Initial media reports falsely accused Senate Majority Leader Mitch McConnell (R-KY) for including the sunscreen measure in the bill because it benefitted L’Oréal, which has a manufacturing plant in Florence, KY.2 The Senator’s aides denied his involvement and I can attest to that since this Sunscreen OTC Reform Bill has been debated in both the House and the Senate since 2018 with minimal involvement from McConnell. The final Senate version of the bill was approved in December 2019 and is void of any special favors for L’Oréal. In fact, the current House bill does not address many of the concerns that the industry and I would like to see included in this OTC Reform Act.
A Review of the Act
I will review this Sunscreen OTC Reform Act and highlight the salient features that it addresses. Embedded in this 880-page stimulus package is the Sunscreen OTC Reform Act on pages 415 through 509. The bill is written in legalese that only skilled lawyers can readily interpret. Here is an example on page 417 Section 203 entitled:
“(2)- Treatment of Sunscreen Drugs-With respect to sunscreen drugs subject to this section, the applicable requirements in terms of conformity with a final monograph, for purposes of paragraph (1)(A)(1), shall be the requirements specified in part 352 of title 21, Code of Federal Regulations, as published on May 21, 1999, beginning on page 27687 of Volume 64 of the Federal Register, except that the applicable requirements governing effectiveness and labeling shall be those specified in section 201.327 of title 21, Code of Federal Regulations.”
I realize that this passage is written by lawmakers, but it takes a specialist to decipher its real meaning. I just wanted you to share in this experience.
I will attempt to review the salient features of the law, which reveals a close cooperation between the FDA and Congress, perhaps as it should be, but our concerns are not totally addressed. Will we be able to still use the 17 approved UV filters or not? Will they allow the introduction of the Time and Extent Application (TEA) ingredients or not? How about combinations allowed with avobenzone? Safety of spray formulations? What about the Sunscreen Innovation Act passed into law by President Barack Obama on November 26, 2019? Will we have a Final Monograph on sunscreens soon? The set deadline on November 26, 2019 for a Final Monograph has come and gone, and all indications are that we will not have one for years to come.
Let me now be objective and describe to my readers the key features in the 2020 Sunscreen OTC Reform Act. I will simplify each of the actual features in the law as outlined by Covington3 followed by what I really believe the statements mean. Section 3851 of this Act adds section 505 G to the Federal Food, Drug and Cosmetic Act (FDCA). This section makes several key changes to how the FDA regulates drugs marketed under the OTC Sunscreen Monograph:
1. Drugs deemed Generally Recognized as Safe and Effective (GRASE): A drug that is in Category I in a final monograph or a Tentative Final Monograph (TFM) and complies with the relevant monograph will be deemed GRASE.
Interpretation: You can only use zinc oxide and titanium dioxide. See No. 2 for other provisions.
2. Drugs permitted to remain on the market: Drugs that are in Category III under TFM or Category I in the Advanced Notice of Proposed Rulemaking (ANPR) and that comply with the applicable provisions of such monographs will be permitted to remain on the market without approved New Drug Applications (NDA) unless and until the FDA issues a final administrative order determining that they are not GRASE.
Interpretation: The remaining 12 organic chemical UV molecules are allowed until they pass the Maximal Usage Trials (MUsT) test and the Developmental and Reproductive Toxicity (DART) tests. The Personal Care Product Council is gallantly attempting to do that. Notice that no deadline is imposed, which adds to my speculation that a Final Monograph is still years away!
3. Drugs to be Removed from the Market: Drugs that are both in Category II in the TFM and the FDA’s February 26 proposed regulations must be removed from the market within 180 days of the enactment of the CARES Act unless the FDA takes action to permit their continued marketing.
Interpretation: Para-aminobenzoic acid (PABA), trolamine salicylate and the 1978 ANPR listing of all Category II filters must go. All dosage forms including towelettes, wipes, bodywash and shampoos claiming sunscreen protection must go. Spray products are subject to the “FDA’s action to permit them” and Sunscreen-Insect Repellant combinations are in doubt unless the FDA and the Environmental Protection Agency take action to allow them to be marketed.
4. New Drugs: Drugs that the FDA has deemed as Non-GRASE as well as non-prescription drugs not in the categories I, II and III above, unless exempt, will be deemed “new drugs” and subject to the requirements of an approved new drug application under section 505.
Interpretation: Any new filters, including the European TEA ingredients, must apply for 5an NDA and comply with all the suggested additional testing of the MUsT and DART tests—a major hurdle! Most importantly, the Sunscreen OTC Reform Act will now be subject to an “Administrative Order Process” that would replace notice-and-comment rulemaking and would establish the conditions of use for OTC monograph filters.
Interpretation: Under the current FDA procedures, it entails a public notice, the opportunity for comment, a dispute resolution procedure, an opportunity for an administrative hearing and an opportunity for a judicial review. Under the new Administrative Order Process, the FDA will be permitted to deny a hearing!
Finally, Section 3854 of the CARES Act would sunset (i.e., scratch, remove, delete, retire, etc.) the Sunscreen Innovation Act (SIA) on September 30, 2022!
As I mentioned in my April column, there is a need for a Sunscreen Summit in Washington, DC. However, due to uncertainty caused by the COVID-19 pandemic, I doubt it will happen anytime soon. In the meantime, we must continue to practice social distancing and look forward to continued discussion on the Sunscreen OTC Reform Bill.
- www.politico.com>news>2020/03/26>stimulus -corona
- Covington.com/-/media/files/corporate/publications/2020/03 over-the-counter-monograph-in-the-cares-act.pdf
& Development Ltd
Dr. Nadim Shaath is the president of Alpha Research & Development, Ltd. in White Plains, NY. He has over 30 years of experience as chairman of the chemistry department at SUNY-Purchase and the CEO of Kato Worldwide. Recently he published his new book entitled “Healing Civilizations: The Search for Therapeutic Essential Oils and Nutrients” Cameron Books, Petaluma, CA.