2022 Significant Developments in the Tobacco Industry and What to Expect in 2023 (Part Two) - Regulatory Oversight Podcast
In August, the U.S. Food and Drug Administration (FDA) issued a new proposed rule that would require importers of electronic nicotine delivery system (ENDS) products to provide an FDA-issued submission tracking number (STN)...more
“Hi, we’re with the Bureau of Alcohol, Tobacco and Firearms, and we’d like to take a look at your tobacco product sales invoices, shipping records, and PACT Act reports.”...more
The Food and Drug Administration’s Center for Tobacco Products (“CTP”) has released a strategic plan intended to guide the Center’s activity for the next five years. While the strategic plan highlights the laudable goals of...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
Tobacco manufacturers and distributors have long made refund/rebate payments to retailers for the retailer’s purchase of cigarettes and other tobacco products from the manufacturer, provided the retailer reduces the price of...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
After standing to one side while vaping hooked a generation of young Americans on nicotine, the Trump Administration has now abruptly decided to try to vaporize youthful vaping by banning candy-like flavorings favored by...more
Federal regulators appear to be getting caught flat-footed yet again as Big Tobacco’s harms metastasize before their very eyes. The federal Food and Drug Administration has given a qualified go-ahead to Philip Morris...more
On September 12, 2018, Food & Drug Administration Commissioner Scott Gottlieb, M.D., addressed the epidemic of youth e-cigarette use, indicating that the FDA will halt sales of certain flavored e-cigarettes if the major...more
In its Clarification of When Products Made or Derived From Tobacco Are Regulated as Drugs, Devices, or Combination Products; Amendments to Regulations Regarding “Intended Uses” (Final Rule), FDA codifies its long-standing...more
On May 10, 2016, the Food and Drug Administration (FDA) issued a final rule extending its regulation of "tobacco products" to include electronic cigarettes and similar products, sometimes called Electronic Nicotine Delivery...more
Manufacturers and retailers must receive premarket authorization for newly deemed tobacco products and comply with other requirements related to FDA’s long-anticipated deeming rule. On May 10, 2016, the U.S. Food and...more