On March 10, 2023, the U.S. Food and Drug Administration (FDA) published a long-awaited proposed rule on Requirements for Tobacco Product Manufacturing Practice (TPMP),[1] which sets forth proposed requirements for the manufacture, design, packing, and storage of tobacco products[2]. The proposed requirements are essentially “good manufacturing practices” for tobacco products and are intended to minimize

On February 22, 2023, the U.S. Food and Drug Administration (FDA) announced the filing of civil money penalty (CMP) complaints against four domestic e-liquid manufacturers, all of which appear to be small vape shops that were producing nicotine-containing e-liquids used in open-system electronic nicotine delivery systems (ENDS) devices.[1] The four named companies are:

To be placed on the European Union market, tobacco and related products must comply with specific requirements and procedures, harmonized at the European level by Directive 2014/40/EU concerning the manufacture, presentation, and sale of tobacco and related products (hereinafter the “Tobacco Products Directive” or the “Directive”). This article provides a general overview of the requirements

The extended early-bird discount for Keller and Heckman’s annual E-Vapor and Tobacco Law Symposium expires tomorrow, Friday, February 3. Register now in order to save $100 on your registration!

In addition to legal experts from Keller and Heckman, this year’s program will feature an impressive lineup of industry experts.

Meet this year’s guest speakers:

Yesterday, Janet Woodcock, M.D., the Principle Deputy Commissioner for the Office of the FDA Commissioner, released a statement regarding the Agency’s approach towards cannabidiol (CBD) and its application in the food and drug industry.

The statement provided that FDA convened a high-level internal working group to explore potential regulatory pathways for CBD products.  The working

From December 5-7, 2022, Keller and Heckman hosted a private conference with the China State Tobacco Monopoly Administration (STMA) on the topic of U.S. and global e-cigarette and tobacco product regulation. The event was approved by China’s Ministry of Science and Technology (MOST) and was attended by over 700 officials from STMA and its local

Keller and Heckman Partner Azim Chowdhury, Counsel Neelam Gill, and Associate Josephine Hsu received the 2022 “Go-To Thought Leader” award from the National Law Review under the “Biotech, Food and Drug” category.

Azim, Neelam, and Josephine received this distinction for their March 16, 2022 article, FDA Receives Authorization to Regulate Synthetic Nicotine

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

  • On November 21, 2022, FDA posted warning letters that had been issued to 11-11-11 Brands, Naturally Infused LLC, Newhere Inc dba CBDFX, Infusionz LLC, and CBD American Shaman, LLC for illegally selling CBD-containing products. Collectively, the warning letters raised several legal objections to the sale of

On November 8, 2022, California voters approved[1] the Referendum on 2020 Law That Would Prohibit the Retail Sale of Certain Flavored Tobacco Products (Proposition 31). The referendum, submitted in accordance with the provisions of Section 9 of Article II of the California Constitution, asked California citizens to vote on whether to uphold a 2020

Keller and Heckman LLP is excited to announce the agenda for our upcoming E-Vapor and Tobacco Law Symposium! Please click here to register and click here to view the agenda.

In addition to the firm’s attorneys, we have several notable experts joining as guest speakers this year, including Derek Yach, the former World Health