21 Şubat Perşembe günü, ABD Gıda ve İlaç İdaresi (FDA), bu temel yaz ürünlerinin güvenliğini ve etkinliğini arttırmayı amaçlayan yeni güneş koruyucu düzenlemeleri önerdiğini açıkladı. Önerilen kurallar, güneşten koruyucularda hangi bileşenlerin kullanım için güvenli olduğu düşünülen güncellemeleri, hangi ürünlerin “geniş spektrumda” pazarlanabileceğini, “güneşten korunma faktörünün” (SPF) ne kadar yüksek olabileceğini ve ürün etiketlerinde hangi bilgilerin bulunması gerektiğini içerir .
FDA Komiseri Dr. Scott Gottlieb yaptığı açıklamada , “Bu önleyici araçların temel şartlarından bazıları on yıllardır güncellenmedi.” Dedi . “Bugünün eylemi, FDA’nın güneşten korunmaların güvenliğini ve etkinliğini sağlamak için modern bilimi göz önünde bulundurma konusundaki devam eden çabalarında önemli bir adımdır.”
The U.S. Food and Drug Administration today issued a proposed rule that would update regulatory requirements for most sunscreen products in the United States.
This significant action is aimed at bringing nonprescription, over-the-counter (OTC) sunscreens that are marketed without FDA-approved applications up to date with the latest science to better ensure consumers have access to safe and effective preventative sun care options. Among its provisions, the proposal addresses sunscreen active ingredient safety, dosage forms, and sun protection factor (SPF) and broad-spectrum requirements. It also proposes updates to how products are labeled to make it easier for consumers to identify key product information.
“Broad spectrum sunscreens with SPF values of at least 15 are critical to the arsenal of tools for preventing skin cancer and protecting the skin from damage caused by the sun’s rays, yet some of the essential requirements for these preventive tools haven’t been updated in decades. Since the initial evaluation of these products, we know much more about the effects of the sun and about sunscreen’s absorption through the skin. Sunscreen usage has changed, with more people using these products more frequently and in larger amounts. At the same time, sunscreen formulations have evolved as companies innovated. Today’s action is an important step in the FDA’s ongoing efforts to take into account modern science to ensure the safety and effectiveness of sunscreens,” said FDA Commissioner Scott Gottlieb, M.D. “The proposal we’ve put forward would improve quality, safety and efficacy of the sunscreens Americans use every day. We will continue to work with industry, consumers and public health stakeholders to ensure that we’re striking the right balance. To further advance these goals, we’re also working toward comprehensive OTC reform, which will help foster OTC product innovation as well as facilitate changes necessary for the FDA to keep pace with evolving science and new safety data.”
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