Proposed Sunscreen Rule, Final MUsT Guidance Jumpstart Next-Gen UV Filter Discussions
CDER agrees to protect DSMs confidential business information by redacting most correspondence but says general meeting minutes will be made public. To address TEA sponsors' concerns about disclosing proprietary information, "in some situations FDA may hold private meetings with sponsors who request them without subsequently disclosing proprietary information," CDER Division of Nonprescription Drug Products responds to DSM request.
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The US Centers for Disease Control and Prevention should “diligently” track systemic exposure to the 12 UV filters currently in question at FDA, the Environmental Working Group says in a recent petition.
Appropriators are "concerned that the lack of dosing information" on OTC drugs for children ages six months to 2 years "may lead to dosing errors, adverse events and inadequate treatment of fever and pain.” They also ask USDA about fraud in its National Organic Program.
FDA proposed final sunscreen monograph identifies zinc oxide and titanium dioxide as GRASE, two other ingredients as non-GRASE and 12 substances with data gaps, meaning firms must provide safety and effectiveness data or reformulate products that rely on inadequately supported UV filters. EWG says the proposal is “exactly the kind of signal that FDA should be providing for the sunscreen industry.”