On May 11, RJ Reynolds Tobacco Company, along with two convenience stores and the American Petroleum and Convenience Store Association, sued the California attorney general and district attorney for Fresno County in their official capacities, seeking declaratory relief that these California officials misinterpreted and misapplied California’s ban on flavored tobacco products and incorrectly concluded that
Michael Jordan is an associate in Troutman Pepper's Richmond office. Michael draws on a diverse range of experiences in government and private practice to help clients navigate complex regulatory issues. He focuses primarily on heavily regulated industries, such as tobacco and cannabis.
Inside FDA’s Response to Reagan-Udall Foundation Report: Spotlight on the Science and Application Review Task Force
This is the second post in our multipart series evaluating the Food and Drug Administration’s response to the Regan-Udall Foundation report on the operations of the Center for Tobacco Products. If you missed our first post, check it out here.
There is a common refrain that appears throughout the Reagan-Udall Foundation report on the Center for Tobacco Products (CTP) at the Food and Drug Administration (FDA) — lack of transparency. The report found that stakeholders generally perceived premarket tobacco product applications (PMTAs) — required for all electronic nicotine delivery systems (ENDS) on the market — as “ineffective and problematic” due in part to a “lack of adequate guidance and transparency regarding CTP expectations,” as well as a “lack of clarity regarding review standards.”…
Continue Reading Inside FDA’s Response to Reagan-Udall Foundation Report: Spotlight on the Science and Application Review Task Force
FDA Won’t Use Its Existing Authority to Regulate CBD After All
On January 26, the Food and Drug Administration essentially threw up its hands and announced that Congress needs to create a new regulatory pathway for cannabidiol (CBD) products because the existing pathways are inadequate to mitigate possible health risks. The agency simultaneously denied three long-pending requests to allow marketing of CBD products as dietary supplements.
Federal Judge Finds NY Cannabis Residency Rules Likely Unconstitutional and Discriminatory Against Out-of-State Applicants
On November 3, Judge Gary L. Sharpe of the U.S. District Court for the Northern District of New York issued a preliminary injunction, blocking cannabis regulators from issuing marijuana retail licenses for five geographic regions across the state, while a constitutional challenge to the program proceeds.
Continue Reading Federal Judge Finds NY Cannabis Residency Rules Likely Unconstitutional and Discriminatory Against Out-of-State Applicants
FDA Hires Cannabis Policy Expert: Is a New CBD Regulatory Framework Around the Corner?
FDA has hired Norman Birenbaum, an experienced cannabis policy expert, as a senior public health advisor at the Center for Drug Evaluation and Research (CDER). The move signals the agency may soon develop a regulatory framework for cannabis-derived products, including cannabidiol (CBD) products — something that CBD stakeholders have been anxiously awaiting.
Prior to joining…
Cannabis Residency Rules Toppling? First Circuit Is the First Domino to Fall
Certain states where cannabis (or marijuana) is legal have long been getting away with a practice that has been declared unconstitutional in almost all other contexts: giving their residents preferential treatment over nonresidents when issuing permits to operate a cannabis business. Earlier this year, we wrote about the widespread use of residency rules in the…
Industry Comments Loom Large in DC Court, Finding FDA Regulation of Premium Cigars “Arbitrary and Capricious”
On July 5, the U.S. District Court for the District of Columbia ruled that the decision of the Food and Drug Administration (FDA) to “deem” premium cigars subject to the same federal law as other tobacco products like cigarettes was “arbitrary and capricious.” In reaching this conclusion, Judge Amit Mehta relied heavily on industry comments…
Bipartisan Coalition of 31 State AGs Urge FDA to Deny Marketing Authorization for Non-Tobacco Nicotine Products
On June 10, a bipartisan coalition of 31 state attorneys general, led by Idaho, Illinois, Nebraska, and Pennsylvania, sent a letter to Food and Drug Administration (FDA) Commissioner Dr. Robert M. Califf, asking the agency to reject premarket tobacco product applications (PMTAs) for all products that contain nicotine not derived from tobacco, also known as…
Delta-8 THC Products to Remain on Virginia Store Shelves, for Now
On April 27, the Virginia Senate voted to send SB 591, which would have effectively eliminated the delta-8 tetrahydrocannabinol (THC) product market in Virginia, back to committee, killing the bill for this year’s legislative session. The move allows Virginia retailers to continue marketing the products for now despite growing calls nationwide for more regulation…
Dr. Califf Takes the Reins at FDA: Five Takeaways for the Tobacco Industry
On February 15, the Senate confirmed cardiologist Robert M. Califf, M.D., to lead the U.S. Food and Drug Administration (FDA). He’s no stranger to the agency. Dr. Califf served a brief stint as FDA’s commissioner of food and drugs from February 2016 to January 2017, and before that, he was deputy commissioner for medical products…