NRT Firms’ Deference To “Informal” FDA Letters In Prop 65 Case Improper
This article was originally published in The Tan Sheet
Executive Summary
NRT firms' reliance on "unpublished, ad hoc" FDA statements to support their contention that a Proposition 65 warning on OTC smoking cessation products conflicts with federal law is improper, according to a brief filed in California Supreme Court April 15
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Prop 65 NRT litigation
Plaintiff Paul Dowhal "is mistaken" in asserting that FDA has only rejected one Prop 65 warning for NRT products, according to a reply brief filed in California Supreme Court June 16. "FDA has prohibited use of any articulation of the message that [Prop 65] requires...because it has determined that the substance of this message conflicts with the FD&C Act's prohibition on misbranding and thwarts the objective of avoiding overwarning," the brief maintains. Filed on behalf of 10 NRT manufacturers, marketers and retailers, the filing also takes issue with Dowhal's contention the firms rely on informal FDA correspondence to support their opposition to a Prop 65 warning (1"The Tan Sheet" April 28, 2003, p. 9). Dowhal "ignores the fact that this correspondence includes five NDA approval letters," the reply brief notes...
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