Almost 10,000 people will die this year from melanoma skin cancer, and according to the American Cancer Society, more than 3.5 million new cases of skin cancer will be diagnosed this year in the United States. Despite these alarming statistics, the U.S. Food Drug and Administration (FDA) has only approved one new over the counter sunscreen ingredient since the 1990s to combat melanoma skin cancer.
Since 2002, there have been eight new sunscreen ingredients filed with the FDA, yet they are all still awaiting approval. In contrast, these same ingredients have been on the market in several countries throughout Europe and Asia for almost 15 years.
Clearly, the cumbersome and ineffective FDA approval process is flawed. Signing into law the Sunscreen Innovation Act of 2014 would allow these cancer prevention ingredients to reach American citizens.
“Americans have gone more than a decade without the kinds of innovative sunscreen products citizens in other countries have enjoyed for years,” stated Michael Werner, the Public Access to Sunscreens (PASS) Coalition Policy Advisor, in a press release from September. “Meanwhile, skin cancer has become a public health crisis that has lead U.S. Surgeon General to issue ‘A Call to Action to Prevent Skin Cancer,’ calling for the government and stakeholders to act immediately to address this deadly, but preventable disease.”
Fortunately, lawmakers on both sides of the aisle in Congress recognize that the FDA needs to expedite the approval of new and more effective sunscreen ingredients. The Sunscreen Innovation Act of 2014 is in the process of being amended and has not yet been signed into law by the president. It is of utmost importance that it remains a priority for the upcoming lame duck session of Congress.
The bill amends the Federal Food, Drug and Cosmetic Act to expedite the current evaluation process for over-the-counter sunscreen components. The bill further permits the Secretary of Health and Human Services to evaluate over-the-counter sunscreen ingredients authorized in other countries and determine if the ingredients meet safety and efficacy standards that are sufficient to conduct a review within the U.S.
It would require the FDA to review the ingredients within 300 day, a vast improvement from the painstaking 10-15 years it presently takes.
So why does it take so long to get new sunscreen ingredients that protect consumers from skin cancer onto the market? In order for a sunscreen ingredient to be approved by the FDA, it must go through several lengthy processes.
This is an extremely slow process, as evidenced by the eight sunscreen products pending approval for up to 12 years. Several other countries have categorized over-the-counter sunscreen ingredients as cosmetics, rather than a drug as in the U.S., allowing for faster approval and less scrutiny. Many products, such as dietary supplements, go through much less, or no, scrutiny with greater potential for harm.
There has been miniscule public awareness surrounding this bill, and now is the time to act. As stated this September by Sen. Johnny Isakson (R-Ga.), melanoma skin cancer survivor, “…it’s essential that Americans have access to the most safe and effective sunscreen.” He continued: “It’s time for the delays at FDA to end… so we can clear the bureaucratic hurdles that have stood between American consumers and the new and innovative sunscreen products that are already available in many other countries.”
Now is the time to keep the momentum moving forward on the Sunscreen Innovation Act 2014. As citizens, we need to contact our congressional leaders and express the necessity to keep this bill a priority during the upcoming lame duck session.
