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FDA under pressure to review sunscreen ingredients

By Michelle YEOMANS , 26-Feb-2014
Last updated on 27-Feb-2014 at 09:12 GMT

The Administration is feeling the heat from the (PASS) Coalition, who is urging it to allow Americans to have access to the latest safe and effective sunscreen products available.

The Public Access to SunScreens Group says the FDA needs to do more to ensure American consumers have access to sunscreens that have been pending in the system for over 10 years.

The request comes as the regulatory body schedules its second public meeting in five years on the OTC monograph process relevant to sunscreen approvals.

Eight pending sunscreen applications have yet to be approved, backlogged for over a decade.

The delays in approvals have caught the attention of Congress and bipartisan legislation will be introduced to reform the sunscreen application process in the very near future.

This legislation will ensure that consumers have access to the latest safe and effective sunscreen ingredients in a timely fashion.

Sunscreen technology currently awaiting approval before the FDA has been widely available in Europe, Asia, Central and South America, in some cases for over 15 years.

Under the spotlight to make a decision

Back in November, representatives of the US Food and Drug Administration appeared before a Committee where they were asked to shed some light on the likes of lengthy approving processes. 

The House Committee on Energy and Commerce had earlier held an oversight hearing which seen Dr. Janet Woodcock, director of the FDA Center for Drug Evaluation discuss pending sunscreen applications whilst also giving insight into why some processes take so long.

It was congressmen Ed Whitfield and John Dingell who specifically took Dr. Woodcock to task about some applications that they said had been waiting for a decision from the Administration for the last 10 years, despite being used on the European market.

We all are aware the workload is heavy at the FDA and that resources are limited, but myself and other senators have drafted legislation to try to expedite the approval process, which we have submitted to you for technical assistance,” he explained.

She added that; “If possible, we are more frustrated than the manufacturers and you all are about this situation. The problem is that we have to do regulations to get these ingredients into monographs and they are backlogged and slow to get through."

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