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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


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


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


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


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


With the Threat of Flavor Bans, How Can I Better Manage Product Returns?
If you’re asking the question, it means you likely already have a Return and Refund Policy which is great. Ideally, it is written down...
clarkespositolaw
Dec 12, 2019


Survival Planning for the FDA's PMTA Deadline in 9 Months
On August 7, 2019, Brent Stafford, of Regulator Watch (https://regulatorwatch.com), interviewed me describing how to survive the...
clarkespositolaw
Aug 16, 2019


FDA Publishes Updated HPHC List on Vape and Tobacco Products
FDA published yesterday (Aug. 5, 2019) an additional proposed 19 harmful or potentially harmful constituents (HPHCs) which may be found...
clarkespositolaw
Aug 6, 2019


Join Deanna at CHAMPS Vegas on 7/17
Deanna will be speaking at CHAMPS.
clarkespositolaw
Jul 11, 2019


FDA Extends Comment Period for Proposed Tobacco Products Law
The FDA has extended the comment period for a new "Substantial Equivalence Report" rule for 30 days.
clarkespositolaw
Jul 8, 2019


FDA/FTC Issue Warning Letters To E-liquid Sellers
The FDA and FTC issued joint Warning Letters to four e-liquid companies.
clarkespositolaw
Jun 13, 2019


Presenting at CHAMPS on Vape Industry FDA Compliance
Deanna addressed a great group of entrepreneurial business owners in Atlantic City, NJ in May and will be doing it again in Las Vegas in...
clarkespositolaw
May 30, 2019
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