欧洲防晒霜比美国防晒霜更安全。
European sunscreens are safer than American (2024)

原始链接: https://www.ms.now/opinion/msnbc-opinion/sunscreen-united-states-fda-ingredients-rcna153526

许多美国人前往欧洲购买在美属非法销售的防晒霜。这是因为美国食品药品监督管理局(FDA)将防晒霜归类为药物,使其必须经过昂贵且缓慢的审批程序;而欧盟则将其视为化妆品,从而实现了更快的创新和更广泛的有效成分应用。 虽然美国的防晒霜能有效阻挡导致晒伤的UVB射线,但在对抗穿透力更强、且是引发黑色素瘤主要诱因的UVA射线方面,往往表现不佳。因此,FDA过度谨慎的监管方式可能因限制了民众获取更佳保护的途径,反而增加了健康风险。这种“危险的预防”模式也延伸到了其他领域,例如新冠病毒快速检测试剂和氨溴索等有效减充血剂在美国的延迟上市。 经济学家亚历克斯·塔巴洛克(Alex Tabarrok)认为,美国的监管体系因扼杀民众获取全球成熟医学进步的途径而让消费者受损。为解决这些长期短缺问题,他提出了一个简单的解决方案:如果某种药物或设备已获得其他发达国家严格监管机构的批准,就应在美国获得快速审批通道。

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原文

Americans visiting beaches in France, Spain or Italy often do something that’s illegal back home: They purchase and use European sunscreens for better protection against sunburn and skin cancer. Many dermatologists argue that American sunscreens are far behind the scientific frontier, and they worry that the Food and Drug Administration’s decadeslong delay in approving new sunscreens for purchase in the U.S. is contributing to rising rates of skin cancer.

Americans visiting beaches in France, Spain or Italy often do something that’s illegal back home: They purchase and use European sunscreens.

In the European Union, sunscreens are regulated as cosmetics, which means greater flexibility in approving active ingredients. In the U.S., sunscreens are regulated as drugs, which means getting new ingredients approved is an expensive and time-consuming process. Because they’re treated as cosmetics, European-made sunscreens can draw on a wider variety of ingredients that protect better and are also less oily, less chalky and last longer. Does the FDA’s lengthier and more demanding approval process mean U.S. sunscreens are safer than their European counterparts? Not at all. In fact, American sunscreens may be less safe.

Sunscreens protect by blocking ultraviolet rays from penetrating the skin. Ultraviolet B (UVB) rays, with their shorter wavelength, primarily affect the outer skin layer and are the main cause of sunburn. In contrast, ultraviolet A (UVA) rays have a longer wavelength, penetrate more deeply into the skin and contribute to wrinkling, aging and the development of melanoma, the deadliest form of skin cancer. In many ways, UVA rays are more dangerous than UVB rays because they are more insidious. UVB rays hit when the sun is bright, and because they burn they come with a natural warning. UVA rays, though, can pass through clouds and cause skin cancer without generating obvious skin damage.

The problem is that American sunscreens work better against UVB rays than against the more dangerous UVA rays. That is, they’re better at preventing sunburn than skin cancer. In fact, many U.S. sunscreens would fail European standards for UVA protection. Precisely because European sunscreens can draw on more ingredients, they can protect better against UVA rays. Thus, instead of being safer, U.S. sunscreens may be riskier.

European sunscreens are also more pleasant to apply, and because they work better with makeup they are probably used more often as part of a skin care regimen, which may reduce the prevalence of skin cancer. Once again, the United States’ slower and seemingly more risk-averse approach actually increases risk.

Dangerous precaution should be a familiar story. During the Covid pandemic, Europe approved rapid-antigen tests much more quickly than the U.S. did. As a result, the U.S. floundered for months while infected people unknowingly spread disease. By one careful estimate, over 100,000 lives could have been saved had rapid tests been available in the U.S. sooner.

American sunscreens work better against UVB rays than against the more dangerous UVA rays. That is, they’re better at preventing sunburn than skin cancer.

Americans have also seen their options for treating colds diminished in recent years. In September 2023, an FDA advisory committee concluded that phenylephrine doesn’t work to clear nasal congestion. The FDA is probably correct, but it’s frustrating that options that do work are not available in the U.S. even though they are available in Europe. Ambroxol is an excellent decongestant available nearly everywhere in the world as a generic. It has been in wide use since 1979 and is regarded as both safe and effective. But it’s not available in the U.S. because getting through the FDA process is too costly.

In 2013, then-FDA Commissioner Margaret A. Hamburg told lawmakers that sorting out the sunscreen issue was “one of the highest priorities.” Yet, it still hasn’t been done. Americans have been without good sunscreen and cough medicine for too long. There is a simple solution to these problems. If a medical drug or device has been approved by another developed country, a country that the World Health Organization recognizes as a stringent regulatory authority, then it ought to be fast-tracked for approval in the U.S.

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