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Keller and Heckman Associate Neelam Gill will be a panelist at the Food and Drug Law Institute’s (FDLI) Enforcement, Litigation, and Compliance Conference, to be held virtually on December 9 – 10, 2021. Neelam will be participating in the panel on “Preparing for Tobacco Product Standards and cGMPs,” which will focus on pending Tobacco Product

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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

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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

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The Office of Information and Regulatory Affairs recently published the Spring 2021 Unified Agenda of Federal Regulatory and Deregulatory Actions. This year’s Department of Health and Human Services’ agenda addresses 8 topics directly related to tobacco and electronic nicotine delivery systems (ENDS), summarized below:

Final Rule Stage

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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 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

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Keller and Heckman’s 4th annual E-Vapor and Tobacco Law Symposium is just around the corner. Take advantage of the early bird discount and register today for the most comprehensive 2-day seminar focused on legal and regulatory issues critical to e-vapor, tobacco and CBD industries. Topics that will be covered include:

  • Status of the Industry: What

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Ahead of the Food and Drug Law Institute’s (FDLI) annual Tobacco and Nicotine Products Regulation and Policy Conference in Washington, DC, on October 23, 2019, Keller and Heckman attorneys Ben Wolf and Kathryn Skaggs presented on FDA’s “Pathways to Market” for new tobacco products during the pre-conference seminar, Introduction to Tobacco and Nicotine Law and

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Keller and Heckman LLP is announcing its 4th annual E-Vapor and Tobacco Law Symposium. This comprehensive 2-day course will address critical legal issues relevant to e-vapor, e-liquid and tobacco product manufacturers, distributors and retailers including youth prevention, FDA compliance, premarket applications, flavor bans, litigation, global and state compliance laws, and more.

Click here to register.

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A coalition of state and national vapor trade associations[i] has moved to intervene in and appeal the District Court for the District of Maryland’s decision in American Academy of Pediatrics, et al. v. FDA, Case No. 8:18-cv-00883, which drastically accelerated the Premarket Tobacco Product Application (PMTA) deadline for vapor products to May 11,