PASS Coalition FDA Proposed Order Comments November 2021
On behalf of the Public Access to SunScreens (PASS) Coalition, I write to submit comments in response to Food and Drug Administration (FDA) “Proposed Order (OTC000008): Amending Over-the-Counter (OTC) Monograph M020: Sunscreen Drug Products for OTC Human Use.” This proposed order would amend and revise the deemed final administrative order concerning nonprescription sunscreen drug products established by the enactment of the Coronavirus Aid, Relief, and Economic Security (CARES) Act (Public Law 116-136).
The PASS Coalition is a multi-stakeholder coalition composed of public health groups, dermatologists, sunscreen manufacturers, and leading advocates for skin cancer patients. The mission of the PASS Coalition 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.
One of the most effective ways to reduce skin cancer risk is by utilizing comprehensive sun-safe practices, including the regular use of sunscreen, covering up with clothing, hats, and sunglasses, and seeking shade. Broad-spectrum sunscreens that provide adequate protection against both UVA and UVB radiation, are essential mechanisms to prevent sunburn, skin damage, and skin cancer. Melanoma represents the deadliest common form of skin cancer, with projections of 106,110 diagnoses and nearly 7,200 deaths associated with invasive melanoma in the United States in 2019 alone.1 Given these facts, the PASS Coalition supports policies to ensure that Americans continue to have access to the broadest range of sunscreens possible to prevent skin cancer and that individuals have access to the sunscreen product they will use every day as part of comprehensive sun-safe behavior.
Read More in the PDF