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FDA提出新的测试规则以确保化妆品不含石棉

2024-12-27 09:04 -ABC  -  363570

  华盛顿-根据周四提出的一项联邦法规,化妆品公司将不得不采取额外措施来确保任何含有滑石粉的产品不含石棉。

  这项由国会授权的食品药品监督管理局提案旨在让消费者对化妆品的安全性放心,婴儿爽身粉和其他个人护理产品。

  这是多年来对约翰逊的诉讼&约翰逊以及其他声称滑石粉婴儿爽身粉和癌症有联系的公司。

  尽管官司缠身,研究发现了癌症和滑石之间潜在联系的混合证据,尽管这种可能性已经被认识了几十年,因为它是如何开采的。

  滑石是一种矿物用于吸收水分或改善化妆品的质地、手感和颜色。它是从有时位于有毒矿物石棉附近的地下矿藏中开采出来的。化妆品公司早就意识到了交叉污染的风险。

  但是最近FDA发起的测试没有发现任何安全问题。据FDA称,自2021年以来,对150多份化妆品样本的实验室分析结果显示,石棉呈阴性。

  尽管如此,对风险的担忧促使国会通过了一项2023年的法律,要求FDA发布新的石棉测试行业标准。

  FDA化妆品和色素办公室主任琳达·卡茨博士在一份声明中说该机构“仔细考虑了与检测和识别滑石和含滑石化妆品中的石棉相关的科学证据和复杂的政策问题。”

  “我们认为,提出的测试技术是检测石棉的适当方法,有助于确保含滑石化妆品的安全性,”卡茨说。

  针对J&j声称,该公司的滑石粉婴儿粉在用于女性卫生时会导致女性患上卵巢癌。

  一个J&一家子公司提议支付约80亿美元来解决数万起诉讼。作为交易的一部分,该子公司将宣布破产,尽管这一提议在法庭上受到了司法部的质疑。

  J&强生公司于2020年在美国市场移除了婴儿爽身粉中的滑石粉,并于2023年在全球范围内移除。该公司表示将继续保证其产品的安全性。

  确定癌症的根本原因是困难的,尤其是在卵巢癌的情况下,这是一种相对罕见的疾病。即使是对数千名女性进行的大型研究,也可能无法收集到足够的数据来显示明确的联系或明确排除其中一个。美国癌症协会表示,如果滑石粉会增加患癌症的风险,“这种风险可能非常小。”

  FDA proposes new testing rules to ensure cosmetics are asbestos-free

  WASHINGTON --Cosmetic companies would have to take extra steps to ensure that any products containing talc are free of asbestos under a federal rule proposed Thursday.

  The proposal from the Food and Drug Administration and mandated by Congress is intended to reassure consumers about the safety of makeup,baby powderand other personal care products.

  It follows years oflawsuits against Johnson&Johnsonand other companies alleging links between talc-based baby powder and cancer.

  Despite the lawsuits,researchhas found mixed evidence of a potential link between cancer and talc, although the possibility has been recognized for decades because of how it is mined.

  Talc is a mineralused to absorb moisture or improve the texture, feel and color of cosmetics. It is mined from underground deposits that are sometimes located near the toxic mineral asbestos. The risk of cross contamination has long been recognized by cosmetic companies.

  But recentFDA-sponsored testinghasn't uncovered any safety issues. Since 2021, laboratory analysis of more than 150 cosmetic samples has come back negative for asbestos, according to the FDA.

  Still, concerns about the risk prompted Congress to pass a 2023 law requiring the FDA to release new industry standards for asbestos testing.

  Dr. Linda Katz, the director of the FDA's Office of Cosmetics and Colors, said in a statement thatthe agencyhas “carefully considered the scientific evidence and complex policy issues related to detecting and identifying asbestos in talc and talc-containing cosmetic products.”

  "We believe that the proposed testing techniques are appropriate methods to detect asbestos to help ensure the safety of talc-containing cosmetic products,” Katz said.

  The long-running litigation against J&J alleges that the company’s talc baby powder caused women to develop ovarian cancer, when used for feminine hygiene.

  A J&J subsidiary has proposed paying roughly $8 billion to settle tens of thousands of lawsuits. As part of the deal, the subsidiary would declare bankruptcy, although that proposal has been challenged in court by the Justice Department.

  J&J removed talc from its baby powder in the U.S. market in 2020 and then internationally in 2023. The company says it continues to stand by the safety of its products.

  Determining the root cause of cancer is difficult, especially in cases of ovarian cancer, which is a relatively rare form of the disease. Even large studies in thousands of women might not gather enough data to show a clear connection or definitively rule one out. The American Cancer Society says that, if there is an increased risk of cancer due to talc, “it is likely to be very small.”

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