FDA Finalizes Two Guidances Concerning Sunscreen TEAs

By Riëtte van Laack –

The Sunscreen Innovation Act (SIA) was enacted in 2014. It amended the FDC Act to provide specific deadlines for FDA’s review of time and extent applications (TEAs ) for sunscreen active ingredients.  Thus far, FDA has proposed sunscreen orders for all eight pending requests, all of which tentatively determined that the active ingredients are not GRASE and that more data are necessary to allow FDA to determine otherwise.

Pursuant to mandate of the SIA, about 11 months ago, FDA issued four draft guidances related to sunscreen time and extent applications (see our previous post here). On Friday, October 7, 2016, FDA issued the final versions of two of the four guidances, the guidance on withdrawal of sunscreen TEAs, and the guidance on requesting advisory committee review.

The final guidance on withdrawal of a sunscreen TEA is virtually identical to the draft guidance. Only two comments were submitted.  Both commenters asserted that FDA has no authority to publish a non-GRASE decision when the sponsor withdraws the TEA after a proposed sunscreen order has been published.  FDA disagreed and maintains its position that because the information was submitted as part of a public process, the information remains part of the public record.   In April, 2016, FDA issued a proposal regarding withdrawal of TEAs, consistent with this position.  Since FDA has issued proposed orders for all eight pending requests, unless the sponsors submit supplemental data supporting GRASE status, sponsors cannot prevent FDA from publishing non-GRASE decisions for all eight ingredients.  

The final guidance on requesting advisory committee review also contains no surprises and is largely identical to the draft guidance. Again, only two comments were submitted.  The final guidance provides additional detail regarding the timing of the request for a meeting.  FDA recommends that the sponsors request the meeting “at the time they submit their initial data package, or no later than at the time of the filing determination” and for sponsors of pending requests are recommended to submit their request at the time they submit their supplemental data package.