JOURNAL OF COSMETIC SCIENCE 230 octinoxate by January 2021 because of their perceived impact on coral reefs (8). This was followed by many countries banning both UV fi lters including the island of Palau and the U.S. Virgin Islands, as well as similar proposals for Key West, Florida, and the State of California. This debate has caught the attention of Congress which is currently legislat- ing the new Over-The-Counter Reform Act. The legislation is expected to pass in early 2020* (See Footnote). The fi scal year 2019 Appropriations Bill currently has language directing the Environmental Protection Agency to coordinate a study with the National academy of Science to investigate the safety of all sunscreen ingredients and their impact on coral reefs and the environment. They were also tasked to evaluate the impact of banning those sunscreen ingredients on public health. The debate goes on! Let me summarize the impact of all the regulations passed, proposed, and in development on the approval of safe and effective sunscreens in the United States. With Hawaii cur- rently proposing a ban on all sunscreens that contain any UV fi lter, other than zinc oxide and titanium dioxide (9), chemists may have no choice but to develop all new sunscreen products using only these two inorganic fi lters, zinc and titanium oxides. This, of course, is an impractical and intolerable proposition. For one thing, the supply industry of those two raw materials is certainly not ready for such a huge demand. Major shortages or delays in product release will understandably occur. Will the consumer, who is used to low- priced mass marketed products, be willing to pay much more for products with similar protection? Will the consumer who is used to elegantly designed products tolerate aes- thetically unappealing sunscreen products with zinc and titanium oxides? Will the consumer—who is used to SPF 60, 70, and even 100—accept SPF ratings of 35 or a maxi- mum of 50? Will the consumer accept not having access to the convenient spray sunscreens that will now be diffi cult to formulate with these two inorganic fi lters? Are we providing the consumer with the most effective broad-spectrum sunscreen products to combat the epidemic rise of skin cancers lately with only those two ingredients? The questions are numerous, and the obvious answer is that it would be impractical, if not impossible, to create an innovative and effective industry with just those two mineral sunscreens. So, what is the solution? Obviously, part of the answer lies in the need for better-designed UV fi lters. We could start out with approving a few of the pending TEA European ingredients. Many of them have been used safely for years worldwide and are designed according to the Dalton 500 principle to reduce skin permeation. Molecules that have MW greater than 500 are gen- erally much less permeable to the skin. This could be tested, and, perhaps, the IVPT, the MUsT test, and the DART test would be a requirement before their approval by the FDA. An evaluation of what constitutes an unsafe level of permeation causing diseases should be conducted. A more realistic safety level of a value different from 0.5 ng/ml may be more appropriate. Do I agree with the FDA’s reluctance to issue a fi nal monograph especially because the usage of sunscreens today is massive? To a certain extent they are currently on the right track in critically evaluating all sunscreen ingredients, but, in my opinion, they are a tad too late. Better late than sorry? True, but their reluctance to approve safe and effective European TEA ingredients, and to instead relegate all the 12 category I ingredients that have been used since 1978, as non-usable, non-GRASE, without alternatives, casts a ma- jor shadow on their use for current skin cancer prevention and protection. How can a nonscientifi c average consumer use those products while the FDA is reporting that they
IMPACT OF SUNSCREEN REGULATIONS ON SUNCARE DEVELOPMENT 231 are being absorbed into our blood and are unsafe to use? Publishing their studies in JAMA without an alternative is a travesty that casted doubts on the current protocols in combating the rising incidence of skin cancer. We need options and real solutions now for adequate protection from the harmful radia- tion of the sun. We need new safer ingredients and protocols for sun protection. Let us start out with approving the tried and true European fi lters. Also, allow American ingenuity the opportunity and the path to introduce new effective and safe ingredients to combat the rising incidents of skin cancer. * Footnote: Since I wrote this article in January 2020, Congress released its Over-The- Counter Reform Act on March 25, 2020 as part of the 2 Trillion dollar stimulus package. For a review, please read my May and June "The Sunscreen Filter" column in HAPPI Magazine for all the recommendations pertaining to Sunscreens in the Reform Act. REFERENCES (1) Skin Cancer Foundation, (2) A. Holzer, M. Athar, and C. Elmets, The other end of the rainbow: infrared and skin, J. Invest. Dermatol., 130, 1496–1498 (2010). (3) C. Calles, M. Schneider, F. Macaluso, T. Benesova, J. Krutmann, and P. Schroederand, Infrared A radia- tion infl uences the skin fi broblast transcriptome: mechanism and consequences, J. Invest. Dermatol., 130, 1424–1436 (2010). (4) A. M. Calafat, L.-Y. Wong, X. Ye, J. A. Reidy, and L. L. Needham, Concentration of the Sunscreen Agent, Benzophenone-3, in Residents of the United States: National Health and Nutrition Examination Survey 2003– 2004. Environmental Health Perspectives 116 (2008). (5) over-the-counter-human-use. 21 CFR Parts 201,310, 347 and 352. (6) M. K. Matta, D. G. Strauss, R. Zusterzeel, N. R. Pilli, V. Patel, D. A. Volpe, J. Florian, L. Oh, E. Bashaw, I. Zineh, C. Sanabria, S. Kemp, and A. Godfrey, Effect of sunscreen application under maximal use conditions on plasma concentration of sunscreen active i ngredients, JAMA, 321, 2082–2091 (2019). (7) (8) 3009002. (9) dozen-chemicals-in-sunscreens/.
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