Training Course Syllabus:
Product Standards, Menthol and FDA's Deeming Regulation Webinar
Time: 10:00 AM PST | 01:00 PM EST
Duration: 60 Minutes
Instructor: Azim Chowdhury
The Food and Drug Administration (FDA) has now proposed to deem products meeting the statutory definition of "tobacco product," except accessories of a proposed deemed tobacco product, to be subject to the Federal Food, Drug, and Cosmetic Act (the FD&C Act), as amended by the Family Smoking Prevention and Tobacco Control Act (Tobacco Control Act). The Tobacco Control Act gives FDA the authority to regulate the manufacturing, labeling, distribution, and marketing of tobacco products in the United States. Specifically, although a "tobacco product" is defined broadly, in pertinent part, as "any product made or derived from tobacco that is intended for human consumption," the law only provides FDA with authority to regulate, through its new Center for Tobacco Products (CTP), cigarettes, cigarette tobacco, roll-your-own tobacco, and smokeless tobacco. However, any “other tobacco products," such as electronic cigarettes and their components may become subject to regulation if FDA "deems" such products to be subject to the new law.
Option 1 of the proposed deeming regulation would extend the agency´s "tobacco product" authorities in the FD&C Act to all other categories of products (including e-cigarettes), except accessories of a proposed deemed tobacco product, that meet the statutory definition of "tobacco product" in the FD&C Act. Option 2 of the proposed rule would extend the Agency´s "tobacco product" authorities to all other categories of products, except premium cigars and the accessories of a proposed deemed tobacco product, that meet the statutory definition of tobacco product" in the FD&C Act. FDA also is proposing to prohibit the sale of "covered tobacco products" to individuals under the age of 18 and to require the display of health warnings on cigarette tobacco, roll-your own tobacco, and covered tobacco product packages and in advertisements.
Why Should you Attend:
The Tobacco Control Act has changed the way the tobacco industry operates in the United States. One of its key features is the ability to establish product standards for regulated products. This webinar will examine the product standards that are already in place for cigarettes, including the characterizing flavor ban, as well as the potential for a menthol ban.
The session will also include a discussion of FDA´s proposed deeming regulations. This rule will substantially change the way e-cigarettes, cigars, and other tobacco products are currently manufactured, marketed and distributed. It is critical for manufacturers of currently regulated tobacco products (e.g. cigarettes, smokeless tobacco and RYO tobacco) as well as manufacturers of cigars, pipe tobacco, electronic cigarettes, dissolvable tobacco and other novel tobacco products to understand current standards and future trends in the industry through this webinar.
Objectives of the Presentation:
- Overview of Tobacco Control Act Product Standards
- Menthol Update - Advanced Notice of Proposed Rulemaking
- FDA´s Deeming Regulation: What´s Included and What´s Not
- Alternative Frameworks for Regulation