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On October 27, FDA issued a new draft guidance, entitled “Tobacco Products:  Principles for Designing and Conducting Tobacco Product Perception and Intention Studies.”  The draft guidance describes the FDA Center for Tobacco Products’ proposed recommendations on designing and conducting tobacco product perception and intention studies (TPPI).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Continue Reading FDA Releases Draft Guidance on the Design and Conduct of Tobacco Product and Intention Studies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

Relying on the regulatory and legal uncertainty surrounding cannabidiol (CBD), Food and Drug Administration statements and state laws, several class actions have been filed since late 2019 against companies selling CBD products, a number of which have been filed in California federal courts. In at least two cases, courts have adopted defendants’ requests to delay the cases while the FDA continues to study CBD and how it should be federally regulated. These cases could represent a developing “wait and see” approach by federal courts dealing with CBD class action lawsuits.
Continue Reading Federal Courts May Be Trending Toward Delaying CBD Consumer Class Action Lawsuits

Following up the R.J. Reynolds-led challenge to FDA’s updated graphic warning label rule, which was filed in the federal court for the Eastern District of Texas, Philip Morris USA Inc. (“Philip Morris”) filed a second, similar challenge on May 6, 2020, in the U.S. District Court for the District of Columbia, Philip Morris USA Inc., et al., v. U.S. Food and Drug Administration, et al., (No. 1:20-cv-01181).

Philip Morris’ complaint makes many of the same challenges seen in the industry’s 2011 challenge to the previous iteration of the graphic warning rule and alleges that the graphic warning label rule violates the First Amendment for multiple reasons.
Continue Reading Philip Morris USA Leads Second Lawsuit Challenging FDA’s Updated Graphic Warning Label Rule

In a May 21, 2020 Vapor Voice article, the Troutman Sanders Tobacco Team discuss the FDA’s enforcement actions against manufacturers and retailers whose electronic nicotine delivery system (ENDS) products and “other components” allegedly target youth. Having targeted flavored e-liquid products, ENDS items that resemble food and ENDS products that resemble devices such as gaming

In recent weeks the U.S. Food and Drug Administration and the Federal Trade Commission have teamed up to prevent companies from advertising and selling products that claim to treat COVID-19. The agencies have specifically targeted companies selling cannabidiol (CBD) products such as Nova Botanix LTD, CBD Online Store, Indigo Naturals, and Native Roots Hemp.
Continue Reading FDA and FTC Target CBD Companies Over COVID-19 Claims

Late yesterday, April 22, 2020, the U.S. District Court for the District of Maryland issued its long-awaited Order formally extending the May 12, 2020 deadline for submitting marketing applications for those deemed “new tobacco products” that were on the U.S. market on August 8, 2016.  That deadline is now September 9, 2020.

Please let us