Comments of Consumer Healthcare Products Association before the Institute of Medicine of the National Academies Committee on identifying and preventing medication errors.
CHPA appreciates the opportunity to provide comments concerning U.S. Government positions in preparation for the 33rd session of the Codex Committee on Food Labelling of the Codex Alimentarius Commission.
In considering the safety of NSAIDs, the use of OTC NSAIDs should be clearly distinguished from long-term prescription NSAID use. OTC medicines have a different overall benefit-to-risk equation and a wider margin of safety than prescription NSAIDs.
Given the millions of units of tooth whitening products used by U.S. consumers and the remarkable safety profile of these products, we believe the U.S. data supports the Colipa recommendation for the marketing of cosmetic tooth whitening products.
CHPA appreciates the opportunity to provide comments to the FDA in response to the draft guidance for industry “Recommended Warning for Over-the-Counter Acetaminophen-Containing Drug Products and Labeling Statements Regarding Serious Skin Reactions”.
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.
