FDA

Subscribe to FDA

On January 2, 2020, the FDA issued guidance concerning its enforcement priorities for electronic nicotine delivery systems (“ENDS”) and other deemed products on the market lacking premarket authorization (the “Guidance”). Just over a month later, the Comptroller of the State of Maryland has announced that the State will increase its enforcement against certain flavored ENDS products. The State purports to shore up a “loophole” in the FDA’s Guidance.
Continue Reading After FDA Guidance, Maryland Increases Enforcement Against Flavored Cartridge-Based and Disposable ENDS

Earlier last week, a US District Court ruled that the Food and Drug Administration’s subjecting of premium cigars to warnings requirements was arbitrary and capricious in violation of the Administrative Procedure Act (“APA”), insofar as the agency failed to provide a reasoned explanation for this action. The court thus declared unlawful (and vacated) the portion of the FDA’s so-called “Deeming Rule” mandating that premium cigars display designated public health warnings on packaging and advertisements.
Continue Reading US District Court Grants Premium Cigars Relief on Warnings

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

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

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.
Continue Reading Montgomery County, Maryland Takes Judicial and Regulatory Action Against E-Cigarette Manufacturers and Distributors

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.
Continue Reading USDA Issues Interim Final Rule on Hemp

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.
Continue Reading Congress Introduces Legislation to Cap Nicotine Levels in ENDS