FDA CPG Sec. 653.100 Animal Grooming Aids
标准简介
CPG Sec. 653.100 Animal Grooming Aids[附网盘链接]是于不久前发布的FDA标准，适用于U.S。标准截图
![CPG Sec. 653.100 Animal Grooming Aids[附网盘链接]](/img/20210914103654spbpi.jpg)
标准文档说明
标准文档类型为CPG Sec. 653.100 Animal Grooming Aids[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
Sec. 653.100 Animal Grooming Aids Compliance Policy Guide Guidance for FDA Staff This compliance policy guide represents the current thinking of the Food and Drug Administration (FDA) 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 the approach satisfies the requirements of the applicable statutes and regulations. To discuss an alternative approach, contact the FDA office responsible for this compliance policy guide as listed on the title page. I. Introduction The purpose of this compliance policy guide (CPG) is to provide guidance for FDA staff on products intended solely to cleanse or beautify animals, commonly referred to as “grooming aids.” In general, FDA’s guidance documents, including this CPG, do not establish legally enforceable responsibilities. Instead, they describe the Agency’s current thinking on various topics and should be viewed only as recommendations, unless specific regulatory or statutory requirements are cited. The use of the word should in Agency guidances means that something is suggested or recommended, but not required. II. Background The Center for Veterinary Medicine (CVM) often receives inquiries concerning the status of products intended for use in animals that are similar to cosmetics. The term cosmetic, as defined in section 201(i) of the Federal Food, Drug, and Cosmetic Act (FD&C Act), is limited to articles intended for use for humans for cleansing, beautifying, promoting attractiveness or altering the appearance. Products intended solely to cleanse or beautify animals, commonly referred to as “grooming aids,” are not subject to the FD&C Act and are not regulated by FDA. However, if a product purporting to be a grooming aid is intended to cure, mitigate, treat, or, prevent disease in animals or to affect the structure or function of the body of animals, the product is a drug under section 201(g) of the FD&C Act. Additionally, it is a new animal drug under section 201(v) of the FD&C Act if it is not generally recognized as safe and effective. To be legally marketed in the United States, new animal drugs must be the subject of an approved new animal drug application, conditionally approved new animal drug application, or index listing under sections 512, 571, and 572 of the FD&C Act.
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