What to Expect from FDA’s Deeming Regulation: E-Cigarettes and Cigars

Event Information
Product Format
Prerecorded Event
60 minutes
Product Description

New FDA Rules on E-Cigarettes: How You Should Be Prepared


The e-vapor industry is rapidly growing around the world, with global sales in 2016 expected to exceed $4 billion. The global regulatory environment for these products is rapidly evolving, particularly in the United States. With recent announcements by the Food and Drug Administration that brings forward tailored laws and regulations that attempt to understand the public health and safety concerns presented by these novel products.

The Food and Drug Administration’s action, which represents the first time the government has regulated the booming market of e-cigarettes, seeks to clamp down on devices that have become increasingly popular, especially among young people, even as they have been subject to almost no oversight. The new rules issued will also extend to long-standing restrictions on traditional cigarettes to a host of other products, including e-cigarettes, hookah tobacco, pipe tobacco and nicotine gels. Minors would be banned from buying the products.

The session will review the legal status of these e-vapor products in the United States, with a focus on the impact of the new FDA rules implemented by the United States Food and Drug Administration (FDA), which propose to treat e-cigarettes and their components, including e-liquid, as tobacco products. Join Mr. Azim Chowdhury in a discussion on how FDA’s proposed rule will substantially change the way e-vapor products are currently manufactured, marketed and distributed in the United States, as well as its potential impact on the global market.

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 (the so-called ‘Deeming Regulations’). This rule will substantially change the way e-cigarettes, cigars, and other tobacco products are currently manufactured, marketed and distributed.

This 60-minute webinar will focus on key points of the Deeming Regulations, discuss the provisions of the rule on which the FDA requested public comment, discuss the potential public health impact and explore the varying stakeholder perspectives. It is critical for manufacturers and importers of cigars, pipe tobacco, electronic cigarettes, dissolvable tobacco and other novel tobacco products to be prepared to comment on Deeming Regulation.

Session Highlights:

This program, will take you through:

  • History of E-Vapor Regulation - 2007-2014
  • The Regulations put forward by FDA
  • How these new regulations will impact your growing business?

You will also get answers to the following tough questions:

  • If an e-liquid company wants to change flavor suppliers after August 8, 2016 do they need FDA approval?
  • Can an e-cigarette company state that its products are smoke-free or less harmful than cigarettes?
  • What submissions need to be made to FDA by August 8, 2016?
  • What products does the FDA now regulate?
  • How does the FDA regulate tobacco product parts and accessories?
  • Does the FDA restrict or prohibit advertising of e-cigarettes?
  • Are flavored tobacco products prohibited?
  • Are newly-covered products subject to premarket review by the FDA?
  • When will the deeming regulation take effect?
  • What other restrictions apply to each product?

Who should attend?

  • General Counsel and Management of tobacco, e-cigarette and e-liquid 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 to Tobacco and E-Cigarette Industries

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About Our Speaker

Azim Chowdhury

Azim Chowdhury is a Partner at Keller and Heckman LLP based in Washington, DC. Mr. Chowdhury 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, and is a nationally recognized expert on tobacco and e-vapor product regulation relating to the implementation of...   More Info
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