Obama signs Sunscreen Innovation Act

3-Dec-2014

The FDA will have to make timely decisions over ingredients awaiting approval

Sunscreens manufactured in the US could soon be modernised – and potentially more effective – following a recent announcement that President Obama has signed the Sunscreen Innovation Act.

The act, which was signed into law on 26 November, means the US Food and Drug Administration (FDA) will now have to make decisions within a set timeframe concerning the approval of a number of sunscreen ingredients – some of which have been pending for over a decade.

Since 2002, eight sunscreen ingredients have been awaiting FDA approval in the US, several of which claim to provide better UVA protection and are already used in European and Asian countries. The FDA's slow action has led to heavy criticism by members of Congress and the House Appropriations Committee; the last time a sunscreen ingredient intended for widespread use was approved in the US was in 1990. Arguably this has negatively impacted US-manufacturered sunscreen efficacy: European manufacturers have access to roughly 27 sunscreen ingredients, compared with just 16 in the US.

Unlike in other countries, where active ingredients such as SPF are regulated as cosmetics, in the US they are classified as drugs, which requires a lengthy approval process. Currently, sunscreen manufacturers in the US seek FDA approval through its Time-and-Extent (TEA) process, a procedure that is designed to allow products to be approved for use in the US based on their use in other countries. Under the current TEA set-up, sponsors must undergo a five-part process, which can experience significant delays. The Sunscreen Innovation Act, however, aims to speed up the review and approval of products under the TEA process.

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Some of the ingredient approval decisions are slated to be made within the next three months.