Two days after the FDA Premarket Tobacco Application submission deadline, a major Chinese e-liquid manufacturer has announced the worldwide release of a line of synthetic nicotine products. It appears Hangsen Technology will sell the products in the United States, possibly setting up a challenge to the FDA’s Deeming Rule.
Shenzhen, China-based Hangsen, which has been selling e-liquid since 2009, will launch its SYN NIcotine e-liquid line in a prefilled, disposable vaping device made by Geek Vape. According to the company, the Geek Bar will launch in North America soon.
“SYN Nicotine is devoid of many of the harmful impurities that tobacco-derived nicotine contains and is an ideal alternative for manufacturers who may not wish to use pure nicotine derived from tobacco,” Hangsen’s executive director said in a statement.
The Hangsen product isn’t the first synthetic nicotine on the market. Other companies produce nicotine that isn’t extracted from tobacco plants, and several e-liquid companies have used it commercially. However, the sale of a sealed device filled with synthetic nic raises especially interesting legal questions.
The Tobacco Control Act gives the FDA regulatory authority over products containing “nicotine made or derived from tobacco.” The FDA claims authority over open-system (refillable) vaping products, because they can be filled with tobacco-derived nicotine, which the agency claims make them components or parts of a tobacco product.
It is questionable whether the Deeming Rule covers a sealed product containing nicotine that isn’t derived from tobacco. Because it isn’t intended to be modified to refill with tobacco-derived nicotine, and because synthetic nicotine isn’t regulated by the Tobacco Control Act, the FDA could probably be challenged successfully in court if the agency tried to enforce against a manufacturer.
Although the FDA may not currently have regulatory authority over synthetic nicotine, there is an active bill in the Senate (which already passed the House) that orders the FDA to regulate synthetic nicotine. If the bill passes, or if the FDA chooses to regulate synthetic nic on its own, the substance could be regulated as a drug rather than a tobacco product—a far more expensive and exacting process than tobacco regulation. Or Congress could alter the Tobacco Control Act to include nicotine from any source.
California vaping advocate Stefan Didak points out that legislative language varies between states. Even if the FDA can’t claim regulatory authority over synthetic nicotine, individual states can include it in their own tobacco laws, and may already have.
Hangsen Technology is a division of Hong Kong-based Hangsen Holding Co., Ltd. The company has manufactured e-liquid from facilities around the world since 2009.
