·标签违规,例如,成分声明中存在纰漏,或成分声明中没有所有规定的英语(或波多黎各西班牙语)标签信息。 着色添加剂和化妆品链接:https://www.fda.gov/industry/color-additives-specific-products/color-additives-and-cosmetics-fact-sheet 7. 着色添加剂和化妆品基本要求 如果您的产品(煤焦油染发剂除外)含有着色添加剂...
非处方药（即非处方药）生物制品，包括：人类疫苗 血液和血液制品 细胞和基因疗法产品 组织和组织制品 ...
着色添加剂违法:所有着色添加剂的预期用途均须获得 FDA 批准。除非通过 FDA的实验室的批量认证,某些着色添加剂不得使用。滥色添加剂导致化妆品成为掺假产品。请参见“Color Additives andCosmetics”页面以及该页面上列出的其他资源 禁止和限制使用的成分:违反此等物质的使用限制会使化妆品成为掺假化妆品。
这个问题，首先须要理清两个概念，一个是保健品，另一个是认证。其次，认清一个基础法律体系前提。一、...
(Is It Really FDA Approved?) Misuse of FDA's logo may violate federal law. 所以,如果有产品声称经美国FDA认证一般都是违法行为。 如果有dietary supplement声称经美国FDA批准也是违法行为。 国内方面,CFDA目前对于所辖行业的产品和相关企业,基本上都采用白名单制度管理,即CFDA先确认产品/企业是否符合既定的国家...
44 Summary: Important Color Additive Requirements • Only approved and listed color additives may be used in foods, drugs, cosmetics, and medical devices marketed in the U.S. • All color additives must comply with the requirements in their listing regulations – Including purity requirements ...
Color additives.The FDA can approve or ban these substances in food, drugs,dietary supplements, cosmetics, and some devices. Products that give off radiation.The FDA oversees devices that emit radiation–everything from microwaves to X-ray machines. ...
1PART1[FDAMissionFDA的责任]目录 Contents 2PART2[FDAAuthorityOver CosmeticsFDA对化妆品的监管]PART1 [FDAMissionFDA的责任]CONTENT1 FDA:theFederalFood,Drug,andCosmeticAct美国食品和药品管理局FPLA:theFairPackagingandLabelingAct正确包装和标识法案 课程名称【化妆品专业英语】CONTENT1[TextReading文章阅读]TheFood...
美国FDA 指导原则 使用工业用非活性成分数据库指南 英文原版.pdf,Using the Inactive Ingredient Database Guidance for Industry DRAFT GUIDANCE This guidance document is being distributed for comment purposes only. Comments and suggestions regarding this draft
FDA cited a period of 3-year exclusivity expiring on July 19, 2016 for another drug – Astellas Pharma US, Inc.’s (“Astellas’s”) 505(b)(1) NDA 204096 for ASTAGRAF XL (tacrolimus extended-release capsules), 0.5 mg, 1 mg, 5 mg, approved on July 19, 2013 for prophylaxis of ...