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We strongly urge the CIC not to “list” acetaminophen as a carcinogen due to the lack of evidence that it has been “clearly shown” to cause cancer, and due to the unnecessary confusion and fear it could cause among consumers and patients.

CHPA comments on the proposed rule, which proposes new warning and other labeling requirements for internal analgesic, antipyretic, and antirheumatic OTC drug products.

CHPA's Internal Analgesics task group seeks the agency's clarification of three provisions of the final rule.

CHPA strongly supports the unanimous votes by the advisory committees to add weight-based dosing directions to the existing age-based labeled dosing directions for children.

Enclosed are comments on "Guidance for Industry; Organ-Specific Warnings: Internal Analgesic, Antipyretic, and Antirheumatic Drug Products for Over-the-Counter Human Use - Labeling for Products that Contain Acetaminophen."

CHPA requests that FDA publish a statement of enforcement policy expressly permitting manufacturers of single-ingredient acetaminophen OTC drugs subject to the ongoing internal analgesic, antipyretic, and antirheumatic monograph proceedings to including labeling on products that provide instructions for use in children aged six months to two years.

FDA has determined that the currently available evidence does not support the conclusion that acetaminophen causes cancer. Accordingly, a Proposition 65 cancer warning on the labeling of products containing acetaminophen would not be scientifically accurate, and such labeling would be false or misleading.

CHPA appreciates the opportunity to provide comments to the FDA in response to the draft guidance for industry “Recommended Warning for Over-the-Counter Acetaminophen-Containing Drug Products and Labeling Statements Regarding Serious Skin Reactions”.

CHPA recognizes the need for modernization of USP monographs. CHPA member companies are dedicated to fulfilling their commitment outlined in the letter to this Planning Committee on February 2, 2011.