FDA Proposes New Sunscreen Rules

"For more than 30 years, consumers have been able to identify the level of UVB protection provided by sunscreens using only sunburn protection factor or SPF values," said Andrew C. von Eschenbach, MD, Commissioner of Food and Drugs, in the FDA press announcement. "Under [this] proposal, consumers will also now know the level of UVA protection in sunscreens, which will help them make informed decisions about protecting themselves and their children against the harmful effects of the sun."

Sunlight is composed of visible light and ultraviolet (UV) light. The two types of UV light of primary concern are UVA and UVB. UVA is responsible for tanning and UVB, for sunburn. Both can damage the skin and increase the risk of skin cancer. According to the FDA the proposed regulation creates a consumer-friendly rating system for UVA products that is designed to help consumers identify the level of UVA protection offered by a product. The ratings system is on a scale of one to four stars. One star would represent low UVA protection, two stars would represent medium protection, three stars would represent high protection, and four stars would represent the highest UVA protection available in an OTC sunscreen product.

If a sunscreen product does not provide at least a low level (one star) of protection, the FDA is proposing to require that the product bear a "no UVA protection" marking on the front label near the SPF value. Ratings would be derived from two tests the FDA proposes to assess the effectiveness of sunscreens in providing protection against UVA light. The first test measures a product's ability to reduce the amount of UVA radiation that passes through it. The second test measures a product's ability to prevent tanning. This test is nearly identical to the SPF test used to determine the effectiveness of UVB sunscreen products.

In addition, a "Warnings" statement in the "Drug Facts" box will be required of all sunscreen product manufacturers. The warning will say: "UV exposure from the sun increases the risk of skin cancer, premature skin aging, and other skin damage. It is important to decrease UV exposure by limiting time in the sun, wearing protective clothing, and using a sunscreen." The warning is intended to increase awareness that sunscreens are only one part of a sun protection program.

"Many consumers incorrectly believe that the only way to protect themselves from skin damage caused by the sun is to apply sunscreens," said Douglas Throckmorton, MD, deputy director of FDA's Center for Drug Evaluation and Research, in a press statement. "The labeling being proposed today strengthens the existing labeling for sunscreens by educating consumers on the added importance of limiting their time in the sun and wearing protective clothing as part of a sun protection regimen."

Once finalized, the proposed regulation would amend the existing OTC sunscreen rule published in 1999 that established regulations related to UVB light and mandated that OTC UVB sunscreen products be labeled with a SPF. The FDA also is reportedly amending its existing 1999 rule to increase the SPF from SPF30+ to SPF50+. Previously, FDA had recognized SPF values up to 30+. Under the proposed amendment, the range would be SPF2 to SPF50+. SPF50 provides more UVB protection than lower SPF values.

Additionally, the proposed rule: revises the existing SPF (UVB) testing procedures; allows new combinations of active ingredients; and asks for comments on the issue of nanoparticles. FDA is accepting comments on the new rule for 90 days until November 26, 2007. Comments must be identified with Docket No. 1978N-0038 and can be submitted electronically or in written form.

食品及藥品管理局對防晒霜提出新規章

美國食品和藥品管理局(簡稱FDA)針對防護紫外線A(UVA)和B(UVB)之非處方(OTC)防晒藥品的配方、測試和貼標籤的標準提出一條新規章。

食品和藥物委員Andrew C. von Eschenbach, 醫學博士在食品及藥品管理局發布新聞，過去30年來，消費者已有能力判斷防晒霜的UVB防護標準或者SPF值只能用於晒黑保護。基於下列[此]提議，消費者現在也當知道防晒霜裡UVA保護標準，將有利於保護他們自己和他們的孩子對於對抗有害的太陽光做出明智的決擇。

陽光由可見光和紫外線組成。主要關心的兩類紫外線是UVA和UVB。UVA主要針對晒黑和UVB則主司晒傷。兩者皆會損傷皮膚並且增加罹患皮膚癌的風險。根據FDA提出的法規，對於UVA產品開創一個容易使用的等級系統，用來幫助消費者鑑別某產品所提供對UVA保護的等級。其等級系統按1至4顆星的比例來區分；某OTC防晒霜產品標示一顆星代表具低度UVA保護，兩顆星表示中度保護，3顆星將表示高度保護，而4顆星則表示可提供最高UVA保護。

如果防晒霜產品不能提供至少一級(一顆星)保護水準，FDA建議要求該產品在SPF值附近的前面標籤上載明"不具UVA防護"。其等級的區分是由FDA提出兩種評價防晒霜的效力試驗而來。第一個試驗是測量產品降低UVA輻射穿透數量的能力。第二個試驗是測量產品防止晒黑的能力。其試驗差不多類似過去用來確定UVB防晒霜產品的效力之SPF測試。

此外，要求所有防晒霜產品製造商在"藥品”外包裝盒增列"警示語"。警示語為︰"暴露於太陽紫外線下將增加罹患皮膚癌的風險，提早造成皮膚老化，及其他傷害。減少暴露在太陽紫外線的時間，穿戴防護衣物，並且使用防晒霜是非常重要的”。警告語的用意乃加強防護意識－防晒霜僅僅只是防護太陽其中一部分而已。

FDA藥物評估研究中心的副主管，Douglas Throckmorton，醫學博士在一篇新聞公報說：“很多消費者具有不正確的觀念，認為保護他們免於受到太陽引發的皮膚傷損害，唯一的方法是使用防晒霜”，”目前提議貼標籤，強化防晒霜的標示，將教育消費者加強管制他們暴露在太陽光的時間，並且穿上防護衣，作為防護太陽的生活方式”。

一但完成本法規，所提議的規章將修改現行於1999年頒布對於UVB光在OTC防晒霜己建立的規章及已貼上SPF標籤之OTC UVB防晒霜產品標示。FDA也據研究報告修改現行1999年規章，將SPF值從30+到增加50+。早先FDA已經承認SPF值超過30+。在提議修正案下，範圍將從SPF2到SPF50+。SPF50與更低的SPF價值相比較可提供更多的UVB保護。

此外，被提議的規章也修正現有的SPF(UVB)測試步驟；允許有效成分的新組合；並且詢問有關奈米粒子的註釋。FDA將接受對於新規章的評論90天直到2007年11月26日。評論意見以1978N-0038號備忘錄識別，並且可透過電子或者以紙本繕寫的形式提交。