Reposted from Keller and Heckman’s Blog, Consumer Protection Connection.

The Federal Trade Commission (FTC) has issued orders to five e-cigarette manufacturers (JUUL Labs, Inc., R.J. Reynolds Vapor Company, Fontem US, LLC, Logic Technology Development LLC, and NJOY, LLC) seeking information about the companies’ 2019 and 2020 sales, advertising, and promotions. The FTC sent similar

Background on the PACT Act

As part of the “Consolidated Appropriations Act, 2021,” in the most recent COVID-19 relief bill signed into law on December 27, 2020, Congress amended the Prevent All Cigarette Trafficking (“PACT”) Act to apply to e-cigarettes and all vaping products. Originally passed in 2009, the PACT Act amended the

Reposted from Keller and Heckman’s Blog, The Daily Intake

  • On January 15, 2021, the U.S. Food and Drug Administration (FDA) issued warning lettersto ten companies that sell electronic nicotine delivery system (ENDS) products, including e-liquids.  FDA’s letters warned that any new tobacco product not in compliance with the premarket authorization requirements of the Federal

Keller and Heckman is pleased to announce the agenda for our 5th Annual E-Vapor and Tobacco Law Symposium.

This year’s virtual program will feature new, timely topics specifically designed to help vapor and deemed tobacco product manufacturers stay in compliance with rapidly evolving laws and policies. Topics that will be discussed include:

  • FDA’s new guidance

Registration is now open for Keller and Heckman’s 5th annual E-Vapor and Tobacco Law Symposium! This comprehensive three-day seminar will address legal, scientific, and public health issues relevant to the e-vapor and tobacco industries as we move forward in a post-PMTA world.

This year’s program will be taking place virtually February 9 – 11, 2021.

The U.S. Food and Drug Administration (FDA) recently released an updated module, “Tobacco Registration and Listing Module Next Generation (TRLM NG)” to its FDA Unified Registration and Listing (FURLS) Tobacco Registration and Listing Module (TRLM) (FURLS TRLM). TRLM NG was developed to better assist industry stakeholders submitting information and to improve system usability.

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

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)

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

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

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