On Thursday, July 30, 2020, Democratic Senator Tina Smith (D-MN) filed a new bill to federally legalize marijuana. The bill, titled the “Substance Regulation and Safety Act,” would “decriminalize and deschedule cannabis” and provide for its regulation by removing both marijuana and tetrahydrocannabinols from the Controlled Substance Act and giving the Food and Drug Administration the authority to regulate cannabis products in the same manner, and to the same extent, as FDA regulates tobacco products. Continue Reading Minnesota Senator Pushes to Decriminalize and Deschedule Cannabis
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Administration (FDA) issued “Cannabis and Cannabis-Derived Compounds: Quality Considerations for Clinical Research, Draft Guidance for Industry.” While it contains little “new news,” the draft guidance describes FDA’s current thinking on several topics relevant to clinical research related to development of drugs containing cannabis or cannabis-derived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 The draft guidance also introduces key FDA regulatory concepts to stakeholders who may be less familiar with the FDA and the FDA’s authorities. Continue Reading FDA Issues Draft Guidance for Clinical Research Regarding Cannabis and Cannabis-Derivatives
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. Continue Reading Is L.A. County’s Flavored Tobacco Ban Unlawful?
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 controllers, FDA is now looking at gear that arguably can fly under parents’ and teachers’ radars.
Troutman Sanders will continue to monitor developments in this ever-changing arena.
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 commerce in the wake of Wayfair. While the Wayfair case involved a sales and use tax and is of interest to interstate sellers across industries, it may be of additional interest to interstate sellers of tobacco products – who may find themselves newly subjected to other states’ tobacco excise taxes. (Five ways South Dakota v. Wayfair affects interstate sellers.)
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 Troutman Sanders Tobacco Team will participate in the May 28, 2020 panel entitled “Regulatory & Legislative Issues: 2020 & Beyond.”
You can sign up for the conference here.
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.
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