CIGARETTES, E-CIGARETTES, AND THE ROLE OF FDA REGULATION Jennifer - - PowerPoint PPT Presentation
CIGARETTES, E-CIGARETTES, AND THE ROLE OF FDA REGULATION Jennifer Pearson, MPH, PhD Assistant Professor School of Community Health Sciences University of Nevada, Reno November 17, 2017 Top opics f s for today ys t s talk 1.
Jennifer Pearson, MPH, PhD Assistant Professor School of Community Health Sciences University of Nevada, Reno November 17, 2017
products
regulatory authority over tobacco products, applied to e-cigarettes
Top
s for today’ y’s t s talk
By EDITH M. LEDERER. The Associated Press
Thursday, February 7, 2008; 11:52 PM
NEW YORK -- The World Health Organization warned in a new report Thursday that the "tobacco epidemic" is growing and could claim 1 billion lives by the end of the century unless governments dramatically step up efforts to curb smoking. World Health Organization Director-General Dr. Margaret Chan, right, speaks about the mpower box as New York Mayor Michael Bloomberg listens during a press conference announcing WHO's Report on the Global Tobacco Epidemic 2008 Thursday, Feb. 7, 2008 in New York. The mpower box is a symbol of the package being offered by the WHO in its effort………..
in US expected to die prematurely from smoking
due to smoking in Washoe county in 2014
Smo moking i is a publi blic h health cr crisis
The burden of death and disease from tobacco use in the United States is overwhelmingly caused by cigarettes and other combusted tobacco products.
Source: U.S. Department of Health and Human Services. The Health Consequences of Smoking—50 Years of Progress. A Report of the Surgeon General. January 2014. The Tobacco Atlas. Country Fact Sheet: United States. Available at http://www.tobaccoatlas.org/country-data/united-states/
health outcomes:
marketing, availability, low prices in poor and minority neighborhoods
cessation aids and support
information about the harms
quitting
norms, which increases initiation and decreases cessation
Smo moking i is a a soci cial j justice i issue
“Smoki king ng i is solved”
“Smoki king ng i is solved”
“Smoki king ng i is solved”
disease from tobacco use in the United States is
lmingly gly c caused d by cigarettes a and other combusted t d tobacc cco pr produ duct cts; rapid elimination of their use will dramatically reduce this burden.”
Smo moking c cau auses the maj majority of
harm arm
Source: U.S. Department of Health and Human Services. The Health Consequences of Smoking—50 Years of Progress. A Report of the Surgeon General. January 2014. The Tobacco Atlas. Country Fact Sheet: United States. Available at http://www.tobaccoatlas.org/country-data/united-states/
cigarette smoking, cigar smoking, cigarillo smoking, hookah smoking, little cigar smoking.
cigarette/vape pen/vape/ENDS to consume nicotine.
(commonly called “vapor”).
An An as asid ide – let’s de define ou
terms
FDA regu regulat atory au auth thori rity
re- 2009 2009
Post-20 2009 09
2009 F 9 Family ly Smoki king ng P Prevent ntion a and Toba bacco cco C Control A Act
Gave FDA authority to regulate the manufacture, distribution, and marketing of tobacco products to protect public health. Created a new section of the FDA – “Center for Tobacco Products” (CTP) Initially limited to cigarettes, roll-your-own, and smokeless tobacco; expanded to all tobacco products (including e-cigarettes) in 2016.
FDA C CTP P au authorities
RYO tobacco (except menthol)
labels
tobacco products
supported by science
descriptors
characteristics & requires premarket certification of products
Calls for FDA CTP decision making to be based on a review of the scientific evidence regarding:
including both users and non-users of tobacco products;
likelihood that existing users of tobacco products will stop using such products; and
likelihood that those who do not currently use tobacco products, most notably youth, will start to use tobacco products.
The Pu Publi blic H Healt lth S Stan andard
Publ blic H Health S Stan andar ard as as a a gu guide f for
research
Population Harm Toxicity Appeal Abuse liability
E-cigarette P Policy R y Rese search F Framewor
Tob
Po Policies Expo posure to P
Tob
e Behav avior
Health Outcomes
Psychosocial al Mediat iators Mod Moderators rs
So Sottera Inc. v . vs US F Food a d and d Drug A Adm dminis istration
e-cigs from Smoking Everywhere and NJOY.
combination intended to help treat withdrawal symptoms of nicotine addiction”
are not a cessation device merely because they deliver nicotine.
tobacco products UNLESS they make cessation claims.
E-cigare garettes are n not a a singl gle p product clas ass
First generation
“Cigalikes”
Second generation
“Mid-size electronic cigarettes”
Third generation
“Advanced personal vaporizers” Slide courtesy of Dr. Andrea Villanti
Fourth Generation?
Nicotine salts - JUUL
E-cigare garettes – much l lower t r toxicity than an cigare garettes
Liquids and exhaled aerosol contain measurable amounts of:
nitrosamines, heavy metals, carbonyls), but but at much lo h lower le levels ( (9-450 t times l lowe wer) than an t tobacco smo smoke Some flavors are more cytotoxic than others, but a all a ll are re le less c cyt ytotoxic t tha han c cigarette s smoke extract
Source: Shahab L, Goniewicz ML, Blount BC, Brown J, McNeill A, Alwis KU, Feng J, Wang L, West R. (2017). Nicotine, Carcinogen, and Toxin Exposure in Long-Term E-Cigarette and Nicotine Replacement Therapy Users: A Cross-sectional Study. Ann Intern Med. Mar 21;166(6):390-400. doi: 10.7326/M16-1107.
E-ciga igarette e nicotine delivery – lower t than an cigar arettes?
Farsalinos KE, Spyrou A, Tsimopoulou K, Stefopoulos C, Romagna G, Voudris V. Nicotine absorption from electronic cigarette use: comparison between first and new-generation devices. Scientific Reports. 2014;4:4133.
Ad Adults - wh who i is using e e-ciga igare rett ttes es?
Source: Schoenborn CA, Gindi RM. Electronic cigarette use among adults: United States, 2014. NCHS data brief, no. 217. Hyattsville, MD: National Center for Health Statistics. 2015.
Ad Adult e e-cigarette u use a and cessa sation
“E-cigarette users were more likely than non-users to attempt to quit smoking, 65.1% v 40.1%, and more likely to succeed in quitting, 8.2% v 4.8%.” “The overall population cessation rate for 2014-15 was significantly higher than that for 2010-11, 5.6% v 4.5%, and higher than those for all other survey years.” “The substantial increase in e-cigarette use among US adult smokers was associated with a statistically significant increase in the smoking cessation rate at the population level.”
Source: Zhu Shu-Hong, Zhuang Yue-Lin, Wong Shiushing, Cummins Sharon E, Tedeschi Gary J. E-cigarette use and associated changes in population smoking cessation: evidence from US current population surveys BMJ 2017; 358 :j3262
E-cigs rare E-cigs common
Mai Main c con
about e e-cig u use an and y you
E-cigarette te us use is harm e enh nhancing f for yout uth ( (and nd a all no non-tobacc cco u users).
2) While not as harmful as cigarettes, e-cigarettes are not harmless or “just watervapor.”
3) Nicotine exposure for the adolescent brain *may* be harmful – best to avoid it. 4) 4) 2.E-cigarette te us use is a ”gateway” y” t to m more h harmful f forms tobacco us use, na namely cig igarette s smokin ing.
5) This is a difficult question to answer without an unethical RCT. 6) Data is all over the map, and conclusions depend on definitions of theexposure and the outcome.
7) Best to think of e-cigarette use as a marker or future risk behavior (but notnecessarily causal)?
Trends i ds in Pa Past st 30 30-Day ay Use se o
Cigarettes an and d E-Cig Cigar arettes a s among H High S School S Stude dents s - NYTS TS
Source: National Youth Tobacco Survey, 2011 - 2016. 15.80% 14.00% 12.70% 9.20% 9.30% 8.00% 1.50% 2.80% 4.50% 13.40% 16.00% 11.30%
0% 2% 4% 6% 8% 10% 12% 14% 16% 18%
20 2011 11 20 2012 12 20 2013 13 20 2014 14 20 2015 15 20 2016 16 Cigarettes E-cigarettes
Youth f frequency of pr product u use, 20 2014 N NYTS TS
Source: Villanti, A. C., et al. (2017). "Frequency of youth e- cigarette and tobacco use patterns in the U.S.: Measurement precision is critical to inform public health." Nicotine Tob Res 19(11): 1345-1350.
It It’s ’s c com
amplify any positive effects and eliminate any negative effects of e-cigarettes on public health?
products:
1. Recent nt FDA a actions ns
The markets react!
Summa mmary
E-cigarettes’ ultimate effect on public health is complex and evolving. We can use policy and regulation to force companies’ priorities to align with ours (as much as possible) as public health professionals. PUBLIC HEALTH CHALLENGE: allow smokers to pursue quitting using WHA HATEVER GETS THE HEM M THE HERE RE (includin ing e-cig igar arettes), while simultaneously avoiding attracting youth e-cigarette users
“The significant problems we face cannot be solved by the same level of thinking that created them.”
Thanks for your attention! Jennifer Pearson, MPH, PhD jennipearson@unr.edu