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.
IMPACT OF SUNSCREEN REGULATIONS ON SUNCARE DEVELOPMENT 229 Nevertheless, the FDA released the conditions for compliance of sunscreens with the Final Rule of December 2012 as follows: (i) It must have an SPF of at least 15. (ii) It must be a broad spectrum with a critical wavelength of at least 370 nm. (iii) It must comply with a modifi ed Principal Display Panel-Drug Facts. It allowed companies to claim that “sunscreens reduce the risk of skin cancer and early skin aging when used as directed.” In my opinion, the claim should not be addressing skin cancer and skin aging but instead that “sunscreen reduces or eliminates (or protects from) the harmful solar radiation.” Period! In their “Proposed Final” that was issued on February 26, 2019 (5), only two fi lters (zinc oxide and titanium dioxide) were classifi ed as GRASE category I fi lters. Two other fi lters (PABA and trolamine salicylate) became category II ingredients (i.e., cannot be used anymore), and the remaining 12 ingredients (avobenzone, oxybenzone, octinoxate, octo- crylene, octisalate, homosalate, meradimate, ensulizole, cinoxate, padimate O, dioxyben- zone, and sulisobenzone) were classifi ed as category III ingredients (i.e., require further extensive testing). The FDA specifi ed that at a minimum two tests were required, namely, the MUsT test and the DART test, before any of those category III ingredients can be reclassifi ed as GRASE category I fi lters. In the FDA’s “Proposed Final” of February 26, 2019, other changes were also proposed: (i) Powders, wipes, towelettes, body washes, and shampoos were disallowed if they can contain UV fi lters with sunscreen claims. (ii) Spray sunscreens will require further safety testing. (iii) The maximum SPF allowed will now be SPF 60+. The marketing of SPF values up to 80 may be allowed but would require an NDA. (iv) The UVA and Broad Spectrum labeling now needs to satisfy not only the critical wavelength test but also a new standard according to the formula below: UVAI/UV ≥ 0.7 ( v) Insect repellent/sunscreen combination products would now be classifi ed as category II (i.e., not allowed). Many petitions were sent to the FDA requesting reversal of this proposal. In May 2019, the FDA released the fi rst of two MUsT tests on sunscreens in the Journal of the American Medical Association (JAMA) revealing that four UV fi lters (avobenzone, oxybenzone, octocrylene, and ecamsule) failed the test because of skin penetration far exceeding the proposed safety levels of 0.5 mg/mL (6). In January 2020, the FDA released its second MUsT study also in JAMA (7), which revealed that six UV fi lters failed the test, bringing the total UV fi lters that failed the test to seven (avobenzone, oxybenzone, octocrylene, octinoxate, octisalate, homosalate, and ecamsule) when both the May 2019 and the January 2020 reports were completed. The Personal Care Product Council set up a work group to lobby the FDA to consider new data on eight of the remaining 12 category II fi lters (avobenzone, oxybenzone, octi- noxate, octisalate, homosalate, ecamsule, octocrylene, and meradimate). No decision by the FDA on this proposal was reached to date. The backdrop of all those developments date back to Hawaii’s 2018 bill in their state legislature (sponsored by State Senator Mike Gabbard) that banned both oxybenzone and
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