Late last year, the US Congress passed a law with broad bipartisan support that may shape the future of the sunscreen industry. The Sunscreen Innovation Act, subsequently signed into law by President Obama, is designed to clear a backlog of sunscreen ingredients that have been pending review from the FDA. Essentially, the law forces the FDA to take action on an issue that the agency has failed to prioritize in recent years. The FDA now has one year to respond to the existing backlog of sunscreen ingredient approval requests and 18 months to reply to any future application.
THE SIGNIFICANCE OF THE LAW
The last new active ingredient the FDA approved was in 1999. That the agency has stalled on the review of new sunscreen ingredients has provoked much speculation over the years but few answers. Fortunately, the FDA's inaction on sunscreens stands in contrast to the progress elsewhere in the realm of sun protection. Overseas, new sunscreens have been approved and used over the last decade, while published data has continued to pour in from around the world articulating the dangerous effects of UV light. Additionally, public advocacy campaigns have intensified in message and influence, the indoor tanning lobby has suffered several setbacks, and many states have passed laws to ban indoor tanning for minors. These developments might suggest that the broader message about UV protection is starting to settle in to the public consciousness.
The FDA is unlikely to offer an explanation for its 16-year neglect of new sunscreen ingredients. However, the new law will no doubt change the regulatory environment going forward, which could lead to a chain of events resulting in a more robust market for sunscreens, with not only more products but hopefully better ones.
Cast against the broader efforts toward greater UV protection and awareness, the new law may not make a huge difference. Sunscreens, after all, occupy only a small part of the wider effort to curb skin cancer. Nevertheless, the law is one of the more positive things the Federal government has done in the scope of health care. It also represents one more piece of evidence that people are listening and care about this issue, which can only bode well for dermatologists and our missions to educate patients and turn UV protection into a public health issue.
BRIGHTER DAYS AHEAD
With so many positive steps across a variety of forums recently, perhaps it isn't unreasonable to think that we could achieve something as sweeping as Australia's national skin cancer prevention act here in this country. Given the course of events over the last 10 to 15 years, physicians and advocates should have reasonable optimism that more action will follow. But more importantly, clinicians should have renewed purpose in making a difference through the channels available to us in our own practices each day.
THE SUNSCREEN INNOVATION ACT: A SNAPSHOT
Passed in September 2014 | Signed into law November 2014
• Amends the Federal Food, Drug, and Cosmetic Act to
establish a process for the review and approval of over-thecounter
(OTC) sunscreen active ingredients.
• Allows any person to request that the Secretary of Health and Human Services (HHS) determine whether an OTC sunscreen active ingredient or combination of ingredients is safe and effective.
• Requires the Director of the Center for Drug Evaluation and Research to complete a review of a filed request and determine the safety and efficacy of the sunscreen active ingredient or combination of ingredients within 300 days for new requests or a shorter timeframe for requests pending before enactment of this Act.
• Allows sunscreen active ingredients that are determined to be safe and effective to be used in OTC sunscreen products.
Jonathan Wolfe, MD is an Associate Professor of Dermatology at the University of Pennsylvania and Division Director of Dermatology Einstein Medical Center Montgomery.