FDA’s Deeming Regulation, the Continuum of Risk and Modified Risk Tobacco

Why Should You Attend:

FDA recently released proposed regulations that would bring tobacco products not currently regulated by the FDA under the control of the Tobacco Control Act (Deeming Regulations). This rule will substantially change the way e-cigarettes, cigars, and other tobacco products are currently manufactured, marketed and distributed. This webinar will focus on key points of the Tobacco Control Act, including the modified risk tobacco product requirements in Section 911, as well as the Deeming Regulation. It is critical for manufacturers and importers of cigars, pipe tobacco, electronic cigarettes, dissolvable tobacco and other novel tobacco products to gain a clear understanding of the requirements to be met.

Areas Covered in the Webinar:

• Overview of Tobacco Control Act and Premarket Review Requirements
• Section 911 Modified Risk Tobacco Products
• FDA’s Deeming Regulation
• The Continuum of Risk of Tobacco Products
• Alternative Frameworks for Regulation

Who Will 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

Instructor Profile:

Azim Chowdhury is an attorney at the law firm of Keller and Heckman LLP in Washington, DC. Mr. Chowdhury has also developed expertise in tobacco and e-vapor product regulation relating to the implementation of the Family Smoking Prevention and Tobacco Control Act, and spearheaded the FDA Tobacco and Electronic Cigarette practice at Keller and Heckman. Specifically, Mr. Chowdhury has experience representing tobacco, e-cigarette and e-liquid manufacturers, suppliers and trade associations in matters of FDA regulatory and corporate compliance.

He is also a frequent contributor to the Food and Drug Law Institute's (FDLI) Update Magazine, has served on the Editorial Advisory Board of the Food and Drug Law Journal, and edited and co-authored FDLI's recent publications, Tobacco Regulation and Compliance: An Essential Resource and FDA Regulation of Tobacco: A Comprehensive Guide – An FDLI Primer. Prior to entering private practice, he served as a judicial law clerk on the Court of Special Appeals of Maryland. Mr. Chowdhury received a B.A. and B.S. 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.

Topic Background:

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 manufacture, 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 the 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.

Follow us :