Nicotine alternatives used in vapes being launched in the US and abroad, such as 6-methyl nicotine, may be more potent and addictive than nicotine itself, though the scientific data remains incomplete, according to the US Food and Drug Administration (FDA) and independent researchers.
The synthetic substances – which have a chemical structure similar to that of nicotine – are not subject to US tobacco and vaping regulations that are designed to control traditional nicotine, a highly addictive drug.
That means manufacturers can sell vapes containing synthetic nicotine analogues such as 6-methyl nicotine in the US without seeking authorisation from the FDA – a process that can be costly, time-consuming and is often unsuccessful.
Big tobacco firms like Altria Group and British American Tobacco have already lost substantial US sales to an influx of disposable vapes containing traditional nicotine that are being illegally sold without FDA authorisation.
Altria, the maker of Marlboro cigarettes in the US, highlighted the emerging use of 6-methyl nicotine in vapes and other smoking alternatives in a May 9 letter to the FDA, according to a copy of the correspondence posted on its website.
It urged the agency to evaluate the compounds and establish what authority it had over them, warning they posed a “new threat” to regulation of the sector.
“The introduction and growth of chemicals intended to imitate the effects of nicotine, if left unchecked, could present unknown risks to US consumers and undermine FDA’s authority,” the letter said.
It cited Spree Bar, a vape launched in October by Charlie’s Holdings Inc that uses 6-methyl nicotine.
The FDA does not comment on its correspondence with individual firms.
In response to Reuters’ questions about 6-methyl nicotine and other nicotine alternatives, the FDA said in a statement: “Although more research is needed, some emerging data show these nicotine analogs may be more potent than nicotine – which is already highly addictive, can alter adolescent brain development and have long-term effects on youth’s attention, learning and memory Read More…
