Spray Sunscreens Stay In FDA Enforcement Discretion Shade
This article was originally published in The Pink Sheet & The Rose Sheet
CDER's enforcement policy guidance for OTC monograph sunscreens clarifies that spray sunscreens are included in the agency's enforcement discretion. But CDER closes the door on other dosage forms that it also identified in its 2011 ANPR for whether delivery formats other than lotions, creams or other traditional forms would be eligible for the monograph.
You may also be interested in...
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.”
FDA aims to publish a tentative final monograph for OTC sunscreen drugs in 2019 that identifies “data gaps that FDA believes need to be filled” for 16 currently listed UV filters to support their continued marketing in the US without new drug approvals.
Report to key US legislators could boost efforts to revamp approaches to making nonprescription ingredients available.