Now that the FDA's PMTA deadline has passed, vapor businesses which could not afford to submit an application are looking for any loophole in the regulations that could allow them to stay in business.
Many companies came up with the idea of simply selling bottles of flavoring mixed with vegetable glycerin or propylene glycol with the intent that customers add nicotine themselves at home. That was a no go. The FDA, likely in anticipation of this ploy since it is widely used in the UK to get around vape regulations there, specifically wrote the regulations to preclude this practice. The FDA gave itself regulatory authority over all “components and parts” of e-liquid, which cleverly includes bottles of flavoring meant to be mixed with nicotine at home as they are a "part" of an e-liquid.
However, one idea seems to be on solid regulatory ground: synthetic nicotine. The FDA has defined nicotine as any nicotine "made or derived from tobacco," which leaves any nicotine not derived from the tobacco plant in the clear.
As it turns out, the tobacco plant isn't the only source of nicotine in the plant kingdom. Potatoes, tomatoes and eggplant, for example, all contain some amount of the addictive chemical. However, the amount is extremely small. A 1993 study found that you'd have to chow down on 22 pounds of eggplant to ingest the nicotine equivalent of just one tobacco cigarette. That makes extracting nicotine from common veggies to use in e-juice formulation far too expensive.
However, there is another option. Nicotine can also be assembled in a laboratory and that's where synthetic nicotine comes in.
A number of U.S. based companies are already manufacturing vape juice using synthetic nicotine and Hangsen Technology, a large Chinese based e-liquid manufacturer, has announced the introduction of its SYN NIcotine line. Hangsen Technology claimed it has “no intention or motivation to circumvent relevant FDA laws and regulations” but it’s difficult to take that statement seriously.
Despite Hangsen Technology’s protests to the contrary, the motivation is certainly there. FDA regulation has put a freeze on the introduction of new flavors to the vape marketplace and any company that did not submit a Premarket Tobacco Product Application to the FDA by the September 9th, 2020 deadline cannot legally sell vape juice in the United States. Circumventing the FDA regulations clearly comes with considerable marketplace advantages.
One disadvantage of synthetic nicotine, however, is the price tag. Synthetic nicotine costs significantly more than nicotine derived from the tobacco plant so expect to see higher prices from companies using this workaround.
Moreover, don’t expect this loophole to last very long. One bill, HR2339, has already passed Congress and would require the FDA to regulate synthetic nicotine (this nasty bill would also ban e-juice flavors and put an end to online vape sales). In addition, individual states can quickly move to close this backdoor and some of them already have.
Bottom line, using synthetic nicotine currently allows companies to skirt FDA’s regulatory authority but don’t expect this party to last very long. More regulations are on the horizon and they will almost certainly shut down the synthetic nicotine loophole in short order.
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