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Sunscreen experts get opportunity to voice opinion on FDA approval process

By Simon Pitman+

28-Aug-2014
Last updated on 28-Aug-2014 at 15:43 GMT

The US Senate is asking for the opinions of industry professionals on a draft bill that aims to streamline and shorten the FDA regulation process for sunscreen ingredients.

The Senate Committee on Health, Education, Labor and Pensions (HELP) wants comments on a discussion draft that aims to update the Sunscreen Innovation Act and its companion bill, s.2141.

“The intent behind the bill is to streamline FDA’s review process for new sunscreen ingredients by providing specific time frames during which the FDA must determine whether a nonprescription sunscreen active ingredient, or a combination of active ingredients, is generally recognized as safe and effective (a “GRASE determination”),” says Angela Diesch, attorney at Greenberg Traurig.

Tackling a massive backlog

The legislation, introduced earlier this year by Senators Jack Reed (D-RI) and Johnny Isakson (R-GA), and Congressmen Ed Whitfield (R-KY) and John Dingell (D-MI) is a responsible way to alleviate the current 12 year backlog of sunscreen ingredients.

They believe it is also a way to streamline the review process so the public can gain access to the most effective and innovative sunscreen products. 

Diesch explains that under the current process the FDA takes around one year to approve any new ingredients, but in reality this process is even longer.

Voice your opinion on the proposal...

“For pending GRASE determination requests, submitted prior to the enactment of the bill under 21 C.F.R. § 330.14, the Act would require FDA to issue a proposed sunscreen order no later than 90 days after the bill is enacted,” Diesch said. 

“This provision is intended to expedite review of existing applications for sunscreen ingredients that have been pending at the FDA for extended periods of time.”

If you have written comments for the HELP Committee, you may make contact by the August 29th 6pm EST deadline by clicking on this email link .

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