Submissions

CHPA appreciates the opportunity to provide comments on FDA’s draft guidance for industry on adverse event reporting for dietary supplements and nonprescription human drug products marketed without an approved application.

CHPA's voluntary plan to address concerns surrounding the safety and efficacy of OTC oral pediatric cough and cold medicines. CHPA, on behalf of its member companies, commits to the following initiatives.

CHPA and its Dietary Supplement Committee (DSC) members appreciate the opportunity to provide comments on the draft guidance. However, we feel that additional time is needed to adequately prepare our response.

The members of the Consumer Healthcare Products Association appreciate the opportunity to provide comments on the interim final rule on the petition to request an exemption from 100 percent identity testing for dietary ingredients.

The CHPA Dietary Supplements Committee appreciates the opportunity to submit nominees for the position of nonvoting industry representative on FDA’s Food Safety Public Advisory Committee. The DSC is nominating two candidates for the industry representative position on the advisory committee

CHPA's nomination for industry representative to the Nonprescription Drugs Advisory Committee.

On June 11, 2007, FDA requested that industry organizations submit notification expressing their desire to participate in the selection process for nonvoting industry representatives on the Food Safety Public Advisory Committee. Please accept this letter as an official request from CHPA to assist in the selection process.

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

FDA issued a proposed rule on labeling requirements for OTC human drugs. The announcement proposed a definition for “convenience-size” OTC drug packages as well as the option of alternative labeling requirements for these products. CHPA welcomes the opportunity to comment on the proposed rule changes.

CHPA welcomes the opportunity to comment on the proposed rule change on labeling requirements for OTC human drugs.