Some cigarette pack labels may soon feature the phrases “95% less nicotine,” “helps reduce your nicotine consumption,” and “… greatly reduces your nicotine consumption.” On December 23, 2021, the Food and Drug Administration...more
While it is always a good idea to focus on maintaining a healthy regulatory compliance program, the start of a new year seems like a particularly good time to review your tobacco company’s corporate hygiene with respect to...more
On December 15, New Jersey Congresswoman Mikie Sherrill introduced the Clarifying Authority Over Nicotine Act of 2021 — a bipartisan bill designed to give the U.S. Food and Drug Administration (FDA) the authority to regulate...more
On October 5, 2021, the Food and Drug Administration (“FDA”) published in the Federal Register its Final Rule on the content and format of reports intended to demonstrate the substantial equivalence of a tobacco product (“SE...more
California’s cigarette tax and escrow requirements apply to inter-tribal sales of cigarettes, held the U.S. Court of Appeals for the 9th Circuit in Big Sandy Rancheria Enterprises v. Bonta. Big Sandy Rancheria Enterprises...more
A number of U.S. Representatives on both sides of the aisle recently cosponsored a proposed bill that would limit the U.S. Food & Drug Administration’s (FDA’s) ability to regulate premium cigars. Although the text of the...more
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...more
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...more
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....more
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...more
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...more
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...more
On April 29, the U.S. Food & Drug Administration (FDA) announced that it will issue proposed tobacco product standards within the next year that will effectively ban menthol cigarettes and characterizing flavors in cigars....more
On February 16, 2021, the Food and Drug Administration published the long-awaited “public list” of “deemed” tobacco products that: (1) were on the US market on August 8, 2016, (2) are currently on the US market, and (3) were...more
The Biden administration and Democratic majorities in both the Senate and House could implement significant changes to federal tobacco and cannabis policy over the next two years. For tobacco, the change in party control of...more
As many in the tobacco industry know, there is a growing trend among state and local governments to prohibit or restrict the sale of flavored tobacco or nicotine products. Some governments are focusing on narrow subsets of...more
On October 27, FDA issued a new draft guidance, entitled “Tobacco Products: Principles for Designing and Conducting Tobacco Product Perception and Intention Studies.” The draft guidance describes the FDA Center for Tobacco...more
On Wednesday, August 19, 2020, the U.S. District Court for the District of Columbia issued an order enjoining FDA from enforcing the premarket review requirement contained in the agency’s “Deeming Rule” against “premium...more