On Friday, July 23, 2021, the attached bill was introduced by a bipartisan group of lawmakers. In the Senate it was introduced by Sen. Jeanne Shaheen (D-NH), along with Lisa Murkowski (R-AK), Richard Durbin (D-IL), Susan Collins (R-ME), Tammy Baldwin (D-WI) and Mitt Romney (R-UT).  The House companion bill was introduced by Rep. Cheri Bustos.

The bill authorizes FDA to collect user fees from all manufacturers of products that have been deemed as tobacco products by FDA, including e-cigarettes.  It is forecast to increase the total amount collected in tobacco user fees by $100 million in fiscal year 2022 and indexes that amount to inflation for future years.  The bill would not affect federal excise taxes on tobacco products.

We previously blogged about two cases challenging the constitutionality of FDA’s “Deeming Rule,” the authority by which FDA extended its regulation of tobacco products to electronic nicotine delivery systems (“ENDS”).

Both of these cases, Big Time Vapes, Inc. v. FDA and Moose Jooce v. FDA recently hit a dead end when the Supreme Court denied both plaintiffs’ petitions for review. Continue Reading Supreme Court Won’t Hear Latest ENDS Industry Challenges to FDA Regulation

Smokable hemp is one of the fastest growing submarkets of the hemp industry, but hemp growers and manufacturers in Texas may not be able to take advantage. A pair of cases in Texas district and appellate courts are trying to make sure that’s not the case. Continue Reading Texas Courts Hear Oral Arguments Regarding State’s Smokable Hemp Ban

Troutman Pepper Strategies (TPS), a full-service government affairs and issue management arm of Troutman Pepper, regularly communicates with members of Congress and staff, including relevant committee staff, regarding the status of tobacco-related legislation and policy. These relationships include and extend beyond the congressional committees with tobacco jurisdiction, such as the House Energy & Commerce Committee and the Senate HELP Committee. Additionally, TPS communicates with agency officials, including the Food and Drug Administration and the White House, about tobacco-related regulations and policy. Continue Reading Tobacco in the 117th Congress

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.