Nicotine-like chemicals in U.S. vapes may be more potent than nicotine, FDA says (updated)
29/05/2024 15:29
(Adds Altria letter, updates FDA response in paragraphs 5-9)
By Emma Rumney
LONDON, May 29 (Reuters) - 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 authorisation from the FDA - a process
that can be costly, time-consuming and is often unsuccessful.
Big tobacco firms like Altria Group MO.N and British
American Tobacco BATS.L have already lost substantial U.S.
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 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.
It cited SPREE BAR, a vape launched in October by Charlie's
Holdings Inc CHUC.N 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 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 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 flavours.
Charlie's Holdings co-founder Ryan Stump told Reuters that
the company only targets adults, adding that flavours 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.
TARGETING INTERNATIONAL MARKETS
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.
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 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.
(Reporting by Emma Rumney; Editing by Matt Scuffham and Daniel
Flynn)
((Emma.Rumney@thomsonreuters.com; +447391409253;))