News & Analysis as of

Regulatory Oversight Tobacco Tobacco Regulations

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FDA Proposes Submission Tracking Number Requirement for ENDS Imports

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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

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PACT Act Basics: Five Things You Should Do if ATF Comes Knocking

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“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

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FDA’s Center for Tobacco Products Publishes Strategic Plan

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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

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FDA Maintains Heightened Enforcement Against Sellers of Illegal E-Cigarettes

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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

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ENDS Companies Take Legal Action Against Allegedly Noncompliant Competitors

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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

Burr & Forman

Cigarette “Buydown” Payments to Retailers Excluded from South Carolina Sales Taxes

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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

Patrick Malone & Associates P.C. | DC Injury...

Trump administration now seeks to vaporize vaping, banning candy flavorings

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

Patrick Malone & Associates P.C. | DC Injury...

Did FDA just let Big Tobacco put another burn on Americans’ health?

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

Mitchell, Williams, Selig, Gates & Woodyard,...

FDA Gives Certain Electronic Cigarette Manufacturers 60 Days to Address Youth Vaping

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

McDermott Will & Emery

FDA Clarifies “Intended Use” for Drugs, Devices, and Tobacco Products

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

Stinson LLP

FDA Regulation of E-Cigarettes: The What, When, and Warnings

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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

Latham & Watkins LLP

FDA to Regulate E-Cigarettes, Cigars and Other Tobacco Products

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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

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