Independent researchers as well as the FDA have sounded the alarm over nicotine alternatives used in vapes being launched in the US and abroad, saying 6-methyl nicotine may be more potent and addictive than nicotine itself.
The synthetic substances, which have a chemical structure similar to nicotine, are not subject to American tobacco and vaping regulations, reports Reuters.
That means manufacturers can sell vapes containing synthetic nicotine analogues like 6-methyl nicotine without getting authorisation from the FDA – often a costly, time-consuming and often unsuccessful process.
Big tobacco firms like Altria Group and British American Tobacco have already lost substantial US sales to an influx of the disposable vapes containing traditional nicotine that are being illegally sold without authorisation.
In a letter to the FDA, Altria highlighted the emerging use of 6-methyl nicotine in vapes and other smoking alternatives, urging the agency to evaluate the compounds and establish what authority it had over them. It also warned that they posed a “new threat” to regulation of the sector.
It specifically cited SPREE BAR, a vape launched in October by Charlie’s Holdings Inc that uses 6-methyl nicotine.
In response to Reuters’ questions, the FDA said: “Although more research is needed, some emerging data show these nicotine analogues 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.”
Traditional nicotine found in many vapes and pouches is extracted from tobacco leaves. In contrast, 6-methyl nicotine is made entirely in the lab, using chemicals.
The FDA said it was considering, from an “agency-wide perspective”, the use of synthetic compounds.
Academic researchers told Reuters that current studies of 6-methyl nicotine are too limited to draw definite conclusions on the health impact or to what degree it is addictive, with Imad Damaj, a professor in the Department of Pharmacology and Toxicology at Virginia Commonwealth University, saying that although his research showed 6-methyl nicotine may be more potent than nicotine, more extensive tests were needed.
The limitations of existing research included that some papers were industry-funded, while others focused on the short-term impact on animals or cells and were insufficient to understand its effects on human bodies, the researchers said.
Charlie’s Holdings calls the 6-methyl nicotine solution – used in its 6 000-puff SPREE BAR – Metatine.
SPREE BAR’s website says Metatine “may have a toxicity profile similar to nicotine”, with the company’s co-founder Ryan Stump acknowledging that more research is needed. He said the company dilutes the solution in its products, which are available in various flavours.
The FDA has yet to approve the sale of any flavoured vape using traditional nicotine in the US, saying companies have not been able to show that the health benefits they offer to smokers outweigh the known risks to young people, who may be more attracted by the flavours.
Stump told Reuters that the company only targets adults, adding that flavours played an important role in its mission to help smokers quit cigarettes.
The company buys the 6-methyl nicotine solution used in SPREE BAR from another US firm called Novel Compounds.
Novel Compounds’ founder Samuel Benaim said he imports 6-methyl nicotine from overseas and alters it to make it easier for manufacturers like Charlie’s Holdings to use in their products.
Tests commissioned by Novel Compounds have found 6-methyl nicotine to be no more harmful than nicotine, Benaim said. But he also said that more research was needed.
Benaim added that Novel Compounds had received legal advice that its product is not classified as a tobacco product or drug in the United States.
As well as in the US, Novel Compounds also sells its 6-methyl nicotine solution around the world, including to the UK, Indonesia, India and Japan.
Four Chinese companies hold patents in China related to the production of 6-methyl nicotine, including Zinwi Biotech, a company that makes the liquid used in vapes.
Zinwi Biotech confirmed it is researching 6-methyl nicotine but did not answer further questions, including on whether it has sold any 6-methyl nicotine so far.
See more from MedicalBrief archives:
Ban flavoured vapes, says EU as as e-cigarette use rises
Illegal vapes packed with unsafe lead, nickel levels, laboratory tests find
Best-selling vape stripped from UK shelves over illegal nicotine levels