Ingredient approval a challenge for sunscreen formulators

20:57 PM | August 26, 2013 | —Vincent Valk

No fun in the sun: A regulatory backlog in the US constricts options for sunscreen makers and consumers.

A backlog in FDA approvals for active ingredients in sunscreen is limiting options for sunscreen formulators, producers say. The backlog restricts opportunities to sell sunscreens that can be labeled as broad spectrum and SPF-15 under FDA’s new sunscreen labeling rules, which were enacted in December of last year. Under the rules, label claims can convey that a sunscreen can reduce skin cancer risk and have antiaging properties, in addition to protecting against sunburn.

FDA, which regulates sunscreens as OTC drugs, launched a new process to review sunscreen ingredients in 2002. The process, called time and extent application (TEA), attempted to use data compiled from other regions to speed the regulatory approval process, says Michael Werner, a partner with law firm Holland & Knight (Washington) and spokesman for the PASS Coalition. PASS is a group of ingredient manufacturers and cancer research groups advocating to clear the backlog and adopt new rules. The group includes BASF, Ashland, L’Oreal, and Procter & Gamble.

Eight ingredients, some of which were submitted to the agency over a decade ago, currently await FDA approval. Three of these ingredients—bisoctrizole, bemotrizinol, and octyl triazone—were submitted by BASF. “These are used in practically every country outside the US and Canada,” says Al Pearce, senior markting manager/personal care at BASF. “You will find these ingredients in the EU, Asia, South America, and Mexico.” In the European Union, sunscreens are treated as cosmetics by regulatory authorities, Pearce notes.

Additionally, the backlog has impacted other companies as well as consumer behavior. “The FDA’s delay in new approvals has slowed the introduction of new technologies and kept the industry and the products offered to the US market behind those available in Europe and Asia,” says Justin Bill, product manager with HallStar (Chicago), a personal-care chemicals maker. Wendy Selig, president and CEO of the Melanoma Research Alliance (Washington), also a member of PASS, notes that “people who can travel end up buying their favorite product in other countries and feel they can get much better options.”

The reasons for the backlog are unclear, according to PASS members. “In terms of specific reasons why FDA hasn’t approved the specific products, we don’t really know,” Werner says. “FDA has said publicly, on several occasions, they were going to clear the backlog or publish a new rule, and it hasn’t happened.” The House Appropriations Committee has, as part of the fiscal 2014 budget, included guidance directing the FDA to clear the backlog and develop a new sunscreen approval rule, Werner adds. Such guidance, however, does not carry the force of law.

BASF’s three ingredients that are currently in regulatory limbo would enable sunscreens to meet SPF-15 and broad-spectrum requirements under the new FDA labeling rules, Pearce says. “It increases the number of products available to formulators,” he notes. While it is early, BASF and the Melanoma Research Alliance both hope that new labeling rules will increase sunscreen use. BASF hopes the rules will spur increased usage and reapplication of sunscreen, Pearce says. Selig also hopes the new rules will provide clearer guidance to consumers as to which products provide which benefits. “The rules were outdated,” she says. “The goal [with the new labeling rules] was to provide something consistent and clear so that people could understand it.”

“US consumers have shown a growing preference for broad-spectrum, high-SPF products. It is likely due to a combination of factors, including the FDA ruling, growing consumer awareness of photostable sun protection, and continued scientific breakthroughs on the effect of UV radiation on our skin,” Bill says. Consumers are also showing an increasing preference for water-resistant sunscreens, HallStar says. The FDA labeling rules allow sunscreens to claim water resistance for 40 or 80 minutes.

Sunscreen makers expect the market to keep growing and are hopeful that the new rules will help and that the ingredient backlog can be resolved in a timely fashion. “Demand for sun protection products will continue to grow at rates higher than the general cosmetics market,” Bill says.