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And is The Final Rule finally on the horizon?
February 1, 2024
By: Nadim Shaath
President
Something in the air tells me that the Final Rule in Sunscreens by the US Food and Drug Administration (FDA) may be issued this month. The Proposed Final Rule that created most of the havoc among consumers was issued in February 2019. This Final Administrative Rule may be issued in several stages, with Part I handling a variety of administrative issues and Part II addressing the approval of additional GRASE ingredients. The Proposed Final Rule removed two UV filters (PABA and trolaminesalate), designated two ingredients (zinc oxide and titanium dioxide) as the only GRASE (Generally Recognized As Safe and Effective) ingredients to date, and relegated all remaining 12 UV filters to Category III; they can still be used temporarily but require additional safety data. But consumers were spooked by the fact that these 12 ingredients were not designated Category I or GRASE. As a result, both the industry and consumers are confused about the consequences of using those sunscreens that incorporate those 12 UV filters into their products. The sunscreen industry, represented by the Personal Care Products Council, decided to pursue the safety testing of eight of those 12 ingredients; namely, avobenzone, octocrylene, octisalate, homosalate, octinoxate, oxybenzone, meradimate and ensulizole. To date, the results submitted have not been commented on by the FDA. If these 8-12 UV filters are not approved by the FDA, the only glimmer of hope is the recent news that possibly BEMT (Bemotrizinol) might be approved by the FDA as a category I ingredient. It hasn’t happened yet, but we are hopeful. In the meantime, the consumer is left bewildered by the state of sunscreen regulations. Any rejection of the current 8-12 organic absorbing molecules, without the approval of new UV filters, would decrease the available sunscreens in use and decrease the protection consumers receive from the sun’s damaging rays. Sun protection, when used properly and consistently, is vital to reduce the incidence of skin cancers. That is an undisputed fact. Sunscreen lotions and creams play a vital role in protection. However, as the FDA is contemplating the fate of the approved UV filters, consumers who are sensitive to the effects of the sun and are prone to developing more serious skin problems, lesions and eventually skin cancers, should heed the warnings of overexposure to the sun. No suntanning. Avoid the harsh 10am-3pm sun exposure. Use sunscreen adequately. Wear protective clothing and eyeglasses. Seek the shade under awnings, tents and umbrellas.
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