The electronic cigarette (e-cigarette), for many considered as a safe alternative to conventional cigarettes, has revolutionized the tobacco industry in the last decades. In e-cigarettes, tobacco combustion is replaced by e-liquid heating, leading some manufacturers to propose that e-cigarettes have less harmful respiratory effects than tobacco consumption. Other innovative features such as the adjustment of nicotine content and the choice of pleasant flavors have won over many users.
Nevertheless, FDA is concerned about the safety of e-cigarettes and their impact on human health. Numerous studies have been performed to understand the impact of e-cigarettes on human health. The studies suggest that e-cigarettes can be less harmful and safer than conventional cigarettes.
The long-term carcinogenic and lung function effects of electronic cigarettes are not known. Although some data demonstrate that electronic cigarettes may be effective in reducing conventional cigarette consumption, there are no data demonstrating the efficacy of electronic cigarettes as a tool to achieve cessation. Until robust longitudinal evaluations demonstrate the safety of electronic cigarettes and efficacy in the treatment of tobacco dependence, their role as a harm reduction tool is unclear.
Under the Family Smoking Prevention and Tobacco Control Act, the FDA Center for Tobacco Products regulates cigarettes, cigarette tobacco, and smokeless tobacco, and the FDA Center for Drug Evaluation and Research regulates smoking-related products marketed for therapeutic benefit (Table 1). Under this act, a “tobacco product” is defined in part as any product “made or derived from tobacco” that is not a “drug,” “device,” or combination product under the Federal Food, Drug, and Cosmetic Act. Drugs and devices are defined as articles intended to diagnosis, cure, treat or prevent disease. The case of Sottera, Inc. v FDA (627 F.3d 891, D.C. Cir 2010) challenged the FDA determination of e-cigarettes as unapproved drug/device combinations. The court held that e-cigarettes can be regulated as tobacco products and are not considered drugs or devices unless marketed for therapeutic purposes. It is anticipated that the FDA will regulate e-cigarettes as tobacco products, not as a tool for the treatment of tobacco dependence. This is in contrast to tightly controlled nicotine replacement therapies such as nicotine patches and inhalers, which are regulated as therapies to promote tobacco cessation.
HQD Tech USA is making sure to prevent youth the access to e-cigarettes in our store.
We ask every visitor to our website to verify their age. We are marking our promotional material with a Warning note - Products sold in our on-line store contain nicotine and that nicotine is an addictive chemical.
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