The Continuum of Risk

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

A major study found that e-cigarettes were twice as effective in helping people quit smoking than nicotine replacement therapies—such as patches, gum, and nasal spray—when both methods were accompanied by behavioral support. The randomized study involved 886 adults who were attending the U.K. National Health Service stop-smoking services. Study participants were randomly given either nicotine-replacement products of their choice for up to 3 months or an e-cigarette starter pack, which consisted of a second-generation refillable…
As previously reported on this blog, on November 15, 2018, citing new data from the 2018 National Youth Tobacco Survey (NYTS) that showed a surge in e-cigarette use among youth, U.S. Food and Drug Administration (FDA) Commissioner Scott Gottlieb, M.D. announced new steps aimed at curtailing illegal underage use of e-cigarettes by limiting where such products can be purchased.  More specifically, the Commissioner indicated that FDA would seek to limit the sale of flavored…
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 compliance, HPHCs and PMTAs, Advertising and Marketing, European Union and Global laws, Environmental, OSHA and CPSC compliance, CBD and cannabis-derived products, and…
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 June 30 every year). See Section 905(b) of the Food, Drug, and Cosmetic Act (FDCA) as amended by the Family…
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 discount! FDA Regulation Update and Preparing for What’s Next Azim Chowdhury FDA’s New Announcement: How it Will Impact Your Business…
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 products.[1]  Spurred by the release of new data from the 2018 National Youth Tobacco Survey (“NYTS”) showing a…
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 12, FDA sent letters to the manufacturers of five Electronic Nicotine Delivery System (ENDS) products (Vuse [British America Tobacco], Blu…
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 violations were also the subject of a recent Nicotine Packaging Advisory Letter from the Director of CPSC’s Office of Compliance…
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.…