Submissions

Letter to Dr. Williams regarding "Development of a New Official Compendium, Separate from USP-NF, for Articles Not Legally Marketed in the U.S."

Letter to Dr. Saldanha regarding the proposed definition of bioactive food components.

We submit these comments on behalf of CHPA in response to the proposed rule regarding security requirements for manufacturers, distributors, importers, and exporters of pseudoephedrine, ephedrine, and phenylpropanolamine.

This letter is submitted on behalf of CHPA, FMI, HDMA, and NACDS. The purpose of the letter is to express our united concern that the DEA’s proposed rule is not supported by existing evidence and will impose a significant burden on the regulated industry.

CHPA supports FDA's proposal to discontinue the use of approvable letters and not approvable letters when taking action on NDAs.

Comments on proposed revisions to the Proposition 65 prioritization procedure submitted by the Consumer Healthcare Products Association, Grocery Manufacturers of America, and the National Food Processors Association.

CHPA and its members share DEA's concerns regarding the diversion of pseudoephedrine, ephedrine, and phenylpropanolamine products. However, CHPA does not believe that the notice of proposed rulemaking provides interested parties an adequate record to evaluate and comment upon the security measures DEA now proposes.

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.