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.
CHPA appreciates the opportunity to provide comments on the premarket notification for new dietary ingredient (NDI) notifications for dietary supplements.
CHPA appreciates the opportunity to provide comments to the FDA in response to the draft guidance for industry “Recommended Warning for Over-the-Counter Acetaminophen-Containing Drug Products and Labeling Statements Regarding Serious Skin Reactions”.
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.
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.
