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CHPA appreciates the opportunity to provide comments to the FDA in response to the draft guidance for industry “Recommended Warning for Over-the-Counter Acetaminophen-Containing Drug Products and Labeling Statements Regarding Serious Skin Reactions”.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.
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.
