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FDA News Realse - E-Cigarrettes |
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FDA NEWS RELEASE For Immediate Release: July 22, 2009 Media Inquiries: Siobhan DeLancey, 301-796-4668, siobhan.delancey@fda.hhs.gov Consumer Inquiries: 888-INFO-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 • 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 • Phone: (800) FDA-1088 # For More Information Electronic Cigarettes FDA Acts to Protect Public Health from Electronic Cigarettes Statement of Matthew L. Myers President, Campaign for Tobacco-Free Kids WASHINGTON, DC (July 22, 2009) – The U.S. Food and Drug Administration has acted to protect public health from so-called electronic cigarettes by seeking to block importation of these products and, during a press briefing today, informing the public about the potential health risks of these products. The FDA announced today that a laboratory analysis of electronic cigarette samples found that they contain carcinogens and toxic chemicals such as diethylene glycol, an ingredient used in antifreeze. We look forward to the FDA taking additional action to stop the marketing and sale of these unapproved products. The FDA appropriately has asserted the authority to regulate these products, which deliver the powerfully addictive drug nicotine, as combination drug-device products under the Federal Food, Drug and Cosmetic Act. Electronic cigarettes have not been tested for safety or approved by the FDA for sale in the United States, yet manufacturers have been marketing and selling these products in stores and shopping mall kiosks throughout the U.S., as well as on the Internet. Electronic cigarettes, which are manufactured primarily in China, pose several serious potential risks to public health. First, there is no credible scientific evidence that these products are safe for human consumption or that they are effective at helping smokers or other tobacco users quit, as some manufacturers have claimed. In contrast to tobacco cessation products that have been approved by the FDA, there are no controls on the amount or potency of the nicotine or other substances in electronic cigarettes. Manufacturers have refused to submit these products to the FDA for regulatory review and in fact have filed a lawsuit challenging the FDA’s authority over their products. Some have gone so far as to claim that electronic cigarettes should not be subject to any regulation to protect public health. We disagree. Second, these products risk deterring current smokers from quitting by providing an alternative source of nicotine in places where smoking is not allowed. They also provide an unproven and unapproved alternative to smoking cessation therapies that have been approved by the FDA as safe and effective. Smokers concerned about their health should utilize approved smoking cessation medications and counseling rather than unapproved products. As the World Health Organization has concluded, until electronic cigarette manufacturers have conducted the necessary scientific studies and gone through the appropriate regulatory process, “WHO does not consider it to be a legitimate therapy for smokers trying to quit.” Third, these products could serve as a pathway to nicotine addiction for children, leading them to smoke cigarettes and use other tobacco products to satisfy their addiction. Electronic cigarettes have been marketed in youth-friendly candy and fruit flavors including bubblegum, cookies and cream, and cola. These products are also readily accessible to youth because they are widely sold in shopping malls and over the Internet and, because they are not traditional tobacco products, they are not subject to age verification laws. No one is suggesting that these products should never be allowed on the market; rather, like other consumer products, electronic cigarettes should be regulated to protect public health before they are permitted to be sold to consumers. The FDA’s press release and additional information can be found at: http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm173222.htm. |
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