Understanding Nicotine Reduction Strategies for Tobacco Regulation

 
Nicotine Reduction Strategy
 
Dorothy Hatsukami, PhDi
Professor of Psychiatry and Behavioral Sciences
Associate Director, Masonic Caner Center
University of Minnesota
 
 
Funding from NIDA, NCI and FDA
None of my comments reflect the opinion of these agencies
 
Disclosures
 
FDA’s Nicotine Strategy
 
FDA Announcement: Comprehensive Plan for
Tobacco and Nicotine Regulation (July 28,
2017)
Envisioning a world where cigarettes would no longer
create or sustain addiction, and where adults who still need
or want nicotine could get it from alternative and less
harmful sources….”
Continuum of Risk
T
h
e
r
e
 
i
s
 
a
 
c
o
n
t
i
nuum
 
risk for 
 n
i
c
o
t
i
n
e
-
c
o
nt
a
i
n
i
ng
 
p
r
o
ducts
 where
combusted products are the most toxic
Nicotine maintains addiction but other constituents kill people
Ultimate goal is  abstinence from all nicotine products
But for people unable or unwilling to quit, the goal is to shift them
to lower risk products
C
OM
B
U
S
TIBL
E
S
N
RT
NON-COMBUSTED PRODUCTS
Push
Reducing Addictiveness of Cigarette
Dose to reduce
addictiveness is 
<
 0.4 mg/g
tobacco
Reduced cigarettes smoked
Reduced dependence and urges
Increased quit attempts
Resulted in no compensatory
smoking
Reduced CPD, smoke exposure
and/or dependence in
vulnerable populations, youth
and non-daily smokers.
   
Higgins et al.,, 2020; Cassidy et al., 2018;
Tidey et al., NTR, 2019; Shiffman et al.,
2018
Donny et al., 2015; WHO, 2019
 
Concerns about Immediate Nicotine Reduction
Immediate nicotine
reduction is
associated with:
Greater withdrawal
symptoms
Higher drop-out rates
Higher non-compliance
with using only study
cigarettes
 
Some smokers will seek other nicotine
sources
Continuum of Risk
 
T
h
e
r
e
 
i
s
 
a
 
c
o
n
t
i
nuum
 
risk for 
 n
i
c
o
t
i
n
e
-
c
o
nt
a
i
n
i
ng
 
p
r
o
ducts
Nicotine maintains addiction but other constituents kill people
Ultimate goal is  abstinence from all nicotine products
But for people unable or unwilling to quit, the goal is to shift them
to lower risk products
 
C
OM
B
U
S
TIBL
E
S
 
N
RT
 
NON-COMBUSTED PRODUCTS
 
Reduced Nicotine Content vs. Normal Nicotine Content Cigarette
plus ANDS
 
Greatest uptake of ANDS in the VLNC group.
Greater uptake of non-combusted products was
significantly  (p< 0.001) associated with:
 
Greater reductions in combusted product use
 
Greater number of days abstinent from combusted products
 
Lower carcinogen exposure
 
Hatsukami et al., Addiction, 2016
Continuum of Risk
T
h
e
r
e
 
i
s
 
a
 
c
o
n
t
i
nuum
 
risk for 
 n
i
c
o
t
i
n
e
-
c
o
nt
a
i
n
i
ng
 
p
r
o
ducts
Nicotine maintains addiction but other constituents kill people
Ultimate goal is  abstinence from all nicotine products
But for people unable or unwilling to quit, the goal is to shift them
to lower risk products
C
OM
B
U
S
TIBL
E
S
N
RT
NON-COMBUSTED PRODUCTS
 
Diversity of E-cigarettes
 
Multitude of Flavors
 
Supporters
 
H
a
r
m
 
R
e
d
u
c
i
n
g
 
Harm Elevating
 
D
i
s
r
u
p
t
i
v
e
 
t
e
c
h
n
o
l
o
g
y
s
h
i
f
t
i
n
g
 
s
m
o
k
e
r
s
 
a
w
a
y
 
f
r
o
m
c
i
g
a
r
e
t
t
e
s
R
e
g
u
l
a
t
i
o
n
s
 
t
o
 
p
r
o
m
o
t
e
 
s
h
i
f
t
 
Uptake among youth
Effects on the developing brain
Gateway to combusted product use
Dual use is common
Harmful to health
 
 
Opposers
 
Harm Reducing
 
H
a
r
m
 
E
l
e
v
a
t
i
n
g
 
Reduced toxicant exposure
Cessation of combusted
Products
Emerging evidence of efficacy
 
U
p
t
a
k
e
 
a
m
o
n
g
 
y
o
u
t
h
E
f
f
e
c
t
s
 
o
n
 
t
h
e
 
d
e
v
e
l
o
p
i
n
g
 
b
r
a
i
n
G
a
t
e
w
a
y
 
t
o
 
c
o
m
b
u
s
t
e
d
 
p
r
o
d
u
c
t
u
s
e
D
u
a
l
 
u
s
e
 
i
s
 
c
o
m
m
o
n
H
a
r
m
f
u
l
 
t
o
 
h
e
a
l
t
h
 
 
 
Toxicity
: Minimize toxicity
Appeal
: flavors (only tobacco and menthol);
Addictiveness
: cap on nicotine
Communication:
  Relative risk of the product
Evaluation of ENDS After Devaluing Cigarettes to Promote
Switching but Prevent Uptake among Non-users
Continuum of Risk
T
h
e
r
e
 
i
s
 
a
 
c
o
n
t
i
nuum
 
risk for 
 n
i
c
o
t
i
n
e
-
c
o
nt
a
i
n
i
ng
 
p
r
o
ducts
Nicotine maintains addiction but other constituents kill people
Ultimate goal is  abstinence from all nicotine products
But for people unable or unwilling to quit, the goal is to shift them
to lower risk products
C
OM
B
U
S
TIBL
E
S
N
RT
M
a
r
c
h
 2,
 
2016
 
| 
 
S
R
N
T
 
P
r
e
-
C
o
n
f
eren
ce
Mitch Zeller (Modified)
NON-COMBUSTED PRODUCTS
Continuum of Risk
 
T
h
e
r
e
 
i
s
 
a
 
c
o
n
t
i
nuum
 
risk for 
 n
i
c
o
t
i
n
e
-
c
o
nt
a
i
n
i
ng
 
p
r
o
ducts
Nicotine maintains addiction but other constituents kill people
Ultimate goal is  abstinence from all nicotine products
But for people unable or unwilling to quit, the goal is to shift them
to lower risk products
 
C
OM
B
U
S
TIBL
E
S
 
N
RT
 
NON-COMBUSTED PRODUCTS
Rapid elimination of combusted products
Reduce gateway effect and dual use
Reduce uptake among youth; promote uptake in smokers
Assure non-combusted products are reduced risk
Provide smokers with NRT that are more effective
 
Smacks of prohibition
Not banning cigarettes
Other less harmful nicotine containing products are available
Limiting continued use of a highly toxic product
Shifting smokers could occur without a draconian measure
Shifting will occur faster, preventing many more lives lost (i.e., herd immunity vs.
vaccine)
Non-supporters of e-cigarettes are going to come to their senses with
increasing evidence of less harm
Reassurance that we are not creating another generation of nicotine addicted
individuals
Controversies
 
8.5 million tobacco related deaths would be averted by 2100 if a
nicotine product standard was implemented in the U.S. alone. 
 
   
Apelberg et al., NEJM, 201
   
  
 
 
 
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This information discusses the importance of reducing nicotine content in tobacco products to lower addiction levels and overall harm. It emphasizes the FDA's comprehensive plan for tobacco and nicotine regulation, aiming to shift users to less harmful alternatives. Immediate reduction in nicotine has shown benefits in reducing cigarettes smoked and dependence, leading to increased quit attempts without compensatory smoking. However, concerns exist regarding withdrawal symptoms and non-compliance.


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  1. Nicotine Reduction Strategy Dorothy Hatsukami, PhDi Professor of Psychiatry and Behavioral Sciences Associate Director, Masonic Caner Center University of Minnesota

  2. Disclosures Funding from NIDA, NCI and FDA None of my comments reflect the opinion of these agencies

  3. FDAs Nicotine Strategy FDA Announcement: Comprehensive Plan for Tobacco and Nicotine Regulation (July 28, 2017) Envisioning a world where cigarettes would no longer create or sustain addiction, and where adults who still need or want nicotine could get it from alternative and less harmful sources .

  4. Continuum of Risk There is a continuum risk for nicotine-containing products where combusted products are the most toxic Nicotine maintains addiction but other constituents kill people Ultimate goal is abstinence from all nicotine products But for people unable or unwilling to quit, the goal is to shift them to lower risk products COMBUSTIBLES NRT NON-COMBUSTED PRODUCTS Reduce appeal and addictiveness Push

  5. Reducing Addictiveness of Cigarette Immediate reduction in nicotine is the best approach et al., JAMA, 2018 Dose to reduce addictiveness is < 0.4 mg/g tobacco Reduced cigarettes smoked Reduced dependence and urges Increased quit attempts Resulted in no compensatory smoking Reduced CPD, smoke exposure and/or dependence in vulnerable populations, youth and non-daily smokers. Higgins et al.,, 2020; Cassidy et al., 2018; Tidey et al., NTR, 2019; Shiffman et al., 2018 Hatsukami Donny et al., 2015; WHO, 2019 12.00 10.00 Immedia te Gradual Days Abstinent 8.00 6.00 4.00 2.00 0.00 Week 20

  6. Concerns about Immediate Nicotine Reduction Immediate nicotine reduction is associated with: 10 MNWS total score, Mean 8 6 Greater withdrawal symptoms Gradual Immediate 4 Control Higher drop-out rates 2 Higher non-compliance with using only study cigarettes 0 -91 0 1 2 3 4 8 10 12 14 16 18 20 Week 6 Some smokers will seek other nicotine sources

  7. Continuum of Risk There is a continuum risk for nicotine-containing products Nicotine maintains addiction but other constituents kill people Ultimate goal is abstinence from all nicotine products But for people unable or unwilling to quit, the goal is to shift them to lower risk products COMBUSTIBLES NRT NON-COMBUSTED PRODUCTS

  8. Reduced Nicotine Content vs. Normal Nicotine Content Cigarette plus ANDS Greatest uptake of ANDS in the VLNC group. Greater uptake of non-combusted products was significantly (p< 0.001) associated with: Greater reductions in combusted product use Greater number of days abstinent from combusted products Lower carcinogen exposure Hatsukami et al., Addiction, 2016

  9. Continuum of Risk There is a continuum risk for nicotine-containing products Nicotine maintains addiction but other constituents kill people Ultimate goal is abstinence from all nicotine products But for people unable or unwilling to quit, the goal is to shift them to lower risk products COMBUSTIBLES NRT NON-COMBUSTED PRODUCTS Regulate

  10. Diversity of E-cigarettes

  11. Multitude of Flavors

  12. Supporters Harm Elevating Uptake among youth Effects on the developing brain Gateway to combusted product use Dual use is common Harmful to health Harm Reducing Disruptive technology shifting smokers away from cigarettes Regulations to promote shift

  13. Opposers Harm Elevating Uptake among youth Effects on the developing brain Gateway to combusted product use Dual use is common Harmful to health Harm Reducing Reduced toxicant exposure Cessation of combusted Products Emerging evidence of efficacy

  14. Evaluation of ENDS After Devaluing Cigarettes to Promote Switching but Prevent Uptake among Non-users Toxicity: Minimize toxicity Appeal: flavors (only tobacco and menthol); Addictiveness: cap on nicotine Communication: Relative risk of the product

  15. Continuum of Risk There is a continuum risk for nicotine-containing products Nicotine maintains addiction but other constituents kill people Ultimate goal is abstinence from all nicotine products But for people unable or unwilling to quit, the goal is to shift them to lower risk products COMBUSTIBLE S NRT NON-COMBUSTED PRODUCTS Innovate March 2, 2016 | SRNT Pre-Conference Mitch Zeller (Modified)

  16. Continuum of Risk There is a continuum risk for nicotine-containing products Nicotine maintains addiction but other constituents kill people Ultimate goal is abstinence from all nicotine products But for people unable or unwilling to quit, the goal is to shift them to lower risk products COMBUSTIBLE S NRT NON-COMBUSTED PRODUCTS Reduce addictiveness Regulate Innovate Rapid elimination of combusted products Reduce gateway effect and dual use Reduce uptake among youth; promote uptake in smokers Assure non-combusted products are reduced risk Provide smokers with NRT that are more effective

  17. Controversies Smacks of prohibition Not banning cigarettes Other less harmful nicotine containing products are available Limiting continued use of a highly toxic product Shifting smokers could occur without a draconian measure Shifting will occur faster, preventing many more lives lost (i.e., herd immunity vs. vaccine) Non-supporters of e-cigarettes are going to come to their senses with increasing evidence of less harm Reassurance that we are not creating another generation of nicotine addicted individuals

  18. 8.5 million tobacco related deaths would be averted by 2100 if a nicotine product standard was implemented in the U.S. alone. Apelberg et al., NEJM, 201

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