On January 8, 2020 FDA published its new final compliance policy guidance, Guidance for Industry: Enforcement Priorities for Electronic Nicotine Delivery Systems (ENDS) and Other Deemed Products on the Market Without Premarket Authorization (January 2020), which goes into effect in February. Under the final guidance, beginning February 6, 2020, FDA intends to prioritize enforcement of premarket review requirements for the following products:
- Any flavored, cartridge-based ENDS product (other than a tobacco- or menthol-flavored ENDS product);
- All other ENDS products for which the manufacturer has failed to take (or is failing to take) adequate measures to prevent minors’ access; and
- Any ENDS product that is targeted to minors or likely to promote use of ENDS by minors.
Importantly, FDA also intends to prioritize enforcement of any ENDS product (on the market as of August 8, 2016) that is offered for sale after May 12, 2020, and for which the manufacturer has not submitted a premarket application (or after a negative action by FDA on a timely submitted application). The May 12, 2020 deadline was initially established by a federal district court in Maryland; that decision is now pending appeal in the Fourth Circuit.
While FDA has identified flavored cartridge-based ENDS as a primary concern for underage use, the Agency is also targeting manufacturers that are not adequately preventing minor access, and any products (open or closed system, including e-liquids sold in vape shops) that, in FDA’s view, are targeted to minors or likely to promote ENDS use by minors. FDA’s broad approach could put a significant portion of the vapor industry is at risk of immediate enforcement.
When determining whether a manufacturer is taking or has taken adequate measures to prevent minors’ access to ENDS products, the Agency will consider, for example:
- Whether adequate programs to monitor retailer compliance with age-verification and sales restrictions have been implemented;
- Whether retailers face manufacturer-established penalties for failing to comply with age verification and sales restrictions, and whether there is a policy of notifying FDA of retailer violations;
- If the manufacturer is also a retailer, whether there is an implementation of programs to ensure age-verification and sales restrictions, checking ID at the door, etc.;
- Whether the manufacturer uses adequate age-verification technology or requires that retailers use such technology to prevent minor access to its website and underage internet sales; and
- Whether a manufacturer limits or requires retailers to limit the quantity of ENDS products that a customer may purchase in a given period of time.
When determining whether an ENDS product is targeted to minors or is marketed in a manner that is likely to promote ENDS use by minors, the Agency will consider, for example:
- Whether the labeling and/or advertising of a product resembles kid-friendly foods and drinks or resemble other non-ENDS products that are appealing to youth. Here FDA highlights the numerous warning letters issued to e-liquid manufacturers over the last couple of years. Those warning letters alleged that the e-liquid products were misbranded because the labeling and/or advertising of the products (i.e., color schemes, label images, brand names, etc.) inappropriately imitated specific food products that are generally marketed toward and/or appealing to children, including cereals (e.g., Cinnamon Toast Crunch, Lucky Charms, Fruit Loops, Franken Berry), candies and snacks (e.g., Life Savers, Sour Patch Kids, Gummy Worms, War Heads, Pocky Sticks, Goobers, Tree Top Apple Juice), and desserts (e.g., Unicorn Cakes, Nilla Wafers, Reddi Wip).
- Whether marketing materials utilize youth appealing cartoon or animated characters, or use popular children’s characters and titles.
- Whether paid social media influencers are used; and
- Whether a product is promoted for being easily concealable (from parents and teachers). In this regard, FDA makes clear in the guidance that the following types of devices and device features present a unique concern for youth, even if adults may prefer these as well:
- Small size that allows for easy concealability and features that facilitate the ease of use (draw activation, prefilled cartridges or pods, and USB rechargeability);
- Small size that allow for use in school, quick concealment, product use in a social setting without others’ awareness, and products’ ability to be concealed with other equipment;
- Products with no settings to change and very little assembly required; and
- Products with features such as pre-filled cartridges, draw activated batteries, and that can be recharged via a USB ports, charging adapters or cell phone.
In short, while FDA’s focus is on the flavored cartridge and pod-systems, ENDS companies should be aware that FDA’s guidance is broad enough to capture a wide variety of open and closed-system products that may be viewed by FDA as accessible to kids, marketed to kids or easily used and/or concealed by kids.