Submissions

The Structured Product Labeling OTC sub-team, under the coordination of CHPA staff, appreciates the opportunity to comment on the "Draft Guidance for Industry: Providing Regulatory Submissions in Electronic Format – Drug Establishment Registration and Drug Listing".

On May 7, 2008, CHPA received correspondence from the United States Food and Drug Administration (FDA) requesting safety data for over-the-counter (OTC) mouth rinse products containing cetylpyridinium chloride (CPC).

These comments are submitted on behalf of a coalition that represents companies that manufacture, distribute, and sell many of the foods, beverages, OTC medicines, nutritional supplements, and personal care products consumed or used by Californians every day.

CHPA and its member companies who make oral pediatric cough and cold medicines strongly believe that the current data support the safety and efficacy of these medicines when used as directed; however, we are committed to working with FDA to better enhance consumer use of these products.

These comments are submitted in response to the public meeting held June 5 and 6, 2008, on evaluating proposed proprietary names for drug products.

CHPA does not believe that the Beneficial Nutrients Regulatory Concept is necessary or supportive of the intent of the Safe Drinking Water and Toxic Enforcement Act of 1986.

CHPA appreciates the opportunity to comment on the advanced notice of proposed rulemaking for revisions to food labeling reference values and mandatory nutrients.

CHPA subcommittee hearing statement in support of federal legislation ensuring that raw, unfinished dextromethorphan does not fall into the wrong hands, and that minors under 18 are not allowed to purchase cough medicine.

CHPA comments on issues associated with the public health benefit of certain drugs being available without a prescription, but only after intervention by a pharmacist.

Members of the CHPA Dietary Supplement Committee (DSC) welcome the opportunity to provide comments on the ANPR. However, we feel that additional time is needed to adequately prepare our response.