January 2020 • Vol. 26 • Issue 1
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The Proposed Final Sunscreen Monograph …by Howard Epstein
he Sunscreen Innovation Act sponsored by Jack Reed was introduced to the Senate Committee Health, Education, Labor, and Pensions on March 13, 2014. It amends the Federal Food, Drug, and Cosmetic Act to establish a process for the review and approval of over-the-counter (OTC) sunscreen active ingredients. The Act allows any person to request that the Secretary of Health and Human Services consider the approval of an OTC sunscreen active ingredient or combination of ingredients that has been in use and that is not included in the stayed sunscreen monograph published by the Food and Drug Administration. The sponsor of the request can provide data and other relevant information on the safety and efficacy of sunscreen active ingredients or combination of ingredients. The Secretary is then required to determine whether the provided information is adequate to conduct an evaluation within 300 days of data submission. On February 26, 2019, the FDA published a proposed rule that would put into effect a final monograph for non-prescription OTC sunscreen drug products. It establishes conditions under which certain OTC drugs may be marketed without approved new drug applications, indicating these products would be Generally Recognized as Safe and Effective (GRASE). The sun care industry was hopeful that data previously submitted to the FDA would lead to the approval of additional sun filters currently used in Europe under the FDA time and extent rule (TEA) policy. The FDA’s time and extent application process provides a pathway for the FDA to determine whether an ingredient is GRASE and can be marketed under the OTC monograph process without the established testing requirements. To be considered eligible under the TEA rule, an active ingredient must be shown to have been marketed for a period of time in a marketed OTC product as specified by FDA regulations. The industry anticipated additional sun filters would be permitted by the FDA. Unfortunately, the FDA concluded that additional safety data would be necessary for the proposed filters that had safety data submitted under the TEA rule. Further, the FDA concluded that only zinc oxide and titanium dioxide would be GRASE. PABA and trolamine salicylate were classified as Category II, meaning they would no longer be considered safe and effective for use as
sunscreen actives. The FDA proposed that the remaining twelve sun filters be classified as Category III, requiring further safety testing. The reason for this classification is regarding a concern for greater penetration of the sun filters into skin than previously thought. To establish safety in use of sunscreen products, the FDA is proposing a Maximal Usage Trial study (MUsT). This is a human pharmacokinetic test that measures the amount of absorption of a drug into the body. This study is new to the cosmetics industry and is more commonly used to study absorption of prescription (continued on Page 3)
A N U P D AT E O N T H E F D A N E W P R O P O S E D S U N S C R E E N R E G U L AT I O N J a n u a r y 2 9 t h • D e l t a H o t e l s Wo o d b r i d g e , I s e l i n , N J