CHPA comments in response to the notice announcing the proposed rule entitled “Food Labeling; Health Claim; Phytosterols and Risk of Coronary Heart Disease.” These remarks specifically address our concern regarding Section VI. of the notice regarding enforcement discretion.
Letter regarding FDA draft guidance entitled “Investigational New Drug Applications (INDs) – Determining Whether Human Research Studies Can Be Conducted Without an Investigational New Drug Application.” These comments are focused on issues related to dietary supplements as referenced in the draft guidance.
CHPA appreciates the opportunity to provide comments on the Alternative Database Rule Proposal that has been made by Commissioners Anne Northup and Nancy Nord.
CHPA does not believe scheduling of dextromethorphan under the Controlled Substances Act is warranted. The prevalence and scope of reported abuse is limited. CHPA believes that there are more effective interventions to address OTC cough medicine abuse.
In order to ensure the continued safe reporting of adverse events associated with our member's products and prevent consumer confusion, we strongly believe OTC and dietary supplement product incident reports should not be included in the CPSC safety incident database.
CHPA and its members support the Transparency Initiative and support FDA's goal of facilitating transparency that promotes public health and innovation, while maintaining confidentiality of trade secrets and individually identifiable patient information.
Today, the manufacturers of OTC medicines containing pseudoephedrine call on Congress to improve the Combat Methamphetamine Epidemic Act by requiring a unified, national electronic tracking system to block illegal sales of PSE‐containing medicines.
