OTC Medicines

The Structured Product Labeling OTC sub-team appreciates the opportunity to comment on the collection of information pertaining to the July 2008 Draft Guidance for Industry: Providing Regulatory Submissions in Electronic Format – Drug Establishment Registration and Drug Listing.

The undersigned trade associations are writing to request that the Commission exercise enforcement discretion with respect to the new general conformity certification requirement imposed by the Consumer Product Safety Improvement Act of 2008 (CSPIA).

The Consumer Healthcare Products Association, Council for Responsible Nutrition, and Natural Products Association submit this response to the request for relevant information on the developmental and reproductive toxicity of caffeine.

Comments concerning abuse potential, actual abuse, medical usefulness, trafficking, and impact of scheduling changes on availability for medical use of ten drug substances.

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Product Labeling OTC sub-team, under the coordination of CHPA staff, appreciates the opportunity to comment on the "Draft Guidance for Industry: Providing Regulatory Submissions in Electronic Format – Drug Establishment Registration and Drug Listing".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