“I hate being the bearer of bad news, but most of the above ingredients will require a miracle to pass the current MUsT test and be reapproved as Category I ingredients. Three of them (avobenzone, octocrylene and oxybenzone) failed the MUsT test with thresholds above the minimal safety levels. PCPC may have to present data justifying a modified MUsT test with differing safety levels. Oxybenzone, octinoxate and octocrylene are already banned in Hawaii, Key West and the US Virgin Islands, and considerable negative publicity has all but killed them as effective UV filters. The remaining four ingredients, homosalate, octinoxate, meradimate and ensulizole, are small molecules with molecular weights well below 500, which is the minimum requirement for non-penetration into the skin. Even though the MUsT test has not been applied to those four ingredients, my guess is that it would take a miracle to expect them to pass the current MUsT test with the 0.5ng/ml safety threshold.”
Quote from Dr. Nadim Shaath 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.
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The FDA shut down PCPC’s proposal for a “sequential” testing approach, under which industry would have conducted pilot and pivotal maximal usage trials (MUsTs) on a single UV filter in its priority list and base subsequent MUsTs on learnings from those studies, initially projected to wrap up in 2023.
Industry suggested in its draft work plan that some non-clinical data gaps also would be addressed after the initial testing phase, an idea the agency likewise rejected.
The FDA is insisting that industry undertake parallel MUsTs on all sunscreen active ingredients for which final rulemaking is deferred. Those deferrals remain up in the air at present, awaiting firm industry commitments to the agency’s satisfaction.
The agency also expects industry to begin tackling all data deficiencies identified in its proposed rule more or less simultaneously and without delay.
Theresa Michele, director of nonprescription drug products at the Center for Drug Evaluation and Research, endeavored to put the FDA’s demands in context, reminding attendees that sunscreen products with SPFs of 15 or higher and broad-spectrum protection can be labeled as effective at preventing skin cancer.
She continued, “So if we’re going out and telling the public, ‘Use this product, use it on a daily basis, use it whenever you go out in the sun, put it on every two hours, start when you’re six months old and wear it until you’re 100’ – that’s pretty significant. And we really need those safety data to support that use, because that’s the public health message that’s out there, and it concerns me that we would be saying that without the data to back it up.”
That said, study summaries, which could ensure some measure of confidentiality, are not adequate, FDA leadership maintains.
Agency experts noted at the meeting that they typically look at individual animal data when evaluating studies relating to dermal safety, carcinogenicity, and developmental and reproductive toxicity, and that such granular information is not routinely included in the summaries found in scientific literature.
The FDA confirmed it 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. It plans to issue its decision September 2020.
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