After conducting an examination of the chemicals found in smokeless cigarettes, the United States Food and Drug Administration (FDA) announced serious concerns. Scientists stated that of the 19 brands examined, most had manufacturing quality issues that point out there are no effective quality control standards in place. In addition, low levels of nicotine were found in all but one of the nicotine-free varieties, and several versions with the same nicotine content labeling distributed drastically variable amounts of nicotine when activated by inhaling. The researchers also noted tobacco specific nitrosamines, cancer-causing agents, in nearly half of the samples tested.
The Smokeless Cigarette Association did not dispute the results of the FDA study, but stated that they are being looked at out of context. First, the Association maintained that the testing was too "narrow to reach any valid and dependable conclusions." Second, the results were published without comparison to nicotine replacement therapies that are FDA approved, which contain similar levels of the same toxins.
Upon receipt of the research results, the FDA firm that smokeless cigarettes constitute a medical device and must be regulated as such under drug/device provisions of the Federal Food, Drug, and Cosmetic Act (FDCA). This conclusion led to the FDA's refusal to allow more than 800 shipments of electronic cigarettes into the U.S., on the grounds that they were adulterated, misbranded, or unapproved drug-device combinations under the FDCA. With "medical device" defined as "articles intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease in man or other animals" and/or "articles (other than food) intended to affect the structure or any function of the body of man or other animals", the FDA asserted that nicotine is a drug that affects the structure or function of the body and that cigarettes and smokeless tobacco were therefore drug/device combinations, regardless of the absence or presence of therapeutic claims.
Some supporters of electronic cigarettes point out that they believe opponents are asking the wrong question. Instead of trying to determine whether electronic cigarettes are inherently safe, they should be looking at whether electronic cigarettes are safer than tobacco products. Thousands of former tobacco users bear witness to the effectiveness of electronic cigarettes in eliminating cravings, and Michael Siegel, a tobacco researcher at Boston University, points out that by isolating nicotine, electronic cigarettes should carry far fewer chemical risks than regular cigarettes. Siegel suggested that electronic cigarettes should be regarded in the same light as heroin needle exchange programs. "It's not that the devices are good for anyone", he said. "They are just better than what they're meant to replace."
The Smokeless Cigarette Association did not dispute the results of the FDA study, but stated that they are being looked at out of context. First, the Association maintained that the testing was too "narrow to reach any valid and dependable conclusions." Second, the results were published without comparison to nicotine replacement therapies that are FDA approved, which contain similar levels of the same toxins.
Upon receipt of the research results, the FDA firm that smokeless cigarettes constitute a medical device and must be regulated as such under drug/device provisions of the Federal Food, Drug, and Cosmetic Act (FDCA). This conclusion led to the FDA's refusal to allow more than 800 shipments of electronic cigarettes into the U.S., on the grounds that they were adulterated, misbranded, or unapproved drug-device combinations under the FDCA. With "medical device" defined as "articles intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease in man or other animals" and/or "articles (other than food) intended to affect the structure or any function of the body of man or other animals", the FDA asserted that nicotine is a drug that affects the structure or function of the body and that cigarettes and smokeless tobacco were therefore drug/device combinations, regardless of the absence or presence of therapeutic claims.
Some supporters of electronic cigarettes point out that they believe opponents are asking the wrong question. Instead of trying to determine whether electronic cigarettes are inherently safe, they should be looking at whether electronic cigarettes are safer than tobacco products. Thousands of former tobacco users bear witness to the effectiveness of electronic cigarettes in eliminating cravings, and Michael Siegel, a tobacco researcher at Boston University, points out that by isolating nicotine, electronic cigarettes should carry far fewer chemical risks than regular cigarettes. Siegel suggested that electronic cigarettes should be regarded in the same light as heroin needle exchange programs. "It's not that the devices are good for anyone", he said. "They are just better than what they're meant to replace."
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