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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Cases of gout are rising in younger individuals, according to a global study.
The condition, which is a type of inflammatory arthritis, steadily increased in people aged 15 to 39 between 1990 and 2021, researchers in China announced.
Although rates vary widely between countries, the total number of young people with the condition is expected to continue rising through 2035.
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The study, published in the journal Joint Bone Spine, investigated 2021 data from the Global Burden of Disease (GBD), spanning 204 countries within the 30-year timeframe.
The data measured gout prevalence, incidence and years lived with disability, tracking global trends over time. The results showed a global increase across all three outcomes.
Gout is expected to continue rising in young people through 2035. (iStock)
Prevalence and disability years increased by 66%, and incidence rose by 62%. In 2021, 15- to 39-year-olds accounted for nearly 14% of new gout cases globally, the study found.
Men from 35 to 39 years old and people in high-income regions had the highest burden, but high-income North America topped the list for highest rates.
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Men were also found to have lived more years with gout due to high BMI, while women tended to have the condition as a link to kidney dysfunction, the study noted.
The total number of cases is expected to increase globally due to population growth, but the study projected that rates per population would decrease.
The researchers noted that data quality, especially in low-income settings, could have posed a limitation to the broad GBD data.
What is gout?
Gout is a common form of arthritis involving sudden and severe attacks of pain, swelling, redness and tenderness in the joints, according to Mayo Clinic. It most often occurs in the big toe.
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The condition occurs when urate crystals accumulate in the joint. These form when there are high levels of uric acid in the blood, which the body produces when it breaks down a natural substance called purines.
A gout flare-up can happen at any time, often at night, causing the affected joint to feel hot, swollen, tender and sensitive to the touch.
Urate crystals, described as sharp and needle-like, build up in the joint, causing intense pain and swelling. (iStock)
Purines can also be found in certain foods, like red meat or organ meats like liver and some seafood, including anchovies, sardines, mussels, scallops, trout and tuna, according to the Mayo Clinic. Alcoholic drinks, especially beer, and drinks sweetened with fruit sugar can also lead to higher uric acid levels.
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Uric acid will typically dissolve in the blood and pass through the kidneys into urine, but when the body produces too much or too little uric acid, it can cause a build-up of urate crystals. These are described by the Mayo Clinic as sharp and needle-like, causing pain, inflammation and swelling in the joint or surrounding tissue.
Risk factors for gout include a diet rich in high-purine foods and being overweight, which causes the body to produce more uric acid and the kidneys to have trouble eliminating it.
Experts urge patients to seek medical attention for gout flare-ups. (iStock)
Certain conditions like untreated high blood pressure, diabetes, obesity, metabolic syndrome and heart and kidney diseases can increase the risk of gout, as well as certain medications.
A family history of gout can also increase risk. Men are more likely to develop the condition, as women tend to have lower uric acid levels, although symptoms generally develop after menopause.
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Untreated gout can cause worsening pain and joint damage, experts caution. It may also lead to more severe conditions, such as recurrent gout, advanced gout and kidney stones.
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The Mayo Clinic advises patients to seek immediate medical care if a fever occurs or if a joint becomes hot and inflamed, which is a sign of infection. Certain anti-inflammatory medications can help treat gout flares and complications.
Fox News Digital reached out to the researchers for comment.
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A new study suggests that annual mammograms may not be the only effective approach for preventing breast cancer.
The research, published in the Journal of the American Medical Association (JAMA), tested a risk-based breast cancer screening approach against standard annual mammography.
The WISDOM randomized clinical trial, led by study authors from universities and healthcare systems across the U.S., considered more than 28,000 women aged 40 to 74 years old, splitting them into a risk-based screening group and an annual mammography group.
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Researchers calculated each woman’s individual risk based on genetics (sequencing of nine breast cancer genes) and other health factors.
A new study suggests that annual mammograms may not be the only effective approach for preventing breast cancer. (iStock)
Those who were at the highest risk were advised to alternate between a mammogram and an MRI scan every six months. Patients with elevated risk were told to get an annual mammography and counseling.
Average-risk women were guided to get mammograms every two years, while low-risk individuals were advised to have no screening until they became higher risk or reached age 50.
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The researchers found that risk-based screening did not lead to more advanced cancer diagnoses (stage 2B or higher) compared with annual screening, indicating that it is just as safe as traditional methods. The risk-based approach, however, did not reduce the number of biopsies overall, as researchers had hoped.
Among the risk-based group of women, those with higher risk had more screening, biopsies and detected cancers. Women at lower risk had fewer procedures.
The research, published in the Journal of the American Medical Association (JAMA), tested a risk-based breast cancer screening approach against standard annual mammography. (iStock)
“[The] findings suggest that risk-based breast cancer screening is a safe alternative to annual screening for women aged 40 to 74 years,” the researchers noted in the research summary. “Screening intensity matched individual risk, potentially reducing unnecessary imaging.”
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Fox News medical contributor Dr. Nicole Saphier, associate professor of radiology at Memorial Sloan Kettering Cancer Center in New Jersey, commented that while these findings are important, the study “completely sidelines” what screenings are designed to do — detect cancer early.
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“If you don’t measure stage 0, stage 1 or stage 2A cancers, you can’t tell whether personalized screening delays diagnosis in a way that matters for survival and treatment intensity,” Saphier, who was not involved in the study, told Fox News Digital in an interview.
Those who were at the highest risk were advised to alternate between a mammogram and an MRI scan every six months. (iStock)
More than 60% of breast cancers in the U.S. are diagnosed at stage 1 or 2A, where cure rates exceed 90%, the doctor noted.
The trial doesn’t “fully evaluate” whether risk-based screening changes detection at the earliest and most treatable stages, where screening “delivers its greatest benefit,” according to Saphier.
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“Mammography is not without risk — radiation exposure, false positives, anxiety and potential over-diagnosis are real and should be acknowledged,” she said. “But it remains the most effective, evidence-based tool for detecting breast cancer early, when treatment is most successful.”
The expert added that labeling women under 50 as “low risk” is “outdated,” as breast cancer diagnoses are on the rise in younger females.
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“Until long-term mortality data support alternative approaches, annual screening beginning at 40 for average risk women should continue,” Saphier added. “Women should be assessed for breast cancer risk by 25 years old to determine if screening should begin earlier.”
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