FDA ‘frustrated’ by sunscreen delay

The Food and Drug Administration (FDA) says that it’s as upset as anyone about delays preventing new ingredients from being used in sunscreens.

Janet Woodcock, head of the FDA’s drug evaluation and research center, told lawmakers in the House on Friday that the delay in approving the ingredients was a “very intractable problem.”

“If possible, we are more frustrated than the manufacturers and you all are about the situation,” she testified before a House Energy and Commerce subcommittee.


Rep. John Dingell (D-Mich.), who has worked on legislation to force the FDA to speed up its work, said that the FDA’s review “has been dawdled by prodigious, over-long delay.”

“I urge you to resolve this problem,” he told Woodcock. “It does do the Food and Drug Administration no credit whatsoever.”

The FDA has spent more than a decade reviewing ingredients that have long been available in sunscreens sold in foreign counties. 

Public health advocates and lawmakers in Congress say that that delay has been far too long, and has prevented companies from making new sunscreen products that might help cut down on the rate of skin cancer in the country. Skin cancer is the most common form of cancer in the U.S., and about 3.5 million cases are diagnosed each year.

The new products might appeal to people who do not currently use sunscreen, they say, and get them to protect themselves from ultraviolet rays.

On Friday, Woodcock said that it can take years to go through the formal rule-making process, which has been a stumbling block for approving the new sunscreen ingredients.

That process “can take six to eight years, and there’s multiple categories of these over-the-counter products that we have to handle,” she said.

Woodcock added that approving the sunscreens was a “public health issue.”