Law.com Subscribers SAVE 30%

Call 855-808-4530 or email [email protected] to receive your discount on a new subscription.

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

By Mike McKee
April 27, 2004

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.

Read These Next
The DOJ's Corporate Enforcement Policy: One Year Later Image

The DOJ's Criminal Division issued three declinations since the issuance of the revised CEP a year ago. Review of these cases gives insight into DOJ's implementation of the new policy in practice.

The DOJ's New Parameters for Evaluating Corporate Compliance Programs Image

The parameters set forth in the DOJ's memorandum have implications not only for the government's evaluation of compliance programs in the context of criminal charging decisions, but also for how defense counsel structure their conference-room advocacy seeking declinations or lesser sanctions in both criminal and civil investigations.

Use of Deferred Prosecution Agreements In White Collar Investigations Image

This article discusses the practical and policy reasons for the use of DPAs and NPAs in white-collar criminal investigations, and considers the NDAA's new reporting provision and its relationship with other efforts to enhance transparency in DOJ decision-making.

Bankruptcy Sales: Finding a Diamond In the Rough Image

There is no efficient market for the sale of bankruptcy assets. Inefficient markets yield a transactional drag, potentially dampening the ability of debtors and trustees to maximize value for creditors. This article identifies ways in which investors may more easily discover bankruptcy asset sales.

A Lawyer's System for Active Reading Image

Active reading comprises many daily tasks lawyers engage in, including highlighting, annotating, note taking, comparing and searching texts. It demands more than flipping or turning pages.