The Food and Drug Administration (FDA) in the United States has made a decision that will result in many electronic cigarette and e-liquid products becoming illegal to sell there. Manufacturers and retailers are up in arms, almost all ecig users are angry, but it appears as though a loophole may be exploited: enter ‘synthetic nicotine’.
All products must submit a Premarket Tobacco Application (PMTA) to the FDA so they can be sold. The FDA has not granted permission to one product – and it appears that no flavoured e-liquid will obtain certification. A possible loophole exists because the FDA regulates “tobacco products”. In America, vape devices and juices were placed under that heading because the eliquid is made using nicotine derived from tobacco leaves. This means the law does not apply to any product using nicotine that does not originate from the tobacco plant.
Hundreds of thousands of jobs and thousands of businesses are set to go because of the FDA’s actions. This is a last role of the dice to keep the independent vape market functioning, preserve jobs, and help smokers switch to a product that is at least 95% less harmful than smoking.
Synthetic nicotine is the same as nicotine from a tobacco plant except it has been produced in a laboratory using chemicals. Initially, scientists were unable to guarantee the purity of the synthetic nicotine made in laboratories, but some companies (including a major supplier of pharmaceutical grade nicotine) have recently filed patents to synthesise pure S-nicotine to add to electronic cigarettes.
As Dr Sven-Eric Jordt wrote in a recent paper, with its purity now assured, synthetic nicotine can be considered the same as tobacco-derived nicotine.
The FDA Centre for Drug Evaluation and Research has tried to regulate synthetic nicotine twice before – and failed. The judges told them they could only regulate this new product if manufacturers made claims about health. The alternative is that the FDA attempts to change classifications and regulates nicotine as a drug, but this is a difficult step for them as the FDA took a beating in courtwhen they tried to ban imports and remain exceptionally nervous about creating a case that would set a precedent.
While the UK has no pressing need for synthetic nicotine products, companies who are manufacturing for European or worldwide distribution may already be considering the shift. The European Commission is looking likely to define vape devices and e-liquids as tobacco products in the next version of their Tobacco Products Directive. This, combined with a press to restrict the range of flavours available, may temp some manufacturers to attempt to circumvent the law as they did when they brought out shortfills following the limit placed on e-liquid bottle size. The UK remains one of the most forward thinking of places when it comes to vaping, relying on high quality independent research. Whatever happens in the future, we can be assured that reliable, independent British academics will study it extensively.