there was no actual conflict.

The case is Dowhal v. SmithKline Beecham Consumer Healthcare, A094460.


Copyright 2002, Metropolitan News Company