The FDA warns that nicotine-like chemicals in vapes may be more powerful than nicotine

• Nicotine alternatives such as 6-methyl nicotine in vapes may be more addictive than nicotine, according to the FDA.
• These synthetics are not covered by U.S. tobacco and vaping laws that control traditional nicotine.
• Traditional nicotine is extracted from tobacco leaves, while 6-methylnicotine is synthesized in laboratories using chemicals.

Nicotine alternatives used in vapes marketed in the U.S. and abroad, such as 6-methyl nicotine, may be more powerful and addictive than nicotine itself, although the scientific data remains incomplete, according to the U.S. Food and Drug Administration. Drug Administration (FDA) and independent researchers.

The synthetic substances – which have a chemical structure similar to nicotine – are not covered by US tobacco and vaping regulations designed to control traditional nicotine, a highly addictive drug.

That means manufacturers in the United States can sell vapors containing synthetic nicotine analogs such as 6-methylnicotine without seeking FDA approval – a process that can be costly and time-consuming and is often unsuccessful.

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Major tobacco companies such as Altria Group and British American Tobacco have already lost significant sales in the US due to an influx of disposable vapes containing traditional nicotine that are being illegally sold without FDA approval.

Altria, the maker of Marlboro cigarettes in the United States, highlighted the emerging use of 6-methylnicotine in vaping and other smoking alternatives in a May 9 letter to the FDA, according to a copy of the correspondence on its website.

It urged the agency to evaluate the compounds and determine what authority it had over them, warning that they posed a “new threat” to the regulation of the sector.

“The introduction and growth of chemicals intended to imitate the effects of nicotine, if left unchecked, could pose unknown risks to American consumers and undermine the FDA's authority,” the letter said.

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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 companies.

In response to Reuters' questions about 6-methylnicotine and other nicotine alternatives, the FDA said in a statement: “While more research is needed, some emerging data show that these nicotine analogues may be more potent than nicotine – which is already very addictive can alter adolescent brain development and have long-term effects on young people's attention, learning and memory.”

Traditional nicotine found in many vapes and pouches is extracted from tobacco leaves. 6-methylnicotine, on the other hand, is made entirely in the laboratory using chemicals.

The FDA said it is considering the use of such synthetic compounds from an “agency-wide perspective” and would use all its resources to protect young people from products that could harm their health. In addition to 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 are in the process of assessing the available data to inform potential actions in this area,” it said in response to Reuters questions.

Three academic researchers told the news agency that current studies on 6-methylnicotine are too limited to draw definitive conclusions about its health effects or to what extent it is addictive.

Imad Damaj, a professor of pharmacology and toxicology at Virginia Commonwealth University, said his research showed that 6-methyl-nicotine may be more powerful than nicotine, but more extensive testing was needed to say what impact it has on people.

Limitations of existing research include that some papers were funded by industry, while others focused on short-term effects on animals or cells and were insufficient to understand 6-methylnicotine's effects on the human body, the researchers said.

Charlie's Holdings calls the 6-methyl nicotine solution used in SPREE BAR Metatine. SPREE BAR's website says Metatine “may have a toxicity profile similar to nicotine.”

SPREE BAR promises users 6,000 puffs from each device and offers fruity flavors including “blue razz ice” and “creamy melon,” according to its website.

The FDA has yet to approve any flavored vape that uses traditional nicotine for sale in the United States, saying companies have not been able to demonstrate that the health benefits they provide smokers outweigh the known risks for young people, who may be more attracted feel the flavors.

Charlie's Holdings co-founder Ryan Stump told Reuters the company was targeting adults only, adding that flavors played an important role in its mission to help smokers quit smoking.

Stump said Charlie's Holdings respects and complies with the laws in every market in which it operates. He acknowledged that more research is needed on 6-methylnicotine, adding that the company dilutes it in its products.

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Anes Saleh sells SPREE BAR at his vape shop in Denver, Colorado called Sultan Smoke. He said he has some customers who only buy Spree Bar instead of a nicotine vape and that he has not had any negative feedback on the product.

“The only protest I would hear if people don't want to try this is that they don't know what Metatin is or does,” he said.

Stump said Charlie's Holdings is working on new variants of SPREE BAR and new products that use 6-methyl nicotine. This year SPREE BAR will be launched internationally. He declined to say where.

The company purchases the 6-methyl nicotine solution used in SPREE BAR from another U.S. company, Novel Compounds, said Samuel Benaim, founder of Novel Compounds.

Novel Compounds imports 6-methyl nicotine from abroad and alters it to make it easier for manufacturers like Charlie's Holdings to use it in their products. She sells this solution under the trade name imotine.

Tests commissioned by Novel Compounds showed that 6-methyl-nicotine was no more harmful than nicotine, Benaim said. But he also said more research was needed on the chemical.

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. The company is committed to regulatory compliance, he said.

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Sven Jordt, a professor at Duke University who has written articles about products like SPREE BAR, said that for me, 6-methylnicotine could be more addictive and toxic than its traditional cousin.

“Do we want such a chemical available to everyone as a recreational product?” he asked. “That's really questionable.”

Neither Jordt nor Damaj – the professor at Virginia Commonwealth University – have received funding from tobacco or vaping companies.

In addition to the United States, Novel Compounds also sells its 6-methyl nicotine solution worldwide, including in the United Kingdom, Indonesia, India and Japan.

Another company, Aroma King, sells 6-methylnicotine in the United Kingdom in sachets, which users place under the lip to get a buzz. The bags are sold in cans decorated with images of gorillas in suits and sunglasses.

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In a February blog post, the company said its 6-methyl nicotine products were “less toxic,” “less harmful” and “less addictive” than regular nicotine products.

In a statement to Reuters, Aroma King cited existing research, its own toxicology and other tests and its supplier, which classifies 6-methylnicotine as less toxic under the European Union's Classification, Labeling and Packaging of Substances and Mixtures (CLP).

Aroma King said 6-methylnicotine was self-classified by its supplier. It declined to say who supplies the chemical to the company.

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 investigating 6-methylnicotine, but did not answer further questions, including whether it has sold 6-methylnicotine to date. Reuters could not find the contact details of the other companies.