FDA Regulation of Ends Analysis
Subject: Public Health
Table of Contents Specific Details and Sponsor of the Regulations Statements in the Public Record Reasons Behind and Impact of Regulations Conclusion References Electronic Nicotine Delivery Systems (ENDS) first appeared on the U.S. market in 2007. Since then, they have gained increasing popularity and have been used by smokers as a substitute for tobacco products. E-cigarettes were not regulated by the Food and Drug Administration (FDA) until 2014 when the FDA considered regulating ENDS by the same rules as tobacco products. At present, in 2016 FDA regulates both tobacco products and ENDS. Specific Details and Sponsor of the Regulations The new FDA regulations concern not only ENDS (e.g., electronic cigarettes, e-pipes, vape pens, etc.) and parts or components of them, but also their import, manufacturing, labeling, sale, and promotion. Nevertheless, if a product is used for therapy for quitters, then it is regulated by the Center for Drug Evaluation and Research (U.S. Food and Drug Administration, 2016). To manufacture any of the listed ENDS, one must consider the new requirements, such as FDA authorization, a listing of ingredients, establishment(s) registration, and many others.
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The sponsor of the new regulations is the FDA. Because ENDS were not regulated at first, their safety with regard to public health was questioned. To prevent any risks to e-cigarette smokers, the FDA “would regulate e-cigarettes for tobacco cessation… and this would require rigorous safety and efficacy studies” (Bhatnagar, Whitsel, Ribisl, Bullen, & Chaloupka, 2014, p. 1426). Due to these regulations, the vapor market in the United States is expected to produce safer and more reliable products. Statements in the Public Record As often happens, opinions about the regulations were divided. The American Heart Association stressed the modest impact of e-cigarettes on probable tobacco cessation, claiming that their effect is “likely equal to or slightly better than that of nicotine patches without behavioral support” (Bhatnagar et al., 2014, p. 1427). Nathan K. Cobb (2014) wrote that e-cigarettes can only displace tobacco products if they are “relatively convenient, satisfying, and inexpensive” (p. 1470). Before the final regulation of ENDS, Camille K. Gourdet examined how state laws had governed e-cigarettes. Thirty-four states regulated them, twenty-two regulated youth access to e-cigarettes, and twelve focused on smoke-free air (Gourdet et al., 2014, p. 337). Riccardo Polosa wrote an article on youthful smokers of e-cigarettes, stating that “experimentation of e-cigarettes in non-smoking high school students is very low, at about 0·4%… none of the students adopted e-cigarettes as a regular behavior” (Polosa, 2013, p. 583). Michael Siegel, a professor at the School of Public Health, argued the advantages of the new regulations, and drew attention to the FDA’s prohibition of improvements in the products, thus triggering safety hazards for their users (Siegel, 2016, p. 26). As the above statements show, regulations have become a widely discussed issue, both in magazines and on the Internet. Reasons Behind and Impact of Regulations There are several major reasons for these regulations. First, they could indeed help chain-smokers quit smoking; second, they help the FDA prevent delivery of other drugs in vaping products; and third, they can help increase quality control during the manufacturing process (Bhatnagar et al., 2014, p. 1426). Nonetheless, these regulations will have an impact on the prices of e-cigarettes: If combustible products are cheaper than e-cigarettes, it is possible that they will be preferred by consumers. Health insurance companies will treat people who smoke combustible and e-cigarettes equally. It is also doubtful that society will shift exclusively to e-cigarettes, although they will most likely help reduce the harm of second-hand smoke (Bhatnagar et al., 2014, p.1421). Electronic cigarettes, used as a cessation aid, will be safer, due to strict control over their manufacturing. Conclusion The new FDA regulations will help to control manufacturers of vaping products and the quality of these products. In addition, wider usage of e-cigarettes can also help reduce chain-smoking, although to a small degree. However, some specific details of the regulations can increase the health hazard offered by these products, and bring damage to consumers. References Bhatnagar, A., Whitsel, L., Ribisl, K., Bullen, C., & Chaloupka, F. (2014). Electronic cigarettes: a policy statement from the American Heart Association. Dallas, TX: the American Heart Association. Cobb, N., & Abrams, D. (2014). The FDA, E-Cigarettes, and the Demise of Combusted Tobacco. The New England Journal of Medicine, 371, 1469-1471.
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Gourdet, C., Chriqui, J., & Chaloupka, F. (2014). A baseline understanding of state laws governing e-cigarettes. Tob Control, 23, 337-340. Polosa, R. (2013). Time for evidence-based e-cigarette regulation. The Lancet Oncology, 14, 582-583. Siegel, M. (2016). POV: New FDA Regulations on Vaping Products a Failure. BU Today, 2(2), 26. U.S. Food and Drug Administration. (2016). Vaporizers, E-Cigarettes, and other Electronic Nicotine Delivery Systems (ENDS). Web.