Health
FDA warns that nicotine-like chemicals in vapes may be more potent than nicotine
- Nicotine alternatives like 6-methyl nicotine in vapes may be more addictive than nicotine, according to the FDA.
- These synthetic substances are not regulated by U.S. tobacco and vaping laws that control traditional nicotine.
- Traditional nicotine is derived from tobacco leaves, while 6-methyl nicotine is synthesized in labs using chemicals.
Nicotine alternatives used in vapes being launched in the U.S. 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 U.S. 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 U.S. 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 United States without seeking authorization from the FDA – a process that can be costly, time-consuming and is often unsuccessful.
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Big tobacco firms like Altria Group and British American Tobacco have already lost substantial U.S. sales to an influx of disposable vapes containing traditional nicotine that are being illegally sold without FDA authorization.
Various vapes, nicotine products and the new Spree Bar, which contains a chemical that mimics nicotine, line the shelves at Sultans’ Smoke in Arvada, Colorado, on May 21, 2024. (REUTERS/Kevin Mohatt/ File Photo)
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 U.S. consumers and undermine 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 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.”
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.
Three academic researchers told the news agency 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.
Imad Damaj, a professor in the Department of Pharmacology and Toxicology at Virginia Commonwealth University, said his research showed 6-methyl nicotine may be more potent than nicotine, but more extensive tests were needed to say what impact it has on humans.
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 6-methyl nicotine’s effects on human bodies, 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 using traditional nicotine for sale in the United States, 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 flavors.
Charlie’s Holdings co-founder Ryan Stump told Reuters that the company only targets adults, adding that flavors played an important role in its mission to help smokers quit cigarettes.
Stump said Charlie’s Holdings respects and abides by laws in every market where it operates. He acknowledged that more research is needed on 6-methyl nicotine, adding that the company dilutes it in its products.
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Anes Saleh sells SPREE BAR in 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 he hasn’t had any negative feedback on the product.
“The only… protest I would hear about people not wanting to try this is that they don’t know what Metatine is or does,” he said.
Stump said that Charlie’s Holdings is working on new varieties of SPREE BAR and new products using 6-methyl nicotine. It will launch SPREE BAR internationally this year. He declined to say where.
The company buys the 6-methyl nicotine solution used in SPREE BAR from another U.S. firm, Novel Compounds, according to Novel Compounds’ founder Samuel Benaim.
Novel Compounds imports 6-methyl nicotine from overseas and alters it to make it easier for manufacturers like Charlie’s Holdings to use in their products. It sells this solution under the trade name imotine.
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 into 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 legal compliance, he said.
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Sven Jordt, a professor at Duke University, who has authored papers on products like SPREE BAR, said 6-methyl nicotine could me more addictive and toxic than its traditional cousin.
“Do we want to have such a chemical as a recreational product, available to anyone?,” he asked. “That’s really questionable.”
Neither Jordt nor Damaj – the professor at Virginia Commonwealth University – have received funding from tobacco or vape makers.
As well as the United States, Novel Compounds also sells its 6-methyl nicotine solution around the world, including in the United Kingdom, Indonesia, India and Japan.
Another company, Aroma King, sells 6-methyl nicotine in the United Kingdom in pouches, which users insert under the lip to get a buzz. The pouches are sold in cans emblazoned with graphics of gorillas in suits and sunglasses.
It said in a February blog post that 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-methyl nicotine as less toxic under the European Union’s Classification, Labelling and Packaging of Substances and Mixtures (CLP) Regulation.
Aroma King said 6-methyl nicotine was self-classified by its supplier. It declined to say who supplies it with the chemical.
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. Reuters was unable to find contact details for the other firms.
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A new study suggests that middle-aged men may be more vulnerable to faster biological aging, potentially linked to exposure to “forever chemicals.”
The research, published in the journal Frontiers in Aging, examined how perfluoroalkyl and polyfluoroalkyl substances, more commonly known as PFAS, could impact aging at the cellular level.
PFAS are synthetic chemicals commonly used in nonstick cookware, food packaging, water-resistant fabrics and other consumer products, the study noted.
Their chemical structure makes them highly resistant to breaking down, allowing them to accumulate in water, soil and the human body.
Chinese researchers analyzed blood samples from 326 adults enrolled in the U.S. National Health and Nutrition Examination Survey between 1999 and 2000.
A new study suggests that middle-aged men could face accelerated biological aging at the cellular level due to exposure to PFAS. (iStock)
The researchers measured levels of 11 PFAS compounds in participants’ blood and used DNA-based “epigenetic clocks” — tools that analyze chemical changes to DNA to estimate biological age — to determine how quickly their bodies were aging at the cellular level, the study stated.
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Two compounds, perfluorononanoic acid (PFNA) and perfluorooctanesulfonamide (PFOSA), were detected in 95% of participants.
Higher concentrations of those chemicals were associated with faster biological aging in men of certain age groups, but not in women.
“People should not panic.”
The compounds most strongly linked to accelerated aging were not the PFAS chemicals that typically receive the most public attention, the researchers noted.
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“The associations were strongest in adults aged 50 to 64, particularly in men,” Dr. Xiangwei Li, professor at Shanghai Jiao Tong University School of Medicine and the study’s corresponding author, told Fox News Digital.
“While this does not establish that PFAS cause aging, it suggests that these widely present ‘forever chemicals’ may be linked to molecular changes related to long-term health and aging.”
The study found that two of the compounds were detected in 95% of participants, and higher levels were linked to faster biological aging in men ages 50–64. (iStock)
Midlife may represent a more sensitive biological period, when the body becomes more vulnerable to age-related stressors, according to the researchers.
Lifestyle factors, such as smoking, may influence biological aging markers, potentially increasing vulnerability to environmental pollutants.
While Li said “people should not panic,” she does recommend looking for reasonable ways to reduce exposure.
That might mean checking local drinking water reports, using certified water filters designed to reduce PFAS, and limiting the use of stain- or grease-resistant products when alternatives are available.
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Meaningful reductions in PFAS exposure will likely depend on broader regulatory action and environmental cleanup efforts, Li added.
The researchers noted that midlife could be a particularly sensitive stage, when the body is more susceptible to stressors associated with aging. (iStock)
Study limitations
The researchers outlined several important limitations of the research, including that the findings show an association, but do not prove that PFAS directly causes accelerated aging.
“The study is cross-sectional, meaning exposure and aging markers were measured at the same time, so we cannot determine causality,” Li told Fox News Digital.
The study was also relatively small, limited to 326 adults age 50 or older, which means the findings may not apply to younger people or broader populations.
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Researchers measured PFAS levels using data collected between 1999 and 2000, and today’s exposure patterns may differ.
Li added that while PFAS is known to persist in the environment and the body, these results should be validated through larger, more recent studies that follow participants over time.
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A drug that has long been used to treat seizures has shown promise as a potential means of Alzheimer’s prevention, a new study suggests.
The anti-seizure medication, levetiracetam, was first approved by the FDA in November 1999 under the brand name Keppra as a therapy for partial-onset seizures in adults. The approval has since expanded to include children and other types of seizures.
Northwestern University researchers recently found that levetiracetam prevented the formation of toxic amyloid beta peptides, which are small protein fragments in the brain that are commonly seen in Alzheimer’s patients.
The medication was found to prevent the formation of amyloid-beta 42 in both animal models and cultured human neurons, according to the study findings, which were published in Science Translational Medicine.
The effect was also seen in post-mortem human brain tissue obtained from individuals with Down syndrome, who are at high risk for Alzheimer’s disease.
The medication was found to prevent the formation of amyloid-beta 42 in both animal models and cultured human neurons. (iStock)
“While many of the Alzheimer’s drugs currently on the market, such as lecanemab and donanemab, are approved to clear existing amyloid plaques, we’ve identified this mechanism that prevents the production of the amyloid‑beta 42 peptides and amyloid plaques,” said corresponding author Jeffrey Savas, associate professor of behavioral neurology at Northwestern University Feinberg School of Medicine, in a press release.
“Our new results uncovered new biology while also opening doors for new drug targets.”
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The brain is better able to avoid the pathway that produces toxic amyloid‑beta 42 proteins in younger years, but the aging process gradually weakens that ability, Savas noted.
“This is not a statement of disease; this is just a part of aging. But in brains developing Alzheimer’s, too many neurons go astray, and that’s when you get amyloid-beta 42 production,” he said.
The effect was also seen in post-mortem human brain tissue obtained from individuals with Down syndrome, who are at high risk for Alzheimer’s disease. (iStock)
That then leads to tau (“tangles”) — abnormal clumps of protein inside brain neurons — which can kill brain cells, trigger neuroinflammation and lead to dementia.
In order for levetiracetam to function as an Alzheimer’s blocker, high-risk patients would have to start taking it “very, very early,” Savas said — up to 20 years before elevated amyloid-beta 42 levels would be detected.
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“You couldn’t take this when you already have dementia, because the brain has already undergone a number of irreversible changes and a lot of cell death,” the researcher noted.
The researchers also did a deep dive into previous human clinical data to determine whether Alzheimer’s patients who were taking the anti-seizure drug had slower cognitive decline. They reported that the patients in that category had a “significant delay” in the span from cognitive decline to death compared to those not taking the drug.
“This analysis supports the positive effect of levetiracetam to slow the progression of Alzheimer’s pathology,” the researcher said. (iStock)
“Although the magnitude of change was small (on the scale of a few years), this analysis supports the positive effect of levetiracetam to slow the progression of Alzheimer’s pathology,” Savas said.
Looking ahead, the research team aims to find people who have genetic forms of Alzheimer’s to participate in testing, Savas said.
Limitations and caveats
The study had several limitations, including that it relied on animal models and cultured cells, with no human trials conducted.
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Because the study was observational in nature, it can’t prove that the medication caused the prevention of the toxic brain proteins, the researchers acknowledged.
Savas noted that levetiracetam “is not perfect,” cautioning that it breaks down in the body very quickly.
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The team is currently working to create a “better version” that would last longer in the body and “better target the mechanism that prevents the production of the plaques.”
“You couldn’t take this when you already have dementia, because the brain has already undergone a number of irreversible changes and a lot of cell death.”
The medication’s common documented side effects include drowsiness, weakness, dizziness, irritability, headache, loss of appetite and nasal congestion.
It has also been linked to potential mood and behavior changes, including anxiety, depression, agitation and aggression, according to the prescribing information. In rare cases, it could lead to severe allergic reactions, skin reactions, blood disorders and suicidal ideation.
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Funding for the study was provided by the National Institutes of Health and the Cure Alzheimer’s Fund.
Fox News Digital reached out to the drug manufacturer and the researchers for comment.
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