In 2016, the Food and Drug Administration (FDA) assumed the authority to regulate all nicotine‐containing products, including electronic nicotine delivery systems, such as e‑cigarettes. E‑cigarette manufacturers were given until September 9, 2020, to submit applications to the FDA for the agency to approve the marketing of their products. The agency received nearly seven million applications by the deadline and is still reviewing many of them. It has rejected more than a million flavored vape applications.
However, non‐nicotine synthetics that have chemical structures resembling nicotine are exempt from FDA regulation. Thus, people who wish to consume relatively harmless nicotine because they value its stimulative and calming effects can work around government obstructions by accessing nicotine‐analog products. The government does not require makers of synthetic nicotine analogs to obtain FDA approval before they can market them to consumers. And consumers are purchasing these products.
According to a letter to FDA Commissioner Robert Califf, MD, from Altria LLC, a nicotine product manufacturer that has complied with FDA regulations, several companies, including many in other countries, are marketing nicotine analogs to consumers. The letter states, “The introduction and growth of chemicals intended to imitate the effects of nicotine, if left unchecked, could present unknown risks to U.S. consumers and undermine FDA’s authority,” urging the FDA to “carefully and quickly evaluate these new compounds to determine what regulatory authority it has over these products.”
Now comes a report by the Reuters news agency stating that the FDA and independent researchers believe that many of these analogs, such as 6‑methyl nicotine, might be “more potent and addictive” than nicotine.
This is another example of the “iron law of prohibition”—the harder the law enforcement, the harder the drug—in action. In this case, the government, largely driven by nicotinophobia, is prohibiting the manufacture and sale of numerous nicotine products, many of which have helped smokers quit the habit.
Prohibition resulted in drug trafficking organizations moving from diverted prescription pain pills to heroin, from heroin to fentanyl, from fentanyl to fentanyl mixed with xylazine, and now from that to fentanyl mixed with medetomidine and nitazenes.
Rinse and repeat.
We are now seeing the same process at work with nicotine. Nicotine prohibition begets more potent forms of nicotine, and new opportunities appear to be on the horizon for the prohibition/law enforcement complex.