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 The findings, published in the journal JAMA Internal Medicine,
provided the latest evidence about health concerns related to
e-cigarettes. Federal health officials are investigating lung
illnesses linked to e-cigarettes and vaping products tied to six
U.S. deaths.
The levels of pulegone, a carginogenic constituent of mint plant
oil, that are inhaled by e-cigarette users are as much as 1,000
times higher than those taken in by smokers of menthol cigarettes,
Duke University School of Medicine researchers said. The study
involved six types of pulegone-containing smokeless tobaccos and
e-cigarette liquids used for vaping.
The Food and Drug Administration barred the use of pulegone as a
food additive after receiving petitions from health and
environmental groups.
"The FDA regulatory regimen for food is much more strict than what
is required for e-cigarettes," said study co-author Sven-Eric Jordt
of the University Program in Environmental Health at the Duke
University School of Medicine. "In the '70s, the tobacco industry
already knew that pulegone was undesirable and moved to synthetic
flavorings."
To calculate acceptable levels of carcinogens in food, the FDA takes
the highest amount animals can consume without developing tumors and
divides it by the estimated amount consumed per day. The resulting
number - called the "margin of exposure," or MOE - needs to be above
10,000 for the food to be deemed safe by regulators. Lower MOEs are
a cause for concern. And the lower the number, the less safe the
food.
"The FDA decided that the intake of a carcinogen from food must be
at least 10,000-fold less than the maximal dose that doesn't cause
cancer in an animal," Jordt said. "Meaning, the product is
10,000-fold safer."
Of the six types of pulegone-containing smokeless tobaccos and
e-cigarette liquids examined, all came out with MOEs below 10,000,
the researchers said.
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Depending on consumption rates, MOEs for the e-liquids ranged
between 325 and 6,012, and for a pulegone-containing smokeless
tobacco they ranged between 549 and 1,646.
The researchers determined that the MOE for one e-cigarette liquid,
V2 Menthol, ranged from 3,084 to 325, depending on how much was
consumed. For that example, daily exposure to pulegone was 86 to
1,608 times higher with e-cigarette use than with a menthol
combustible cigarette.
Dr. Panagis Galiatsatos, director of the Tobacco Treatment Clinic at
the Johns Hopkins Medical School, called the findings "highly
concerning."
This is yet another example of something that has been looked at by
the FDA only as a food and not as an inhalant, Galiatsatos said.
Galiatsatos, who was not involved in the research, added that the
study "tells us how willing e-cigarette makers are to create an
enhanced experience at the cost of health ramifications."
The researchers noted that the tobacco industry has minimized
pulegone levels in cigarette flavorings because of toxicity
concerns.
"Our findings appear to establish health risks associated with
pulegone intake and concerns that the FDA should address before
suggesting mint- and menthol-flavored e-cigarettes and smokeless
tobacco products as alternatives for people who use combustible
tobacco products," the researchers wrote.
President Donald Trump's administration last week announced plans to
remove all flavored e-cigarettes from store shelves in a widening
crackdown on vaping, as officials warned that sweet flavors have
drawn millions of children into nicotine addiction.
SOURCE: http://bit.ly/32DHan8
JAMA Intern Med 2019.
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