Coalition of 60 Environmental Groups & Community Leaders Demand FDA Ban & Reclassify Oxybenzone, Octinoxate & Octocrylene in OTC Sunscreen


Citing multiple scientific studies and an abundance of evidence showing the harmful impact of oxybenzone, octinoxate and octocrylene, the “Toxic 3 Os” commonly found in chemical sunscreens, a coalition of 60 environmental groups, community leaders, academics and businesses submitted a Citizen Petition to the FDA calling for the removal of affected products from the marketplace and reclassification of these chemicals to “Not Generally Recognized as Safe & Effective” (GRASE Category II). The initiative was started by Island Green Living Association in the U.S. Virgin Islands and Lisa Bishop of Friends of Hanauma Bay, Cynthia Punihaole of The Kohala Center, and Ted Bohlen of the Hawaii Reef and Ocean Coalition. The U.S. Virgin Islands and Hawaii are especially vulnerable to the environmental impact of contaminants on coral reefs and both have laws on the books banning toxic sunscreen.

The petitioners, Harith Wickrema, President of Island Green Living Association and Joe DiNardo, retired scientist and industry toxicologist, are the designated signatories for the coalition. This includes those in original group as well as Senator Janelle K. Sarauw, Senator Marvin A. Blyden, Senator Steven D. Payne Sr. of the US Virgin Islands; Senator Mike Gabbard, Senator Chris Lee, Representative Gene Ward, Representative Nicole Lowen, Maxx Phillips of Center for Biologic Diversity, and Pat B. Lindquist of the Napili Bay and Beach Foundation of Hawaii; Kurt Lieber of Ocean Defenders Alliance, and Mark Okrusko of AirtimeWatertime, Inc., of California; Key West Mayor Teri Johnson and Mill McCleary of Reef Relief of Florida; as well as Katie Day of 500K-member Surfrider Foundation, and nearly 50 additional environmental organizations, community leaders, academics, businesses and members of the public. The Citizen Petition was prompted by the chemicals’ health risks and the negative impacts to waterways and coastlines. The full Citizen Petition, which includes all signatories and referenced research, can be found HERE.

In May 2021, the FDA published a notice of intent (NOI) to prepare an Environmental Impact Statement (EIS) under the National Environmental Policy Act to evaluate the potential environmental effects of certain sunscreen products for OTC use without prior approval of a new drug application (NDA). They will issue a proposed order addressing sunscreens by September 27, 2021. Oxybenzone, octinoxate and octocrylene, along with 11 other Soluble Organic UV Filters (SOUVF), were removed from the GRASE Category I (generally recognized as safe & effective) list in February 2019 “because the public record does not currently contain sufficient data to support positive GRASE determinations.” Since then, they have been designated GRASE Category III “insufficient data for use in sunscreens” while continuing to be widely available. It is now time to ensure that all sunscreen products are safe for both people and the environment and remove those ingredients that are not. If the FDA doesn’t protect the public from unsafe sunscreens, then the FDA has not done its job.

Extensive published research demonstrates that oxybenzone, octinoxate and octocrylene, active ingredients present in more than 2/3 of all sunscreens, pose a threat to public health, marine life and coral reefs. This includes the latest studies earlier this year showing that octocrylene in sun protection products degrades into benzophenone, a carcinogen that can also interfere with key hormones and reproductive organs. Only mineral sunscreens formulated with titanium dioxide and zinc oxide are considered GRASE Category I (generally recognized as safe & effective) by the FDA. These mineral sunscreens, along with rash guards, hats, sunglasses and avoiding direct sun during peak hours, are critical in protecting people against the harmful effects of UV radiation.

The “Toxic 3 Os” have been shown to destroy coral and trigger health risks to people and marine life. They cause human cell damage that has been linked to cancer, disrupt hormones, have been found in breast milk, blood and urine and are known allergens. Likewise these chemicals are devastating to coral reefs and marine life. They wash off people’s bodies when they swim and contaminate through waste water runoff and cause ‘zombie’ coral which looks healthy but is unable to reproduce, coral bleaching as well as other issues. Coral reefs take up less than one percent of the ocean floor but are home to more than twenty-five percent of marine life. They are vital to protecting coastlines, especially crucial given climate change and rising sea levels, as well as supporting ocean life and have the highest biodiversity of any of the planet’s eco-systems. Oxybenzone is particularly toxic to corals at concentrations as low as a few parts per trillion — the equivalent of three drops in an Olympic-size swimming pool may be enough to severely damage or kill coral. The “Toxic 3 Os” are also detrimental when there is fishing in contaminated waters, impacting human health and the economy.

The “Toxic 3 Os” and the other SOUVF listed in the FDA’s 2019 docket are structural and functional analogues to human estrogen, pesticides like DDT, BPA (Bisphenol A), phthalates, atrazine and glyphosate (Roundup), parabens, and other known hormone disruptors. They will never be found to be GRASE or environmentally safe because they aren’t. No amount of further research can change their chemical nature. It is for this reason that the coalition urges the FDA to apply the Precautionary Principle that the burden of proof for potentially harmful actions by industry or government rests on the assurance of safety and that when there are threats of serious damage, scientific uncertainty must be resolved in favor of prevention.

Established in 2004, Island Green Living Association is a registered 501 (c)(3) not for profit organization on St. John dedicated to sustainability throughout the USVI. http://www.islandgreenliving.org.

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