Other Issues

The Industry Coalition on 21 CFR Part 11 is pleased to submit the attached Citizen Petition to FDA for consideration. The Coalition comprises 13 trade associations representing manufacturers of products including foods, drugs, cosmetics, veterinary drugs, and medical devices.

We would like to commend the U.S. Government position previously taken on the vitamin and mineral supplement draft guidelines, and encourage the U.S. Government to maintain a similar position.

CHPA requests CFSAN to commit to the finalization of Good Manufacturing Practices for dietary supplements as one of its highest priorities for FY 2005.

CHPA welcomes the opportunity to provide comments to this proposed rule on nutrient content and health claims and supports the Agency’s efforts to facilitate the communication of truthful and non-misleading information to consumers.

CHPA welcomes the opportunity to be a participant in this rulemaking process for health claims and dietary guidance and supports the Agency’s efforts to develop a process that facilitates the communication of information to consumers about health claims on food and dietary supplement products.

We would like to add our voice to the American Herbal Products Association, the Council for Responsible Nutrition, and the National Nutrition Foods Association in supporting the joint industry submission.

On behalf of member companies who manufacture and distribute dietary supplement products, CHPA requests an extension of the comment period on the Advance Notice of Proposed Rulemaking for Food Labeling for Health Claims and Dietary Guidance.

CHPA supports rules governing the regulation of dietary supplements as a special type of food. The association has long advocated Good Manufacturing Practices for dietary supplements.

Letter to Daniel E. Troy, Esq. regarding whether there should be different trade-name evaluation procedures for different classes of drugs (Rx versus OTC).