Tobacco Asia

Volume 20, Number 4

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tobaccoasia 21 Vapor products will be required to display the following statement on labels: "WARNING: This product contains nicotine. Nicotine is an addictive chemical." There is some controversy in scientific circles regarding whether nicotine per se is addictive. The Royal College of Physicians' 2000 report on nicotine addiction states that "it is reasonable to conclude that nicotine delivered through tobacco smoke should be regarded as an addictive drug," but it may be that additional chemicals found in smoke work to create the attraction. Products that deliver only nicotine such as the nicotine patch or gum have not proven to be ad- dictive when given to nonsmokers. If the manufacturer submits a self-certification statement to FDA that the newly regulated prod- uct does not contain nicotine (and that the manu- facturer has data to support this assertion), then an alternate statement must be used on product pack- ages and advertisements: "This product is made from tobacco." Vapor products contain no tobacco. Some liq- uids contain a pharmaceutical grade chemical (nico- tine), which has been extracted from tobacco, but doesn't make them "made from tobacco" any more than an aspirin tablet is made from willow bark. But more to the point, this is the label pre- scribed for products that do not contain nicotine. Therefore, the product would contain nothing whatsoever that could possibly be mistaken for being "made from tobacco." The government is requiring companies to display false statements about their products. 2. Protect young people from the risk of addiction By the time the rule went into effect, 48 of the 50 states already restricted sales of vapor products to persons under age 18, and in two cases to per- sons under age 21. Thus, in terms of protecting youth from possible exposure to vapor products, the new federal rule is a bit superfluous. But more importantly, if a person doesn't use a substance, it is impossible to become addicted to it. The Monitoring the Future survey found that the majority of nonsmoking youth who experiment with e-cigarettes opt for flavored liquids that con- tain no nicotine. Regular use of e-cigarettes among youth, as in adults, is almost entirely concentrated in those who already smoke, and most are using the products with a goal of quitting smoking. But even if nonsmoking youth use vapor prod- ucts that do contain nicotine, what is the risk of be- coming addicted? In "Nicotine Without Smoke," the Royal College of Physicians stated that "there is no evidence thus far that e-cigarette use has re- sulted, to any appreciable extent, in the initiation of smoking in either adults or children," and that "even if such gateway progression does occur, it is likely to be inconsequential in population terms." Lynn T. Kozlowski is a professor of health be- havior at the University at Buffalo, the State Uni- versity of New York. He has pointed out, "The focus on minor gateway effects for youth should not distract from the need to explore policy and clinical questions about harm and disease risk from adult use of legal tobacco products." 3. Make products meet 'relevant public health standard' The usual framework for regulation of any prod- uct involves specifying requirements for the prod- uct to meet and banning products that fail to meet the standards. The Tobacco Act took a different approach. Instead, products that had been com- mercially marketed in the United States as of Feb. 15, 2007 (referred to as the "predicate date" or "grandfather date"), were permitted to remain on the market. For tobacco companies, that covered a lot of ground since there were thousands of conventional cigarettes on the market before the predicate date. As of Feb. 15, 2007, there were no vapor prod- ucts—no electronic cigarettes or electronic nico- tine delivery systems—that had been commercially marketed in the United States. Therefore, all vapor products will be required to undergo an extensive and expensive pre-market approval process. In addition to extensive toxicology testing of both liquids and vapor, companies must conduct full investigations of health risks and describe how their product compares to other products "legally on the market (i.e., either grandfathered or with a marketing authorization in effect)." Studies must also be conducted to show that the new product will be appropriate for the pro- Looks like you're on top of the regulations

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