FDA Proposed Rule: Establishment Registration and Product Listing for Tobacco Products
This in-depth course equips manufacturers, importers, and regulatory professionals with the knowledge needed to comply with the FDA’s proposed regulations for tobacco product establishment registration and product listing (21 CFR Part 1108). Learn what information must be submitted, who must register—including foreign facilities—key deadlines, recordkeeping standards, exemption categories, and how these requirements will impact legal distribution in the U.S. Get clarity on new compliance expectations, documentation, and public health objectives driving these changes.
In this course you will learn the following:
* Understand the goals and statutory authority behind the proposed rule.
* Identify who must register and list tobacco products with FDA.
* Describe the required information and procedures for registration and product listing.
* Recognize the recordkeeping and update requirements.
* Explain the implications for foreign establishments.
* Understand the public availability of information and misbranding provisions.
* Appreciate the opportunity for public comment and the evolving nature of the proposed rule.
NOTE: Unless otherwise indicated, all course purchases are for access to the course for a period of 1-year. At the end of the one year term, the course will be set to “inactive”.