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US gov passes bill to speed up FDA sunscreen approvals

By Michelle Yeomans+

29-Jul-2014
Last updated on 29-Jul-2014 at 17:40 GMT

The U.S. House of Representatives has finally passed a bill that will streamline the process for reviewing and approving ingredients in sunscreen products.

The Sunscreen Innovation Act (H.R. 4250) was created in co-operation with the FDA and is the first major update to the review process since the 1990s.

With this ruling, the act won’t change the level of scientific review required for approval, but will speed up some of the procedural steps that can draw out the review process.

If it becomes law, it would only apply to sunscreen products that have been marketed outside the U.S. for at least five years.

The bipartisan Sunscreen Innovation Act was recently introduced by Reps. Ed Whitfield (R-Ky.) and John Dingell (D-Mich.) in the House and Sens. Jack Reed (D-R.I.) and Johnny Isakson (R-Ga.) in the Senate.

The last over-the-counter (OTC) sunscreen ingredient to be approved by FDA was in the 1990s.

Clear the backlog

Since 2002, eight new sunscreen applications have been filed and are still awaiting review 12 years later. New sunscreen technologies currently awaiting approval in the U.S. have been widely available in Europe, Asia, and Central and South America, in some cases for more than 15 years.

The Sunscreen Innovation Act aims to ensure that sunscreen ingredients going through the FDA approval process receive a transparent review within a predictable timeframe -11 months or less, depending on whether it is a new or existing submission.

As it stands now, there is no mandatory timeline for this process. Existing FDA eligibility requirements would be maintained; meaning an ingredient must be used extensively and safely for at least five years in at least one country.

Industry backing bill

Specialty ingredients supplier Ashland has voiced its support and approval of the Sunscreen Innovation Act, H.R. 4250 as it looks to develop its new products.

The announcement follows the Public Access to SunScreens (PASS) Coalition in applauding the House Energy and Commerce Committee for bipartisan support of the new Act.

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