Photo of Azim ChowdhuryPhoto of Eric P. Gotting

Bidi Vapor, LLC LogoLast year, Bidi Vapor LLC (Bidi or the Company), represented by Keller and Heckman LLP Partners Eric Gotting and Azim Chowdhury, petitioned the 11th Circuit Court of Appeals to review the Food and Drug Administration’s (FDA) order denying the Premarket Tobacco Product Applications (PMTA) for its non-tobacco flavored BIDI® Sticks, a disposable electronic nicotine

Photo of Azim ChowdhuryPhoto of Josephine Hsu

Since it became effective in 2016, the cigar industry has mounted several challenges to the U.S. Food and Drug Administration’s (FDA) “Deeming Rule,” which extended the Agency’s tobacco product authority beyond cigarettes, cigarette tobacco, smokeless tobacco, and roll-your-own tobacco, to all products that meet the “tobacco product” definition in the Food, Drug and Cosmetic Act,

Photo of Azim ChowdhuryPhoto of LieAnn T. Van-TullPhoto of Josephine Hsu

On June 23, 2022, the U.S. Food and Drug Administration (FDA) issued marketing denial orders (MDOs)[1] to Juul Labs Inc. for all of the company’s JUUL electronic nicotine delivery system (ENDS) products currently marketed in the United States. After review, FDA determined that Juul’s Premarket Tobacco Product Applications (PMTAs), submitted more than two years

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

  • On May 4, 2022, FDA announced that it had issued warning letters to five companies selling products (including gummies, capsules, tinctures, lotions, vaping products, pet products, and hand sanitizers) labeled as containing delta-8 tetrahydrocannabinol (delta-8 THC), as well as cannabidiol (CBD), in violation of the Federal

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On April 26, 2022, the U.S. Food and Drug Administration (FDA) authorized an additional four tobacco-flavored electronic nicotine delivery system (ENDS) products for marketing under the Premarket Tobacco Product Application (PMTA) pathway. Marketing granted orders (MGOs)[1] were issued for the following NJOY tobacco-flavored ENDS products:

  • NJOY Ace Device: Closed e-cigarette device
  • NJOY Ace Pod

Photo of Azim Chowdhury

FOR IMMEDIATE RELEASE
April 12, 2022
Media Contact: Caryn Wick
wick@khlaw.com
+1 202.434.4318

—Washington, D.C.— International regulatory law firm Keller and Heckman LLP welcomes the addition of Counsel, Daniel P. McGee, to the firm’s expanding Tobacco and E-Vapor practice.

Prior to joining Keller and Heckman, Daniel worked as in-house counsel for several multinational tobacco,

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FDA Premarket Tobacco Product Application (PMTA) Pathway

Under FDA’s premarket tobacco product application (PMTA) pathway, manufacturers or importers of tobacco products must demonstrate to the U.S. Food and Drug Administration (FDA) that the marketing of a new tobacco product would be appropriate for the protection of the public health (APPH). See Section 910(c)(2)(A) of the

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

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

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