On Friday, November 13, 2020, a federal district court entered a preliminary injunction against the City of Philadelphia’s Ordinance 180457, which purported to ban the sale of flavored tobacco products, with minor exceptions. As in all cases where a preliminary injunction is entered, the court found that the Plaintiffs demonstrated a likelihood of success on the merits and would be irreparably harmed absent an injunction, and that the balance of the equities and the public interest weighed in favor of an injunction. Continue Reading Federal Court Enjoins City of Philadelphia Ban on Flavored Tobacco Products
On October 27, FDA issued a new draft guidance, entitled “Tobacco Products: Principles for Designing and Conducting Tobacco Product Perception and Intention Studies.” The draft guidance describes the FDA Center for Tobacco Products’ proposed recommendations on designing and conducting tobacco product perception and intention studies (TPPI).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 Continue Reading FDA Releases Draft Guidance on the Design and Conduct of Tobacco Product and Intention Studies
Bryan Haynes of the Troutman Pepper Tobacco Team presented at the Food and Drug Law Institute Tobacco and Nicotine Products Regulation and Policy Conference on October 23, 2020.
Bryan participated in a panel discussion entitled “The Post-PMTA Deadline Landscape: What Happens After September 9th?” The panelists discussed enforcement, compliance and the review of FDA requests for marketing authorization for “deemed” tobacco products submitted prior to September 9, 2020. Bryan discussed his experience with PMTAs, substantial equivalence reports and requests for exemption from substantial experience for deemed tobacco products, including electronic nicotine delivery systems (ENDS), cigars, pipe tobacco and waterpipe tobacco, including FDA’s progress thus far and looming enforcement issues.
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 this space. There are many legal issues facing online retailers, like bans or restrictions on “flavored” tobacco products, minimum age and age-verification requirements, and state and local licensing and tax requirements.
In an October 22, 2020 Vapor Voice article, the Troutman Pepper Tobacco Team discuss some of the key legal issues associated with selling ENDS to consumers online and highlight proposed state legislation that may impose more requirements on the industry
Plaintiffs have appealed to the Eighth and Ninth Circuits, challenging flavored tobacco bans in Los Angeles County, California, and the City of Edina, Minnesota. The cases could have implications for similar laws in other States and localities.
Has Congress preempted local authority to ban the sale of flavored tobacco products? Two different U.S. Courts of Appeals will have the opportunity to answer the question in R.J. Reynolds Tobacco Co., et al. v. City of Edina, et al., No. 20-2852 (8th Cir.), and R.J. Reynolds Tobacco Co., et al. v. Los Angeles County, et al., No. 20-55930 (9th Cir.). Continue Reading Two U.S. Courts of Appeals to Consider Federal Preemption of Local Flavor Bans
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 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