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How is the FDA Processing PMTAs?
The U.S. Food and Drug Administration (FDA) continues to process, review, and take action on as many timely premarket tobacco product...
clarkespositolaw
Jul 12, 2021

FDA Guidance on Marketing and Distributing a "New" Tobacco Product
The Food and Drug Association (FDA) defines a new tobacco product as any new product or product modification marketed in the U.S. after...
clarkespositolaw
Jul 8, 2021

FDA Publishes Progress on Tobacco Product Application Review
Following the release of the Premarket Tobacco Product Application (PMTA) List on May 20, 2021, the U.S. Food and Drug Administration...
clarkespositolaw
Jun 15, 2021

General Enforcement Discretion Re: Sept. 9 Premarket Tobacco Applications
Submissions of applications for marketing orders were required by Sept. 9, 2020 for new deemed tobacco products on the market as after...
clarkespositolaw
Jun 10, 2021

US Postal Service Puts PACT Act on Pause
As many in the vapor industry have been preparing for the impending Prevent All Cigarette Trafficking (PACT) Act changes affecting ENDS...
clarkespositolaw
Jun 7, 2021

FDA Releases PMTA List (Finally!)
On May 20, 2021 the U.S. Food and Drug Administration (FDA) finally released the Premarket Tobacco Product Application (PMTA) list to the...
clarkespositolaw
Jun 1, 2021

What is the FDA's New Proposed Menthol Ban?
On April 29th, 2021, in response to a citizen petition, the U.S. Food and Drug Administration (FDA) announced it is pursuing two new...
clarkespositolaw
May 16, 2021

New York State Cannabis Legalization
On March 31st, New York State (NYS) governor Cuomo signed "The Marijuana Regulation and Taxation Act," legalizing adult recreational use...
clarkespositolaw
Apr 21, 2021

Where is FDA’s Final Rule on Tobacco & Vapor Products?
Many businesses operating in the vapor and tobacco product sectors have been wondering what happened to the much-anticipated US Food and...
clarkespositolaw
Mar 28, 2021

Can I Continue To Ship My Vapor Products Under The PACT Act? – Yes, But You’d Better Hurry!
Tobacco and vapor product sellers alike nationwide have questions about navigating the recent changes to the Jenkins Act, aka the Prevent...
clarkespositolaw
Mar 3, 2021

Join Deanna on 2/12/21 for a PACT Act Webinar on Shipping Vapor and Cannabis Products Via USPS
Join Deanna Clark-Esposito to learn about the PACT Act and actionable steps your business should be taking now to continue shipping...
clarkespositolaw
Feb 7, 2021

FDA Issues Warning Letters Mandating the Removal of Unauthorized E-Liquid Products From Market
On January 15, 2021, the U.S. Food and Drug Administration issued warning letters to 10 firms who manufacture and operate websites...
clarkespositolaw
Jan 29, 2021

2020 Primary Election Cycle Passed Drug-Related Ballot Proposals
In the most recent presidential election cycle many states took the opportunity to introduce new statute and regulatory proposals on...
clarkespositolaw
Jan 21, 2021

FDA Issues Multiple Warnings to Companies Illegally selling CBD Products
On December 22, 2020 the U.S. Food and Drug Administration (FDA) issued warning letters related to the sale of CBD products to Bee...
clarkespositolaw
Jan 4, 2021


CBD Sales Online: Tips for Managing Legal Issues Across State Lines
Has your hemp or CBD business run into state compliance issues you didn’t even know existed? Retailing industrial hemp and CBD products...
clarkespositolaw
Nov 8, 2020

FDA's Center for Tobacco Products' Statement on Premarket Authorization for Premium Cigars
On August 19, 2020, after a ruling from the U.S. District Court of the District of Columbia, the US Food and Drug Administration (FDA)...
clarkespositolaw
Nov 2, 2020

Have you received an FDA Warning Letter about Sales of Tobacco or CBD Products? Take it seriously
As a manufacturer, importer or retailer of tobacco or CBD products, should you receive an FDA Warning Letter, do not ignore it. FDA...
clarkespositolaw
Oct 12, 2020


How Can I Find Out if My Vendors Have Applied for a PMTA?
This is a great question and an important one too. The PreMarket Tobacco Application, otherwise known as the “PMTA,” which now has a...
clarkespositolaw
May 13, 2020


FDA’s Request for Extension of Premarket Review Deadline for Certain Tobacco Products Granted
On July 12, 2019, the Food and Drug Administration (FDA) set forth the process to require manufacturers of e-cigarettes, cigars and other...
clarkespositolaw
Apr 28, 2020


Have I Purchased the Right Insurance Policies for My Vapor or CBD Business?
For better or worse, as old as the insurance industry is, it finds it difficult to adjust to offering services to new industries it...
clarkespositolaw
Feb 10, 2020
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