Evidentiary support in public comments to the Fda'S Center for tobacco products

Journal of Health Politics, Policy and Law

Volumn 42, Issue 4, 2017, Pages 645-666

  Hemmerich, Natalie ^a   Klein, Elizabeth G ^a   Berman, Micah ^a,b  

^a OHIO STATE UNIVERSITY   (United States)

^b OXFORD UNIVERSITY PRESS   (United Kingdom)

Author keywords

Deeming; Electronic nicotine delivery systems; Flavors; Food and drug administration; Tobacco regulatory science

Indexed keywords

FLAVORING AGENT;

COMMERCIAL PHENOMENA; COMMUNITY PARTICIPATION; ELECTRONIC CIGARETTE; FOOD AND DRUG ADMINISTRATION; HUMAN; LEGISLATION AND JURISPRUDENCE; PUBLIC OPINION; TOBACCO; UNITED STATES;

COMMERCE; COMMUNITY PARTICIPATION; ELECTRONIC NICOTINE DELIVERY SYSTEMS; FLAVORING AGENTS; HUMANS; PUBLIC OPINION; TOBACCO; UNITED STATES; UNITED STATES FOOD AND DRUG ADMINISTRATION;

EID: 85025701609     PISSN: 03616878     EISSN: 15271927     Source Type: Journal    
DOI: 10.1215/03616878-3856121     Document Type: Article

References (54)

1. Undersigned Public Health Groups. 2014. "Comment from 24 Undersigned Public Health Groups," August 8.
2. Abramson, John. 2008. Overdosed America: The Broken Promise of American Medicine, 3rd ed. New York: Harper Perennial.
3. Angell, Marcia. 2005. The Truth about the Drug Companies: How They Deceive Us and What to Do About It. New York: Random House.
4. Anonymous. Electronic Regulation from Form. 2014. "Comment from Anonymous," August 7. www.regulations.gov/#!documentDetail;D=FDA-2014-N-0189-74588.
5. Arrazola, Rene, Tushar Sing, Catherine Corey, Corinnne Husten, Jeff Neff, Benjamin Apelberg, Rebecca Bunnell, et al. 2015. "Tobacco Use among Middle and High School Students-United States, 2011-2014." Government 14. Morbidity and Mortality Weekly Report 64. Centers for Disease Control and Prevention.
6. Benjamin, Georges C. 2014. "Comment from American Public Health Association (APHA)," August 7. www.regulations.gov/#!documentDetail;D=FDA-2014-N -0189-75034.
7. "Big Survey 2014-Initial Findings Eliquid j Vaping.com." 2015. vaping.com/data /big-survey-2014-initial-findings-eliquid. (accessed July 1).
8. Blanke, D. Douglas. 2014. "Comment from Tobacco Control Legal Consortium," August 8. www.regulations.gov/#!documentDetail;D=FDA-2014-N-0189-81033.
9. Brandt, Allan. 2009. The Cigarette Century: The Rise, Fall, and Deadly Persistence of the Product That Defined America. New York: Basic Books.
10. Brose, Leonie S., Sara C. Hitchman, Jamie Brown, Robert West, and Ann McNeill. 2015. "Is the Use of Electronic Cigarettes While Smoking Associated with Smoking Cessation Attempts, Cessation and Reduced Cigarette Consumption? A Survey with a 1-Year Follow-Up." Addiction 110, no. 7: 1160-68. doi: 10.1111 /add.12917.
11. Brown, Jessica E.,Wentai Luo, Lorne M. Isabelle, and James F. Pankow. 2014. "Candy Flavorings in Tobacco." New England Journal of Medicine 370, no. 23: 2250-52. doi: 10.1056/NEJMc1403015.
12. Brown, Nancy. 2014. "Comment from the American Heart Association and the American StrokeAssociation," August 8.www.regulations.gov/#!documentDetail;D=FDA -2014-N-0189-80309.
13. Bryer, Thomas A. 2013. "Public Participation in Regulatory Decision-Making." Public Performance and Management Review 37, no. 2: 263-79. doi: 10.2753 /PMR1530-9576370204.
14. Burris, Scott. 2014. "A Technical Guide for Policy Surveillance." SSRN Scholarly Paper ID 2469895. Rochester, NY: Social Science Research Network. papers .ssrn.com/abstract=2469895.
15. Carpenter, Daniel. 2010. Reputation and Power: Organizational Image and Pharmaceutical Regulation at the FDA, 1st ed. Princeton: Princeton University Press.
16. Choi, Kelvin, Lindsey Fabian, Neli Mottey, Amanda Corbett, and Jean Forster. 2012. "Young Adults' Favorable Perceptions of Snus, Dissolvable Tobacco Products, and Electronic Cigarettes: Findings from a Focus Group Study." American Journal of Public Health 102, no. 11: 2088-93. doi: 10.2105/AJPH.2011.300525.
17. Conference of Parties. 2008. "Guidelines for Implementation of Article 5.3 of the WHO Framework Convention on Tobacco Control." World Health Organization Framework Convention on Tobacco Control.www.who.int/fctc/guidelines/adopted /article_5_3/en/.
18. Convenience Store Decisions. 2014. "E-Cigarette Sales Set to Surge in 2014." March www.cstoredecisions.com/2014/03/21/e-cigarette-sales-set-surge-2014/.
19. Couch, Elizabeth, Benjamin Chaffee, Gwen Essex, and MargaretWalsh. 2014. "FDA Should Prohibit Use of Flavors in Deemed Tobacco Products as Part of the Current Rulemaking." University of California San Fransisco School of Dentistry. Unpublished, preliminary findings.
20. Etter, Jean-François. 2015. "E-Cigarettes: Methodological and Ideological Issues and Research Priorities." BMCMedicine 13, no. 1: 32. doi: 10.1186/s12916-014-0264-5.
21. Farsalinos, Konstantinos E., Giorgio Romagna, Dimitris Tsiapras, Stamatis Kyrzopoulos, Alketa Spyrou, and Vassilis Voudris. 2013. "Impact of Flavour Variability on Electronic Cigarette Use Experience: An Internet Survey." International Journal of Environmental Research and Public Health 10, no. 12: 7272-82. doi: 10.3390/ ijerph10127272.
22. FDA (Food and Drug Adminsitration) 2015. "FY 2016 Food and Drug Administration Budget." Department of Health and Human Services. www.fda.gov/downloads /AboutFDA/ReportsManualsForms/Reports/BudgetReports/UCM432322.pdf.
23. Garne, David,MeganWatson, SimonChapman, and FionaByrne. 2005. "Environmental Tobacco Smoke Research Published in the Journal Indoor and Built Environment and Associations with the Tobacco Industry." Lancet 365, no. 9461: 804-9. doi: 10.1016 /S0140-6736(05)17990-2.
24. Grana, Rachel A., Lucy Popova, and Pamela M. Ling. 2014. "A Longitudinal Analysis of Electronic Cigarette Use and Smoking Cessation." JAMA Internal Medicine 174, no. 5: 812-13. doi: 10.1001/jamainternmed.2014.187.
25. Hatchard, Jenny L., Gary J. Fooks, Karen A. Evans-Reeves, Selda Ulucanlar, and Anna B. Gilmore. 2014. "A Critical Evaluation of the Volume, Relevance and Quality of Evidence Submitted by the Tobacco Industry to Oppose Standardised Packaging of Tobacco Products." BMJ Open 4, no. 2: e003757. doi: 10.1136 /bmjopen-2013-003757.
26. Healy, David. 2006. "Did Regulators Fail over Selective Serotonin Reuptake Inhibitors?" BMJ 333, no. 7558: 92-95. doi: 10.1136/bmj.333.7558.92.
27. Hilts, Philip J. 2004. Protecting America's Health: The FDA, Business, and One Hundred Years of Regulation, 1st ed. Chapel Hill: University of North Carolina Press.
28. Hwang, Thomas J., Jerry Avorn, Daniel Carpenter, and Aaron S. Kesselheim. 2014. "Quantifying the Food and Drug Administration's Rulemaking Delays Highlights the Need for Transparency." Health Affairs (Project Hope) 33, no. 2: 309-15. doi: 10.1377/hlthaff.2013.0564.
29. Hwang, Thomas J., Jerry Avorn, and Aaron S. Kesselheim. 2014. "Life Cycle of Medical Product Rules Issued by the US Food and Drug Administration." Journal of Health Politics, Policy and Law 39, no. 4: 751-80. doi: 10.1215/03616878- 2743027.
30. IOM (Institute of Medicine). 2012. Scientific Standards for Studies on Modified Risk Tobacco Products. Washington, DC: National Academies. www.nap.edu/catalog /13294.
31. Jenson, Desmond, Joelle Lester, and Micah L. Berman. 2016. "FDA's Misplaced Priorities: Premarket Review under the Family Smoking Prevention and Tobacco Control Act." Tobacco Control, April. doi: 10.1136/tobaccocontrol-2015-052391.
32. King, Brian A., Suhana Alam, Gabbi Promoff, Rene Arrazola, and Shanta R. Dube. 2013. "Awareness and Ever-Use of Electronic Cigarettes among U.S. Adults, 2010-2011." Nicotine and Tobacco Research, February. doi: 10.1093/ntr/ntt013.
33. King, Brian A., Michael A. Tynan, Shanta R. Dube, and Rene Arrazola. 2014. "Flavored-Little-Cigar and Flavored-Cigarette Use Among U.S. Middle and High School Students." Journal of Adolescent Health 54, no. 1: 40-46. doi: 10.1016/ j.jadohealth.2013.07.033.
34. Klein, Sarah M., Gary A. Giovino, Dianne C. Barker, Cindy Tworek, K. Michael Cummings, and Richard J. O'Connor. 2008. "Use of Flavored Cigarettes among Older Adolescent and Adult Smokers: United States, 2004-2005." Nicotine and Tobacco Research 10, no. 7: 1209-14. doi: 10.1080/14622200802163159.
35. Kong, Grace, Meghan E. Morean, Dana A. Cavallo, Deepa R. Camenga, and Suchitra Krishnan-Sarin. 2014. "Reasons for Electronic Cigarette Experimentation and Discontinuation among Adolescents and Young Adults." Nicotine and Tobacco Research, December. doi: 10.1093/ntr/ntu257.
36. Light, Donald W., Joel Lexchin, and Jonathan J. Darrow. 2013. "Institutional Corruption of Pharmaceuticals and the Myth of Safe and Effective Drugs." Journal of Law, Medicine and Ethics 41, no. 3: 590-600. doi: 10.1111/jlme.12068.
37. Madigan, Lisa, Greg Zoeller, Martha Coakley, Eric Schneiderman, Tom Horne, Kamala Harris, John W. Suthers, et al. 2014. "Comment from 18 State Attorneys General," August 8. www.regulations.gov/#!documentDetail;D=FDA-2014-N -0189-79248.
38. Maryland Department of Health and Mental Hygiene. 2011. "Cigar Use among Youth."
39. Maxwell, John C. 2015. "The Maxwell Report: Year End and Fourth Quarter 2014 Cigarette Industry." Richmond, VA: John C. Maxwell Jr.
40. Olson, Samantha. 2014. "Many Young Parents Say E-Cigarettes Are Less Harmful, But Are They?" Medical Daily, May 4. www.medicaldaily.com/81-young-parents -say-e-cigarettes-are-less-harmful-people-around-them-are-they-really-280168.
41. Orellana-Barrios, Menfil A., Drew Payne, Zachary Mulkey, and Kenneth Nugent. 2015. "Electronic Cigarettes-A Narrative Review for Clinicians." American Journal of Medicine 128, no. 7: 674-81. doi:10. 1016/j.amjmed.2015.01.033.
42. Pepper, Jessica K., Paul L. Reiter, Annie-Laurie McRee, Linda D. Cameron, Melissa B. Gilkey, and Noel T. Brewer. 2013. "Adolescent Males' Awareness of and Willingness to Try Electronic Cigarettes." Journal of Adolescent Health: Official Publication of the Society for Adolescent Medicine 52. no. 2: 144-50. doi: 10.1016/ j.jadohealth.2012.09.014.
43. Proctor, Robert N. 2012. Golden Holocaust: Origins of the Cigarette Catastrophe and the Case for Abolition. Oakland: University of California Press.
44. Sutfin, Erin L., Beth A Reboussin, Beata Debinski, Kimberly G. Wagoner, John Spangler, and MarkWolfson. 2015. "The Impact of Trying Electronic Cigarettes on Cigarette Smoking by College Students: A Prospective Analysis." American Journal of Public Health 105, no. 8: e83-e89. doi: 10.2105/AJPH.2015.302707.
45. Swauger, James E. 2014. "Comment from RAI Services Company," August 8. www .regulations.gov/#!documentDetail;D=FDA-2014-N-0189-79096.
46. Tobacco Control Research Group. 2014. "Tobacco Industry's Investment in Non- Cigarette Nicotine Products." University of Bath. www.tobaccotactics.org/images /3/3b/Ecig_investment_timeline_Sept_2014.pdf.
47. Ulucanlar, Selda, Gary J. Fooks, Jenny L. Hatchard, and Anna B. Gilmore. 2014. "Representation and Misrepresentation of Scientific Evidence in Contemporary Tobacco Regulation: A Review of Tobacco Industry Submissions to the UK Government Consultation on Standardised Packaging." PLoS Med 11, no. 3: e1001629. doi: 10.1371/journal.pmed.1001629.
48. Villanti, Andrea C., Amanda Richardson, Donna M. Vallone, and Jessica M. Rath. 2013. "Flavored Tobacco Product Use among USYoung Adults." American Journal of Preventive Medicine 44, no. 4: 388-91. doi: 10.1016/j.amepre.2012.11.031.
49. Wagner, Wendy E., Katherine Y. Barnes, and Lisa Peters. 2010. "Rulemaking in the Shade: An Empirical Study of EPA's Air Toxic Regulations." SSRN Scholarly Paper ID 1531243. Rochester, NY: Social Science Research Network. papers.ssrn .com/abstract = 1531243.
50. Wahba, Phil. 2014. "US E-Cgarette Sales Seen Rising 24.2% per Year through 2018." Fortune, June 10. fortune.com/2014/06/10/e-cigarette-sales-rising/.
51. Weiss, Jeff. 2014. "Comment from NJOY, Inc," August 8. www.regulations.gov /document?D=FDA-2014-N-0189-81859.
52. West, William F., and Connor Raso. 2013. "Who Shapes the Rulemaking Agenda? Implications for Bureaucratic Responsiveness and Bureaucratic Control." Journal of Public Administration Research and Theory 23, no. 3: 495-519. doi: 10.1093/ jopart/mus028.
53. Yackee, Jason Webb, and Susan Webb Yackee. 2006. "A Bias towards Business? Assessing Interest Group Influence on the US Bureaucracy." Journal of Politics 68, no. 1: 128-39. doi: 10.1111/j.1468-2508.2006.00375.x.
54. Yackee, Susan Webb. 2006. "Sweet-Talking the Fourth Branch: The Influence of Interest Group Comments on Federal Agency Rulemaking." Journal of Public Administration Research and Theory 16, no. 1: 103-24. doi: 10.1093/jopart/ mui042.