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

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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

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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)

Photo of Sheila A. MillarPhoto of Azim Chowdhury

In March of this year, the Consumer Product Safety Commission (CPSC) announced that it would interpret the Child Nicotine Poisoning Prevention Act of 2015 (CNPPA) as mandating specific flow-restrictor requirements for liquid nicotine containers that are sold, offered for sale, manufactured for sale, or distributed in commerce. CPSC soon began aggressive enforcement of its new