The Continuum of Risk

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

Latest from The Continuum of Risk

Supplemental New Drug Application Submitted for FDA-Approved CBD Drug Epidiolex

February 11, 2020

Reposted from Keller and Heckman’s Blog, The Daily Intake As previously reported in this blog, the 2018 Farm Bill removed hemp – defined as Cannabis sativa L. with less than 0.3% THC on a dry weight basis – from the definition of “marijuana.” As a result, while marijuana remains a Schedule I drug, hemp is no longer a controlled substance under Federal law. However, since CBD has been approved for use in…

The Continuum of Risk

In the Wake of Heightened Regulatory Scrutiny of Vaping Products, Nicotine-Containing Toothpicks are Next to Come Under Fire by FDA

By Keller and Heckman

February 4, 2020

Reposted from Keller and Heckman’s Blog, The Daily Intake The U.S. Food and Drug Administration recently issued a warning letter to Smart Toothpicks LLC, of Tempe, Arizona, for several violations of the Federal Food, Drug, and Cosmetic Act (FD&C Act), as amended by the Family Smoking Prevention and Tobacco Control Act. Smart Toothpicks sells nicotine-infused birch toothpick products in different flavors, including “Peppermint Ice,” “Wintergreen,” and “Cinnamon” Nicotine Toothpicks. FDA’s warning letter focused on the…

The Continuum of Risk

FDA’s New Enforcement Priority Guidance for E-Cigarettes Focuses on Flavored Cartridge-Based Devices as well as Companies and Products that FDA Views as Targeting Youth

By Azim Chowdhury & LieAnn Van-Tull

January 14, 2020

On January 8, 2020 FDA published its latest compliance policy guidance, Guidance for Industry: Enforcement Priorities for Electronic Nicotine Delivery Systems (ENDS) and Other Deemed Products on the Market Without Premarket Authorization (January 2020), which goes into effect in February. Pursuant to the final guidance, beginning February 6, 2020, FDA intends to prioritize enforcement of premarket review requirements for the following products: Any flavored, cartridge-based ENDS product (other than a tobacco or menthol-flavored ENDS product);…

The Continuum of Risk

Register Today: E-Vapor and Tobacco Law Symposium

By Azim Chowdhury

December 4, 2019

Keller and Heckman’s 4th annual E-Vapor and Tobacco Law Symposium is just around the corner. Take advantage of the early bird discount and register today for the most comprehensive 2-day seminar focused on legal and regulatory issues critical to e-vapor, tobacco and CBD industries. Topics that will be covered include: Status of the Industry: What Happens Next? Flavor Bans and FDA’s Compliance Policy Litigation Update: PMTA Deadline Appeal and New Lawsuits Product Liability: Youth Prevention,…

The Continuum of Risk

FDA Won’t Enforce Pre-Market Review Requirement for E-Liquid Packaging Modified to Incorporate “Flow Restrictors”

By Sheila Millar, Azim Chowdhury & Boaz Green

November 27, 2019

In March of this year, the Consumer Product Safety Commission (CPSC) announced that it would interpret the Child Nicotine Poisoning Prevention Act of 2015 (CNPPA) as mandating specific flow-restrictor requirements for liquid nicotine containers that are sold, offered for sale, manufactured for sale, or distributed in commerce. CPSC soon began aggressive enforcement of its new interpretation, sending out dozens of Notices of Violations to manufacturers of e-liquids, demanding immediate stop sale, withdrawal, destruction of products…

The Continuum of Risk

Keller and Heckman Presents at FDLI’s Introduction to Tobacco and Nicotine Law and Regulation seminar on “Pathways to Market”

By Kathryn C. Skaggs & Azim Chowdhury

October 23, 2019

Ahead of the Food and Drug Law Institute’s (FDLI) annual Tobacco and Nicotine Products Regulation and Policy Conference in Washington, DC, on October 23, 2019, Keller and Heckman attorneys Ben Wolf and Kathryn Skaggs presented on FDA’s “Pathways to Market” for new tobacco products during the pre-conference seminar, Introduction to Tobacco and Nicotine Law and Regulation. The presentation slides are available here. Registration is now open for Keller and Heckman’s E-Vapor and Tobacco…

The Continuum of Risk

Keller and Heckman’s E-Vapor and Tobacco Law Symposium

By Azim Chowdhury

October 21, 2019

Keller and Heckman LLP is announcing its 4th annual E-Vapor and Tobacco Law Symposium. This comprehensive 2-day course will address critical legal issues relevant to e-vapor, e-liquid and tobacco product manufacturers, distributors and retailers including youth prevention, FDA compliance, premarket applications, flavor bans, litigation, global and state compliance laws, and more. Click here to register. Seminar Details Date: February 11 – 12, 2020 Cost: $899 if you register by January 10th; $1,099 if you register…

The Continuum of Risk

FDA Will Seek to Remove Flavored E-Cigarettes from the Market

By Keller and Heckman

September 13, 2019

Reposted from Keller and Heckman’s Blog, The Daily Intake On September 11, 2019 President Trump, along with HHS Secretary Azar and FDA Commissioner Sharpless, announced that the Food and Drug Administration (FDA) intends to soon finalize a compliance policy to prioritize enforcement of the premarket authorization requirements against non-tobacco flavored e-cigarettes. E-cigarettes on the market as of August 8, 2016, the effective date of FDA’s “Deeming Rule”, are currently allowed to be marketed until Premarket Tobacco…

The Continuum of Risk

Michigan Seeks to Ban Flavored E-Cigarettes Through Emergency Rulemaking

By LieAnn Van-Tull & Azim Chowdhury

September 10, 2019

On September 4, 2019, Michigan Governor Gretchen Whitmer announced soon-to-be-filed Emergency Rules banning the sale of flavored e-cigarettes in Michigan.[1] The proposed flavor ban, the first of its kind at the state-level, is being promulgated without any public notice and comment using the Michigan Department of Health and Human Services’ (MDHHS) emergency rulemaking powers. Once effective, the rules would ban the sale of flavored vapor and alternative nicotine products (except tobacco-flavored products) in stores…

The Continuum of Risk

CPSC’s E-Liquid Enforcement is Hurting Small Businesses

By Sheila Millar, Azim Chowdhury & Boaz Green

August 21, 2019

Small businesses are facing serious compliance burdens as a result of the Consumer Product Safety Commission (CPSC)’s recent interpretation of the Child Nicotine Poisoning Prevention Act (CNPPA). Keller and Heckman partner Sheila Millar testified on behalf of the E-Vapor Coalition about the adverse impact at the Small Business Administration’s (SBA) regulatory fairness hearing held on August 19, 2019. As we previously reported, CPSC’s enforcement position on requirements for e-liquid packaging exceeds its statutory authority,…

The Continuum of Risk

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

Blog Authors

Supplemental New Drug Application Submitted for FDA-Approved CBD Drug Epidiolex

In the Wake of Heightened Regulatory Scrutiny of Vaping Products, Nicotine-Containing Toothpicks are Next to Come Under Fire by FDA

FDA’s New Enforcement Priority Guidance for E-Cigarettes Focuses on Flavored Cartridge-Based Devices as well as Companies and Products that FDA Views as Targeting Youth

Register Today: E-Vapor and Tobacco Law Symposium

FDA Won’t Enforce Pre-Market Review Requirement for E-Liquid Packaging Modified to Incorporate “Flow Restrictors”

Keller and Heckman Presents at FDLI’s Introduction to Tobacco and Nicotine Law and Regulation seminar on “Pathways to Market”

Keller and Heckman’s E-Vapor and Tobacco Law Symposium

FDA Will Seek to Remove Flavored E-Cigarettes from the Market

Michigan Seeks to Ban Flavored E-Cigarettes Through Emergency Rulemaking

CPSC’s E-Liquid Enforcement is Hurting Small Businesses

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