Keller and Heckman is pleased to announce the agenda for this year’s E-Vapor and Tobacco Law Symposium. This comprehensive 2-day course will provide you with guidance on how to stay in compliance with FDA’s recent announcements and much more. Click here to view the agenda.

Topics that will be covered include: FDA and State law

As a reminder, the registration requirement for domestic U.S. tobacco product manufacturing establishments, including manufacturers of deemed products such as e-liquids and cigars, is a biannual obligation that requires each such establishment to “update” their Registration and Product Listing information with FDA by December 31 every year (product listing information must also be updated by

Learn how to stay in compliance with FDA’s recent announcements and much more at Keller and Heckman’s upcoming E-Vapor and Tobacco Law Symposium on January 29 – 30, 2019, in Miami, Florida. Below is a sampling of topics that will be covered at the event. Sign up now and take advantage of our early bird

Following a series of actions over the last several months, on November 15, 2018, the U.S. Food and Drug Administration (“FDA”) announced new steps aimed at protecting youth from tobacco, including, among other things, preventing access to flavored electronic nicotine delivery system (“ENDS”) sold in certain retail locations, and potentially banning menthol in combustible tobacco

The U.S. Food and Drug Administration (FDA) is expected to announce today detailed plans to curtail the growing number of youth who are using certain types of e-cigarette products. Below is a summary of the Agency’s recent actions and compliance deadlines.

September 12, 2018 Letters to Vuse, Blu, JUUL, MarkTen XL, and Logic

  • On September

We have observed two recent enforcement trends at the Consumer Product Safety Commission (CPSC) that may affect the e-vapor industry: (1) a spike in recalls of products harmful or fatal to children if ingested but lacking required child-resistant packaging; and (2) an increased focus on the absence of certificates of compliance. Both forms of regulatory

Azim Chowdhury and Adam Susser have been published in the Washington Legal Foundation’s Critical Legal Issues Working Paper Series, Number 210, October 2018 edition. In the paper, Implementing the Continuum of Risk: Modified Risk Tobacco Products, Azim and Adam address how the Food and Drug Administration (FDA) can better implement the Tobacco Control Act’s

Azim Chowdhury and Sam Jockel have been published in the latest Issue of Food and Drug Law Institute Update Magazine, “Spotlight on Tobacco – Future Developments in the Regulation of Electronic Nicotine Delivery Systems: Potential Over-the-Counter Pathway.” Update is open access online. To read the article, click here. This article is republished with the

On May 23, 2018, Bill S-5 (“An Act to amend the Tobacco Act and the Non-smokers’ Health Act and to make consequential amendments to other Acts”) became law in Canada, representing a major shift in Canada’s regulatory framework, as the Bill establishes a nationalized approach to the regulation of vaping products and tobacco products through

Registration is open for Keller and Heckman’s 3rd Annual E-Vapor and Tobacco Law Symposium being held January 29-30, 2019 in Miami, Florida. Click here to register.

This comprehensive 2-day course will address regulatory and business issues relevant to e-vapor, e-liquid and tobacco product manufacturers, distributors and retailers including, among other things:

  • FDA enforcement and inspections

On September 11, 2018, Nicopure Labs, LLC and the Right to be Smoke-Free Coalition (the “Appellants”) appeared for oral argument before a three-judge panel in the United States Court of Appeals for the District of Columbia Circuit to appeal a decision issued last year by the U.S. District Court for the District of Columbia, which ruled in favor of the U.S. Food and Drug Administration (“FDA”) in the first lawsuit challenging various provisions of the Family Smoking Prevention and Tobacco Control Act (“TCA” or “Act”) and the FDA’s Deeming Rule as they are being applied to the vapor industry. During oral argument, the Appellants argued that the Modified Risk Tobacco Product (“MRTP”) preclearance requirement imposed by Section 911 of the TCA violates the First Amendment as applied to e-cigarettes and other vapor products. In addition, the Appellants argued that application of the Act’s free sample ban to vapor products violates the First Amendment, and that FDA failed to tailor the premarket tobacco application (“PMTA”) requirements to ensure the continued availability of vapor products. Below, we provide a brief overview of the issues discussed at the oral argument. The recording of the hearing is available here. For background on the appeal, see our previous blog posts, including copies of the legal briefs, available here and here.
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