FDA CVM GFI #236 Clarification of FDA and EPA Jurisdiction Over Mosquito-Related Products
标准简介
CVM GFI #236 Clarification of FDA and EPA Jurisdiction Over Mosquito-Related Products[附网盘链接]是Food And Drug Administration于不久之前发布的FDA标准，适用于US。标准截图
![CVM GFI #236 Clarification of FDA and EPA Jurisdiction Over Mosquito-Related Products[附网盘链接]](/img/20210914103703fej2v.jpg)
标准文档说明
标准文档类型为CVM GFI #236 Clarification of FDA and EPA Jurisdiction Over Mosquito-Related Products[附网盘链接]高清PDF版本（文字版），标准文档内可进行搜索，可以复制原文，可粘贴。标准部分原文
Clarification of FDA and EPA Jurisdiction Over Mosquito-Related Products Guidance for Industry This guidance represents the current thinking of the Food and Drug Administration (FDA or Agency) on this topic. It does not establish any rights for any person and is not binding on FDA or the public. You can use an alternative approach if it satisfies the requirements of the applicable statutes and regulations. To discuss an alternative approach, contact the FDA office responsible for this guidance as listed on the title page. I. INTRODUCTION This guidance provides information for industry and other stakeholders regarding regulatory oversight of articles, including substances, for use in or on mosquitoes (“mosquito-related products”). We are providing this guidance to clarify circumstances under which such products are regulated by the Food and Drug Administration (FDA) as new animal drugs under the Federal Food, Drug, and Cosmetic Act (FD&C Act) and other circumstances under which such products are regulated by the Environmental Protection Agency (EPA) as pesticides under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA). FDA’s guidance documents, including this guidance, do not establish legally enforceable responsibilities. Instead, guidances describe the Agency’s current thinking on a topic and should be viewed only as recommendations, unless specific regulatory or statutory requirements are cited. The use of the word should in the Agency’s guidances means that something is suggested or recommended, but not required. II. BACKGROUND Both FDA and EPA regulate products intended for use in or on animals. FDA is charged with protecting the public health by, among other things, ensuring that animal drugs are safe and effective [21 U.S.C. §393(b)(2)(B)]; under FIFRA, EPA is charged with protecting human health and the environment by ensuring registered pesticide products, when used according to the label directions, result in no unreasonable adverse effects to man or the environment. [7 U.S.C. §136a(c)(5)]. A. New Animal Drugs The FD&C Act defines the term “drug” as, among other things, “articles intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease in man or other animals” and “articles (other than food) intended to affect the structure or any function of the body of man or other animals.” [21 U.S.C. §321(g)(1)]. With very limited exceptions for animal drugs that are generally recognized as safe and effective or are subject to a “grandfather” clause, the FD&C Act defines drugs that are intended for use for animals as “new animal drugs.” As such, these drugs
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