PASS Coalition Submits Comments in Response to FDA’s Draft Guidance on OTC Sunscreens’ Safety and Effectiveness

For Immediate Release: February 22, 2016

Contact: Aimee Steel Lubin, / 202-828-1895

(Washington, D.C.) — The Public Access to SunScreens (PASS) Coalition submitted comments in response to the FDA’s Draft Guidance “Over-the-Counter Sunscreens: Safety and Effectiveness Data Draft Guidance for Industry” (the Guidance) published in the Federal Register on November 23, 2015, as required by the Sunscreen Innovation Act (Public Law 113-195).

The Act required FDA to issue draft and final guidance on the safety and effectiveness data to be used in the agency’s review of new sunscreen ingredients. The final guidance is required under the Act by November 26, 2016. The following is a brief excerpt of the Coalition’s comments:


The PASS Coalition appreciates that the FDA has issued this guidance and is attempting to balance benefit and risk when determining the appropriate safety and effectiveness data manufacturers must provide. Nonetheless, in our view the approach proposed falls short. By calling for manufacturers to complete new tests prior to marketing – including tests never before used on sunscreen ingredients, tests required by no other countries and for which there is no agreed-upon protocol – the FDA’s proposal may simply continue to deny Americans access to the latest skin cancer prevention products available throughout the rest of the world.


The PASS Coalition remains willing to work collaboratively with the FDA to develop and appropriate testing regime for new sunscreen ingredients – that will ensure safety while balancing the need for new and effective sunscreens to combat the ever-increasing risk of cancer.


“As a result of President Obama’s announcement of an Administration-wide initiative led by Vice President Biden to prevent and cure cancer at his last State of the Union address, making sure we get the Final Guidance right is critical. Since skin cancer is the most common form of cancer in the United States, removing the red tape for new broad spectrum sunscreens would be a moonshot victory for the 5 million Americans that will be diagnosed with the disease this year,” said Michael Werner, PASS Coalition Policy Advisor

When the bipartisan Sunscreen Innovation Act was signed into law in 2014, Americans expected that they would soon be able to get the latest in sunscreen technology long available to citizens of countries all over the world. But well over a year has gone by and the FDA still has not approved these sunscreens despite their track record of safety and effectiveness,” Werner concluded. “The PASS Coalition looks forward to working with the FDA in an effort to get the latest in sunscreen technology in the hands of consumers, thus helping to reduce the risk of melanoma.”

Skin cancer is the most common form of cancer diagnosed in the U.S. Each year there are more new cases of skin cancer — including melanoma — than the combined incidence of breast cancer, prostate cancer, lung cancer and colon cancer.  From 1975-2011, rates of melanoma in young men and women ages 20-39 years increased by 34% in men and by 84% in women.

According to the Surgeon General, nearly 5 million Americans are diagnosed with skin cancer and one person dies every hour of every day from melanoma, the deadliest skin cancer.  The cost to treat skin cancer is over $8 billion, which doesn’t include the pain and suffering for families that lose their loved ones from the disease.  The Surgeon General and CDC both regularly call on Americans to wear sunscreen to prevent skin cancer.

The bipartisan Sunscreen Innovation Act (Public Law No: 113-195) streamlined the approval process for new sunscreen ingredients to ensure that new sunscreen ingredients receive a transparent review within a predictable timeframe. The law was intended to ensure the American public gains access to the latest safe, effective and innovative sunscreen products to protect against the sun’s most harmful rays.

The last over-the-counter (OTC) sunscreen ingredient to be approved by FDA was in the 1990s. Since 2002, eight new sunscreen applications have been filed and are still awaiting final decisions 13 years later. New sunscreen technologies currently awaiting approval in the U.S. have been widely available in Europe, Asia, and Central and South America, in some cases for more than 15 years.


The PASS Coalition is a multi-stakeholder coalition of public health organizations, dermatologists, sunscreen ingredient companies, and concerned citizens who will work collaboratively with the FDA, the White House and Congress to establish a timely and transparent framework for approval of the next generation of UV active filters for OTC sunscreens. Click here to see the full membership of the PASS Coalition.

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