Newsweek recently reported that the FDA is concerned about unregulated chemicals entering vaping devices. Some producers have been using nicotine analogs to side-step nicotine analogs flavor bans and burdensome Premarket Tobacco Product Applications requirements. Using compounds like 6-methyl nicotine is an attempt by producers to avoid the red tape and get their products on the shelf.
The problem with these chemical analogs is that their effect on the body is unknown. Much of the preliminary research suggests that nicotine analogs are not only more potent but “more toxic” than standard nicotine, leading health officials to worry about the effect on adolescent brain development.
The irony is that the FDA is to blame for this potential threat to public health. The FDA must have amnesia and forgot the synthetic marijuana crisis of the 2010s, a direct byproduct of marijuana prohibition. The emergence of potentially dangerous vapes is because the FDA fails to realize that restrictions don’t curb demand, make drugs stronger, and expose consumers to more harmful products.
Flavored e-cigarettes are here to stay. Even post-flavor ban, 77.3 percent of vapers report using flavored e-cigarettes. As we have seen with alcohol prohibition and the war on drugs, product legality does not curb demand.
Vaping devices are practically unique because they are addictive and cannot be substituted for by other cessation methods. E-cigarettes contain nicotine because it is an addictive substance, and it is very demand inelastic. Regardless of the price, if there are producers, people will keep vaping.
E-cigarettes are nearly impossible to replace because no other method of quitting simulates the sensation of smoking the way vaping does. For many vapers, flavored e-cigarettes are the only effective method of quitting tobacco.
The Premarket Tobacco Product Applications process for electronic nicotine devices has done little to diminish the supply of flavored vapes. Manufacturers may comply with the FDA’s lethargic approval process, but foreign makers like Elfbar have filled the void. Elfbar was one of the most popular e-cigarette brands in 2023. In response, many advocates have called for stricter enforcement of electronic nicotine device regulations to slow the tide of foreign-made flavored vapes.
The use of compounds like 6-methyl nicotine is an attempt to stay one step ahead of the FDA. The 6-methyl nicotine is unregulated by the agency. Further attempts to regulate e-cigarettes will devolve into a game of whack-a-mole. As we learned with cannabinoids a decade ago, ban one compound, another other will be synthesized. The FDA will be languishing to keep up with the proliferation of molecularly altered nicotine variants.
While the FDA might fret about the effect of nicotine on kids, no one has considered what would replace nicotine vapes in the event of bans or stringent regulations. The Iron Law of Prohibition sheds light on the emergence of nicotine analogs in e-cigarettes: “the harder the law enforcement, the harder the drug.”
As restrictions on e-cigarettes become more stringent, the potency of e-cigarettes will increase. For this reason, economist Mark Thronton has found that prohibition “undermines” its objectives by introducing users to more potent and potentially harmful substances.
The more potent e-cigarettes tend to be flavored disposable devices made in China. It is more cost-effective to send over fewer ocean containers with stronger vaping cartridges to avoid U.S. Customs and Border Protection. The possibility of detection comes into focus after a “three-day joint operation” confiscated 1.4 million units/$18 million’ worth of unauthorized e-cigarettes.
Nicotine analogs might be out of the FDA’s clutches for now, but using chemicals like 6-methyl nicotine not only circumvents nicotine restrictions but anticipates future regulations. It has been found in rodent studies “far more potent than nicotine in targeting the brain’s nicotine receptors.” If the FDA gains authority over 6-methyl nicotine, it would be more efficient to ship than even the most potent nicotine devices. An additional consideration is the addiction potential. The higher strength could make it a lucrative product for export.
The use of nicotine analogs in vaping products is still a new phenomenon. The one e-cigarette sold in the United States that contains 6-methyl nicotine, Spree Bar, wasn’t on shop shelves until October 2023.
The effects of nicotine are much more thoroughly researched than the chemical analogs that have recently made their way into e-cigarettes. The effect of these chemicals on e-cigarette users is relatively unknown. Vapers desiring fruit-flavored e-juice are opting to be human guinea pigs.
Paralleling the emergence of synthetic cannabinoids, producers exploit a loophole and provide marijuana enthusiasts with a legal alternative. Little was known about the effects when cannabis analogs were sold commercially. After several notable instances, it was clear that synthetic weed was more dangerous.
Consumers experienced adverse effects because of the restrictions on recreational marijuana. There has been a 37 percent decrease in the number of poisonings from synthetic cannabis in states where marijuana is legal. Prohibition makes people more apt to experiment with potentially more harmful alternatives.
The 6-methyl nicotine has the potential to be the next synthetic marijuana. The preliminary research on new nicotine analogs might be scant but hints at these chemicals being more harmful than nicotine.
In terms of lethality, 6-methyl nicotine is “ 50 percent lethal dose for 6-methyl nicotine is at least 1.5–3 fold lower than for nicotine, suggesting that 6-methyl nicotine is more toxic than nicotine.” Rat studies have found the compound to have a five times greater psychoactive effect on behavior. These chemicals could lead to a more pronounced effect on the mental health of users beyond addiction.
The FDA’s Premarket Tobacco Product Applications are tempting e-cigarette manufacturers and vapers to play with fire. Potentially dangerous nicotine analogs wouldn’t even be on the table if premarket approval was more friendly toward flavored products.
The hubris of public health officials is disturbing. Even when faced with restrictions, people are not going to stop vaping. They will look for the next best alternative. Unfortunately, this new trend will be the vaping equivalent of under-researched research chemicals. Prohibition never works. And it will not work for mango-peach vaping cartridges.