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March 24, 2021

The Important Role of Dermatologists in Public Education on Sunscreens

Author Affiliations
  • 1Department of Dermatology, Henry Ford Health System, Detroit, Michigan
JAMA Dermatol. 2021;157(5):509-511. doi:10.1001/jamadermatol.2020.5393

The Sunscreen Innovation Act was enacted on November 26, 2014, to help expedite the approval process for UV filters by the US Food and Drug Administration (FDA), given that no new filters had been approved in several years. Nearly 5 years later, on February 26, 2019, the FDA released a proposed rule (84 FR 6204)1,2 in response to the Sunscreen Innovation Act that addressed the classification and labeling of over-the-counter sunscreen products. A component of this FDA proposal is to classify the 16 sunscreen active ingredients (ie, UV filters) listed in the 1999 FDA final monograph into 3 categories: category I, generally recognized as safe and effective (GRASE); category II, not GRASE; and category III, insufficient safety data to support a positive GRASE determination. Currently, sunscreen manufacturers are working with the FDA to discuss safety data needed for 8 of the 12 active ingredients listed in category III.

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    2 Comments for this article
    The Important Role of Dermatologists in Public Education on Sunscreens
    Joe DiNardo, MS in Toxicology | Retired Personal Care Industry Toxicologist
    Dermatologists play a significant role in educating the public about sunscreens and have made incredible advances in treating skin cancers, especially melanomas. However, the prevalence and mortality rates associated with skin cancers continues to climb. As noted in the paper it is necessary to “provide objective and updated information on sunscreens.” To date the main source of sunscreen education to dermatologists has come from the sunscreen industry who have a multibillion-dollar investment in sunscreens.

    In the last few years there has been a flood of scientific papers looking at the safety and efficacy of these products which has
    triggered the FDA to remove 14 organic sunscreens from the Generally Recognized As Safe & Effective for human use category. With that said, there is an incredible need to develop not only new active ingredients, but also to develop models that will definitively prove that these ingredients are effective against skin cancers. To date there are no models available to determine basal cell carcinoma or melanoma inhibition; there are some models in mice that look at cutaneous squamous cell carcinoma prevention, but they should also be validated.

    Lastly, it could be advantageous if dermatology journals like JAMA and AAD would be more inclusive allowing scientists, not associated with the industry, to publish. This perhaps would give dermatologists additional sources of information that could be helpful in educating consumers ahead of magazine and news outlets, minimizing confusion to all.
    Dermatologists and Affiliated Organizations have been at the Helm of Public Education on Sunscreens for over 4 decades.
    Denis Dudley, MB,BS. DABOG, FRCS(C) | Retired Physician - Sub-specialty practice in Maternal-Fetal Medicine and Reproductive Endocrinology
    I am married to a dermatologist and attended AAD meetings for over 30 years. I took the time to read most articles published in mainstream dermatology medical journals on sunscreens and the prevention of skin cancer. As a specialist in MFM, I am acutely aware of the risk to the fetus from the bioavailability of SOLUBLE organic UV filters. Dermatology journals ignore this issue almost completely. The claim that these sunscreens prevent skin cancer is open to serious question given recent publications - Silva et al 2018 in the European J of Dermatol, and Waldman & Grant-Kels 2019 in the JAAD that confirm others dating back to 1973, when Emmett pointed out that there was no evidence, only inference that sunscreens prevent skin cancer. The incidence and mortality from skin cancer has risen in the USA and across the globe in parallel with the education programs and the use of soluble organic sunscreens. The concept of UVB-BIASED sunscreens that transmit 10X more UVA than UVB to skin is never discussed by dermatologists and they miss a key factor in rising cancer rates.

    If they are to lead Public Education on Sunscreens as they arguably have been for decades, they must look at the issue of human toxicity - that is very real when daily application of bioavailable filters that are structural and functional congeners to estrogen, pesticides, and other hormone disrupters. The new data that UVB and sunburn may not be the primary drivers for melanoma must be looked at seriously - UVA, low Vitamin D levels, and HPV acting on squamous cells in the epidermis explain why traditional sunscreens have not reduced the incidence of melanoma.

    New approaches are required and a broader expertise is necessary in the development of safe and effective sunscreens. It appears that efficacy will likely rest with INSOLUBLE Large Molecular Weight UV filters that avoid bioavailability and any risks thereof, while providing the Ultra UVA attenuation and true broad spectrum protection, similar to textiles and indoor shade. Antiquated ineffective label Regimes need a broad consultation with biophysics. Saying more research is needed on the question of human toxicity is incompatible with the physicians first duty of “Do No Harm” and the Precautionary Principle. Dermatologists must address the issue that proper Benefit Risk Assessment has never been done for sunscreens as for other therapeutic measures, and lead the initiative in this direction with toxicologists, obstetricians, endocrinologists, and the basic scientists who are independent of the sunscreen industry.
    CONFLICT OF INTEREST: Researcher in the development of safe and effective sunscreens using INSOLUBLE UV Filters that aim for spectral homeostasis (uniform extinction of UVR) w/o bioavailability to humans.