04-2532 Kelso v. Bayer Corp.

By: dmc-admin//February 21, 2005//

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“[A]s Bayer points out, the Food and Drug Administration has issued a monograph that dictates the language that manufacturers must use for labeling topical nasal decongestants such as Neo-Synephrine. 59 Fed. Reg. 43386, 43396 (Aug. 23, 1994) (‘All OTC drug labeling required by a monograph or other regulation (e.g., statement of identity, warnings, and directions), must appear in the specific wording established under the OTC drug monograph or other regulation where exact language has been established and identified by quotation marks . . . .’). Bayer maintains that because its warning, excerpted above, complied with the FDA-required warning, Kelso cannot challenge the adequacy of the warning. For this added reason, we conclude that the warning provided was adequate as a matter of law.”

Affirmed.

Appeal from the United States District Court for the Northern District of Illinois, Holderman, J., Manion, J.

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