Nadim A. Shaath, Alpha R&D08.30.19
DSM announced this week that it is seeking approval of the UV filter bemotrizinol (BEMT) that was originally developed by Ciba. A meeting between the FDA and DSM officials was held via a teleconference on June 7, 2019. On August 9, 2019, Theresa Michele MD, director of the Division of Non Prescription Drug Products responded to DSM's request to submit study plans to support a determination that BEMT (at a maximum concentration of 10%) is GRASE (Generally Regarded As Safe and Effective) and if the data is acceptable maybe included as an active ingredient for sunscreen use under the OTC Sunscreen Monograph. DSM notified the FDA late in August that it will submit the necessary data (For more on DSM's submission, click here).
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 alpharnd@aol.com
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 alpharnd@aol.com
