Smoking and Health, American Legacy Foundation, American Academy of Pediatrics, and the Association for the Treatment of Tobacco Use and Dependence have all issued statements supporting
FDA efforts to take them off the US market.34 In the United States, the courts will ultimately determine whether the FDA has the legal authority to do this, but we question the ethical and health policy merits of this approach.
Do products with established user bases warrant a different regulatory approach than entirely new products? This would seem to follow from consistent application of the principal of nonmaleficence –‘do no harm.’ Products yet to enter the market have only potential beneficiaries, people who can only speculate about what the precisetherapeutic effects of the product will be for them.
In contrast,products already on the market have users who may already bederiving benefits. By definition, enacting a ban will harm currentusers, unless the evidence suggests that the harms outweigh thebenefits for those already using the product. The burden of proofis on the regulatory agency to demonstrate that the product isunreasonably dangerous for its intended use.
How does this principle apply to electronic cigarettes? For the many vapers who report using them in place of cigarettes,33the benefits of the product are readily observable, already established.
Simply demonstrating that electronic cigarettes are ‘not safe’ may not be sufficient grounds to ban them. Unless the evidence suggests that vaping does not yield the anticipated reduction in harm to the user, enacting an electronic cigarette prohibition will do harm to hundreds of thousands of vapers already using electronic cigarettes in place of tobacco ones – a clear violation of nonmaleficence.
The essential rationale for the FDA’s pre-market approval process– to keep dangerous products out of the marketplace – may not easily extend to new nicotine products because a range of extraordinarily deadly nicotine products is already grandfathered into the market.
This has led to an awkward nicotine regulatory structure where dirty tobacco products face few barriers to market entry whereas cleaner products are subject to oft onerous hurdles. The FDA contends that they can and should regulate electronic cigarettes as ‘drug-device combinations’ that are required to meet stringent Federal Food Drug and Cosmetic Act (FDCA) safety standards. The FDA reasons that electronic cigarettes do not qualify for the usual exemption from
Crucially, electronic cigarettes could entice smokers who were not otherwise inclined, to attempt to quit. Although the use of electronic cigarettes by nonsmokers is a theoretical concern, there is no existing evidence that youths or nonsmokers are using the product.
Regulations can address the sale and marketing of these products to minors. Skepticism about the role of combusted products in harm reduction Electronic cigarettes, such as NRT, are not tobacco products and no combustion takes place.
Alternatives promoted as safer may actually be equally or more dangerous Thus far, none of the more than 10 000 chemicals present intobacco smoke,4 including over 40 known carcinogens, has beenshown to be present in the cartridges or vapor of electroniccigarettes in anything greater than trace quantities. No one hasreported adverse effects, although this product has been on themarket for more than 3 years. Still, the FDA struck a more ominoustone in its July 2009 press release, warning of the presence ofcarcinogens at ‘detectable’ levels.29 Yet it failed to mention thatthe levels of these carcinogens was similar to that in NRT products
Whereas electronic cigarettes cannot be considered safe, as there is no threshold for carcinogenesis, they are undoubtedly safer than tobacco cigarettes.
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