The Continuum of Risk

A Law Blog for Vapor, Tobacco and Reduced-Harm Product Companies

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 Modified Risk Tobacco Product (MRTP) provisions to benefit the public health.  To read the full article, click here.…
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 permission of FDLI.…
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 the implementation of the Tobacco and Vaping Products Act (TVPA). This legislation represents a milestone for vaping products. Prior to…
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 – how to prepare and protect your business; Product compliance – including advertising and labeling compliance, and preparing for Premarket Tobacco Product Applications…
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…
On Tuesday October 2, at 2PM EST, Azim Chowdhury and Ben Wolf will present a webinar, “Ingredients Listing: Walk Through” sponsored by the Smoke-Free Alternatives Trade Association (SFATA). Ingredient listing reports for small-scale tobacco product manufacturers are due by November 8, 2018. This program is recommended for manufacturers of deemed tobacco products, including e-liquids, their management, and staff who are responsible for regulatory compliance. Participants will learn how to prepare and submit ingredient listing reports…
On September 12, 2018, in a self-described “blitz”, FDA announced a deluge of enforcement actions, including more than 1,300 warning letters and fines to retailers aimed at addressing youth use of e-cigarettes, which FDA asserts has reached “epidemic” proportions, based on new, not-yet-released survey data.[1]  FDA also requested manufacturers of five “national brands,” whose cartridge (pod) based e-cigarettes the Agency claimed make up 97% of the “current e-cigarette market” (but apparently excluding the…
On September 6, 2018, a coalition of vapor industry trade associations and businesses – specifically the Smoke-Free Alternatives Trade Association (SFATA), the American E-Liquid Manufacturing Standards Association (AEMSA), the American Vapor Association (AVA), and SV3, LLC (collectively, the “Vapor Coalition”) – submitted comments to the U.S. Trade Representative (USTR) arguing against the Trump Administration’s additional proposed tariffs that would apply to certain vapor products imported from China (see Docket No. USTR-2018-0026). The Vapor Coalition’s…
In a widely anticipated move, FDA has significantly increased the frequency of inspections of vapor manufacturing and retail facilities over the past few weeks, with some inspections spanning two days. We have received reports from vapor businesses across the country that they are receiving unannounced visits from FDA investigators conducting biannual inspections pursuant to Sections 704 and 905 of the Food, Drug, and Cosmetic Act as amended by the Tobacco Control Act. Under the Act,…