What is synthetic nicotine, and can it save vaping?

In a recent survey conducted by the tobacco harm reduction research firm Pinney Associates, an astounding 52.9 percent of Americans wrongly believe that nicotine causes cancer.  In a similar study released September 1 by scientists from Rutgers University, a whooping 77.2 percent of cancer doctors (oncologists) have the same misconception. 

The scientific community has known for decades that the tar produced in combustible cigarette smoke is the true cause of cardiovascular, respiratory, and carcinogenic disease.  The thick, gooey substance clogs the arteries, the lungs, and airways which increases the risks of stroke, heart attacks, bronchitis, emphysema, and chronic obstructive pulmonary disease (COPD).  Furthermore, several hundred of the thousands of chemicals used in combustible tobacco cigarettes manufacturing are documented cancer-causing agents.   

In short, it’s not the nicotine that kills smokers.  It’s the tar. 

What is synthetic nicotine?

As far back as 2016, a company named Next Generation has been experimenting with the fabrication of an artificially produced nicotine product which could revolutionize the vaping industry.    Currently, most e-liquids contain nicotine solutions derived from the tobacco plant, which allows the U.S. Food and Drug Administration (FDA) to classify nicotine-based vapes as “tobacco products” per the deeming regulations of 2016. 

Related Article:   Rutgers survey: 77% of doctors mistakenly believe nicotine (not smoking) causes cancer

Synthetic nicotine, however, is made in a lab.  No tobacco leaves are involved.  This tobacco-free product lacks the impurities of conventional nicotine solutions while possessing the same biological properties of the tobacco-derived varieties.   The result is a cleaner, more flavorful vaping experience made from a synthetic nicotine that is both odorless and tasteless.

What is the FDA’s regulatory view on synthetic nicotine?

The Governor of California, Gavin Newsom, recently signed into law a new bill passed by both houses of the state congress which will ban the sales of all favored vapor products statewide effective January 1, 2021.  Other states are attempting to follow suit by implementing vaping bans of their own.   As more and more anti-vaping legislation is enacted at the local, state, and federal levels, can a transition to synthetic nicotine help save vaping from complete annihilation?

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On a section of the FDA website entitled Commonly Asked Questions: About the Center for Tobacco Products, the FDA provides a rather obscure answer to this very question.

“Q: The product I manufacture contains no substance made or derived from tobacco, e.g. is zero-nicotine, or has synthetic nicotine or nicotine made from tomatoes. Is my product subject to FDA regulation?”

“A: The definition of “tobacco product” includes any product made or derived from tobacco, including any component, part, or accessory of a tobacco product. E-liquids that do not contain nicotine or other substances made or derived from tobacco may still be components or parts and, therefore, subject to FDA’s tobacco control authorities.

However, it’s possible that a disposable, closed system device that contains an e-liquid with truly zero nicotine (or synthetic nicotine) would not be regulated by the FDA as a tobacco product, if it is not intended or reasonably be expected to be used in such a fashion. FDA intends to make these determinations on a case-by-case basis, based on a totality of the circumstances.”  

The second paragraph is perhaps the most noteworthy.   At first glance, the FDA seems to suggest that the agency’s current view is that the FDA should not be involved with the regulation of tobaccoless nicotine.  But in the same sentence, they acknowledge that they reserve the right to change their mind in the future, “on a case-by-case basis.”

Related Article:   HHS Sec. Alex Azar opens legal loophole to challenge FDA deeming regulations on vapes

There are other issues to consider before the American vaping industry decides to make the leap into all-synthetic nicotine e-juices.  For example, price is a crucial factor.  Because tobaccoless nicotine is man-made, it costs more to manufacture.  Nevertheless, these additional costs might be significantly reduced if the entire industry made the transition collectively and simultaneously.    

Still, even if every vapor company made the switch at the same time, there is nothing keeping the FDA from changing the rules at any time and without prior notice.  Also, would synthetically-produced vapes still fall under the California ban, for example?  An industrywide transition to synthetic nicotine will likely need to be worked out in advance through the courts. 

Related Article:   Absence of carbon monoxide makes e-cigs ‘substantially less harmful’ than smoking, says study

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