FDA Smokefree PA urges FDA to rescind draft guidance banning flavored vape sales

[Bill Godshall]

I submitted the following comments to FDA on April 30 at Regulations.gov
(but removed the section revealing the increase in teens vaping substances that aren't permitted to be discussed on ECF).
My Comment Tracking Number: 1k3-99n8-d5pc

Food and Drug Administration
Center for tobacco Products
(Docket No. FDA-2019-D-0661)

Modifications to Compliance Policy for Certain Deemed tobacco Products;
Draft Guidance for Industry; Availability

April 30, 2019

Comments by
William T. Godshall, MPH
Executive Director
Smokefree Pennsylvania
1926 Monongahela Avenue
Pittsburgh, PA 15218
412-35-5880
BillGodshall@verizon.net


The FDA should immediately rescind its recently issued draft guidance for the following reasons, which are delineated in this submission.

• FDA’s draft guidance violates the 2009 Tobacco Control Act
• Regulatory changes in FDA’s draft guidance were not lawfully promulgated (1)
• Most smokers who switched to vaping use flavors targeted by FDA (2)
• Many/most youth who vape are vaping substances other than nicotine (3)
• Many high school students who vape are 18 year old adults (7)
• Very few never smoking youth vape daily or frequently (8)
• Vaping is far less harmful than cigarette smoking (16)
• No evidence daily nicotine use increases human disease risk (16)
• Nicotine is very similar to caffeine (16)
• Most youth who vape obtain products from social sources, not retailers (17)
• Youth engage in many far more harmful behaviors than nicotine use (18)


FDA’s draft guidance violates the 2009 Tobacco Control Act

Section 906 (d) (3) (A) (i) of the 2009 Tobacco Control Act (TCA) prohibits DHHS/FDA from banning "the sale of any tobacco product in face-to-face transactions by a specific category of retail outlets", including FDA’s draft guidance banning sales of the vast majority of flavored vapor and some tobacco products at retail stores that allow youth entry. (see page 22)
https://www.govinfo.gov/content/pkg/PLAW-111publ31/pdf/PLAW-111publ31.pdf

When the text of the TCA was being negotiated in 2003/2004, Philip Morris insisted this clause (along with Section 906 (d) (3) (A) (ii), which prohibited FDA from banning the sale of any tobacco product to anyone 18 years or older) be included in subsequent legislation that was introduced by Sens. Kennedy and DeWine, and Reps. Waxman and Davis, which CTFK’s Matt Myers and then GlaxoSmithKline lobbyist Mitch Zeller agreed to.

There were several reasons why Philip Morris wanted this clause in the TCA, to prevent FDA from banning tobacco sales at pharmacies (which some anti tobacco activists were advocating), and to prevent FDA from banning tobacco sales at retailers that allowed youth in their stores, as I and others were advocating banning cigarette sales at retail stores that allowed youth entry.

Since the TCA banned self service tobacco product displays in retail stores that allowed youth entry, Philip Morris was concerned that FDA would attempt to impose additional regulations on retailer stores that allowed youth entry.


Regulatory changes in FDA’s draft guidance were not lawfully promulgated

The regulatory changes imposed by FDA’s draft guidance were never lawfully proposed or promulgated as required by different federal laws, and as stipulated by the Federal Register.
https://www.federalregister.gov/uploads/2011/01/the_rulemaking_process.pdf

If FDA wants to change the Deeming Rule for electronic cigarettes, it must formally propose a new regulation in the Federal Register (as it did with the Deeming Rule in 2014), and allow for public comment before it can impose or enforce the new regulation. Alternatively, the FDA could propose an Advanced Notice of Proposed Rulemaking (ANPRM), as the agency did several times in 2018, but hasn’t taken further action on them.


Most smokers who switched to vaping use flavors targeted by FDA

A study by Farsalinos et al (which was sent to FDA in the summer of 2018) of 69,233 ever e-cigarette users that found 70% of those who quit smoking considered flavorings in vapor products “extremely important” in their attempt to quit, 17% considered them “very important”, and 9% considered them “important”
Submitting to the FDA the findings of the largest ever survey on e-cigarette flavors use by US vapers
Dropbox - Docket No. FDA-2017-N-6565_FARSALINOS.pdf - Simplify your life

A study by Russell et al found that fruit, dessert and candy flavored vapor products were the most popular vapor product flavorings used by adult vapers who quit smoking cigarettes, while tobacco and menthol flavored vapor products were used by far fewer vapers.
Changing patterns of first e-cigarette flavor used and current flavors used by 20,836 adult frequent e-cigarette users in the USA


Many high school students who vape are 18 year old adults

Although CDC and FDA have repeatedly referred to all high school students as ‘youth’, many 9th-12th graders who vape are 18+ adults, and the 2009 TCA prohibits FDA from banning sales of cigarettes and other tobacco products to anyone 18 or older.

Brad Rodu reveals the 2017 NYTS found that 18.5% of e-cigarette users in grades 9-12 (including 16% of exclusive e-cig users, and 23% of dual users) were 18+ adults
Tobacco Truth: Not All Teen Smokers & Vapers Are Lawbreakers

Meanwhile, the 2017 YRBS found 34% of 9th-12th graders who used a vapor product in the past 30 days were 18+ adults, as just 8.7% of 9th-12th graders <18 years used a vapor product in the past 30 day (compared to 13.2% of all 9th-12th graders). Note that CDC buried this important finding in a footnote in Table 72 at
Youth Risk Behavior Surveillance — United States, 2017

The 2017 NYTS found that 12th graders (most of whom were 18+ adults) were far more likely than 9th-11th graders to use e-cigarettes frequently and in the past 30 days (data provided by Christine Delnevo)

Grade Past-30-Days 20+ Days
9th 8.8% 1.0%
10th 11.4% 2.0%
11th 11.8% 2.2%
12th 15.2% 4.4%
9th-12th 11.7% 2.3%


Very few never smoking youth vape daily or frequently, while former and current cigarette smokers are far more likely to vape than never smokers

Teen smokers are still exponentially more likely than never smokers to frequently vape, and are still far more likely to vape in the past 30 days and to ever vape. Meanwhile, most teens who vape do so infrequently.

An NIH funded study (whose author David Hammond leaked it to tobacco controllers and the news media last year to lobby for vapor product sales bans in CA and US) found vaping has been a gateway away from cigarettes for 16-19 year olds in US, Canada and UK, as detailed below.
https://www.cbc.ca/news/health/health-canada-youth-teenage-vaping-smokinghammond-
1.4937593?cmp=rss
Leaked | Public Gets Long Overdue Look at Youth Vaping Study
https://regulatorwatch.com/brent_stafford/cherry-pick-expert-analysis-of-leaked-vaping-study/
http://davidhammond.ca/wp-content/uploads/2018/09/ITC-P3-Youth_Wave1_TechnicalReport_2018.pdf

In 2018, 16-19 year olds in US who smoked 100+ cigarettes in their life were 16, 15 and 9 times more likely than never cigarette smokers to vape 15+ days/month, the past week, and past 30 days respectively. Consistently, those who smoked 1-100 cigarettes in their life were 7, 8 and 6 times more likely than never cigarette smokers to vape 15+ days/month, in past week, and past 30 days respectively.

16-19 y/o Cigarettes Smoked in Life
Vape Status None 1-100 100+
Ever Vaped 16.0% 67.1% 81.4%
Past 30 Days 5.9% 33.6% 55.7%
Past Week 3.0% 22.7% 44.8%
15+ Days/Mo 1.5% 10.5% 23.4%

In 2017, 16-19 year olds in US who smoked 100+ cigarettes in their life were 40, 33 and 23 times more likely than never cigarette smokers to vape 15+ days/month, in past week and in past 30 days respectively. Consistently, those who smoked 1-100 cigarettes in their life were 12, 12 and 10 times more likely than never cigarette smokers to vape 15+ days/month, in past week and past 30 days respectively.

16-19 y/o Cigarettes Smoked in Life
Vape Status None 1-100 100+
Ever Vaped 13.1% 65.5% 85.4%
Past 30 Days 2.4% 24.4% 55.2%
Past Week 1.1% 13.5% 36.3%
15+ Days/Mo 0.5% 6.0% 19.8%

“Ever smokers” in 6th-12th grade were 14, 35 and 23 times more likely than “never smokers” to have used an e-cig in “past-30-days” in 2011, 2012, and 2013 respectively.
https://www.cdc.gov/tobacco/data_statistics/surveys/nyts/data/index.html

"Ever smokers" who reported "past 30 day" e-cig use
2011 - 2.8%
2012 - 7.0%
2013 - 6.9%

"Never smokers" who reported "past 30 day" e-cig use
2011 - 0.2%
2012 - 0.2%
2013 - 0.3%

In 2016, Villanti et al revealed the 2014 NYTS found <0.1% of never tobacco users in 6th-12th grades reported vaping on 10 or more of the past 30 days
http://ntr.oxfordjournals.org/content/early/2016/12/24/ntr.ntw388

Analysis of 2015 NTYS data (among 6th-12th graders) found:
https://www.sciencedirect.com/science/article/pii/S074937971831626X
(note ‘frequent’ use = 20+ of past 30 days, and ‘infrequent’ use = <20 of past 30 days)

- just 0.3% of never smokers were frequent e-cigarette users,
- just 4.6% of never smokers used an e-cigarette in the past 30 days, and 59% of them did so just one or two days,
- frequent smokers were 84 times more likely than never smokers to vape daily (16.9% v 0.2%), while infrequent smokers were 36 times more likely (7.3% v 0.2%),
- frequent smokers were 73 times more likely than never smokers to vape frequently (21.8% v 0.3%), while infrequent smokers were 41 times more likely (12.2% vs 0.3%),
- frequent smokers were 14 times more likely than never smokers to vape in past 30 days (64.7% v 4.6%), while infrequent smokers were 11 times more likely (50.4% v 4.6%)
https://www.sciencedirect.com/science/article/pii/S074937971831626X

 

[Bill Godshall]

Smokefree Pennsylvania comments to FDA continued:

Brad Rodu revealed the 2017 NYTS found 38% of 6th-12th graders who used e-cigarettes, cigarettes and cigars in past 30 days frequently used e-cigarettes on 20+ of the past 30 days, compared to 21% who used e-cigarettes and cigars, 20% who used e-cigarettes and cigarettes, and just 12% who exclusively used e-cigarettes.
Tobacco Truth: FDA Tobacco Center Exaggerates Number of Youth Tobacco Users

Rodu also revealed the 2017 NYTS found 74% of exclusive past 30 day e-cigarette users in 6-12th grade used e-cigarettes just 1-5 of past 30 days, compared to 56% who used e-cigarettes and cigarettes, 57% who used e-cigarettes and cigars, and 35% who used e-cigarettes, cigarettes and cigars in past 30 days.


A newly published 2016/17 survey of 18-21 year olds in US found:
- The group at highest risk for habitual cigarette smoking was those who smoked a cigarette as youth (<18 years), much more so than those who just vaped as youth.
- Those who tried vaping but not cigarette smoking as youth (<18 years) were 78% less likely to become daily and past 30 day cigarette smokers (than those who didn’t vape or smoke as youth).
- Those who smoked a cigarette but didn’t as youth (<18 years) were 175% more likely to have smoked in past 30 days and 161% more likely of to be a daily smoker (than those who smoked a cigarette and vaped as a youth).
- Trying cigarettes and then vapor products yielded sizable increases in both habitual smoking measures, whereas trying vaping before smoking yielded smaller effects.
https://www.ajpmonline.org/article/S0749-3797(19)30086-8/pdf


FDA PATH data analysis of 12-15 year olds (mean 13.4 years) at baseline in 2013/14 found just 15.3% of past-30-day cigarette smokers (i.e. 43,446/283,964) in 2015/16 used an e-cig prior to smoking their first cigarette, and that e-cigs were NOT the first tobacco product used by 84.7% of past-30-day cigarette smokers. The analysis also found never smoking ever e-cig users were 2.75 times more likely than never tobacco/e-cig users to report past-30-day cigarette smoking two years later in 2015/16.
Electronic Cigarette Use and Subsequent Cigarette Smoking Initiation

At baseline, 86.4% were never tobacco/e-cig users, 8.6% had ever used an e-cig, and 5.0% had ever used an OTP. After two years, just 2.1% of all study participants (i.e. who were all never cigarette smokers at baseline) reported past 30-day use of cigarettes, including 8.8% of ever-OTP-users, 5.7% of ever-e-cig-users, and 1.4% of never-tobacco/e-cig-users.

Prior e-cig users accounted for 15.3% (about 1 in 6) of the 2.1% of past-30-day smokers in 2015/16, or just 0.32% of study participants.


According to the NYTS, 6.0% and 5.8% of 6th-12th graders smoked a cigarette in the past-30- days in 2015 and 2016 respectively for a mean of 5.9%. If 15.3% of past-30-day teen smoking was/is attributable to prior e-cig use, e-cigs would be attributable for just 0.9% of the 5.9% of past-30-day teen cigarette smokers in 2015/16.

As such, in a purported attempt to prevent 1% of teens from becoming cigarette smokers in the future, the FDA’s draft guidance (by banning sales of 99.9% of flavored vapor products at stores that allow youth entry) is threatening the lives of nearly 20% of US adults (who smoke cigarettes and/or vape).

A meta analysis published in JAMA Pediatrics found non past-30-day teen smokers who were past-30-day e-cig users (at baseline) were 4.28 more likely than non past-30-day users of cigarettes or e-cigs (at baseline) to report past-30-day cigarette smoking (21.5% vs 4.6%) at followup (typically two years later).
e-Cigarette Use and Subsequent Cigarette Smoking in Adolescents and Young Adults

Per FDA’s comments to the news media and public about policy changes in the draft guidance, it appears FDA relied upon cherry picked data from the 2018 NYTS data, while ignoring data from that and other DHHS surveys that refute and contradict FDA’s public claims.
Historical NYTS Data and Documentation | CDC

As the data show, lifetime, past 30 day, frequent and daily cigarette smoking by 6-12th graders have sharply declined since 2011 as e-cigarette use has increased.

Cumulative Number of Cigarettes 6th-12th graders (%) Smoked in their Lifetime (NYTS)
Cigs 2011 2012 2013 2014 2015 2016 2017 2018
0 70.1 73.3 74.4 77.3 77.7 79.3 82.8 82.3
<1 28.1 25.2 23.9 21.4 20.8 18.7 16.6 16.9
1+ 19.3 17.1 15.4 13.5 13.2 10.9 10.2 10.5
2+ 17.0 15.3 13.7 11.7 11.5 9.3 8.8 8.9
6+ 12.4 10.9 9.7 7.8 7.6 7.3 6.0 6.0
16+ 9.8 8.4 7.6 5.8 5.6 5.5 4.4 4.7
26+ 8.1 6.9 6.3 4.7 4.5 4.3 3.6 3.7
100+ 5.5 4.5 4.3 3.2 2.9 2.9 2.2 2.4

Cumulative Number of Days in Lifetime Using an E-cigarette (6-12th graders: NYTS)
Days 2015 2016 2017 2018
0 74.3 77.1 78.3 73.6
1 7.3 6.5 6.4 6.2
>1 16.8 15.1 14.1 18.0
>10 9.3 8.3 7.5 11.0
>20 6.4 5.7 5.1 8.3
>50 3.8 3.6 3.1 5.8
>100 2.1 2.1 1.9 3.9

Cumulative Days Smoked a Cigarette in Past-30-Days by 6-12th graders (%) NYTS
Days 2011 2012 2013 2014 2015 2016 2017 2018
0 86.6 88.8 89.6 91.8 91.8 93.3 93.4 93.1
1+ 10.5 9.3 8.2 6.1 6.0 5.8 5.6 5.9
3+ 7.3 6.2 5.6 3.8 3.8 3.7 3.3 3.5
6+ 5.8 4.9 4.5 3.0 2.8 3.0 2.4 2.6
10+ 4.8 4.1 3.7 2.4 2.3 2.5 1.9 2.1
20+ 3.5 3.0 2.7 1.8 1.7 1.8 1.3 1.4
All 30 2.5 2.1 2.0 1.3 1.2 1.3 0.9 1.0

Cumulative Days Used an E-cigarette in Past-30-Days by 6-12th graders (%) NYTS
Days 2014 2015 2016 2017 2018
0 89.3 87.4 90.0 90.6 84.4
1+ 9.1 11.2 8.4 8.2 13.5
3+ 4.8 6.2 4.9 4.8 8.7
6+ 3.3 4.2 3.1 3.2 6.6
10+ 2.3 2.8 2.2 2.5 5.2
20+ 1.4 1.7 1.4 1.6 3.5
All 30 0.9 1.1 1.1 1.1 2.4

Past-30-day Cigarette / E-cigarette use by 6-12th graders (NYTS)
Year Cigarette / E-cigarette
2011 10.5% / 1.0%
2012 9.3% / 2.0%
2013 8.2% / 2.9%
2014 6.1% / 9.1%
2015 6.0% / 11.2%
2016 5.8% / 8.4%
2017 5.6% / 8.2%
2018 5.9% / 13.5%

6th-12th graders who smoked a cigarette daily in past 30 days vs those who used an e-cigarette daily (NYTS)
2011 2012 2013 2014 2015 2016 2017 2018
2.5% 2.1% 2.0% 1.3% 1.2% 1.3% 0.9% 1.0% Daily Cigarette Smoking
0.9% 1.1% 1.1% 1.1% 2.4% Daily E-cigarette Use

6th-12th graders who smoked a cigarette 20+ of past 30 days vs those who used an e-cigarette 20+ days (NYTS)
2011 2012 2013 2014 2015 2016 2017 2018
3.5% 3.0% 2.7% 1.8% 1.7% 1.8% 1.3% 1.4% Smoked Cigarettes 20+ Days
1.4% 1.7% 1.4% 1.6% 3.5% Used E-cigarettes 20+ Days

6th-12th grade students who last smoked a cigarette (even one puff) “today” (NYTS)
2011 – 3.7%
2012 – 3.0%
2013 – 2.9%
2014 – 2.0%
2015 – 2.0%
2016 – 1.9%
2017 – 1.3%
2018 – 1.4%

6th-12th grade students who last smoked a cigarette (even one puff) during past “week” (NYTS)
2011 – 7.8%
2012 – 6.6%
2013 – 6.0%
2014 – 4.3%
2015 – 4.4%
2016 – 3.9%
2017 – 3.3%
2018 – 2.0%

Brad Rodu’s analysis of 2018 NYTS data reveals the changing patterns of vaping and cigarette smoking among high school students in 9th-12th grade.
Tobacco Truth: Some FDA Claims About Teen Vaping Confirmed, Others Evaporate

Brad Rodu: The FDA’s Teen E-Cigarette-Addiction Epidemic Doesn’t Add Up
Tobacco Truth: The FDA’s Teen E-Cigarette-Addiction Epidemic Doesn’t Add Up
Reveals the 2017 NYTS found that just 1.24% of nonsmoking high school students used an e-cigarette on 20 or more of the past 30 days (hardly an epidemic of addiction).

Brad Rodu revealed the 2017 NYTS found that 18+ adults comprised 18.5% of e-cigarette users in grades 9-12 (including 16% of exclusive e-cig users, and 23% of dual users).
Brad Rodu: Not all teen smokers & vapers are lawbreakers
Tobacco Truth: Not All Teen Smokers & Vapers Are Lawbreakers

Brad Rodu revealed the 2017 NYTS found 53% of past 30 day cigarette smokers in 9th-12th grade also used e-cigarettes in the past 30 days (.042/.079=.53), and accounted for 35% of 9th-12th graders who used an e-cigarette in the past 30 days (.042/.119=.35).
Tobacco Truth: Slight Teen Vaping Increase and A Continued Smoking Decline in 2017

Brad Rodu revealed the 2016 NYTS found 53% of past 30 day cigarette smokers in 9th-12th grade also used e-cigarettes in the past 30 days (.044/.083=.53), and accounted for 38% of 9th-12th graders who used an e-cigarette in the past 30 days (.044/.116=.38)
Tobacco Truth: 1.7 Million High Schoolers Vaped in 2016, As Both Vaping and Smoking Declined
Tobacco Truth: Slight Teen Vaping Increase and A Continued Smoking Decline in 2017

Brad Rodu revealed the 2015 NYTS found 56% of past 30 day cigarette smokers in 9th-12th grade also used e-cigarettes in the past 30 days (.054/.096=.56), and accounted for 33% of 9th-12th graders who used an e-cigarette in the past 30 days (.054/.162=.33)
Tobacco Truth: 1.7 Million High Schoolers Vaped in 2016, As Both Vaping and Smoking Declined
Tobacco Truth: Slight Teen Vaping Increase and A Continued Smoking Decline in 2017

Brad Rodu revealed the 2015, 2016 and 2017 NYTS found that 56%, 53% and 53% respectively of past 30 day cigarette smokers in 9th-12th grade also used an e-cigarette in
the past 30 days, and accounted for 33%, 38% and 35% respectively of 9th-12th graders who used an e-cigarette in the past 30 days in 2015, 2016 and 2017.
Tobacco Truth: Slight Teen Vaping Increase and A Continued Smoking Decline in 2017

Brad Rodu revealed the 2016 NYTS found 22% of 9th-12th graders who used e-cigarettes and smoked tobacco in past 30 days vaped e-cigs on all 30 days, compared to 8% who exclusively used e-cigarettes in past 30 days. Rodu also revealed 27% of 9th-12th graders who used e-cigarettes and smoked tobacco in past 30 days used e-cigarettes on 20+ of past 30 days, compared to 12% who exclusively used e-cigarettes in past 30 days.
https://rodutobaccotruth.blogspot.com/2018/01/17-million-high-schoolers-vaped-in-2016.html

Rodu also revealed the 2016 NYTS found 48% of exclusive past 30 day e-cigarette users in 9th-12th grade used e-cigarettes on just 1 or 2 of past 30 days, compared to 24% who used e-cigarettes and smoked tobacco in past 30 days. Rodu also revealed 69% of exclusive past 30 day e-cigarette users in 9th-12th grade used e-cigarettes on 1-5 of past 30 days, compared to 50% who used e-cigarettes and smoked tobacco in past 30 days.


The 2018 NIDA funded MTF survey also found sharp declines in daily and past 30 day cigarette smoking by 8th-12th graders.
http://monitoringthefuture.org/data/18data.html#2018data-drugs

MTF Daily Cigarette Smoking Rates (%) for 8th, 10th and 12th Graders
Grade 2010 2011 2012 2013 2014 2015 2016 2017 2018
8th 2.9 2.4 1.9 1.8 1.4 1.3 0.9 0.6 0.8
10th 6.6 5.5 5.0 4.4 3.2 3.0 1.9 2.2 1.8
12th 10.7 10.3 9.3 8.5 6.7 5.5 4.8 4.2 3.6
http://monitoringthefuture.org/data/18data/18drtbl4.pdf

MTF Daily Cigarette Smoking Rates (%) by 8th, 10th and 12th Graders Combined
2010 2011 2012 2013 2014 2015 2016 2017 2018
6.4 5.7 5.2 4.7 3.6 3.2 2.5 2.3 2.0
http://monitoringthefuture.org/data/18data/18drtbl8.pdf

MTF Past 30 Day Cigarette Smoking Rates (%) for 8th, 10th and 12th Graders
Grade 2010 2011 2012 2013 2014 2015 2016 2017 2018
8th 7.1 6.1 4.9 4.5 4.0 3.6 2.6 1.9 2.2
10th 13.6 11.8 10.8 9.1 7.2 6.3 4.9 5.0 4.2
12th 19.2 18.7 17.1 16.3 13.6 11.4 10.5 9.7 7.6
http://monitoringthefuture.org/data/18data/18drtbl3.pdf

MTF: Past 30 Day Cigarette Smoking Rate (%) for 8th, 10th and 12th Graders Combined
2010 2011 2012 2013 2014 2015 2016 2017 2018
12.8 11.7 10.6 9.6 8.0 7.0 5.9 5.4 4.6
http://monitoringthefuture.org/data/18data/18drtbl7.pdf


Consistently, the CDC NHIS survey found that smoking by 18-24 year old adults declined by more than half from 2009-2017 (from 21.8% to 10.4%) as many switched from cigarettes to vaping. Meanwhile cigarette smoking rates by adults over 25 declined at a slower rate.

NHIS Adult Cigarette Smoking Rates by Age
Year Total 18-24 25-44 45-64 65+
2007 19.8 22.2 22.8 21.0 8.3
2008 20.6 21.4 23.7 22.6 9.3
2009 20.6 21.8 24.0 21.9 9.5
2010 19.3 20.1 22.0 21.1 9.5
2011 19.0 18.9 22.1 21.4 7.9
2012 18.1 17.3 21.6 19.5 8.9
2013 17.8 18.7 20.1 19.9 8.8
2014 16.8 16.7 20.0 18.0 8.5
2015 15.1 13.0 17.7 17.0 8.4
2016 15.5 13.1 17.6 18.0 8.8
2017 14.0 10.4 16.1 16.1 8.2
https://www.cdc.gov/mmwr/volumes/67/wr/mm6744a2.htm
https://ftp.cdc.gov/pub/Health_Statistics/NCHS/NHIS/SHS/2017_SHS_Table_A-12.pdf
https://www.cdc.gov/mmwr/volumes/67/wr/mm6702a1.htm
https://ftp.cdc.gov/pub/Health_Statistics/NCHS/NHIS/SHS/2016_SHS_Table_A-12.pdf
https://www.cdc.gov/mmwr/volumes/66/wr/mm665152a7.htm
https://www.cdc.gov/mmwr/volumes/66/wr/mm6644a2.htm
https://ftp.cdc.gov/pub/Health_Statistics/NCHS/NHIS/SHS/2015_SHS_Table_A-12.pdf
https://www.cdc.gov/nchs/data/databriefs/db217.htm
https://www.cdc.gov/nchs/data/databriefs/db217.pdf
https://ftp.cdc.gov/pub/Health_Statistics/NCHS/NHIS/SHS/2014_SHS_Table_A-12.pdf
https://www.cdc.gov/mmwr/volumes/65/wr/mm6527a1.htm
https://www.cdc.gov/mmwr/preview/mmwrhtml/mm6444a2.htm
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5779518/
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5779518/
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4584648/
https://www.cdc.gov/mmwr/preview/mmwrhtml/mm6144a2.htm
https://www.cdc.gov/mmwr/preview/mmwrhtml/mm6035a5.htm
https://www.cdc.gov/mmwr/preview/mmwrhtml/mm5935a3.htm
https://www.cdc.gov/mmwr/preview/mmwrhtml/mm5844a2.htm


Vaping is far less harmful than cigarette smoking

Public Health England: E-cigarettes around 95% less harmful than tobacco estimates landmark review

Key findings of the review include:
• the current best estimate is that e-cigarettes are around 95% less harmful than smoking
• nearly half the population (44.8%) don’t realise e-cigarettes are much less harmful than smoking
• there is no evidence so far that e-cigarettes are acting as a route into smoking for children or non-smokers
https://www.gov.uk/government/news/...armful-than-tobacco-estimates-landmark-review
https://www.gov.uk/government/publications/e-cigarettes-an-evidence-update


No evidence daily nicotine use increases human disease risk

Despite repeated claims by the FDA, CDC, SG and other DHHS agencies since 1987 that
“nicotine is addictive”, there is no evidence that daily nicotine use harms humans (which is a prerequisite for a drug addiction, and was why FDA approved NRT for long term use).

And despite repeated claims by the FDA, CDC, SG and other DHHS agencies in recent years, there is no evidence that youth nicotine use increases risk of brain damage, as rodents are NOT humans, and all the cited studies involved rodents (not humans).


Nicotine is very similar to caffeine

According to the Royal Society for Public Health, nicotine is very similar to caffeine
• Nicotine and caffeine temporarily increase BP and heart rate.
• Nicotine and caffeine can create daily dependence.
• No evidence daily nicotine or caffeine use increase disease risks.
• Nicotine “no more harmful to health than caffeine”
https://www.rsph.org.uk/about-us/news/nicotine--no-more-harmful-to-health-than-caffeine-.html


Most youth who vape obtain products from social sources, not retailers

NYTS - Sources of e-cigarettes (6th-12th graders, includes 8% who were 18+ years)
During the past 30 days, where did you get or buy the e-cigarettes that you have used? (Select one or more)
2015 2016 2017 2018
82.1% 85.6% 79.8% - I have never tried an e-cigarette in the past 30 days
10.1% 8.9% 7.6% 10.3% - From a friend
4.2% 3.1% 2.1% 2.9% - From family member
4.0% 3.0% 1.8% 3.4% - A vape shop or other store that only sells e-cigarettes
1.9% 1.7% 1.1% 1.7% - From some other person not a family member or a friend
2.5% 1.8% 1.0% 1.9% - A gas station or convenience store
1.1% 1.2% 0.7% 0.9% - On the internet
0.8% 0.5% 0.3% 0.5% - A drug store
0.9% 0.6% 0.3% 0.4% - A mall or shopping center kiosk/stand
0.5% 0.3% 0.1% 0.3% - A grocery store
0.9% 0.7% 0.4% 0.5% - Some other place not listed here

Brad Rodu revealed 2017 NYTS data for sources of vapor products among the 9.3% of 9th-12th graders <18 years who vaped in the past 30 days. “During the past 30 days, where did you get or buy the e-cigarettes that you have used? (Select one or more)”
64.0% - From a friend
5.8% - From family member
11.8% - A vape shop
4.7% - On the internet
4.0% - From some other person that is not a family member or friend
3.4% - A gas station or convenience store
1.2% - A drug store
1.4% - A mall or shopping center kiosk/stand
<1% - A grocery store
3.6% - Some other place not listed her
https://rodutobaccotruth.blogspot.com/2018/10/not-all-teen-smokers-vapers-are.html

Brad Rodu revealed 2014-15 PATH data for sources of e-cigarettes by 12-17 year olds who used an e-cigarette in past 30 days
https://rodutobaccotruth.blogspot.com/2018/04/fda-is-targeting-e-cigarette-retailers.html
In the past 30 days, how did you usually get your own e-cigarette/cartridges and e-liquid?
46% - Someone offered me one
16% - Gave someone else money to buy them
9.9% - Bought them myself
9.7% - Asked someone to give me one
6.9% - Got them some other way
4.1% - Took them from a store or another person
3.2% - Bought them from another person
4.2% - Don’t know, refused to answer
100% - Total


During the past 30 days, how did you get your own tobacco products? (Select One or More) (6th-12th graders, includes 8% who were 18+ years, NYTS)
2014 2015 2016 2017 2018
83.6% 81.7% 86.0% 86.2% 84.1% - I did not get any during the past 30 days
4.6% 4.5% 3.7% 3.2% 3.5% - I had someone else buy them for me
5.4% 4.9% 3.3% 2.9% 3.1% - Someone offered them to me
4.2% 4.3% 3.6% 2.9% 3.5% - I bought them myself
3.3% 3.1% 2.5% 2.1% 2.2% - I asked someone to give me some
1.3% 1.4% 1.1% 1.1% 1.6% - I bought them from another person
0.9% 1.0% 0.6% 0.6% 0.6% - I took them from a store or another person
2.6% 2.5% 2.2% 1.5% 2.1% - I got them some other way

During the past 30 days, where did you buy your own tobacco products? (Select One or More) (6th-12th graders, includes 8% who were 18+ years, NYTS)
2014 2015 2016 2017 2018
89.1% 87.3% 90.2% 89.8% 87.3% - I did not buy tobacco products in the past 30 days
5.5% 5.1% 3.8% 3.6% 3.8% - A gas station or convenience store
0.8% 1.1% 0.9% 0.7% 0.8% - A drug store
0.4% 0.6% 0.7% 0.5% 0.6% - On the internet
0.9% 0.8% 0.8% 0.4% 0.7% - A grocery store
0.5% 0.3% 0.4% 0.3% 0.3% - A vending machine
0.2% 0.3% 0.4% 0.2% 0.3% - Through the mail
2.9% 2.8% 2.8% 2.2% 3.3% - Some other place not listed here


Youth engage in many far more harmful behaviors than nicotine use

High School students engage in far more harmful behaviors than vaping and nicotine use (according to CDC’s 2017 YRBS)
https://www.cdc.gov/mmwr/volumes/67/ss/ss6708a1.htm
• 39.2% texted or e-mailed while driving in past 30 days
• 5.9% rarely or never used a seat belt when riding in a car
• 5.5% drank alcohol and drove in past 30 days
• 16.5% rode in a vehicle in past 30 days driven by someone who had drank alcohol
• 13.5% binge drank alcohol (i.e. 4+ drinks) in past 30 days
• 14.0% ever used prescription pain medicine without a doctor’s prescription
• 23.6% were in a physical fight in past year
• 7.4% were forced to have sexual intercourse when they did not want to
• 7.4% attempted suicide in past year
• 17.2% seriously considered attempting suicide in past year
• 14.8% were obese

 

[zoiDman]

Thank You for All you do Bill.

 

[Bill Godshall]

My biggest concern about FDA's draft guidance (that bans sales of vast majority of flavored vapor products at stores that allow youth to enter the store) is that nobody will challenge it in federal court because:
- suing the FDA could cost $500,000 - $1M each year for the next three years,
- FDA's Deeming Rule is going to ban sales of >99.9% of nicotine vapor products on 8/8/2022 (or 8/8/2021 if nobody challenges the draft guidance in court and if FDA strictly imposes it),
- the cost of even successful litigation exceeds the profits that can be earned by the vast majority of affected manufacturers, wholesalers and retailers during the next three or four years.

Hopefully, a vapor manufacturer, wholesaler, retailer and/or trade associations will challenge FDA's flavored vapor sales ban in federal court.