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Administration (FDA) issued “Cannabis and Cannabis-Derived Compounds: Quality Considerations for Clinical Research, Draft Guidance for Industry.” While it contains little “new news,” the draft guidance describes FDA’s current thinking on several topics relevant to clinical research related to development of drugs containing cannabis or cannabis-derived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 The draft guidance also introduces key FDA regulatory concepts to stakeholders who may be less familiar with the FDA and the FDA’s authorities.

Cases challenging Los Angeles County’s flavored tobacco ban could define the limit of State and local authority in addressing flavored tobacco products and could have implications for similar laws in other States and localities.

Los Angeles County’s flavored tobacco ban is being challenged in two cases: R.J. Reynolds Tobacco Co., et al. v. Los Angeles County, et al., No. 2:20-cv-04880 (C.D. Cal.), and CA Smoke & Vape Association, Inc., et al. v. Los Angeles County, et al., No. 2:20-cv-4065 (C.D. Cal.). Both cases are before the Honorable Dale S. Fischer of the U.S. District Court for the Central District of California.

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.

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.

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…

In a recent article in Bloomberg Tax, Troutman Sanders attorneys Robert Claiborne and Agustin Rodriguez discuss a House subcommittee hearing on the effect of the U.S. Supreme Court’s Wayfair decision on small businesses and whether Congress might try to mitigate the effects of state and local taxation on interstate…

TMA is presenting an unprecedented digital conference addressing the business and policymaking of the tobacco and nicotine industries.  Titled “Unsteady Ground: Shifting Landscapes,” this eight-part series is a must for industry members seeking to stay abreast of recent initiatives and to gain insights on future developments.

Bryan Haynes of the…

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.

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…

On April 9, 2020, RJ Reynolds Tobacco Company and its affiliates (“Reynolds”) filed complaints before the United States International Trade Commission (“ITC”) and the United States District Court for the Eastern District of Virginia seeking to stop Altria Group (“Altria”), Philip Morris International (“PMI”) and certain of their respective affiliates from importing and selling the IQOS heated tobacco device system.  This system is a “heat not burn” device whereby the user inserts a disposable “tobacco stick” into an electronic holder and turns on the device, which then heats the tobacco stick enough to generate an aerosol but not combust the stick.