|
|
 |
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
Regular Mail: use postage-paid FDA form 3500 available at:
http://www.fda.gov/Safety/MedWatch/HowToReport/DownloadForms/default.htm
and mail to
MedWatch
5600 Fishers Lane
Rockville, MD 20852-9787
Fax: (800) FDA-0178
|
