On July 5th, the U.S. District Court for the District of Columbia ruled that the decision of the Food and Drug Administration (FDA) to “deem” premium cigars subject to the same federal law as other tobacco products like...more
The US Food and Drug Administration (FDA) recently announced plans to publish a proposed rule that would establish a maximum nicotine level in cigarettes and certain “other combusted tobacco products.” At the moment, it is...more
On June 10, a bipartisan coalition of 31 state attorneys general, led by Idaho, Illinois, Nebraska, and Pennsylvania, sent a letter to Food and Drug Administration (FDA) Commissioner Dr. Robert M. Califf, asking the agency to...more
Status report concerns FDA’s review of 240 PMTAs submitted on or before September 9, 2020, for vapor products with larger market shares. FDA estimates that it will resolve most of these in the periods before July 2022 and...more
Under Judge Grimm’s Revised Remedial Order, FDA must submit quarterly status reports regarding its review of pending PMTAs for certain popular vapor products....more
On February 15, the Senate confirmed cardiologist Robert M. Califf, M.D., to lead the U.S. Food and Drug Administration (FDA). He’s no stranger to the agency. Dr. Califf served a brief stint as FDA’s commissioner of food and...more
As part of a federal funding bill, language giving the Food and Drug Administration authority over synthetic nicotine, and any other nicotine that is not derived from tobacco, was passed by Congress on March 11. President...more
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
Introduction -
Although marijuana legalization continues to be a hot topic in the new year, it is noteworthy that the federally legal hemp industry continues to develop across the country. New York, one of the nation’s...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
The term tetrahydrocannabinol (THC) is most often associated with the delta-9 THC cannabinoid, which is one of over 100 cannabinoids found in both high-THC marijuana and low-THC hemp. Delta-9 THC is also the cannabinoid most...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 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
On December 22, 2020, we blogged about the omnibus 2021 Consolidated Appropriations Act passed by Congress, which included legislation extending the applicability of the Prevent All Cigarette Trafficking (“PACT”) Act to...more
Did the FDA violate the Constitution when it issued its rule Deeming Tobacco Products to Be Subject to the Federal Food, Drug, & Cosmetic Act, 81 Fed. Reg. 28,973 (May 10, 2016) (the “Deeming Rule”)? No, according to a recent...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