On June 23, 2022, the U.S. Food and Drug Administration (FDA) issued marketing denial orders (MDOs)[1] to Juul Labs Inc. for all of the company’s JUUL electronic nicotine delivery system (ENDS) products currently marketed in the United States. After review, FDA determined that Juul’s Premarket Tobacco Product Applications (PMTAs), submitted more than two years
LieAnn T. Van-Tull
LieAnn Van-Tull practices in the area of food and drug law, as well as tobacco and e-vapor regulation. She advises domestic and foreign clients on compliance with global food and drug packaging requirements. Ms. Van-Tull also provides state and federal legislative counsel to tobacco and e-vapor suppliers and manufacturers.
Prior to joining Keller and Heckman, Ms. Van-Tull served as regulatory counsel for the Food and Drug Administration (FDA). While at FDA, she was on the lead counsel team on enforcement actions against companies that produce electronic nicotine delivery systems. Ms. Van-Tull also developed policies and programs involving matters affecting the regulation of the tobacco industry. Ms. Van-Tull also has a background in chemistry.
Admitted to practice in Maryland only. Practice limited to matters before the FDA and matters ancillary thereto.
FDA Authorizes Tobacco-Flavored Logic Technology Electronic Nicotine Delivery System (ENDS) for Marketing & Issues Marketing Denial Orders for Fontem’s myblu ENDS Products
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…
FDA Releases Updated Module, “Tobacco Registration and Listing Module Next Generation (TRLM NG)” for Tobacco Product Manufacturing Establishments
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.…
FDA’s New Enforcement Priority Guidance for E-Cigarettes Focuses on Flavored Cartridge-Based Devices as well as Companies and Products that FDA Views as Targeting Youth
On January 8, 2020 FDA published its latest compliance policy guidance, Guidance for Industry: Enforcement Priorities for Electronic Nicotine Delivery Systems (ENDS) and Other Deemed Products on the Market Without Premarket Authorization (January 2020), which goes into effect in February. Pursuant to the final guidance, beginning February 6, 2020, FDA intends to prioritize enforcement…
Michigan Seeks to Ban Flavored E-Cigarettes Through Emergency Rulemaking
On September 4, 2019, Michigan Governor Gretchen Whitmer announced soon-to-be-filed Emergency Rules banning the sale of flavored e-cigarettes in Michigan.[1] The proposed flavor ban, the first of its kind at the state-level, is being promulgated without any public notice and comment using the Michigan Department of Health and Human Services’ (MDHHS) emergency rulemaking powers.…