“It definitely hurts how we approach development of new UV filters,” said Al Pearce, a personal care senior marketing manager for BASF, which owns several of the pending applications at FDA. “The U.S. market is one of the largest markets in the world. If it’s not open to new innovation, it’s extremely limiting.”
Even as the sunscreen ingredient applications have remained in a regulatory purgatory, the FDA has taken other action on sunscreens. In 2011, it announced long-awaited rules meant to cut back on misleading labels and give consumers clearer information.
For instance, only products that meet FDA standards for protecting against both UVA and UVB rays can be labeled as providing “broad spectrum” protection. In addition, the new rules barred the use of the terms “sun block,” “sweatproof” and “waterproof,” because the agency said such claims overstate the effectiveness of the sunscreens.
The agency said manufacturers could label their products “water resistant” but also must say how long the sunscreen remained effective in water. It also proposed limiting the maximum sun protection factor on labels to “50+,” saying there wasn’t sufficient data to show that products with higher SPF values provide greater protection.
But when it comes to finally allowing new sunscreen ingredients to reach the market, the wait continues in the United States. Eleven months ago, in a hearing on Capitol Hill, FDA Commissioner Margaret A. Hamburg told lawmakers that sorting out the sunscreen issue was “one of the highest priorities.”
Rigel, the New York dermatologist, hopes that’s still true.
“I want the ultimate, perfect sunscreen for my patients,” he said. “No such perfect sunscreen exists yet. But these ingredients would help us get closer to that goal.”