‘Nicotine-like chemicals in US vapes may be more potent than nicotine’

LONDON: 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.

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That means manufacturers can sell vapes containing synthetic nicotine analogues such as 6-methyl nicotine in the United States 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 United States, 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.”

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Traditional nicotine found in many vapes and pouches is extracted from tobacco leaves. 6-methyl nicotine, in contrast, is made entirely in the lab using chemicals.

The FDA said it was considering the use of such synthetic compounds from an “agency-wide perspective” and would use all of its resources to protect youth from products that may harm their health. As well as tobacco products, the FDA also regulates drugs, foods, cosmetics and more to ensure safety and efficacy.

“The FDA is a data-driven agency, and we’re in the process of reviewing the available data to inform potential actions in this space,” it said in response to Reuters’ questions.