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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

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 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

Photo of Azim ChowdhuryPhoto of Kathryn C. Skaggs

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.

Photo of Azim ChowdhuryPhoto of Kathryn C. Skaggs

On February 2, 2018, U.S. Smokeless Tobacco Company LLC (UST), a wholly owned subsidiary of Altria Group, Inc., filed suit against the U.S. Food and Drug Administration (FDA), U.S. Department of Health and Human Services (HHS), HHS Secretary Alex Azar, and FDA Commission Scott Gottlieb in the U.S. District Court for the District of Columbia