Nota Bene Episode 71: Shifting Regulatory Landscapes at the FDA: Cannabis, Vaping and Intelligent Medical Devices with Allison Fulton
A court-approved agreement brings welcome certainty for retailers selling vapor and nicotine-pouch products in Alabama—confirming that companies with a standard tobacco license may continue selling FDA-authorized products,...more
Throughout 2024, the U.S. Food and Drug Administration (FDA) endeavored to curb sales of unauthorized electronic nicotine delivery systems (ENDS) in the U.S. In light of persistent demand for flavored ENDS — nearly all of...more
2023 was an exciting year for Section 337 litigation at the ITC, particularly in the final quarter of the year. As we ring in the new year, Wolf Greenfield Shareholder Libbie DiMarco examines five of the most noteworthy ITC...more
In December, the U.S. Food and Drug Administration (FDA) issued warning letters to online retailers for reportedly selling unauthorized e-cigarette products. Consistent with the Center for Tobacco Products’ (CTP) recent...more
Recently, NJOY LLC filed a complaint in the U.S. District Court for the Central District of California against more than 30 foreign and domestic defendants that manufacture, market, distribute, and sell tobacco products in an...more
The Georgia Board of Pharmacy has begun accepting applications from independent, licensed pharmacies for authorization to dispense authorized medical marijuana products, and nearly 120 pharmacies reportedly have agreed to...more
Vape product sellers face a new legal landscape after Congress recently expanded the Prevent All Cigarette Trafficking (“PACT”) Act to cover vaping devices. The amendments to the PACT Act came in the waning days of 2020 as a...more
Manufacturers, distributors, and suppliers of CBD products should embrace and participate in reform to address public health concerns, write Bilzin Sumberg attorneys. Consumer groups like the Arthritis Foundation are stepping...more
The FDA actions that dominated 2019 demonstrated a shifting regulatory landscape for certain product types, such as e-cigarettes, foods and supplements containing cannabidiol (CBD), and digital health / machine learning...more
Tens of millions of Americans may have been startled in recent days by the much-publicized pulling from the shelves of widely used drugs like ranitidine (aka Zantac), an over-the-counter heartburn remedy, and select lots of...more