Given the massive wave of medical and adult use marijuana laws being passed across the country, the average person may think there is no longer any debate as to whether marijuana has legitimate medical applications. On June 10, 2021, however the federal Court of Appeals for the Ninth Circuit heard argument on exactly that question. The case has potential to set important precedent not just for marijuana scheduling, but also other Schedule I substances being studied for their therapeutic potential. Continue Reading 9th Circuit Hears a New Attempt at Forcing the DEA’s Hand on Marijuana Scheduling
On June 11, 2021, the U.S. Food and Drug Administration (FDA) withdrew an advanced notice of proposed rulemaking (ANPRM) for premium cigars issued in March 2018 as part of the Spring 2021 Unified Agenda of Regulatory and Deregulatory Actions, which is published twice a year. Nevertheless, FDA commissioned a study to obtain information similar to what it sought in the ANPRM. The study is scheduled to be complete in Spring 2022. Thus, there is still a chance FDA takes a modified approach with respect to premium cigars in the future. Continue Reading FDA Withdraws Notice of Proposed Rulemaking For Premium Cigars
The Troutman Pepper Tobacco Team will participate in the Food and Drug Law Institute’s Annual Conference. The event is virtual and will be held May 18-20, 2021.
The conference has a well-rounded agenda addressing timely topics of interest for tobacco and nicotine industry stakeholders. FDA Center for Tobacco Products Director Mitch Zeller will address CTP’s key priorities for the coming year and answer questions from the audience. Other sessions will address premarket tobacco applications, substantial equivalence reports and tobacco and nicotine risk communication.
We look forward to seeing our clients and friends virtually!
On April 22, Senator Dick Durbin and others introduced the Tobacco Tax Equity Act of 2021 (S. 1314). The bill would establish a federal excise tax for electronic nicotine delivery systems (“ENDS”) and all other tobacco products that are not currently subject to federal tobacco products excise taxes. The bill would also double the tax rates for cigarettes and impose equivalent rates for most other tobacco products. Continue Reading Senators Introduce Federal Legislation to Tax ENDS and Substantially Increase Taxes for Other Tobacco Products
On June 11, 2021, the FDA Center for Tobacco Products Office of Science will host a meeting on the scientific review of deemed tobacco product applications. The meeting will focus on the application intake process, review progress and allocation of review resources. There will be a question and answer session with Office of Science staff.
We expect that the meeting will be informative for anyone with pending premarket tobacco applications, substantial equivalence reports or requests for exemption from substantial equivalence. The update will be timely, as deemed tobacco applications submitted around the September 9, 2020 compliance deadline will have been pending for about nine months. We look forward to hearing from the Office of Science regarding the status of its review progress.
Stakeholders can register for the meeting on FDA’s website here.
In Global Hookah Distribs. v. Florida, No. 1D20-822 (Apr. 12, 2021), a case before the First District Court of Appeal of Florida, Global Hookah Distributors (Global) unsuccessfully sought a refund of tobacco excise taxes it paid to the State of Florida. Global’s argument rested principally on its lack of a substantial “nexus” with the State. Continue Reading Florida Court Finds Nonresident Tobacco Distributor On the Hook For Excise Taxes Regardless of Physical Presence
In late February, we blogged about legislation passed by the Virginia General Assembly legalizing recreational marijuana. On March 31, 2021, Virginia Governor Ralph Northam submitted a substitute bill to the Senate for consideration. See https://lis.virginia.gov/cgi-bin/legp604.exe?212+sum+SB1406. The General Assembly is scheduled to reconvene Special Session I on April 7th, when it will consider the Governor’s marijuana proposal. Continue Reading Virginia Governor Pushes for Additional Changes to Marijuana Legislation Passed by the General Assembly
In January, we reported that the United States Department of Agriculture (USDA) issued its final rule establishing a domestic hemp production program, publishing it days before President Biden was inaugurated. The new Administration then instituted a “regulatory freeze pending review” with respect to published rules not yet in effect.
In a USDA Agricultural Marketing Service Bulletin issued on Monday, March 8, 2021, the agency stated “[a]s part of the transition, USDA and many other agencies took the opportunity to review new and pending regulatory actions. This is a routine process done at the beginning of new administrations to ensure longstanding as well as new programs are structured and resourced appropriately and to ensure programs are implemented to best serve their intended stakeholders.”
As such, the final rule will move forward as originally planned and will become effective on March 22, 2021.
The vapor industry has been dealing with the FDA’s Deeming Tobacco Products to Be Subject to the Federal Food, Drug, & Cosmetic Act, 81 Fed. Reg. 28,973 (May 10, 2016) (the “Deeming Rule”) for some time now. Is it constitutional? Continue Reading Vapor Litigants Ask Supreme Court to Review Deeming Rule Cases