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

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

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. Once FDA issues proposed tobacco product standards, it will need to go through the notice and comment rulemaking process (and possibly litigation), so it could take several years before FDA implements any new standards.


Continue Reading FDA Proposes to Ban Menthol Cigarettes and Characterizing Flavors in Cigars

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 U.S. market, and (3) were the subject of a request for marketing authorization submitted to FDA by September 9, 2020. The stated intent of the “public list” is to advise stakeholders of “deemed” tobacco products that can be legally sold in the United States.  However, FDA’s approach to the list leaves critical gaps that, in many cases, fails to apprise stakeholders of unlawfully marketed products and, in other cases, fails to identify products that are lawfully marketed.
Continue Reading FDA Publishes “Public List” of Deemed Tobacco Products, But Leaves Critical Flaws in Apprising Stakeholders of Lawfully-Marketed Products

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 the White House and Senate will likely revive the debate around electronic nicotine delivery systems (ENDS) products. For cannabis, the policy may shift toward outright reform (such as federal decriminalization or legalization), federal taxation, or the enactment of legislation beneficial to the cannabis industry.
Continue Reading Tobacco & Cannabis Policy in 2021

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 Products’ proposed recommendations on designing and conducting tobacco product perception and intention studies (TPPI).  Such studies may be submitted as part of FDA tobacco product applications, including modified risk tobacco product (MRTP) applications, premarket tobacco applications (PMTA) and substantial equivalence (SE) reports. 
Continue Reading FDA Releases Draft Guidance on the Design and Conduct of Tobacco Product and Intention Studies

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 cigars” (as defined in the order) until the agency completes a review of the question of “whether a streamlined substantial equivalence process is appropriate for premium cigars.”  The opinion does not throw out the Deeming Rule in its entirety but only remands it to the agency for further consideration of this question.
Continue Reading FDA Premarket Review Process for Premium Cigars Halted

On Tuesday, July 21, 2020, the U.S. Food and Drug Administration (FDA) issued “Cannabis and Cannabis-Derived Compounds: Quality Considerations for Clinical Research, Draft Guidance for Industry.” While it contains little “new news,” the draft guidance describes FDA’s current thinking on several topics relevant to clinical research related to development of drugs containing cannabis or cannabis-derived compounds, including sources of cannabis for clinical research, information on quality considerations and recommendations regarding calculating delta-9 tetrahydrocannabinol (THC) levels. The draft guidance also introduces key FDA regulatory concepts to stakeholders who may be less familiar with the FDA and the FDA’s authorities.
Continue Reading FDA Issues Draft Guidance for Clinical Research Regarding Cannabis and Cannabis-Derivatives