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.
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.
The Health in Hand Foundation is dedicated to helping consumers lead happier, healthier lives by providing information and guidance on how to safely use, store, and dispose of OTC medicines, dietary supplements, and OTC medical devices.
Know Your Dose (KYD) educates patients and consumers about the safe and effective use of acetaminophen, the most commonly used drug ingredient in the United States.
Current good manufacturing practices establish uniform standards to ensure quality throughout the manufacturing, packaging, labeling, and holding of OTC medicines and dietary supplement products.
Lawmakers should support the centralized progress made on ingredient evaluation, labeling, and packaging protections by specialized national children’s health agencies instead of allowing jurisdiction confusion that ultimately hinders healthcare advancement for all ages.
