However, two other ingredients PABA and trolamine salicylate--are not
GRASE for use in sunscreens because of safety issues, Theresa Michele, MD, director of the Division of Nonprescription Drug Products Division of Nonprescription Drug Products in the FDA's Center for Drug Evaluation and Research.
If you read the new proposed monograph, the FDA approved as
GRASE (Category I) only zinc oxide and titanium dioxide.
Proposed
GRASE Status of Active Ingredients listed in the stayed 1999 Final Monograph.
* Change Generally Recognized as Safe and Effective (
GRASE) standards;
For Proposed Orders stating that more information is needed, necessary data must be submitted in order to obtain a
GRASE determination.
Based on new scientific information and concerns expressed by outside scientific and medical experts on an FDA advisory committee, the agency is requesting additional scientific data to demonstrate that health care antiseptics in the over-the-counter drug monograph are generally recognized as safe and effective (
GRASE) for their intended use to reduce bacteria that potentially can cause disease.
First, the FDA implemented a new requirement that any new UV filters considered by the TEA process must pass the stringent requirements of
GRASE (Generally Recognized As Safe and Effective), a standard that exceeds the requirements of the very costly and time consuming New Drug Application (NDA).
The new hurdle set by the FDA is that all such ingredients must pass the stringent requirements of
GRASE (Generally Recognized as Safe and Effective).
