Other Issues

The following comments represent a consolidated set of comments from organizations that have decided to form an Industry Coalition for Rational Implementation of USP <467> to express industry’s concerns with FDA’s implementation of <467>.

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Product Labeling OTC sub-team, under the coordination of CHPA staff, appreciates the opportunity to comment on the "Draft Guidance for Industry: Providing Regulatory Submissions in Electronic Format – Drug Establishment Registration and Drug Listing".

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.

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.

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.

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.