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Experts question why FDA won't approve new sunscreens
Patty Merola, of Guilderland, has battled cancer more than once. One of those fights, was with melanoma.
"It doesn't ever leave your mind. I have a body that's cut up and you look in the mirror and it's a constant reminder," she said.
Today, Merola is cancer free. She doesn't know what caused the melanoma, but is taking precautions to stay healthy.
"Here I am, a strong survivor," she said. " I use sunscreen every day, every day - winter, spring, summer and fall."
She told CBS6 News that if there's better sunscreen out there, that's safe, she would like to have access to it.
"I want to be afforded every possible opportunity to keep myself healthy," she said.
That is why some are making noise, saying that the US Food and Drug Administration, or FDA, is taking too long to approve new sunscreen ingredients. In 2002, the agency created a new process, called the Time and Extent Application, to give an alternate pathway for over the counter drug ingredients to be approved. Since then, eight ingredients have been submitted for review under that process, none have been approved.
One product, Ecamsule, was approved by the FDA through the New Drug Application (NDA), an alternate approval process, in 2006. But it is only approved to be used a few specific products. A spokesperson for L'Oreal told CBS6 that it received approval for Ecamsule, through the NDA process, for three specific products sold in the United States. It is waiting for Ecamsule to be approved through the TEA process now for wider use.
"It is something that's very important and it is the job of government. Who else can do this?" said Michael Burgess, New York Government Relations Director for the American Cancer Society Cancer Action Network. "It takes too long. A lot of people believe the process is broken and it needs to be fixed."
Burgess says that some of the pending ingredients are already being used in other places, like Europe.
"It's reasonable to expect that there would be some kind of action or they could just deny it if they don't think it's safe. To not have acted, I think is not right," he said.
The American Cancer Society, some dermatologists, sunscreen ingredient companies and some health organizations have teamed up to create the Public Access to Sunscreen (PASS) Coalition. The Coalition is working with the FDA and Congress on a solution. Some lawmakers are taking action.
A bill, named the Sunscreen Innovation Act, has been introduced at the federal level. The goal is to get the sunscreen ingredients reviewed faster. Right now the bill is in committee.
CBS6 News asked the FDA about those pending applications and was told that it recently issued feedback letters about two sunscreen ingredients. Both asked for more data to prove the ingredients are "generally recognized as safe and effective."
Andrea Fischer, a spokeswoman for the FDA, told CBS6 in an email that "the FDA will issue responses to the safety and efficacy data submitted for each ingredient in the near future. We are committed to completing the TEA process for the sunscreen active ingredients currently under review as quickly as possible, consistent with available agency resources and competing public health priorities."
Fischer also emailed this response from the FDA, "Consumers have access to a number of sunscreen products that contain active ingredients already included in the monograph for use in sunscreens in the United States. The FDA remains committed to allowing sunscreens containing additional ingredients to be made available to consumers if there is enough data to show that they are generally recognized as safe and effective for use in over-the-counter (OTC) sunscreens. The FDA recognizes the public health importance of sunscreen use, and has prioritized reviewing the safety and effectiveness of additional sunscreen ingredients as quickly as possible given the Agency's resources."
Doctor Howard Schlossberg is with New York Oncology Hematology. He treats patients with blood disorders and cancer, including skin cancer. He said that sun protection is important and more options for doing that, is better. But he said, that even if the process is changed, approvals could still take time.
"It takes time to really determine is something really safe. Some bad side effects won't show up for years," he said. "Sometimes the science takes time."
He said there are still options, like metal based sunscreens, clothing, hats and moderation.
"Even the best sunscreen does wear off," said Dr. Schlossberg. "The main thing is to limit your exposure just all together."
Merola does. She is careful about the sun, but won't let it stop her active lifestyle.
"It's one life, live it," she said.
The FDA also said that sunscreen is treated as a drug in the US, so the standards are high. In other countries, like Europe, it's considered a cosmetic product.