Nicotine alternatives may be more potent than nicotine, US regulator says
Anes Saleh, owner of Sultans' Smoke, takes a package of the Spree Bar, which contains a new chemical that mimics nicotine, from the shelf of his store in Arvada, Colorado, U.S., May 21, 2024. REUTERS/Kevin Mohatt
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.
That means manufacturers can sell vapes containing synthetic nicotine analogues such as 6-methyl nicotine in the US 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 US, 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."
The label on a Spree Bar package provides a brief description of Metatine, a new chemical meant to mimic the effects of nicotine but does not contain nicotine in Denver, Colorado, U.S., May 21, 2024. REUTERS/Kevin Mohatt
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".
Charlie's Holdings co-founder Ryan Stump acknowledged that more research is needed on 6-methyl nicotine, adding that the company dilutes it in its products.
Spree Bar promises users 6,000 puffs from each device and offers fruity flavours including "blue razz ice" and "creamy melon", according to its website.
The FDA has yet to approve any flavoured vape using traditional nicotine for sale 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. He said Charlie's Holdings respects and abides by laws in every market where it operates.
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 US 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 US. The company is committed to legal compliance, he said.
More potent than nicotine?
Sven Jordt, a professor at Duke University, who has authored papers on products like Spree Bar, said 6-methyl nicotine could be 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 US, Novel Compounds also sells its 6-methyl nicotine solution around the world, including in the UK, Indonesia, India and Japan.
Another company, Aroma King, sells 6-methyl nicotine in the UK 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.
Following the initial response condemning the Budget as 'the most damaging for independent retailers in recent memory' from the British Independent Retailers Association (Bira), members have shared their stark reactions to the triple burden of doubled business rates, increased National Insurance, and higher minimum wage costs.
Multiple retailers have calculated specific impacts on their businesses, with costs ranging from £90,000 to £150,000 per year.
"This budget was horrendous for us as a company. Estimated costs to be around £110,000 - £120,000 per year," said Andrew Massey of Masseys DIY in Swadlincote, Derbyshire.
The immediate impact on employment is already evident. Peter Massey of R Massey & Son Ltd, employing 38 staff, said: "We decided last night that we will not replace the next two members of staff that leave. We are also considering what to do with our coffee shop that employs quite a few youngsters."
Kevin Arthur of Pewsey RadioVision in Wiltshire highlighted the broader staffing implications: "The minimum wage rising to £25.5k per year (40hr week) is scandalous. Having to pay this type of salary for your most basic of employees will mean less employees, resentment amongst 'more valuable' staff who believe they are 'worth' far more than a basic employee, and less ability to pay staff bonuses. I am now looking to reduce staff hours, reduce staff numbers, and Christmas bonuses will be curtailed and any other 'perks' reduced."
A store owner in the South West, whose business has traded for over a century, revealed: "Prior to the budget we were looking at taking on a new store and creating 12 new jobs. The colossal impact that Labour has imposed on our business means that not only will this new store not happen, but we will be reviewing our sites and having to make redundancies in order to survive."
William Coe, of Coes in Ipswich, highlighted the challenge facing customer-focused businesses: "We all want the same thing – Growth – however for growth businesses need to make a profit to enable them to invest. With the cost rises put upon them yesterday this gets harder and harder especially for the retail and leisure sectors where the ability to make savings through technology is limited."
John Jones, Managing Partner of Philip Morris Direct in Hereford, warned: "We've been saying for months that the issue for small business is the cumulative effect of so many extra costs. These add up to a level of costs that just aren't sustainable, and I fear there will be a blood bath of small business on the high street."
The impact threatens the very existence of some long-established businesses.
A West Midlands clothing retailer with over 100 years of trading history confirmed they are "closing the doors in the near future," adding that "the cumulative effect of the rate hike, NI increase and the Minimum Living Wage increases mean that already emptying towns will become wastelands."
For smaller independents, the situation is particularly acute. Tracey Clark of Albert's Hardware in Somerset revealed: "I work in excess of 70 hrs a week with little to no personal financial gain. I can't see myself surviving the next six months."
The disparity between high street retailers and online competition was highlighted by several members, with concerns raised about UK-based businesses bearing the cost burden while international competitors selling cheap imported clothing operate with minimal tax liability.
A Greater Manchester fashion retailer emphasised the disconnect between policy makers and small business reality: "They are completely detached from reality. They need someone advising that has lived and breathed a small business. There should at least have been a threshold where businesses below a certain turnover aren't hit by these things."
The impact extends beyond retail to related sectors.
A West Midlands builders' merchant warned of broader economic consequences. The owner said: "The Government has put the boot in to small business. We are paying for everything. Farmers are in real trouble now and the economy will suffer. They went round telling businesses rates were unfair and would sort it out, then just put them up. They lied to us all and now jobs will go and inflation will rise."
Many retailers expressed frustration at what they see as broken promises. A Birmingham-based jewellery store owner said: "High Streets are the cash cow for Governments and when most have disappeared, they will scratch their heads and wonder why."
The combined impact of these measures threatens not just individual businesses but entire local economies. With many retailers already reporting worse trading conditions - Bira's recent survey showed 46% reported worse trading in early 2024 compared to 2023 - these additional costs could prove the final straw for many independent businesses.
Andrew Goodacre, CEO of Bira said: "For some, the Budget has forced immediate operational decisions. Several retailers mentioned reviewing staffing levels, reconsidering expansion plans, and in some cases, accelerating closure plans. The impact on future generations is particularly concerning, with multiple family businesses questioning their long-term viability."
A Midlands hardware store owner summed up the common challenge: "This will make trading near impossible with wage increases and the business rates, and no one wants to pay any more for goods."
Brocks at Rockwell Green, a Premier-branded convenience store near Wellington, Somerset is on the market as owners Simon and Rachel Brock are now looking to retire - after running the store for nearly 25 years.
Selling a wide range of products and everyday essentials, the store is “well-established and popular” among both the local communities.
“It has been a pleasure running the store for the last 23 years and serving the local community. It has been a tough decision to sell but we felt now was the best time to retire,” Simon said.
Specialist business property adviser Christie & Co has been instructed to market the property, which also features a variety of storage spaces, offices and independently accessed three-bedroom accommodation.
Matthew McFarlane, business agent at Christie & Co who is managing the sale, commented: “This is a fabulous store and property, offering a large sales area, great storeroom and residential accommodation. The sales figures are very strong which represents an excellent opportunity for corporate buyers or established multi operators.”
Wrexham Lager Beer Co Ltd, the oldest lager brewery still existing in Britain that has been brewing in Wales since 1882, has announced Rob McElhenney and Ryan Reynolds as new co-owners of the company alongside the Roberts family.
The acquisition was made by Red Dragon Ventures, a joint venture formed by The R.R. McReynolds Company, majority owner of Wrexham AFC, and the Allyn family of Skaneateles, New York. Red Dragon Ventures was created to drive growth in the Wrexham community and Wrexham AFC.
This transaction represents another landmark deal for the Welsh town and will considerably scale up Wrexham Lager’s infrastructure and international production, distribution, and marketing efforts.
“As co-chairmen of Wrexham AFC we have learned a lot,” said Rob McElhenney and Ryan Reynolds. “The connection between club and community, the intricacies of the offsides rule and the occasional need for beer – especially after finance meetings. Wrexham Lager has a 140-year-old recipe and a storied history and we’re excited to help write its next chapter.”
The Roberts family, who have owned and operated the business since 2011, will maintain an active role within the business, continuing to oversee quality control across all markets, local brewery operations, and community engagement projects.
Recently appointed chief executive James Wright will continue to lead the business after already overseeing rapid UK growth, as well as international expansion into Australia, Japan, and Scandinavia. Distribution in the US and Canada is set to go live in the coming months.
“This is a brand with great heritage – the oldest lager brewery in Great Britain, once enjoyed across the world,” Wright said. “So, to have Rob and Ryan onboard as we embark on international expansion is huge for us. They have been doing wonders for the town of Wrexham and strongly share our passion for once again seeing Wrexham Lager enjoyed in all the far-flung corners of the globe.”
Wrexham Lager Beer Co currently produces the 4% ABV Wrexham Lager, 5% ABV Wrexham Lager Export, and recently introduced 4.6% ABV Pilsener. The 4% Wrexham Lager is produced using an original recipe from 140 years ago that was once available in the world-famous Harrods luxury department store in London, as well as chosen as the only lager to be served on the White Star Line’s Titanic.
Ten global beverage companies have joined forces under a new industry-wide consortium, called REfresh Alliance, which is designed to help accelerate renewable energy adoption across the industry’s supply chain.
The new initiative invites additional companies from across the beverage industry to pool and scale their resources to remove barriers to renewable energy adoption in the supply chain, provide education on best market practices and support the industry’s transition to Net Zero.
Companies currently part of the REfresh Alliance include: Bacardi, Carlsberg Group, Constellation Brands, Diageo, Heineken, Molson Coors Beverage Company, Pernod Ricard, The Coca-Cola Company and Whyte & Mackay.
The programme is managed by leading energy solution provider, Enel X. Through its Advisory Services division, Enel X connects the participants with renewable energy providers and supports renewable energy transactions, aiming to accelerate renewable energy adoption.
The programe also features a dedicated educational platform to help program participants prepare for renewable energy adoption.
Scope 3 emissions, which are not directly produced by a company but from its supply chain, often account for approximately 90 per cent of a beverage company’s carbon footprint. As suppliers continue to face a number of barriers to decarbonisation, REfresh has already engaged with more than 300 suppliers to discuss their involvement in the programme as it aims to support their adoption of renewable energy solutions.
“We have long recognised the need for industry collaboration to deliver the most impact and to accelerate the transition across our supply chains,” Ralf Peters, chief procurement officer of Coca-Cola Europacific Partners (CCEP), and chairman, Coca-Cola Cross Enterprise Procurement Group (CEPG), said.
“I know from my experience across the Coca-Cola system that supporting our supply partners is a key part of our sustainability action – and that encouraging them to transition to renewables is one of the most impactful things we can do to help decarbonise their businesses, and to do the same in ours.”
Hervé Le Faou, chief procurement officer of Heineken, said: “Scope 3 emissions are one of the biggest challenges that the industry faces in delivering on our Net Zero ambitions. We must work together to identify areas of our supply chains where we can pool our resources to accelerate this transition for our suppliers. We look forward to working with other beverage companies to achieve this and accelerate the decarbonization of our industry.”
Jane Liang, chief procurement officer of Diageo, said: “The climate crisis is the most pressing issue of our time and the transition to Net Zero is becoming increasingly important. However, there is only so much we can do as individual businesses. The REfresh Alliance will drive collective action within the industry to accelerate the adoption of renewable energy. We are calling on all companies and suppliers within the industry to join us and support the industry in its transition to Net Zero.”
REfresh intends to initially launch in the mature renewable energy markets of Europe and North America, where it will be able to use existing networks to accelerate impact in support of the industry’s decarbonization efforts. As it continues to grow, the consortium will look to expand to other markets and welcome businesses from across the beverage industry to join it in supporting suppliers in their decarbonization journeys.
The latest findings highlighted by Lumina Intelligence Convenience Tracking Programme reveal a shift towards lighter shopping trips, the impact of weather on daytime meal occasions, and strategic growth in forecourt impulse purchases driven by expanded meal deal offerings.
The Convenience Tracking Programme has uncovered significant shifts in the UK's convenience shopping landscape, indicating a continued rise in market penetration with a notable trend towards "lighter" shopping. The number of shoppers in the market has grown, with an impressive +2.8 percentage point increase in year-on-year penetration. Managed convenience channels are driving much of this growth, reflecting heightened consumer interest in convenience store options.
However, while more shoppers are making trips to convenience outlets, they are increasingly favouring lighter shopping trips. The data indicates a -10 per cent decrease in items per trip, paired with a modest -0.4 per cent decline in total spend per visit. This shift suggests a consumer preference for smaller, more frequent purchases as opposed to larger basket sizes, with customers prioritising efficiency and value.
The data also revealed an increase in share for daytime meal occasions, rising by +0.8 percentage points. This shift is partly due to a rebalancing in food-to-go purchases, which peaked last year during an extended period of favourable weather. This year’s comparatively poorer weather has driven shoppers to consume more meals at home, leading to a greater focus on in-home meal preparation. Consumers are purchasing ingredients and essentials to make meals at home, highlighting a sustained demand for convenient meal solutions that align with at-home dining.
In an otherwise stabilised market, forecourts have emerged as a unique growth channel for impulse purchases, registering a +1.3 percentage point increase year-on-year. Meal deals have been a pivotal driver of this growth, up +4.1ppts as a reason for purchasing on impulse. Leading forecourt operators, including BP and Shell, have expanded meal deal offerings in partnership with established retailers, delivering enhanced value and variety to time-pressed consumers. This strategic move addresses the evolving needs of busy shoppers, who are seeking quick, affordable meal solutions.