Stakeholders have teamed up to light a fire under FDA, frustrated with the agency's lack of progress in making state-of-the-art, broad-spectrum sunscreens available to Americans.

The panel, assembled by Citizens for Sun Protection, consists of Chemicals supplier Ciba, Fallene Cosmeceuticals, Rep. Nita Lowey (D-N.Y.), dermatologists, the Skin Cancer Foundation, and skin cancer survivor and 2006 Miss Maryland Brittany Lietz.

They submitted a petition to FDA in late November.

"The FDA continues to delay action on implementing sunscreen standards which would provide more effective and informative labeling, an important line of defense against the damaging rays of the sun," Rep. Lowey said.

In its Nov. 20 request for action, the panel asserts that "several thousand" cases of skin cancer could be prevented each year in the U.S. if the latest photostable, broad-spectrum sunscreen products were available to the public.

"I do feel that we have a responsibility to do everything we can to help the FDA understand that we are dealing with a health-care crisis and that there are steps that we can take to improve the protection of American consumers," Catherine Ehrenberger, president of home and personal care at Ciba Corporation, told "The Rose Sheet."

Ciba's sunscreen actives bisoctrizole (Tinosorb M) and bemotrizinol (Tinosorb S) are both stalled in FDA's Time and Extent Application process.

The TEA pathway, created in 2002, allows drugs with "material" overseas marketing data to be eligible for FDA's over-the-counter drug review rather than undergo New Drug Application.

The Tinosorb filters are touted as photostable and broad-spectrum-protective in that they defend against not only UVB rays responsible for sunburns and linked to skin cancer, but also UVA rays believed to increase UVB effects and directly cause some melanomas. Ciba filed for approval of the ingredients in April 2005.

Following a notice of eligibility published by FDA in December of that year, comments on the ingredients were accepted through March 2006; the Estee Lauder Companies and Fallene Cosmeceuticals were among those in support of Ciba's filters (¹ Also see "Ciba Seeks Addition Of UVA Filters To FDA Sunscreen Monograph" - HBW Insight, 7 July, 2008., p. 7).

The panel notes that an advance notice of proposed rulemaking is scheduled for publication in the Federal Register in May 2009. However, "these scheduled dates are not obligatory, so it is internal agency priorities that will ultimately determine the publication date."

The panel is hopeful that its petition will expedite the "now stagnant" review of sunscreen filters under consideration for inclusion in the OTC sunscreen monograph.

After "almost three years ... the agency has still not reached a decision on products that have been approved by every major global regulatory institution in the world and have been protecting the people of the rest of the world for almost 10 years," it says.

In a Dec. 3 interview, Dr. Harry Fallick, chief medical officer at sunscreen manufacturer Fallene, noted that the company is interested in formulating with Ciba's Tinosorb filters. Currently Fallene's Total Block and Cotz sunscreen lines derive their UVA protection from micronized titanium dioxide and zinc oxide.

As a physician, "my belief is that if somebody in Mexico can get an ingredient ... it would be nice to see it made available here," Fallick said. "For a long time I've been hearing that physicians were telling their patients to buy products from Europe, and there's only a certain population that can afford to do that," he added.

Ehrenberger was similarly discouraged. "The U.S. always considers that it has the best - the best access to health care, the best products," she said. But "in the sunscreen area the U.S. actually has the lowest standards and no access to really state-of-the-art sunscreen filters."

FDA issued a proposed rule amending its final sunscreen monograph in August 2007. Publication of the final monograph, issued in 1999, has consistently been stayed due to industry pressure.

Does FDA Have Its Priorities Straight?

Currently, review of new over-the-counter sunscreen products is listed on the federal regulatory agenda as a planned "long-term action," which means it is not legally bound to specific deadlines, according to the petition.

The panel argues that the approval of broad-spectrum sunscreen actives should be made an "economically critical" priority.

A spokesperson pointed out that the U.S. accounts for $1.15 billion of the annual $6 billion generated in global sunscreen sales, but does not have access to the more advanced formulations available in major markets including Europe, Australia, Brazil, Japan and Mexico. "Americans are spending billions annually on ineffective products," she said.

Meanwhile, more than 1.2 million cases of skin cancer are being diagnosed annually in the U.S., and treatment costs are approaching the billion-dollar mark at an estimated $1,000 per diagnosed case, the petitioners note.

Most concerning to the panel is the scarcity of sunscreen ingredients approved in the U.S. that address both UVB and UVA radiation.

A sunscreen product's sun protection factor (SPF) reflects primarily its effectiveness at protecting against UVB rays. In recent years research has shown UVA to be equally if not more damaging.

In fact the increased incidence of skin cancer in the U.S. may be due to overextended time spent in the sun by consumers who feel a false sense of security in sunscreen formulations that put off the sunburn caused by UVB exposure but do nothing to minimize the effects of UVA, the panel suggests.

FDA's draft sunscreen rule includes UVA protection standards in the form of a controversial 4-star system (² Also see "Industry Groups Burned About Proposed Sunscreen Labeling Requirements" - HBW Insight, 14 January, 2008., p. 3).

Currently sunscreen makers and the American public have limited options for defending against more deeply penetrating, long-wavelength UVA rays. FDA currently allows zinc oxide, titanium dioxide, avobenzone and L'Oreal's Mexoryl SX to be used for that indication.

The Mexoryl SX complex contains ecamsule, which also is undergoing TEA review (³ Also see "FDA Deems UVA Filter Ecamsule Eligible For Monograph, Seeks Data" - HBW Insight, 15 September, 2008., p. 9).

L'Oreal aims to use the ingredient in a wider range of products without having to complete a New Drug Application for each. Approval of its TEA also would introduce another UVA option to competing manufacturers. In the meantime L'Oreal has exclusive rights to Mexoryl SX.

The panel notes that review of new sunscreen ingredients, including innovative UVA filters, ranks no higher on FDA's priority list than its consideration of skin-bleaching agents, an analgesic hangover treatment, and a product addressing upset stomach due to over-indulgence.

Assuming that FDA focuses its resources on initiatives most critical to protecting human health, the panel cites the agency's reconsideration of OTC cold and cough products for children under 6 years of age as an example of an appropriately prioritized activity.

That undertaking came about in response to a citizen petition highlighting numerous unintentional overdoses that resulted in the death of at least 8 children in the past 25 years, according to the panel.

"We applaud the FDA's sense of urgency to protect children and believe skin cancer deserves the same sense of urgency," it says, noting that the morbidity rates associated with skin cancer outweigh those for all other cancers combined, and by far those associated with the abuse of cold and cough medicines.

Legislation has been introduced in the House by Lowey and in the Senate by Sens. Chris Dodd (D-Conn.) and Jack Reed (D-R.I.) to impose deadlines on the agency for finalizing the sunscreen monograph (⁴ 'The Rose Sheet' Aug. 4, 2008, In Brief).

"There doesn't need to be any additional legislation," Ehrenberger said. "FDA has everything done. They've had all the scientific review, they have the standards proposed, [and now] they just need to finish the job."

- Ryan Nelson (r.nelson@elsevier.com)

Industry, Docs And Congress Combine Voices In Call For Final Sunscreen Regs

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