By Troutman Pepper Tobacco Practice, Bryan Haynes, Agustin Rodriguez, & Nicholas Ramos on October 22, 2020
Online businesses selling electronic nicotine delivery systems (ENDS) to consumers must contend with a “patchwork quilt” of state laws. This patchwork of laws creates significant regulatory uncertainty and risk for businesses selling online in
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.
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.
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Administration (FDA) issued “Cannabis and Cannabis-Derived Compounds: Quality Considerations for Clinical Research, Draft Guidance for Industry.” While it contains little “new news,” the draft guidance describes FDA’s current thinking on several topics relevant to clinical research related to development of drugs containing cannabis or cannabis-derived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 The draft guidance also introduces key FDA regulatory concepts to stakeholders who may be less familiar with the FDA and the FDA’s authorities.
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.
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