Sunscreen Innovation Act
Talking Points
Q. Tell me what happened.
On Nov. 13, Congress passed the Sunscreen Innovation Act — a bill that the American Academy of Dermatology Association (AADA) has been working to push through for years. The bill is designed to require the Food and Drug Administration (FDA) to review new sunscreen ingredients in a more predictable timeframe. Many of these ingredients have been used in other countries for years, but stuck in a backlog of applications in the U.S. President Barack Obama signed the bill into law on Nov. 26. The AADA has been working for years to see this type of undertaking.
Q. So what does this mean?
Under current law, if an ingredient is on the market in another country for five years, it may go through a process to be determined eligible by the FDA. An advisory committee of experts then weighs in on the safety and effectiveness of the product, and the agency makes the final determination as to whether it is approved. The Sunscreen Innovation Act makes two primary changes to this process. First, it institutes an eight-month deadline for the FDA to make a decision, replacing a current review process that lacks a mandatory end date. Second, the law no longer requires the FDA to issue a regulation every time it wants to approve an ingredient.
Q. What ingredients are we talking about?
The ingredients under consideration ― enzacamene, bemotrizinol, bisoctrizole, iscotrizinol, ecamsule and drometrizole trisiloxane ― will ultimately enhance sunscreen products, as these new ingredients provide longer-lasting UVA protection.
Q. What does this mean to the public?
More than 3.5 million skin cancers in more than 2 million people are diagnosed annually. These ingredients have been approved for use in other countries and are believed to provide enhanced sun protection. With the expedited FDA review, we are hopeful that these ingredients will be incorporated into sunscreens in the U.S. and will offer more options for consumers seeking protection for UV radiation. Additionally, with more options available to consumers, we hope that it will encourage the regular use of broad-spectrum sunscreen to prevent skin cancer and early signs of aging.
Q. Until these ingredients are approved, what should the public do?
The Academy is committed to educating the public on the dangers of overexposure to the sun and the need to practice safe sun habits. The Academy encourages a complete sun protection plan that includes the use of clothing, hats, sunglasses, and shade as the principal methods of sun protection, along with the use of broad-spectrum sunscreen with an SPF 30 or higher.