Photo of Azim ChowdhuryPhoto of Neelam Gill

Two months after the September 9, 2021 PMTA enforcement discretion deadline, the US Food and Drug Administration (FDA) has taken action on well over 90% of timely submitted Premarket Tobacco Product Applications (PMTAs), and has issued over 323 marketing denial orders (MDOs) for more than
1.2 million non-tobacco and non-menthol flavored Electronic Nicotine Delivery Systems

Photo of Azim ChowdhuryPhoto of Neelam Gill

Keller and Heckman Partner Azim Chowdhury and Associate Neelam Gill published an article for the Food and Drug Law Institute (FDLI) titled, “Will FDA Extend Its Proposed Ban on Menthol Cigarettes and Characterizing Flavors in Cigars to Flavored ENDS Products?” The article discusses FDA’s recent announcement to initiate a rulemaking to ban menthol cigarettes, as

Photo of Sheila A. MillarPhoto of Tracy P. Marshall

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

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

Photo of Azim ChowdhuryPhoto of LieAnn T. Van-Tull

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

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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)

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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

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