FDA Denies PMTAs for 22 SMOK Devices, Pods and Coils

The FDA today took a major step toward banning open-system vaping hardware sold without e-liquid. Open-system products are refillable, allowing consumers to use them with bottled e-liquid from any manufacturer—including e-liquid that contains no nicotine, or non-nicotine ingredients like CBD.

The FDA issued marketing denial orders (MDOs) for six SMOK-brand vaping devices, and 14 pods and replacement coils used in the prohibited devices. These are the devices:

·SMOK Nfix
·SMOK Nord 2

After receiving a marketing denial order, the product is barred from U.S. sale or distribution, and the manufacturer is subject to FDA enforcement actions if the order is violated. Several dozen vape manufacturers have challenged MDOs in U.S. federal courts, in many cases receiving stays allowing products to remain on store shelves.

The MDOs were issued to Shenzhen IVPS Technology Co., Ltd., based in Shenzhen, China. IVPS owns the SMOK brand, one of the oldest and most recognizable names in the Chinese vaping industry.

FDA says batteries and metal coils are tobacco products
The 2016 Deeming Rule, in which the FDA granted itself regulatory authority over vaping products, defines most vaping hardware as “components and parts of a tobacco product,” which means manufacturers must justify the products’ existence to the agency before they can be sold—even if they contain no nicotine or e-liquid.

Until now, the FDA has ignored premarket tobacco applications (PMTAs) from standalone hardware manufacturers, instead focusing on prefilled devices (including disposables) usually sold in convenience stores and gas stations.

Today’s decision is a clear indication the agency intends to pursue products popular only in the vape shop/online segment of the market, which caters to consumers of open-system hardware products and bottled e-liquids.

FDA misquotes its own survey results to justify banning SMOK products
The agency’s justification for the action is twofold: First, the products can be used with any e-liquid, including “unauthorized” products. The agency has authorized no vaping products in non-tobacco flavors, and no bottled e-liquids in any flavor. Second, the agency says a large number of youth use the denied SMOK products.

For these reasons, according to an FDA press release, the agency has “determined that the applications lacked sufficient evidence to demonstrate that permitting marketing of the products would be appropriate for the protection of the public health.”

In its press release, the FDA claims that teenagers taking the National Youth Tobacco Survey frequently cited SMOK as the brand they prefer. The FDA said SMOK was “the sixth most commonly reported brand among current youth e-cigarette users, with 11.3% of middle and high school students reporting past 30-day use of SMOK products.”

However, the agency misquoted the NYTS results. It was 11.3 percent of students who vaped that named SMOK—not 11.3 percent of all students. Fewer than one percent of all surveyed students named SMOK.

The American Vapor Manufacturers Association (AVM) announced it had formally requested that the FDA recall the press release or issue a correction.