Reposted from Keller and Heckman’s Blog, The Daily Intake The Food and Drug Administration (FDA) is one of 27 agencies and offices within the U.S. Department of Health and Humans Services (HHS). FDA’s final rules have typically been signed by the FDA Commissioner, or more often a lower appointed officer within the agency. FDA’s rules have not usually been signed by the HHS Secretary, who is a Cabinet member with the primary role of advising…

The Continuum of Risk

Keller and Heckman LLP Files Citizen Petition Requesting 180-day Extension of PMTA Deadline for Small Open-System Vape Companies Due to COVID-19

By Azim Chowdhury & Eric Gotting

September 3, 2020

On August 24, 2020, Keller and Heckman LLP filed a citizen petition (here) with the U.S. Food and Drug Administration (FDA) on behalf of a group of small vapor product manufacturers, retailers, and trade associations requesting that the agency seek a 180-day extension of the September 9, 2020 deadline (until March 8, 2021) for filing Premarket Tobacco Product Applications (“PMTAs”) due to continuing delays experienced by manufacturers in preparing the applications caused by…

The Continuum of Risk

Maryland District Court Extends Premarket Application Submission Deadline to September 9, 2020 In Light of Coronavirus Outbreak; Appeal of the Merits Continues with the Fourth Circuit

By Azim Chowdhury & Eric Gotting

April 29, 2020

On April 22, 2020, the U.S. District Court for the District of Maryland modified its July 12, 2019 Remedies Order (the “Remedies Order”) in American Academy of Pediatrics, et al. v. FDA, et al., No. 8:18-cv-00883 (D. Md.) to extend the May 12, 2020 premarket application deadline to September 9, 2020 for all deemed tobacco products (e.g., e-cigarettes, cigars, hookah, etc.) on the market as of August 8, 2016. Although the vapor[i] and cigar…

The Continuum of Risk

CBD in Food and Dietary Supplements: What is the legal status?

By Natalie Rainer & Paula Pastuskovas

April 22, 2020

Since the Farm Bill of 2018 changed the definition and regulatory status of hemp from an agricultural perspective, confusion and misinformation has been rife on the U.S. Food and Drug Administration (FDA) regulatory status of hemp and its products—including cannabidiol (CBD), a non-psychoactive cannabinoid. Despite there not being a clear basis for concluding that CBD has an appropriate FDA regulatory status for use in food, CBD has gained mass popularity, and it is not uncommon…

The Continuum of Risk

Insurance Coverage for Coronavirus (COVID-19)

By Arthur S. Garrett III

March 20, 2020

Businesses from all industries and of all sizes are being severely impacted by coronavirus (COVID-19). We have no way of knowing the final outcome of this global pandemic; however, to relieve the burden of uncertainty, Keller and Heckman’s Insurance Coverage practice can help you navigate your company’s insurance policies*. The number one question a business wants to know is “do we have coverage for losses due to COVID-19?” This depends on a company’s policies and…

The Continuum of Risk

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

By Azim Chowdhury & Neelam Gill

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 I. 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

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

Blog Authors

A New Policy by HHS Secretary Alex Azar Will Prevent FDA and Other Health Agencies From Signing Final Rules

Keller and Heckman LLP Files Citizen Petition Requesting 180-day Extension of PMTA Deadline for Small Open-System Vape Companies Due to COVID-19

Maryland District Court Extends Premarket Application Submission Deadline to September 9, 2020 In Light of Coronavirus Outbreak; Appeal of the Merits Continues with the Fourth Circuit

CBD in Food and Dietary Supplements: What is the legal status?

Insurance Coverage for Coronavirus (COVID-19)

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”

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