We encourage the FDA to continue to abide by its current guidance statement which indicates that there is no causal link between the intake of synthetic food colors and childhood hyperactivity.
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Letter regarding FDA draft guidance entitled “Investigational New Drug Applications (INDs) – Determining Whether Human Research Studies Can Be Conducted Without an Investigational New Drug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 These comments are focused on issues related to dietary supplements as referenced in the draft guidance.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.
