Product Standards, Menthol and FDA's Deeming Regulation

Duration: 60 Minutes
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.
FDA Deeming Regualtions
Instructor: Azim Chowdhury
Product ID: 500768

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
Who can Benefit:
  • General Counsel and management of tobacco companies, e-cigarette companies, etc.
  • Regulatory compliance associates and managers
  • Medical professionals, public health and consumer advocates, and other individuals working in the smoking control/harm reduction area
  • Regulatory affairs professionals and scientists who work in this area
  • Manufacturers and importers of e-cigarettes and other novel tobacco products
  • Suppliers in the tobacco industry
$300
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Instructor Profile:
Azim Chowdhury is an Attorney at the law firm of Keller and Heckman LLP in Washington, DC. In this role, he advises domestic and foreign corporations in matters of FDA and international regulatory compliance. In particular, he assists corporations in establishing clearances for food and drug additives in the U.S., Canada, and European Union, with an emphasis on indirect additives used in food-contact materials.

Mr. Chowdhury has also developed expertise in tobacco product regulation and has experience representing tobacco manufacturers and suppliers, including electronic cigarette companies, in FDA regulatory matters. He is also a frequent contributor to the Food and Drug Law Institute’s (FDLI) Update Magazine, currently serves on the Editorial Advisory Board of the Food and Drug Law Journal, and is edited and co-authored FDLI’s first tobacco-exclusive publication, Tobacco Regulation and Compliance: An Essential Resource. Mr. Chowdhury received a BA and BS from Johns Hopkins University, a MBA from the University of Maryland Robert H. Smith School of Business and a JD, cum laude, from the University of Maryland School of Law.
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