The FDA has declared that satisfactory DART (Developmental and Reproductive Toxicology) and MUsT (Maximal Usage Test) are required for approval by the FDA to designate BEMT as GRASE. If approved, BEMT will be the first UV filter designated as Category I UV filter by the FDA for nearly 20 years. The Time and Extent Application (TEA) was submitted by Ciba to the FDA on April 11, 2005!
In view of the FDA's recent Proposal to designate zinc oxide and titanium dioxide as the only two UV filters as GRASE, approval of BEMT will be a significant development. BEMT has been used effectively and safely in Europe and most of the world since 1999. It is a powerful photostable UVA filter designed according to the Dalton 500 requirements.
I will be chairing the Saturday session at next month's Florida Sunscreen Symposium in Orlando. The session will feature Dr. Theresa Michele from the FDA, Carl D'Ruiz from DSM and Consultant Uli Osterwalder formerly of Ciba, BASF and DSM. That panel of speakers should make for a lively and informative session.
About the Author
Dr. Nadim Shaath is the president of Alpha Research & Development, Ltd. in White Plains, NY. He has over 30 years of experience as chairman of the chemistry department at SUNY-Purchase and the CEO of Kato Worldwide. Recently he published his new book entitled “Healing Civilizations: The Search for Therapeutic Essential Oils and Nutrients” Cameron Books, Petaluma, CA. Contact him at firstname.lastname@example.org