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.
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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.
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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. 
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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.” 
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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.
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On October 16, the Montgomery County Council publicly authorized its lawsuit filed in federal court on October 11, against Juul Labs and Altria Group for alleged violations of Maryland and federal law based on claims of aggressive marketing of e-cigarette products to minors.

Council President Nancy Navarro remarked, “The Council authorizes taking legal action against Juul Labs and Altria Group. This lawsuit supports our ongoing efforts to protect our community members from the public health impacts associated with e-cigarette products and vaping.
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Last week, the United States Department of Agriculture (USDA) issued its interim final rule on the establishment of a domestic hemp production program.  It is intended to be effective for two years and then be replaced with a final rule.  The rule outlines provisions for USDA to approve plans submitted by States and Native American tribes for the US domestic production of hemp.
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On October 7, 2019, Illinois Congressman Raja Krishnamoorthi introduced the “Ending Nicotine Dependence from Electronic Nicotine Delivery Systems Act of 2019” (or “END ENDS Act”), which was referred to the House Committee on Energy and Commerce. According to the bill, the Act would “amend the Federal Food, Drug, and Cosmetic Act to establish a tobacco product standard prohibiting any e-liquid with a concentration of nicotine higher than 20 milligrams per milliliter” in an attempt to reduce adolescent use of ENDS.
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In a Vapor Voice article entitled “All Hands On Deck”, Timothy Donahue sifts through the information regarding the premarket tobacco review process as it pertains to the vapor industry. Donahue’s article condenses the key factors of what could be an overwhelming process for many vapor companies. As Donahue notes, “the clock just started ticking a lot faster” for vapor companies who plan to submit PMTAs, due to a court-ruling by a U.S. District Court in Maryland that bumped the original PMTA deadline from August 2022 to May 2020.
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On September 20, 2019, the Food and Drug Administration announced that it will issue a proposed rule governing the process for premarket tobacco applications, including for electronic nicotine delivery systems.  The rule (when finalized) would establish binding procedures for PMTAs, as opposed to the current non-binding procedures reflected in FDA guidance.
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