Recent warning letters demonstrate that the FDA is looking beyond devices when enforcing its rules against youth appeal.
By Bryan Haynes, Agustin E. Rodriguez and Dascher Pasco
On April 27, 2020, the U.S. Food and Drug Administration (FDA) sent warning letters to 10 retailers and manufacturers who “sell, manufacture and/or import unauthorized electronic nicotine delivery system (ENDS) products targeted to youth or likely to promote use by youth.”1 Nine of these warning letters targeted ENDS products such as flavored e-liquids and ENDS designed to look like handheld gaming systems, watches and fidget spinners.
However, one warning letter targeted products “such as a backpack and sweatshirt designed with stealth pockets to hold and conceal an e-cigarette.” In its warning letter to Vaprwear Gear, the FDA asserted authority over Vaprwear’s sweatshirts and backpacks because they were components and parts of tobacco products.
Pursuant to the “Deeming Rule,” published in May of 2016, the FDA has asserted authority over all tobacco products, including ENDS products and their “components and parts.” However, the FDA does not have authority over tobacco products’ “accessories.”2 The practical consequence of the Deeming Rule is that ENDS, and their components and parts, are subject to the tobacco control authorities set forth in the Tobacco Control Act (TCA). This includes premarket authorization requirements, which, when not met, result in deemed new tobacco products being considered adulterated.
Earlier this year, the FDA published guidance clarifying how it intended to prioritize enforcement resources regarding the marketing of certain deemed new tobacco products that do not have premarket authorization. Specifically, the FDA stated it would prioritize enforcement against flavored, cartridge-based ENDS products, as well as ENDS products that were targeted to minors or the marketing of which was likely to promote use of ENDS by minors. The guidance noted that the FDA is particularly concerned with ENDS products with flavors that youth find appealing as well as products with design features that make them more appealing to youth by allowing discreet use, or enabling youth to “use the product in circumstances where the use of tobacco products is prohibited.”3
Given the FDA’s stated priorities, much of what was seen in the April 27 warning letters did not come as a surprise. For example, some of the warning letters targeted e-liquids that the FDA claimed were labeled and/or advertised in a way that resulted in the product resembling “food products that are typically marketed toward and/or appealing to children.”4 Others targeted ENDS products that resembled smartwatches, identified by FDA as a product that is “commonly worn by children” allowing the ENDS product to “be carried and worn without revealing to parents, teachers, or other adults that the product is a tobacco product.”5 As e-liquids and ENDS products, the products targeted in those warning letters are well recognized as regulated products within the FDA’s authority as stated in the Deeming Rule.
Less obvious is the basis of the FDA’s authority to regulate products such as sweatshirts and backpacks as “components and parts” of ENDS. For purposes of the Deeming Rule, components and parts are defined as “any software or assembly of materials intended or reasonably expected: (1) to alter or affect the tobacco product’s performance, composition, constituents or characteristics; or (2) to be used with or for the human consumption of a tobacco product.” In contrast, accessories do not contain tobacco, are not derived from tobacco and do not affect or alter the performance, composition, constituents, or characteristics of a tobacco product.6
The warning letter to Vaprwear states that the Vaprwear Weekend Pullover, Vape-Ready Hoodies and Vaprwear HydroVape, as well as the Vape-Ready Backpacks are all components or parts of tobacco products and, as such, are subject to FDA jurisdiction. While FDA’s regulation of these products initially seems like a startling overreach, upon closer inspection of the products and their marketing it becomes more apparent how FDA claims authority.
Each of these products contains a “hosing system” that can be connected to a pod system and used to deliver vapor to the wearer. For example, the Vape-Ready Hoodies contain a drawstring made from hosing and woven into the hood. One end of the drawstring connects to the device and the other end is used to inhale. The Vaprwear products are largely monochromatic with few or no graphics and contain pockets that allow for storage of the ENDS device while it is being used with the products’ vapor delivery system, allowing for discreet use of ENDS devices in a number of environments.
The hosing system, which is an integral part of Vaprwear’s products, physically connects to the ENDS device and is used to deliver vapor directly to the consumer. This system is identified by Vaprwear as a “vapor delivery system” that “delivers compatibility with the hundreds of vape devices now on the market,”7 and allows the FDA to claim that the products are used for the consumption of a tobacco product and alter or affect the tobacco product’s performance, composition, constituents or characteristics.
There are a couple of takeaways from FDA’s warning letter to Vaprwear. First, the FDA’s decision to target Vaprwear’s sweatshirts and backpacks demonstrates FDA’s view that a product does not have to be a necessary element of an ENDS device, such as an e-liquid or an atomizer, to be considered a component or part within the FDA’s purview. Additionally, the FDA is not only focused on discreet ENDS devices, but on all products that may be appealing to youth because they facilitate discreet use.
In conclusion, the April 27 warning letters highlight the FDA’s continued focus on ENDS marketing. The FDA appears to be keeping up with the ENDS market and its consumers, recognizing and regulating the new ways individuals can easily and discreetly vape. Much of this regulatory energy is focused on retailers.
For example, while some of the companies that received an April 27 warning letter were manufacturers, each of the 10 entities operates as a retailer. Further emphasizing this point, both Wizman Limited, a manufacturer and online retailer, and EighCIt, an online retailer, received warning letters regarding a product manufactured by Wizman Limited.
The bottom line is that the FDA expects retailers to undertake appropriate due diligence with regard to all marketed products. Retailers may ultimately be held responsible by the FDA, whether or not any action is taken against the manufacturer, as the agency continues to focus on the ENDS industry and the potential youth appeal of its products.
Bryan Haynes, a partner with Troutman Sanders, specializes in tobacco industry regulatory compliance and enforcement matters.
Augustin Rodriguez, counsel for Troutman Sanders, provides cross-functional, multidisciplinary counsel to advertising, marketing and consumer goods and services companies.
Dascher Pasco, an associate with Troutman Sanders, specializes in government and regulatory white collar and government investigations and enforcement actions and investigations.
1 FDA, news release, “FDA Warns Manufacturers and Retailers to Remove Certain E-cigarette Products Targeted to Youth from the Market,” April 27, 2020, available at https://bit.ly/2LIenHu.
2 21 CFR § 1100.1.
3 FDA, “Enforcement Priorities for Electronic Nicotine Delivery Systems (ENDS) and Other Deemed Products on the Market Without Premarket Authorization” (Revised), April 2020, available at https://bit.ly/3dYFkTu.
4 FDA, Warning Letter to VapeCentric, MARCS-CMS 607375, April 27, 2020, available at https://bit.ly/36dWGZO (finding the product appeared “very similar to Pocky Strawberry biscuit sticks”) and FDA, Warning Letter to Vape Royalty, MARCS-CMS 606271, April 27, 2020, available at https://bit.ly/3bHKDVX (finding the product appeared “very similar to Sour Patch Kids candy”).
5 FDA, Warning Letter to Vapewear, MARCS-CMS 605196, April 27, 2020, available at https://bit.ly/2XfBs9O and Warning Letter to Shenzhen Uwell Technology Co., Ltd. d/b/a DTD Distribution Inc., April 27, 2020, available at https://bit.ly/2yf7uu8.
6 81 FR 28973 at 28975. The Deeming Rule defines an accessory as “any product that is intended or reasonably expected to be used with or for the human consumption of a tobacco product; does not contain tobacco and is not made or derived from tobacco; and meets either of the following: (1) is not intended or reasonably expected to affect or alter the performance, composition, constituents, or characteristics of a tobacco product or (2) is intended or reasonably expected to affect or maintain the performance, composition, constituents, or characteristics of a tobacco product but (i) solely controls moisture and/or temperature of a stored product or (ii) solely provides an external heat source to initiate but not maintain combustion of a tobacco product.”
7 https://vaprwear.com/, last viewed May 6, 2020.