'Data Gaps' Keep 12 Ingredients Off FDA's Proposed OTC Sunscreen Monograph
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.”
You may also be interested in...
Three-fourths of sunscreens marketed in the US offer “inferior” protection or contain “worrisome” chemicals, according to the Environmental Working Group’s 2020 Sunscreen Guide. The guide shows overwhelming preference for mineral over chemical sunscreens, while also suggesting that Americans would be better off if UVA-protective chemical filters in Europe were allowed stateside.
FDA’s food, dietary supplement and cosmetics division seeks funding to support its artificial intelligence capabilities, including post-market surveillance and speedy interventions in instances where safety issues arise. Also of note, the agency cites UV filters’ effects on the skin microbiome as a research priority in its fiscal 2021 budget justification to Congress.
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.