On July 19, 2022, Venable attorney Claudia Lewis was featured in a Happi Q&A about the latest developments in OTC Monograph Reform, including the U.S. Food and Drug Administration's (FDA) Deemed Final Orders (DFO). The following is an excerpt:
HAPPI: Are there any developments regarding the OTC Monograph Reform including the FDA’s Deemed Final Orders that beauty and personal care companies must have on their radar right now? What are they and why are they a concern—or should be a concern—for beauty and personal care brands?
Lewis: Yes, there are many products in the market to address skin lightening and discoloration. It is important to note that it appears that the Monograph Reform effectively makes it illegal to sell skin lightening products, except for the FDA-approved drug Tri-Luma. FDA is prioritizing enforcement in this space and has issued numerous Warning Letters to companies marketing skin lightening products in recent months. Another issue that I am watching is sunscreen. Companies that sell sunscreen or companies that are thinking of entering the sunscreen market should be aware that sunscreen is considered a drug and must comply with FDA’s Deemed Final Order (DFO) on sunscreen. Importantly, FDA is preparing to amend the sunscreen DFO, and while we do not know exactly what that amendment will look like or when it will become final, there is a possibility that FDA will severely limit the types of active ingredients that can be used in sunscreen.
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