FDA计划要求抗菌皂商家提交效果证明
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FDA计划要求抗菌皂商家提交效果证明
笔记 2013-12-19 FDA,Lachman CONSULTANTS FDA于12月16日发布了一份137页的拟议法规，旨在探讨抗菌洗手皂是否比使用简单的肥皂更安全有效。由于对广泛使用这些产品可能形成细菌耐药性的持续关注，FDA正采取措施评估其安全性和有效性。拟议法规不包括在医疗机构中使用的消毒洗手液、湿巾等抗菌用品。相反，该法规针对消费者日常清洗手部和身体使用的广告标榜含有抗菌剂的众多固体和液体皂。 FDA指出“根据这一方案，如果企业无法证明这样的安全性和有效性，为留在市场，这类产品将需要重新配方或重新标签。” FDA的新闻稿接着指出：“数以百万计的美国人使用抗菌洗手皂和沐浴露产品。尽管消费者普遍认为这些产品是有助于防止病菌传播的有效工具，但目前并没有证据表明，它们在预防疾病方面比普通肥皂和清水更有效。此外，一些数据表明，长期暴露于抗菌产品中使用的某些活性成分中 — 例如，三氯生（液体皂）和三氯卡班（固体皂）— 可能会带来健康风险，如细菌耐药性或激素影响。” 企业不需要在这个时候撤销自己的产品；然而，如果他们不能证明安全性和有效性，将要求企业重新配方其产品并修订标签。拟议法规将允许有180天的评议期，同时有一年的期限让企业生成并向FDA提交所需数据用于评估。 多年来，我们一直听到科学家表达他们对于在家庭和非医疗机构广泛使用抗菌剂的关注。这些年来发生的多个耐药微生物菌株，为研究新型和更有效的抗生素提供了动力。FDA在做尽职调查时也表达了对这一问题的关切，但令人欣慰的是，看到FDA正收集数据，千方百计解决这一问题。记住，我们需要担心的不仅是生活中的大事件（如车祸或枪击），对于国民健康而言，像超级菌这样的小东西存在相当重大（和潜在致命）的风险。 Lachman CONSULTANTS - Bob Pollock先生 2013-12-16 校译： 识林-椒，识林-Kapok 2013-12-19 Let's Clean This Up! Today, FDA announced the issuance of a 137 page Proposed Rule designed to investigate whether antibacterial hand soaps are any more safe or effective than washing with simple bar soap. FDA is taking this action to evaluate the safety and effectiveness of these products due to the continued concern about the potential development of bacterial resistance from the widespread use of these agents. The Proposed Rule does not cover does not cover hand sanitizers, wipes or antibacterial products used in the healthcare setting. Rather, it is targeted towards the multitude of bar and liquid soaps used by consumers in routine daily hand and body washes that are advertised as, and contain an antimicrobial agent. The Agency notes that "[U]nder the proposal, if companies do not demonstrate such safety and effectiveness, these products would need to be reformulated or relabeled to remain on the market." The FDA News Release goes on to say; "Millions of Americans use antibacterial hand soap and body wash products. Although consumers generally view these products as effective tools to help prevent the spread of germs, there is currently no evidence that they are any more effective at preventing illness than washing with plain soap and water. Further, some data suggest that long-term exposure to certain active ingredients used in antibacterial products—for example, triclosan (liquid soaps) and triclocarban (bar soaps)—could pose health risks, such as bacterial resistance or hormonal effects." Firms will not be required to remove their products at this time; however, if they fail to demonstrate safety and efficacy, they will be required to reformulate their products and or revise the labeling. The Proposed Rule will allow for a 180-day comment period, with a concurrent one-year period for firms to generate and submit required data to the Agency for evaluation. The FDA News Release can be found here, and the Proposed Rule can be found here. For years, we have heard scientists voice their concern relative to the widespread use of antimicrobial in the home and non-healthcare settings. The development of multiple strains of resistant microorganisms over the years has provided an incentive for the research into new and more effective antibiotics. The FDA in doing its due diligence had also expressed its concern regarding this issue, but it is reassuring to see that the Agency will be collecting data to put this issue to rest one way or the other. Remember, it is not only the big things in life that we need to worry about (like car accidents or shootings), the small things like superbugs present quite a significant (and potentially deadly) risk to the health of the nation. FDA NEWS RELEASEFDA issues proposed rule to determine safety and effectiveness of antibacterial soaps The U.S. Food and Drug Administration today issued a proposed rule to require manufacturers of antibacterial hand soaps and body washes to demonstrate that their products are safe for long-term daily use and more effective than plain soap and water in preventing illness and the spread of certain infections. Under the proposal, if companies do not demonstrate such safety and effectiveness, these products would need to be reformulated or relabeled to remain on the market. Today's action is part of a larger, ongoing review of antibacterial active ingredients by the FDA to ensure these ingredients are proven to be safe and effective. This proposed rule does not affect hand sanitizers, wipes, or antibacterial products used in health care settings. Millions of Americans use antibacterial hand soap and body wash products. Although consumers generally view these products as effective tools to help prevent the spread of germs, there is currently no evidence that they are any more effective at preventing illness than washing with plain soap and water. Further, some data suggest that long-term exposure to certain active ingredients used in antibacterial products—for example, triclosan (liquid soaps) and triclocarban (bar soaps)—could pose health risks, such as bacterial resistance or hormonal effects. "Antibacterial soaps and body washes are used widely and frequently by consumers in everyday home, work, school, and public settings, where the risk of infection is relatively low," said Janet Woodcock, M.D., director of the FDA’s Center for Drug Evaluation and Research (CDER). "Due to consumers' extensive exposure to the ingredients in antibacterial soaps, we believe there should be a clearly demonstrated benefit from using antibacterial soap to balance any potential risk." The widespread consumer use of antibacterial products, the accumulated scientific information and concerns raised by health care and consumer groups have prompted the FDA to reevaluate what data are needed to classify the active ingredients in consumer antibacterial products as "generally recognized as safe and effective" or GRASE. Under the proposed rule, manufacturers who want to continue marketing antibacterial products will be required to provide the agency with additional data on the products' safety and effectiveness, including data from clinical studies to demonstrate that these products are superior to non-antibacterial soaps in preventing human illness or reducing infection. "While the FDA continues to collect additional information on antibacterial hand soaps and body washes, we encourage consumers to make an educated choice about what products they choose to use," said Sandra Kweder, M.D., deputy director, Office of New Drugs at CDER. "Washing with plain soap and running water is one of the most important steps consumers can take to avoid getting sick and to prevent spreading germs to others." Consumers should continue to be diligent about washing their hands. If soap and water are not available, an alcohol-based hand sanitizer that contains at least 60 percent alcohol should be used. More information on appropriate hand washing from the CDC may be found here. Almost all soaps labeled "antibacterial" or "antimicrobial" contain at least one of the antibacterial ingredients addressed in the proposed rule. The most common active ingredients in antibacterial soaps are triclosan and triclocarban. Some soaps labeled "deodorant" may also contain these ingredients. The proposed rule does not require the antibacterial soap products to be removed from the market at this time. When the proposed rule is finalized, as previously stated, either companies will have provided data to support an antibacterial claim, or if not, they will have to reformulate (remove antibacterial active ingredients) or relabel (remove the antibacterial claim from the product's labeling) these products in order to continue marketing. The proposed rule is available for public comment for 180 days, with a concurrent one year period for companies to submit new data and information, followed by a 60-day rebuttal comment period. For more information:
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