PASS Coalition Works Toward FDA Acceptance Of New(ish) UV Filters

The newly formed Public Access to Sunscreens coalition says it plans to work with FDA, legislators and stakeholders to facilitate review of sunscreen actives. The group proposes user fees as one method of ensuring FDA has the resources it needs to complete sunscreen ingredient evaluations, some of which have been pending as time and extent applications since 2002.

Sunscreen stakeholders including ingredient suppliers, finished product marketers, dermatologists and special interest organizations have joined together to advocate for reform in FDA’s sunscreen approval process.

Called Public Access to Sunscreens (PASS), the coalition’s mission is to work with the agency, the White House, Congress, health providers, consumer organizations and sunscreen manufacturers “to establish a regulatory pathway for timely pre-market review of new, safe and effective sunscreen ingredients,” it says.

The group’s members include the Skin Cancer Foundation, the Melanoma Research Foundation, Suncare Research Laboratories, Beiersdorf, L’Oreal USA, [Ashland Inc.], BASF Corp. and others.

Formed in early 2013, PASS is presently focused on pending time-and-extent applications for sunscreen actives. Eight UV filters await FDA’s evaluation, some under the agency’s consideration since 2002.

In 2002, FDA established the TEA process as a pathway for adding substances to an over-the-counter drug monograph that have been marketed “to a material extent and for a material time” – in a foreign market, for example – and have safety data to back them up.

The agency’s final rulemaking on the matter stated that it would strive to complete TEA applications in 90-180 days and expected to approve 30 TEA applications annually, PASS notes on its website.

“Unfortunately, the TEA process is broken,” according to PASS, which highlights the fact that FDA has not approved a sunscreen ingredient through TEA since the program began.

The delay is a disservice to consumers, as many of the ingredients offer “enhanced safety” and are widely used in Europe, the group asserts.

In its annual Sunscreen Guide released in May, the Environmental Working Group suggested that FDA has “failed” consumers by needlessly delaying approval of UV filters that are available to consumers overseas (Also see "Most U.S. Sunscreens Not So Hot, Reflecting FDA Failures – EWG" - HBW Insight, 27 May, 2013.).

The NGO says that avobenzone, approved by FDA for use as a filter in 1972, is the most commonly used sunscreen active in the U.S., but that three European-cleared actives (BASF Corp.’s Tinosorb S and Tinosorb M and L'Oreal SA’s Mexoryl SX) are more effective.

"America is a leader in innovation and scientific advancement, and yet while advanced sunscreen technology is available globally, it isn’t available in the U.S.,” Al Pearce, personal-care senior marketing manager for BASF Corporation, says in a March 14 release, adding: “The PASS Coalition intends to play an active role in calling on lawmakers and regulators to join forces to provide the public with the most effective and innovative sunscreens available."

User Fees Proposed

According to PASS, FDA has indicated that “a lack of resources currently stand in the way” of completing its review of pending sunscreen applications.

The group calls that “unacceptable,” and says it will work to ensure the agency has the resources it needs for sunscreen active reviews.

While PASS says on its website that it is “considering a variety of reform solutions that will ensure a predictable and transparent review of sunscreen ingredient applications,” it cites user fees as one important possibility.

By charging TEA applicants a fee, FDA would have the funds it needs to ensure quick turnaround on decisions.

“If implemented, this type of program would benefit the American public because consumers would gain more rapid access to the safest and most effective sunscreens, [and] new active ingredients would receive a thorough review for effectiveness and safety within a predictable timeline,” according to PASS.

UV Filters Awaiting TEA Approval

Active Name	Brand Name	Marketer	Year Of FDA Application
Amiloxate	Neo Heliopan	Symrise	2002
Enzacamene	Eusolex	Merck	2002
Octyl Triazone	Uvinul	BASF	2002
Bemotrizinol	Tinosorb S	BASF	2005
Bisoctrizole	Tinosorb M	BASF	2005
Iscotrizinol	Uvasorb HEB	3V Sigma	2005
Ecamsule	Mexoryl SX	L’Oreal	2007
Drometrizole Trisiloxane	Mexoryl XL	L’Oreal	2009