As we previously reported, the Reagan-Udall Report evaluated FDA’s Center for Tobacco Products (CTP) and reported that stakeholders were concerned over, among other things, a lack of clear guidance and transparency regarding regulations, the premarket review process, and enforcement priorities. On February 24, 2023, CTP responded to the report and committed to addressing all
FDA
Keller and Heckman Files Supreme Court Amicus Brief on Behalf of Public Health Experts in Support of Avail Vapor’s Cert Petition Challenging FDA’s Marketing Denial Order



On June 14, 2023, Keller and Heckman Partners Eric Gotting and Azim Chowdhury, on behalf of a group of public health experts, filed an amicus brief with the Supreme Court of the United States (SCOTUS) in support of Avail Vapor’s writ of certiorari petitioning SCOTUS to review the Fourth Circuit’s decision to uphold the Food…
The Reagan Udall Foundation – A Critical Evaluation of FDA’s Center for Tobacco Products



I. Reagan-Udall Report
In July 2022, the Food and Drug Administration (FDA) Commissioner, Dr. Robert Califf, released a public statement saying the agency “has confronted a series of challenges that have tested our regulatory frameworks and stressed the agency’s operations.” As such, Commissioner Califf was “prompt[ed] . . . to take a closer look at…

FDA Publishes Proposed Rule on Tobacco Product Manufacturing Practices


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…

FDA Files Civil Money Penalty Complaints Against Four Small Vape Shops for Alleged Premarket Review Violations


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:
…
Take a Look at this Year’s Lineup of Guest Speakers for Keller and Heckman’s E-Vapor and Tobacco Law Symposium
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:…
FDA Concludes that New Regulatory Frameworks for Foods and Supplements Containing Cannabidiol are Needed, Will Work with Congress
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…
Azim Chowdhury, Neelam Gill, and Josephine Hsu Awarded 2022 “Go-To Thought Leader” Distinction by The National Law Review

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…
FDA Issues Warning Letters to Companies Illegally Selling CBD Products
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
…
Agenda Announced and Super Early-Bird Deadline Extended for Keller and Heckman’s E-Vapor and Tobacco Law Symposium
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…