CHPA submits these comments on the proposal published by the Food and Drug Administration in 64 Fed. Reg. 66822 (November 30, 1999) to revise its citizen petition regulations, 21 C.F.R. § 10.25 and 21 C.F.R. § 10.30.
CHPA submits these written comments in response to FDA’s notice in the Federal Register concerning “Guidance for Industry: Significant Scientific Agreement in the Review of Health Claims for Conventional Foods and Dietary Supplements.”
Request for agency exercise of enforcement discretion regarding the addition of new Warning language to Drug Facts labeling for Over-the-Counter benzocaine liquid/gel products indicated for relieving oral discomfort.
CHPA and its members, the U.S. manufacturers and distributors of OTC medicines and nutritional supplements, recognize the efforts of the FDA to further develop methodologies and techniques for characterization of nanomaterials for drug applications.