J. Cosmet. Sci., 71, 227–231 (July/August 2020) 227 Impact of Sunscreen Regulations in the United States on Suncare Development NADIM A. SHAATH , PhD, Alpha Research & Development, Ltd., New York, NY It is estimated that fi ve million skin cancer incidences are diagnosed in about three mil- lion patients in the United States annually (1% of the population). These incidences of skin cancer are more than breast, prostate, lung, and colon cancers combined. There are about a 100,000 new cases of malignant melanomas (MM), the deadliest form of skin cancer, and almost 10,000 die each year from MM (1). It is well known that skin cancer is due mostly from ultraviolet radiation, although credible evidence has surfaced that other wavelengths of the solar spectrum, most notably the high- energy frequency visible rays, and the infrared rays may also cause damage to the skin (2,3). Concerns that I—and others—have expressed for many years about burgeoning skin can- cer rates also pertain to the development of ultraviolet fi lters incorporated into sunscreens in the United States. Presently, in the United States, with the exception of zinc and tita- nium oxides, the fi lters are poorly designed and rely on technology developed in the last century, and thus they are all smaller molecules of molecular weights (MW) (Daltons) of less than 400. This makes them less effi cient in ultraviolet (UV) absorbance, protecting predominantly in the UVB region, with the molecules small enough to permeate the bloodstream when applied to the skin. As the new U. S. Food and Drug Administration (FDA) data revealed (which will be discussed in more detail later in this article), all the small molecule fi lters tend to penetrate the skin. The Centers for Disease Control reported that oxybenzone was found in the breast milk of mothers as well as in the blood of 96% of Americans who were tested (4) . As new data surface about skin cancer incidences and the lack of adequate ultraviolet fi l- ters to protect us from UV radiation, in particular the UVA region, it is obvious that scientists and regulators need to triple their efforts in protecting the consumer. Of the 16 fi lters currently approved by the FDA, only four UV fi lters offer some protection from the UVA region. They are avobenzone (which, unfortunately, is photo unstable), oxybenzone (which is currently under severe attack from environmentalists and the medical commu- nity), menthyl anthranilate (which practically no one uses), and fi nally zinc oxide (which has its own challenges in formulations). On February 26, 2019, the FDA proposed new rules governing the regulation of sunscreens in the United States (5). If approved (see discussions in the following text), then it will basically render zinc oxide and titanium Address all correspondence to Nadim A. Shaath at alpharnd@aol.com

JOURNAL OF COSMETIC SCIENCE 228 dioxide as the only two approved and Generally Recognized as Safe and Effective (GRASE) category I fi lters in the United States. Finally, the European time and extent application (TEA) fi lters, all eight of them, were categorically rejected by the FDA under the TEA process. Let us now review the current FDA regulations in the United States. Sunscreens are regu- lated as drugs and not cosmetics in the United States. They are regulated as cosmetics in most of the world, including all of Europe, ASEAN countries, Japan, China, India, Hong Kong, Korea, Taiwan, Russia, the Middle East, and Mercosur countries. Australia has both “therapeutic” and “cosmetic,” whereas Canada classifi es sunscreens as both “drugs” and “natural health products” depending on the product. Classifying sunscreens as drugs exposes both their use and approval to the extensive scrutiny that drug approvals undergo in the United States. For approval, they will need a New Drug Application (NDA), a TEA approval, or are grandfathered in by the FDA as they did in 1978 when they pub- lished the Advanced Notice of Proposed Rulemaking (ANPR). Recently, however, the FDA has suggested that all fi lters and sunscreens be subjected to in vitro permeation testing (IVPT), the Maximum Usage Trial (MUsT) tests, and the developmental and re- productive toxicology (DART) test. Those new hurdles will undoubtedly eliminate most of our currently approved ultraviolet absorber fi lters in the United States. The ANPR classifi ed 21 UV fi lters as category I. It specifi ed the level they could be used in sunscreens. They were allowed in sunscreen products in any combination so long as they had their appropriate Sun Protection Factor (SPF) and UVA testing completed as required by the FDA. The ANPR was followed by a “Tentative Final Monograph” (TFM) on sunscreens issued in 1993, then the “Final Rule” was implemented in 2012, and fi nally the “Proposed Final Rule” in 2019. No fi nal monograph has yet been issued. The deadline imposed by the Congressional Sunscreen Innovation Act of November 26, 2019 has come and gone, and all indications are that it will be another 12–18 months before the fi naliza- tion of the sunscreen monograph. In all honesty, the FDA has serious issues to consider. Way back in 1978 when the ANPR was released, solar radiation protection by sunscreens was minimal, skin cancer rates were not well documented, available technology for designing ultraviolet fi lters was primitive, and achieving a tan was not the rage at the time. Affl uency, people seeking the sun, and vacationing in popular resort destinations in the middle of winter were not fashionable or affordable. As the incidence of skin cancer spiraled out of control, new measures for protection—including the use of sunscreen—became paramount. Today, sunscreens are used by the vast majority of consumers in the United States. Many products are targeted for year-round daily use. Sunscreens sold today are recommended for both day and night use, rain or shine, and UV fi lters have been incorporated into a wide variety of sunscreens, skin- care lotions, night creams, lip balms, haircare and anti-aging products. Many sunscreens were poorly formulated and rely predominantly on UVB protection with little or no UVA broad-spectrum protection. The sunscreen products today may contain up to six UV fi lters with a total percentage of UV fi lters well exceeding 25% of the formulation. Maximum SPF values were regulated by the ANPR in 1978 at 15, then 30 by the TFM in 1993, and then 50 by the Final Rule in 2012, with companies today insisting that the consumer needs higher SPF’s reaching 70 and even higher than 100!! Collectively, these developments have startled the FDA, suncare manufacturers, and researchers alike. When sunscreens were ap- proved in 1978, most of the current usage was never envisioned but ultimately led to the FDA’s current stance to regulate or overregulate sunscreens in the United States.