nanotechnology products-美国开始规范

清歌一曲月如霜

如今，三最终指导原则和一个指南草案由美国食品和药物管理局提供的行业更严格的监管澄清在FDA监管的产品中使用纳米技术的发行。
最后一个指导解决了该机构的的，它规定所有产品的整体方法，而另外两个最终的指导原则和新的指导意见草案规定了食品，化妆品及食品动物的区域，分别具体指导。
纳米技术是一项新兴技术，使科学家可以的规模在纳米粒子非常小，它们不能被看作一个普通的显微镜测量创造，探索和操作材料。该技术具有广泛的潜在应用，如改善食品的包装和改变化妆品的外观和感觉。
“我们的目标仍然是确保透明和可预测的监管途径，在现有最佳科学接地，以支持纳米技术的产品负责任的发展，说：”FDA局长Margaret A. Hamburg医师“我们正在采取审慎的科学的方法来评估各产品本身的优点，并且不作出有关的纳米技术产品的安全性广泛的，一般的假设。“
这三个最终的指导文件反映了FDA的目前的想法对这些问题考虑到先前发出相应的指导文件草案收到的公众意见后（在2011年选秀机构的指导;和化妆品草案和食品指导原则，2012年）。
美国食品药物管理局并没有做出明确的判断，认为纳米技术本质上是安全的或有害的，并会继续考虑个别产品的具体特点。所有四个指导性文件鼓励生产商服用他们的产品推向市场之前，与该机构进行磋商。协商与FDA在产品开发过程中的帮助，以促进对相关的纳米技术产品的具体的科学和监管问题，以及有关安全性，有效性，公共卫生影响和/或产品的监管地位帮助解决问题，相互理解早期。
该指导原则是：
最终的行业指南：考虑是否在FDA监管的产品涉及纳米技术的应用
该指南概述了首要考虑所有FDA监管的产品，确定点的时候确定产品是否涉及使用纳米技术的考虑。它旨在帮助行业和其他识别时，他们应该考虑监管状态，安全性，有效性或公众健康的影响时可能出现的纳米技术在FDA监管products.Final行业指南的应用程序的潜在影响：纳米材料在化妆品安全
Theguidance介绍了FDA的关于纳米材料的安全性评价目前的想法在化妆品中使用时，并鼓励制造商对测试方法和支持产品的安全性的实体化所需的数据与FDA进行磋商。
最终的行业指南：评估的重要生产加工的变化，包括新兴技术，在安全和食品配料和食品接触的物质，包括食品添加剂的监管现状是颜色添加剂的影响
该指南提醒制造商的任何显著制造工艺的变化，包括涉及纳米技术的变化，对安全性和食用物质管理状况的潜在影响。本指南还描述了确定已经在市场上显著制造工艺的变化对食品物质是否会影响食物物质的身份，安全或监管状况，可能warranting监管提交给FDA的考虑。
行业指南草案：使用纳米材料在食品动物
本指导原则草案涉及的问题关系到拟在食品中使用的动物性食品配料使用纳米技术的问题。在这个指导意见草案公众意见由2014年9月10日要求。
美国食品药物管理局将继续奉行持续的科学研究和监管力度，并会考虑新的研究和数据，因为他们成为可用，以确定未来的行动。科学是该机构正在进行的产品审查的一个重要组成部分。 FDA已经投资了纳米技术的监管科学计划，这将提高该机构的科研能力。如需要额外的指导原则为产业将得到发展。
美国食品药物管理局，卫生和人类服务部美国的一个机构，以确保人类和兽药，疫苗等生物制品的人用，和医疗器械的安全性，有效性和安全保护公众健康。该机构还负责我们国家的食品供应，化妆品，膳食补充剂，发出的电子辐射产品，以及用于调节烟草产品的安全性和安全性。

Today, three final guidances and one draft guidance were issued by the U.S. Food and Drug Administration providing greater regulatory clarity for industry on the use of nanotechnology in FDA-regulated products.
One final guidance addresses the agency’s overall approach for all products that it regulates, while the two additional final guidances and the new draft guidance provide specific guidance for the areas of foods, cosmetics and food for animals, respectively.
Nanotechnology is an emerging technology that allows scientists to create, explore and manipulate materials on a scale measured in nanometers—particles so small that they cannot be seen with a regular microscope. The technology has a broad range of potential applications, such as improving the packaging of food and altering the look and feel of cosmetics.
“Our goal remains to ensure transparent and predictable regulatory pathways, grounded in the best available science, in support of the responsible development of nanotechnology products,” said FDA Commissioner Margaret A. Hamburg, M.D. “We are taking a prudent scientific approach to assess each product on its own merits and are not making broad, general assumptions about the safety of nanotechnology products.”
The three final guidance documents reflect the FDA’s current thinking on these issues after taking into account public comment received on the corresponding draft guidance documents previously issued (draft agency guidance in 2011; and draft cosmetics and foods guidances in 2012).
The FDA does not make a categorical judgment that nanotechnology is inherently safe or harmful, and will continue to consider the specific characteristics of individual products. All four guidance documents encourage manufacturers to consult with the agency before taking their products to market. Consultations with the FDA early in the product development process help to facilitate a mutual understanding about specific scientific and regulatory issues relevant to the nanotechnology product, and help address questions related to safety, effectiveness, public health impact and/or regulatory status of the product.
The guidances are:
Final Guidance for Industry: Considering Whether an FDA-Regulated Product Involves the Application of Nanotechnology
The guidance outlines overarching considerations for all FDA-regulated products, identifying points to consider when determining whether a product involves the use of nanotechnology. It is intended to help industry and others identify when they should consider potential implications for regulatory status, safety, effectiveness or public health impact that may arise with the application of nanotechnology in FDA-regulated products.Final Guidance for Industry: Safety of Nanomaterials in Cosmetics
Theguidance describes the FDA’s current thinking on the safety assessment of nanomaterials when used in cosmetic products and encourages manufacturers to consult with the FDA on test methods and data needed to support the substantiation of a product’s safety.
Final Guidance for Industry: Assessing the Effects of Significant Manufacturing Process Changes, Including Emerging Technologies, on the Safety and Regulatory Status of Food Ingredients and Food Contact Substances, Including Food Ingredients that are Color Additives
The guidance alerts manufacturers to the potential impact of any significant manufacturing process change, including changes involving nanotechnology, on the safety and regulatory status of food substances. This guidance also describes considerations for determining whether a significant manufacturing process change for a food substance already in the market affects the identity, safety, or regulatory status of the food substance, potentially warranting a regulatory submission to the FDA.
Draft Guidance for Industry: Use of Nanomaterials in Food for Animals
This draft guidance addresses issues related to the use of nanotechnology in food ingredients intended for use in food for animals. Public comments on this draft guidance are requested by September 10, 2014.
The FDA will continue to pursue ongoing scientific research and regulatory efforts and will consider new studies and data, as they become available, to determine future actions. Science is a critical component of the agency’s ongoing review of products. FDA has invested in a nanotechnology regulatory science program that will enhance the agency’s scientific capabilities. Additional guidances for industry will be developed as needed.
The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.