FDA Enforcement Priorities for Electronic Nicotine Delivery System (ENDS) and Other Deemed Products on the Market Without Premarket Authorization

标准简介

Enforcement Priorities for Electronic Nicotine Delivery System (ENDS) and Other Deemed Products on the Market Without Premarket Authorization[附网盘链接]是Food And Drug Administration于不久前发布的FDA标准,适用于U.S。

标准截图

Enforcement Priorities for Electronic Nicotine Delivery System (ENDS) and Other Deemed Products on the Market Without Premarket Authorization[附网盘链接]
Enforcement Priorities for Electronic Nicotine Delivery System (ENDS) and Other Deemed Products on the Market Without Premarket Authorization[附网盘链接](截图)

 

标准文档说明

标准文档类型为Enforcement Priorities for Electronic Nicotine Delivery System (ENDS) and Other Deemed Products on the Market Without Premarket Authorization[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

Enforcement Priorities for Electronic Nicotine Delivery Systems (ENDS) and Other Deemed Products on the Market Without Premarket Authorization (Revised) 1

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 staff responsible for this guidance as listed on the title page. I. INTRODUCTION This guidance document describes how we intend to prioritize our enforcement resources with regard to the marketing of certain deemed tobacco products that do not have premarket 2

authorization. 1

This guidance was prepared by the Office of Compliance and Enforcement, Office of Health Communication and Education, Office of Regulations, and Office of Science in the Center for Tobacco Products at FDA. 2

As with FDA’s prior compliance policies on deemed new tobacco products that do not have premarket authorization, this guidance document does not apply to any deemed product that was not on the market on August 8, 2016.

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