Submissions

CHPA strongly believes that companies should continue to utilize a set of robust metrics to drive internal continuous improvement activities to enhance product quality and ensure consumer safety.

The members of the stakeholder selection committee respectfully submit these candidates to serve as the non-voting industry representative and alternate (as needed) for the FDA Pediatric Advisory Committee.

Echoing earlier comments submitted to the agency, CHPA and its member companies marketing dietary supplement products support the presumption of safety for dietary ingredients outlined in the 1994 passage of DSHEA.

CHPA requests that FDA publish a statement of enforcement policy expressly permitting manufacturers of single-ingredient acetaminophen OTC drugs subject to the ongoing internal analgesic, antipyretic, and antirheumatic monograph proceedings to including labeling on products that provide instructions for use in children aged six months to two years.

CHPA's comments on this Draft Guidance are organized into three General Comments and Detailed Comments by Section.

CHPA supports advancing modernization of USP's quality monographs, updating and improving the compendial test methods and establishing product standards which can provide an additional measure of safety for OTC products.

Enclosed herein are comments on "510(k) Device Modifications: Deciding When to Submit a 510(k) for a Change to an Existing Device: Public Meeting: Request for Comments".

We take this opportunity to voice our support of comments submitted by the Council for Responsible Nutrition (CRN) regarding the appropriate interpretation of the term “chemically altered” under Section 413(a)(1) of the Federal Food, Drug, and Cosmetic Act.

We take this opportunity to voice our support of comments submitted by the American Herbal Products Association regarding proposed revisions to the agency's Draft Guidance on New Dietary Ingredient Notification.