Perspective: Protect the USA from UVA

Abstract

A ccording to the Skin Cancer Foundation, more than 3.5 million skin cancers and 76,000 melanomas are diagnosed each year in the United States, and, on average, one person dies from melanoma every hour. As with most diseases, the best way to fight melanoma is to prevent it. Unfortunately, the latest sunscreen ingredients that can help to reduce the risk of melanoma and other skin cancers have languished for decades awaiting approval from the US Food and Drug Administration (FDA). The ultraviolet (UV) filters in sunscreen work by absorbing, reflecting or scattering the UV light emitted by the Sun. UVA radiation, which represents roughly 90% of UV radiation, can accelerate skin ageing, cause skin damage and create a risk of skin cancer by damaging DNA. The other component, UVB, leads to sunburn and also increases the risk of skin cancer. The most effective protection blocks both UVA and UVB. But ingredients delayed by the FDA approval process would provide additional options, especially for UVA protection. The active ingredients used in sunscreens are regulated by the FDA as drugs. But the FDA has not approved an over-the-counter sunscreen ingredient since 1999. In 2002, it created a new pathway to market for non-prescription ingredients, such as sunscreens, that allowed manufacturers to use data from other countries to establish that a product is safe and effective. To qualify for this 'time and extent application' (TEA) process, the company must establish that a product is approved in at least one comparable country and that it has been in use for at least five years in sufficient quantity. The TEA process was designed to streamline the review of new ingredients, and the FDA said that it expected to complete the evaluation of sunscreen ingredients within 90-180 days. Protect the USA from UVA The United States does not have access to the latest sunscreens. The Sunscreen Innovation Act could set that right, says Michael J. Werner.

Photopatch testing in a tropical country, Thailand: 20 years' experience

“…Tinosorb S is a new generation, broad‐spectrum, organic filter 28,29 . Its use in the European Union was approved in 2000, and it is currently awaiting the approval of the United States Food and Drug Administration 30 . The accessibility of, and exposure to, this UV filter might be less than that for conventional UV filters.…”

“…28,29 Its use in the European Union was approved in 2000, and it is currently awaiting the approval of the United States Food and Drug Administration. 30 The accessibility of, and exposure to, this UV filter might be less than that for conventional UV filters. Consequently, Tinosorb S has rarely been reported in the literature as causing a photoallergic contact reaction.…”

Wie Chemie vor Hautkrebs schützt

“…Sie nennen sich Public Access to Sunscreens (Pass) Coalition 2. Ihr strategischer Berater Michael Werner von der Anwaltskanzlei Holland and Knight in Washington DC schrieb im November 2014 in Nature , dass die FDA endlich “die bekannten Risiken von Hautkrebs in Betracht ziehen und die Vorteile von Sonnenschutz gegen die potenziellen Gefahren abwägen sollte” 3…”

My New Year's wish is for an effective sunscreen

“…Manufacturers have submitted other, newer UVA blockers to the FDA, but no new sunscreen ingredients have been approved since 1999. 2 Despite years of carping by interested parties, nothing has happened.…”

“…Nothing has happened, though, and despite the TEA process at least eight ingredients are currently waiting for an FDA decision. 2 One of the newer UVA blockers, for example, is ecamsule, which is widely available in European sunscreen products. L'Oreal applied for and received FDA approval for a few preparations that include ecamsule, but they were approved under new drug approval rules as complete formulations only.…”