The latest in Acara Partners’ guest blog series, this post comes from Ted Ebel, Chief Business Officer at Colorescience®.
As we head into the summer months, it is an ideal time to review what is happening with the FDA sunscreen regulations. Not surprisingly, many people do not know that sunscreens are regulated as over-the-counter (OTC) drugs by the Federal Drug Administration (FDA). In addition to the federal regulations administered by the FDA, certain states and destination travel locations have adopted additional requirements that we will also review.
Taking a look back at the history of the FDA sunscreen monograph, we look back to 1978 when the FDA began formally regulating sunscreens under a draft OTC monograph. Since then, the FDA has modified and revised the draft monograph over the past 40+ years and it is not yet finalized. In February 2019, the FDA circulated a proposed “Tentative Final Monograph” which documented the FDA’s current perspective on FDA regulations. Most notably in this Tentative Final Monograph, the FDA asserted that only two ingredients, zinc oxide and titanium dioxide, had established sufficient safety and efficacy to be warranted as Category I or Generally Recognized as Safe and Effective (GRASE). Other than a few ingredients that the FDA listed as banned, all other active chemical filter ingredients for sunscreen were determined to be Category III and requiring additional data before they could be considered GRASE.
In a bold move, the FDA subsequently followed the Tentative Final Monograph by submitting two different FDA-authored articles in the Journal of American Medical Association (JAMA), one in 2019 and the most recent in January of 2020. These studies demonstrated that many of the leading chemical active ingredients in sunscreen today can be absorbed in the bloodstream at potentially significant levels. Based on a Maximum Use Trial (MuST), the FDA noted that each of the six studied active ingredients exceeded the absorption threshold established by the FDA by a factor of over 10 times, with some of these ingredients remaining in the bloodstream for well over a week after the last dose.
As part of the Tentative Final Monograph and following these JAMA publications, and as a result of the absorption profile of such ingredients, the FDA has requested that the industry submit additional data demonstrating that these ingredients are both safe and effective at levels used by consumers. Many dermatologists, rightfully so, took to making sure that these study results do not “scare” people away from using sunscreens. Protection is key and many skin health experts will recommend an all-mineral sunscreen over a chemical one to address any concerns about the ingredient safety.
Another update may have also gone unnoticed by doctors and consumers. In the summer of 2020, the CARES act modified the way the FDA oversees OTC products, now relying on administrative orders instead of a monograph process. The FDA is expected to publish a new administrative order at some point in the future to clarify their final position on sunscreens, but in the interim, their position can be found in the 2019 Tentative Final Monograph.
In addition to the FDA, certain states and cities have undertaken their own initiatives to further restrict certain sunscreen ingredients that may be sold in their territory. Hawaii, for instance, has recently banned the sale and use of products that contain oxybenzone and octinoxate because of concern that those two substances may damage marine life, leading to coral bleaching. Other places that have also implemented bans on specific chemical sunscreen ingredients include Palau, Bonaire, Aruba and the US. Virgin Islands.
At Colorescience®, we have always only used zinc oxide and titanium dioxide as our sun protection active ingredients. With our technology partner, Solésence, we have developed a patented and proprietary triple-coated mineral formulation called EnviroScreen™, which has been tested, proven, peer-reviewed and published to show how our Total Protection™ Products go beyond SPF and protect skin from UVA, UVB, HEV (blue light), infrared radiation and pollution. It has also been tested and shown to reduce the formation of free radicals from UV and pollution, and protect other topical antioxidants from being incinerated by UV exposure.
While the landscape of sunscreen ingredients may change, an all-mineral, physical defense against environmental aggressors will always be a safe and sure way to protect skin health.
About Ted Ebel
Ted Ebel is the chief business officer at Colorescience, Inc., a leading professional skincare brand that is bringing innovation to sun protection and skincare. Prior to Colorescience, Ted was the senior vice president of corporate development at SkinMedica®, a dermatology company that was sold to Allergan in 2012. Ted has held executive and management positions at CancerVax, MP3.com and Amgen.
Previously, Ted served on the Board of Menlo Therapeutics (MNLO), a publicly traded biopharmaceutical company developing products for itch and chronic cough, where Ted chaired the compensation committee and served on the audit committee. Ted also serves as a director on the Board of Vitamedica, a leading professional nutritional and supplement company.
Ted received his bachelor of arts from Duke University and his MBA from the Wharton School at the University of Pennsylvania. He enjoys staying connected to his alma maters as the chair of alumni interviews in San Diego for Duke University and past president of the Wharton Healthcare Management Alumni Association. Ted enjoys spending time with his wife and their three kids. Together, they enjoy the outdoors in San Diego, especially recreational sports such as fly fishing and skiing.