The FDA found chemicals in some e-cigs which are also used in
anti-freeze, as well as carcinogens in a sample it tested. The FDA
also reported such unpleasant symptoms as "racing pulse, dizziness,
slurred speech, mouth ulcers, heartburn, coughing, diarrhea and sore
throat" (see the link at the end of this blog for more information
from the FDA).
FDA and Public Health Experts Warn About Electronic Cigarettes
The U.S. Food and Drug Administration today announced that a
laboratory analysis of electronic cigarette samples has found that
they contain carcinogens and toxic chemicals such as diethylene
glycol, an ingredient used in antifreeze.
Electronic cigarettes, also called "e-cigarettes," are
battery-operated devices that generally contain cartridges filled with
nicotine, flavor and other chemicals. The electronic cigarette turns
nicotine, which is highly addictive, and other chemicals into a vapor
that is inhaled by the user.
These products are marketed and sold to young people and are readily
available online and in shopping malls. In addition, these products do
not contain any health warnings comparable to FDA-approved nicotine
replacement products or conventional cigarettes. They are also
available in different flavors, such as chocolate and mint, which may
appeal to young people.
Public health experts expressed concern that electronic cigarettes
could increase nicotine addiction and tobacco use in young people.
Jonathan Winickoff, M.D., chair of the American Academy of Pediatrics
Tobacco Consortium and Jonathan Samet, M.D., director of the Institute
for Global Health at the University of Southern California, joined
Joshua Sharfstein, M.D., principal deputy commissioner of the FDA, and
Matthew McKenna, M.D., director of the Office of Smoking and Health
for the Centers for Disease Control and Prevention, to discuss the
potential risks associated with the use of electronic cigarettes.
"The FDA is concerned about the safety of these products and how they
are marketed to the public," said Margaret A. Hamburg, M.D.,
commissioner of food and drugs.
Because these products have not been submitted to the FDA for
evaluation or approval, at this time the agency has no way of knowing,
except for the limited testing it has performed, the levels of
nicotine or the amounts or kinds of other chemicals that the various
brands of these products deliver to the user.
The FDA's Division of Pharmaceutical Analysis analyzed the ingredients
in a small sample of cartridges from two leading brands of electronic
cigarettes. In one sample, the FDA's analyses detected diethylene
glycol, a chemical used in antifreeze that is toxic to humans, and in
several other samples, the FDA analyses detected carcinogens,
including nitrosamines. These tests indicate that these products
contained detectable levels of known carcinogens and toxic chemicals
to which users could potentially be exposed.
The FDA has been examining and detaining shipments of e-cigarettes at
the border and the products it has examined thus far meet the
definition of a combination drug-device product under the Federal
Food, Drug, and Cosmetic Act. The FDA has been challenged regarding
its jurisdiction over certain e-cigarettes in a case currently pending
in federal district court. The agency is also planning additional
activities to address its concerns about these products.
Health care professionals and consumers may report serious adverse
events (side effects) or product quality problems with the use of
e-cigarettes to the FDA's MedWatch Adverse Event Reporting program
either online, by regular mail, fax or phone.
Online: http://www.fda.gov/Safety/MedWatch/default.htm
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