Will the FDA Impose Another Deadline on the Sunscreen Industry?
By Nadim Shaath, PhD, Alpha R&D | 09.22.21
What is pending in the Administrative Order of September 27, 2021 and how will it impact formulators?
And then there were…two? I am writing this column two weeks before the September 27 deadline imposed by the CARES Act of 2020 for the US Food and Drug Administration to publish its Final Administrative Order on sunscreens. Last year, as part of the CARES Act, the Sunscreen Innovation Act of 2014 was suspended. So, what is pending in the Administrative Order of September 27, 2021?
The FDA submitted Proposed Regulations on February 21, 2019. It was followed by the CARES Act on March 27, 2020, which would presumably reform and modernize the US Regulatory Framework for OTC Drug Review. It specifically introduced:
1. The Administrative Order (AO) Process replacing the original “Notice and Comment” Rulemaking Process.
2. Expanded FDA resources via a User Fee Program authorized for five years (OMUFA and OMOR fees).
3. Suspension of the Sunscreen Innovation Act (SIA) of Nov 26, 2014.
4. A mandate that the status of existing OTC Monograph and Ingredients be finalized by September 27, 2021.
The issue of finalizing the status of the 16 UV filters approved in the US as Category I ingredients is of paramount importance to the sunscreen industry and for ensuring that consumers are protected from the ravaging rays of the sun. Those solar rays presumably are responsible for the skin cancer epidemic that we are experiencing today in the US and around the world. After the publication of the MUsT studies in the Journal of the American Medical Association (JAMA) by the FDA scientists, the proposed regulations determined that only two UV filters (zinc oxide and titanium dioxide) are Generally Regarded As Safe and Effective (GRASE). Two filters (triethanolamine salicylate and PABA) were banned, and the remaining 12 Category I filters were given a Category III designation calling into question their safety. Despite the FDA’s repeated assertions that these 12 filters could still be used for solar protection, consumers were left confused and bewildered and having to make their own decisions on their use.
A multi-billion-dollar industry relying on only two filters, zinc oxide and titanium dioxide, is impractical and would be a total nightmare. Sunscreen products on the US market today with these two ingredients represent, at best, 15% of the total sunscreens in use. While these two ingredients are excellent UV blockers, they have serious limitations in filling the gap of the 85%, or more, of sunscreen products that currently use the 12 organic absorbing UV filters that are under the scrutiny of the FDA today. When you couple the potential banning of some, or all, of the remaining 12 organic filters by the FDA along with the news that some UV filters affect coral reefs, and the reluctance of the FDA to allow the European filters to be approved in the US under the Time and Extent Application (TEA) process, we are looking at an economic disaster in the sunscreen industry and a potential public health calamity due to a lack of adequate solar protection. I have stopped predicting what the FDA will decide on the major issues concerning sunscreen regulations, but I know that if it bans all or some of the 12 filters in question on September 27, we will see a major upheaval in the industry and a potential rise of more melanoma and skin cancer incidents in the US.
Some Good News
On a more positive note, the PASS Coalition met on September 10 with the staffers of six senators and three representatives in Congress. We had lengthy discussions on several of the critical issues that the industry and the public face today including the following:
1. The upcoming FDA announcements on September 27
2. The impact of the banning of any of the filters in use today
3. The potential prospect of having only two approved GRASE UV filters (ZnO and TiO2)
4. The non-approval of the European Time and Extent Application (TEA) ingredients
5. The rise of skin cancer in the US and the need for solar protection
6. The Hawaii legislation, the Reef Safe Act in Congress, and the perceived environmental impact of sunscreens on coral reefs
7. The National Academy of Science’s study on the environmental effects of sunscreens •
Finally, scientists and marketers from all over the world will be meeting in Florida September 23-26 to attend the all-important Sunscreen Symposium (Florida Sunscreen Symposium). As expected there are six speakers addressing the issues pertaining to the use of ZnO and TiO2, since the FDA has proposed them as the only two approved GRASE filters for use in the US. Other interesting topics presented include a potentially new UV filter from space- based technology, SPF methodology and its faults, one talk entitled “Fall from GRASE;” and others among the 23 scheduled presentations.
Interestingly, there will be five technical presentations by the FDA mainly addressing the MUsT paradigm and other absorption studies. I am sure that none of the FDA speakers will address regulations and in particular the September 27 deadline alluded to in this column. Rest assured, however, that we are all looking forward to debating the imminent FDA decisions and to listen to the latest developments in sun care.
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 in the sunscreen industry. He served as the 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. Nadim@alpharnd.com
The FDA submitted Proposed Regulations on February 21, 2019. It was followed by the CARES Act on March 27, 2020, which would presumably reform and modernize the US Regulatory Framework for OTC Drug Review. It specifically introduced:
1. The Administrative Order (AO) Process replacing the original “Notice and Comment” Rulemaking Process.
2. Expanded FDA resources via a User Fee Program authorized for five years (OMUFA and OMOR fees).
3. Suspension of the Sunscreen Innovation Act (SIA) of Nov 26, 2014.
4. A mandate that the status of existing OTC Monograph and Ingredients be finalized by September 27, 2021.
The issue of finalizing the status of the 16 UV filters approved in the US as Category I ingredients is of paramount importance to the sunscreen industry and for ensuring that consumers are protected from the ravaging rays of the sun. Those solar rays presumably are responsible for the skin cancer epidemic that we are experiencing today in the US and around the world. After the publication of the MUsT studies in the Journal of the American Medical Association (JAMA) by the FDA scientists, the proposed regulations determined that only two UV filters (zinc oxide and titanium dioxide) are Generally Regarded As Safe and Effective (GRASE). Two filters (triethanolamine salicylate and PABA) were banned, and the remaining 12 Category I filters were given a Category III designation calling into question their safety. Despite the FDA’s repeated assertions that these 12 filters could still be used for solar protection, consumers were left confused and bewildered and having to make their own decisions on their use.
A multi-billion-dollar industry relying on only two filters, zinc oxide and titanium dioxide, is impractical and would be a total nightmare. Sunscreen products on the US market today with these two ingredients represent, at best, 15% of the total sunscreens in use. While these two ingredients are excellent UV blockers, they have serious limitations in filling the gap of the 85%, or more, of sunscreen products that currently use the 12 organic absorbing UV filters that are under the scrutiny of the FDA today. When you couple the potential banning of some, or all, of the remaining 12 organic filters by the FDA along with the news that some UV filters affect coral reefs, and the reluctance of the FDA to allow the European filters to be approved in the US under the Time and Extent Application (TEA) process, we are looking at an economic disaster in the sunscreen industry and a potential public health calamity due to a lack of adequate solar protection. I have stopped predicting what the FDA will decide on the major issues concerning sunscreen regulations, but I know that if it bans all or some of the 12 filters in question on September 27, we will see a major upheaval in the industry and a potential rise of more melanoma and skin cancer incidents in the US.
Some Good News
On a more positive note, the PASS Coalition met on September 10 with the staffers of six senators and three representatives in Congress. We had lengthy discussions on several of the critical issues that the industry and the public face today including the following:
1. The upcoming FDA announcements on September 27
2. The impact of the banning of any of the filters in use today
3. The potential prospect of having only two approved GRASE UV filters (ZnO and TiO2)
4. The non-approval of the European Time and Extent Application (TEA) ingredients
5. The rise of skin cancer in the US and the need for solar protection
6. The Hawaii legislation, the Reef Safe Act in Congress, and the perceived environmental impact of sunscreens on coral reefs
7. The National Academy of Science’s study on the environmental effects of sunscreens •
Finally, scientists and marketers from all over the world will be meeting in Florida September 23-26 to attend the all-important Sunscreen Symposium (Florida Sunscreen Symposium). As expected there are six speakers addressing the issues pertaining to the use of ZnO and TiO2, since the FDA has proposed them as the only two approved GRASE filters for use in the US. Other interesting topics presented include a potentially new UV filter from space- based technology, SPF methodology and its faults, one talk entitled “Fall from GRASE;” and others among the 23 scheduled presentations.
Interestingly, there will be five technical presentations by the FDA mainly addressing the MUsT paradigm and other absorption studies. I am sure that none of the FDA speakers will address regulations and in particular the September 27 deadline alluded to in this column. Rest assured, however, that we are all looking forward to debating the imminent FDA decisions and to listen to the latest developments in sun care.
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 in the sunscreen industry. He served as the 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. Nadim@alpharnd.com
