The Continuum of Risk

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

Reposted from Keller and Heckman’s Blog, The Daily Intake Interest in products derived from cannabis (Cannabis sativa L.) and its components, including cannabidiol (CBD) has been high for the past couple of years and only increased when Congress passed the 2018 Farm Bill in December 2018.  Among other things, the law established a category for “hemp,” defined as cannabis (Cannabis sativa L.), and derivatives of cannabis (e.g., CBD) with extremely low (less than 0.3% on a dry weight…
The Food and Drug Administration’s (FDA’s) recently published draft guidance, Modifications to Compliance Policy for Certain Deemed Tobacco Products (hereinafter, the “Revised Compliance Policy Draft Guidance”)[1], revises the Agency’s controversial “compliance policy” for new deemed tobacco products on the market when the Deeming Rule went into effect on August 8, 2016.  We describe FDA’s proposed changes to the policy below and what companies can do to remain in compliance. Compliance Policy Background: The…
Reposted from Keller and Heckman’s Blog, The Daily Intake The San Francisco City Attorney, in coordination with the City’s Board of Supervisors, announced on March 20, 2019 that it will introduce legislation to prohibit the sale and delivery of e-cigarettes in the City unless such products have been established as “appropriate for the protection of the public health” through the Food and Drug Administration (FDA) Premarket Tobacco Product Application (PMTA) process.  Notably, the City Attorney…
Section 904(a)(3) of the Food, Drug and Cosmetic Act, as amended by the Tobacco Control Act, (FDCA) requires manufacturers and importers to report the quantities of Harmful and Potentially Harmful Constituents (HPHCs) found in their tobacco products, or in the smoke produced by their products, by brand and sub-brand.  21 U.S.C. § 387d(a)(3).  This requirement was extended to all deemed products such as e-cigarettes, e-liquid, cigars, hookah and pipe tobacco when the Deeming Rule…
On February 21, 2019, FDA released the second of two draft guidance documents related to the development of novel nicotine replacement therapies (NRT).  The first draft guidance document, Nonclinical Testing of Orally Inhaled Nicotine-Containing Drug Products Guidance for Industry is available here, and the second draft guidance document,  Smoking Cessation and Related Indications: Developing Nicotine Replacement Therapy Drug Products is available here. The draft guidance documents are one part of FDA’s efforts in…
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…