The PASS Coalition stands for the Public Access to SunScreens Coalition. The PASS Coalition is a multi-stakeholder coalition of public health organizations, dermatologists, sunscreen ingredient companies and concerned citizens whose mission is to help prevent skin cancer and improve public health by ensuring Americans have access to safe and effective sunscreens and evidence-based education on sun-safe practices..
According to the Skin Cancer Foundation, in the United States, more than 9,500 Americans are diagnosed with skin cancer every day, and more than two people die of the disease every hour. Fortunately, these statistics can be reduced with the regular daily use of an SPF 15 of higher, which can reduce the risk of developing melanoma by 50 percent. In this year alone, melanoma deaths are expected to increase by 4.8 percent.
While there are numerous sunscreen ingredients currently available in the United States that are approved by the Food and Drug Administration (FDA) as safe and effective. However, the last time the FDA approved a new over-the-counter (OTC) sunscreen ingredient was the 1990s.
Unfortunately in recent years, states such as Hawaii becoming the first state to pass legislation that would ban certain FDA-approved sunscreen ingredients found in over 70 percent of sunscreen products, such as oxybenzone and octinoxate, from being sold without a prescription.
The urgency is even greater now, to provide consumers with more options for safe skincare products.
There have been no new sunscreen ingredients approved in the United States in over 20 years. Many of these ingredients have shown great promise in other countries around the world for years for more effectively protecting individuals from cancer-causing UV radiation. However, without an effective pathway for their approval at FDA, these ingredients are not accessible to Americans.
The FDA regulates sunscreens as OTC drugs in the United States. A new sunscreen ingredient must be approved by the FDA before it is available for sale in the United States.
Under the Coronavirus Aid, Relief, and Economic Security Act (CARES Act), the FDA has increased abilities to regulate the thousands of OTC drugs, including sunscreen ingredients. The law includes several important provisions to ensure Americans have access to the latest sunscreen technologies, including:
- Changing the review process for OTC ingredients from a lengthy notice-and-public-comment review process to an administrative order process within FDA, which is the same process used to consider other FDA-regulated products like prescription drugs and medical devices
- A user fee program that will establish a more transparent and timely review for new OTC drug applications
- Additional flexibility for the FDA to determine when to request a new drug application from sponsors
- The ability for sunscreen sponsors to have individual meetings with FDA to discuss confidential data requirements and testing protocols
- Market exclusivity for new OTC ingredients to encourage new and innovative sunscreen ingredients to come to market to protect Americans from the dangers of cancer-causing UV radiation
The new law also includes a pathway for the eight pending TEA ingredient applications (below) that were considered as part of a pathway authorized under the Sunscreen Innovation Act (Public Law 113-195) to ensure consideration of these ingredients should sponsors choose to continue to pursue these applications.
Previously, the FDA created the “time and extent application” (TEA) process to address gaps in the approval processes for new OTC products not covered by the New Drug Applications (NDAs) or the existing OTC monographs. TEAs attempted to provide an approval route for OTC drugs whose safety and efficacy could be reviewed and determined based on a minimum of five continuous years of safe use in another jurisdiction. However, this process did not result in any new OTC sunscreen ingredient approvals and the FDA consistently indicated that regulatory delays and a lack of resources stood in the way of approval of new ingredients.
The FDA has not approved a single sunscreen ingredient through the TEA process since the creation of the program in 2002. Eight OTC sunscreen ingredients have been submitted to the FDA for review and approval. The FDA has not completed a review of ANY of these applications.
- Amiloxate (2002)
- Enzacamene (2002)
- Octyl Triazone (2002)
- Bemotrizinol (2005)
- Bisoctrizole (2005)
- Iscotrizinol (2005)
- Ecamsule (2007)
- Drometrizole Trisiloxane (2009)
Approvals for the above active ingredients have been on hold for over a decade in some cases — and at the expense of enhanced safety for American consumers. The UV filters Bisoctrizole and Bemotrizinol, for example, have been widely used in Europe and other countries since 2000 and have proven to provide broad-spectrum formulations for more efficacious products. Other safe ingredients such as Ecamsule and Drometrizole Trisiloxane have also been commercially available around the world in various broad-spectrum topical formulations including creams, lotions, spays and sticks since the 1990s.
In addition, we urge the public to be supportive of the NAS study mentioned above, which provides a public forum for engaging on issues related to sunscreen and the environment.
Over the past several years, claims have been made regarding the effects of currently marketed sunscreen ingredients on the marine environment and specifically coral reefs. Because of these concerns, numerous jurisdictions have placed restrictions on the sale of sunscreens to improve coral reef health. A Hawaii state law signed in July 2018 and local ordinances in Florida in late 2018 and early 2019, would eliminate OTC access to over 70% of sunscreens by banning the sale of the ingredients oxybenzone and octinoxate. A similar and more recent law in the U.S. Virgin Islands expanded these sunscreen restrictions beyond oxybenzone and octinoxate to octocrylene, and similar efforts are underway in Hawaii to expand the ban to most sunscreen ingredients. These alarming actions could significantly reduce consumer access to sunscreen in parts of the world where people are exposed to high levels of UV radiation from the sun, thus putting consumers at greater risk for skin cancer.
Because of the significant data gaps that exist concerning the effects of sunscreen on the environment, as well as the lack of data collected on the effects on the public health of curbing access to FDA-approved sunscreen ingredients, the PASS Coalition is strongly supportive of a current study by the National Academy of Sciences (NAS), authorized under the Further Consolidated Appropriations Act of FY 2020, to conduct a review of the scientific literature of currently marketed sunscreens' potential risks to the marine environment while also reviewing the current scientific literature on the potential public health implications associated with reduced use of currently marketed sunscreen ingredients for protection against excess ultraviolet radiation. The study will be completed in early 2022 and will help inform measured policy changes to ensure Americans can adequately protect themselves from skin cancer while also ensuring preservation of the marine environment.
For more information on the study, please visit https://www.nationalacademies.org/our-work/environmental-impact-of-currently-marketed-sunscreens-and-potential-human-impacts-of-changes-in-sunscreen-usage.
Please urge your Member of Congress and your representatives in your state legislatures to reject any efforts to ban FDA-approved sunscreen ingredients, such as oxybenzone and octinoxate – two ingredients that are widely used in sunscreens and are supported by decades of safe use in sunscreens. A ban on these ingredients removes consumer choice and access to superior sunscreens, putting the public at higher risk for sun-related health issues like skin cancer. In addition, we urge the public to be supportive of the NAS study mentioned above, which provides a public forum for engaging on issues related to sunscreen and the environment.
To find out who your Member of Congress is, please visit the following websites: