On January 21, 2020, the U.S. Court of Appeals for the Fourth Circuit issued an order disposing of several motions before it in American Academy of Pediatrics, et al. v. U.S. Food & Drug Administration, et al., Nos. 19-2130, -2132, -2198, -2242. This is an appeal from the U.S. District Court for the District of Maryland, which:

  1. held that the FDA’s August 2017 guidance did not lawfully extend tobacco product compliance deadlines; and
  2. ordered new deadlines of May 12, 2020, for filing applications, and one year after application for approval.

The district court’s rulings amounted to a roughly two-year acceleration of the FDA’s deadlines. Continue Reading Fourth Circuit Expedites Appeal, but District Court’s May 12 FDA Premarket Review Deadline Remains For Now

On January 16, a federal judge in the Eastern District of Kentucky dismissed a case brought by a vapor trade organization and one of its members, leaving in place the court-mandated May 12, 2020 deadline for premarket review submissions for suppliers of “deemed” tobacco products, such as electronic nicotine delivery systems (ENDS), cigars, pipe tobacco and hookah tobacco. Continue Reading Federal Judge Dismisses Kentucky Case Challenging FDA’s May 2020 Deadline

As we previously blogged, FDA announced on December 26th that it is illegal for a retailer to sell any tobacco product – including cigarettes, cigars and e-cigarettes – to anyone under 21.  The announcement drew much criticism because it failed to provide retailers guidance regarding whether FDA would exercise enforcement discretion, even on a shorter time frame, to allow retailers to upgrade systems, replace signage and train personnel.  Continue Reading FDA Clarifies Position on Enforcement of Tobacco 21

In the August 2019 edition of SMOKESHOP Magazine, Troutman Sanders attorneys Robert Claiborne and Bryan Haynes discuss the tobacco regulatory implications of President Trump’s 2017 Executive Order 13771 reducing regulation and adding cost controls. The Office of Management and Budget (OMB) issued guidance surrounding the Order which prompted a lawsuit to be filed in the U.S. District Court in the District of Columbia challenging the Order and the guidance. Some anti-tobacco groups also have entered the case claiming the Order can jeopardize current tobacco regulations which could affect rules regarding modified risk tobacco products, ingredient listings and graphic warnings.

 

Earlier today, FDA issued a 52-page Industry Guidance document announcing that, effective on or around February 1, 2020 (30 days from today), it will “prioritize enforcement action” against (implicitly banning from lawful sale) all “flavored, cartridge-based” ENDS products on the market (other than tobacco- or menthol-flavored ENDS products).  The Guidance defines a cartridge-based product as a product that “consists of, includes, or involves a cartridge or pod that holds liquid that is to be aerosolized through product use,” and defines a “cartridge or pod” as “any small, enclosed unit (sealed or unsealed) designed to fit within or operate as part of an electronic nicotine delivery system.”  Continue Reading FDA issues New ENDS Guidance; Intends to Remove from the Market Flavored, Cartridge-Based ENDS Other than Tobacco – or Menthol-flavored Offerings

FDA announced yesterday via an update to its website that it is now illegal for a retailer to sell any tobacco product – including cigarettes, cigars and e-cigarettes – to anyone under 21.  This announcement (the day after Christmas) follows the signing into law on December 20, 2019 of legislation amending the Federal Food, Drug, and Cosmetic Act to raise the federal minimum age of sale of tobacco products from 18 to 21 years. Continue Reading FDA Alert: Tobacco Age 21 Effective Immediately Per FDA

The federal government currently imposes federal excise taxes on cigarettes, cigars, smokeless tobacco, roll-your-own tobacco and pipe tobacco. Will Congress add a tax on the nicotine used in electronic nicotine delivery systems?

That is the aim of H.R. 4742, introduced by Congressman Tom Suozzi (D-N.Y. 3d Dist.) and co-sponsored by Congressman Pete King (R-N.Y. 2d Dist.). As introduced, H.R. 4742 was titled as a bill “to amend the Internal Revenue Code of 1986 to impose a tax on nicotine used in vaping, etc.” Congressman Suozzi said in support, “Increasing the cost of vaping will have a direct correlation to decreasing the usage of vaping products.” Continue Reading A Federal Tax on Nicotine? Bill in Congress Seen as Way to Tax Vapor Products

In a joint statement, four federal agencies in consultation with state bank regulators clarified that, as a result of the Agriculture Improvement Act of 2018 (2018 Farm Bill), banks are no longer required to file a Suspicious Activity Report (SAR) on customers “solely because they are engaged in the growth or cultivation of hemp.” The guidance was issued by the Board of Governors of the Federal Reserve Board, the Federal Deposit Insurance Corporation, the Financial Crimes Enforcement Network (FinCEN), and the Office of the Comptroller of the Currency in consultation with the Conference of State Bank Supervisors. Continue Reading Inter-agency Guidance Issued on Providing Banking Services to Hemp Producers

On November 27, Massachusetts Governor Charlie Baker signed An Act Modernizing Tobacco Control into law. The new law restricts the sale of e-cigarettes and nicotine vaping products as well as flavored tobacco products.

Specifically, the law immediately restricts all flavored nicotine vaping products to licensed smoking bars where they may only be consumed on-site. Additionally, the law restricts the sale of all vaping products with a nicotine content over 35 milligrams per milliliter to licensed, adult-only retail tobacco stores and smoking bars. Continue Reading Massachusetts Becomes First State to Ban Flavors

With recent headlines focusing on tobacco and electronic nicotine delivery systems, it is no surprise that federal and state legislators are turning their attention toward the industry.  Did you know that Troutman Sanders’ lobbyists can help? Continue Reading As Federal and State Legislators Increase Scrutiny of Tobacco and ENDS Companies, Troutman Sanders Lobbyists Can Help