Final OTC Sunscreen Monograph Postponed, FDA Leadership Confirms
The US FDA is still working through more than 20,000 comments on its February proposed rule to establish a final OTC sunscreen drug monograph. Thus, it will not meet the 26 November 2019 deadline set by the Sunscreen Innovation Act of 2014, said Theresa Michele, director of FDA’s nonprescription drug division, during a 21 November public meeting with industry advocates.
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Benefits of OTC monograph reform legislation passed in March likely will take at least several years, according to GAO report to Congress. It notes the FDA still is analyzing the legislation and it may need two years to add and train staff.
The FDA emphasizes that findings from its second, more extensive clinical study on the absorption potential of sunscreen active ingredients are not in themselves signals that the UV filters are unsafe. However, they portend heavy work ahead for industry if the ingredients are to remain GRASE and available for use in OTC sunscreen drug products stateside.
Cosmetics Market In 2019: CBD, Microplastic And US Sunscreen Uncertainty Among Year’s Biggest Issues
The opportunity represented by cannabidiol, and the uncertain future for commonly used sunscreen active ingredients in the US and microplastic in the EU, were issues of high interest among cosmetics industry stakeholders in 2019.