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FDA Issues Guidance Document with Enforcement Policy Regarding Flavored E-Cigarettes, Flavored Cigars and Hookah Tobacco

The following is an update from the National Association of Tobacco Outlets (NATO) sourced through their January 2nd online bulletin. Reposted with permission.

Today, the FDA issued a Final Guidance Document titled “Electronic Nicotine Delivery Systems (ENDS) and Other Deemed Products on the Market Without Premarket Authorization.”  This Final Guidance Document is the FDA’s current thinking on the topic of enforcing the Family Smoking Prevention and Tobacco Control Act (the law that authorizes the FDA to regulate tobacco products) and does not establish legally enforceable responsibilities.  However, the Final Guidance Document describes the enforcement policy that the FDA will take relative to certain flavored e-cigarettes, flavored cigars, and flavored hookah tobacco.

Background:  The Family Smoking Prevention and Tobacco Control Act provides that tobacco products which came on the market after February 15, 2007 must obtain a premarket authorization order from the FDA in order to be legally sold.  Those tobacco products that were on the market as of February 15, 2007 and are still on the market are “grandfathered” and are not required to go through the FDA’s premarket authorization application process.  According to the FDA, this means that those products which were introduced on the market after February 15, 2007 that have not yet received a premarket authorization order from the FDA are essentially illegally marketed tobacco products.  Based on a recent court ruling, manufacturers that make tobacco products which are not grandfathered must file premarket authorization applications with the FDA by May 12, 2020.  If such an application is not filed by May 12, 2020, then the manufacturer of that product and the product itself is subject to enforcement action by the FDA.

What the Final Guidance Document Does:  The main provisions of the Final Guidance Document are as follows:

  • The Final Guidance Document would take effect thirty days after the Final Guidance document is published in the Federal Register.  The Final Guidance document should be published in the Federal Register in the next day or two.  NATO will inform members of the exact date that the Final Guidance Document will take effect.
  • The FDA will prioritize enforcement against those companies that manufacture, distribute or sell flavored cartridge-based electronic nicotine delivery products (except tobacco-flavored, menthol-flavored and non-flavored cartridge-based electronic nicotine delivery products) that have not received a premarket authorization order from the FDA.  This includes prioritized enforcement action against retailers.  FDA enforcement actions can include issuing a warning letter, issuing an import alert and refusing admission of tobacco products imported or offered for import into the United States, initiating seizure or injunction court actions, and criminally prosecuting persons engaging in illicit trade in tobacco products.
  • “Cartridge-based” electronic nicotine delivery products are defined by the FDA as consisting of “a cartridge or pod that holds liquid that is to be aerosolized through product use” and “a cartridge or pod is any small, enclosed unit (sealed or unsealed) designed to fit within or operate as part of an electronic nicotine delivery system.”  An example of an electronic nicotine delivery product that is not a “cartridge-based” product and would continue to be legal to sell in any kind of store is a flavored or non-flavored e-cigarette that is a completely self-contained and disposable product.
  • Flavored cartridge-based electronic nicotine delivery products (except tobacco-flavored, menthol flavored, and non-flavored cartridge-based products) would need to be removed from the market, including from retail stores, within 30 days after the Final Guidance Document is published in the Federal Register.  The FDA states in the Final Guidance Document that these products are not being completely banned from the market, but could come back on the market if manufacturers file premarket authorization applications by May 12, 2020 and the FDA subsequently approves the application.
  • The FDA also intends to prioritize enforcement against those cartridge-based products for tobacco-flavored, menthol-flavored, or non-flavored electronic nicotine products and any non-cartridge flavored electronic nicotine products if they lack a premarket authorization order from the FDA and the manufacturer has not taken or is not taking adequate measures to prevent minors’ access to these products, without regard to whether or not, or when, a premarket application for such product has been submitted.
  • The FDA also intends to prioritize enforcement against any electronic nicotine products targeted to, or whose marketing is likely to promote use by, underage persons.  Examples include electronic nicotine products with labeling or advertising that resembles kid-friendly foods and drinks (e.g., juice boxes, candy or kid-friendly cereal), or with youth-appealing cartoon or animated character advertising, or marketed on popular children’s YouTube channels and television shows.
  • The FDA also intends to prioritize enforcement of any electronic nicotine product (either cartridge-based or non-cartridge based product) that is offered for sale after May 12, 2020, and for which the manufacturer has not submitted a premarket authorization application (or after a negative action by FDA on a timely submitted application).
  • The FDA will not at this time take enforcement action against “open system” electronic nicotine products nor small manufacturers such as vape shops that mix e-liquids on-site and primarily sell non-cartridge-based electronic nicotine products, unless they market to youth, fail to take adequate measures to prevent youth access, or do not file a premarket authorization.
  • The Final Guidance Document does not target specific kinds of stores for enforcement action, but rather focuses on specific kinds of electronic nicotine products (i.e., certain flavored cartridge-based electronic nicotine products).
  • The FDA has decided not to prioritize enforcement against flavored cigars and flavored hookah tobacco products before May 12, 2020 because underage use of these tobacco products is significantly lower than cartridge-based electronic nicotine products. However, the FDA reiterates in the Final Guidance Document that flavored cigars and flavored hookah tobacco are required to submit premarket authorization applications to the agency for those products by May 12, 2020.  The FDA acknowledges that there are a number of “grandfathered” flavored cigars that are lawfully marketed and would remain available to consumers regardless of FDA’s enforcement of premarket authorization requirements.