http://www.jstc.or.jp/
E-mail desk@nosmoke55.jp〒162-0063 東京都新宿区市谷薬王寺町 30-5-201
Tel 03-5360-8233 FAX 03-5360-6736

To the honorable Swedish ambassador,
On November 27, a meeting to promote heated tobacco and nicotine vapor will take place at yourdistinguished embassy:	 
“This	 is	 the	 Embassy	 of	 Sweden,	 Commercial	 Affairs	 Division.	 	 
We	 will	 hold	 a	 seminar	 on	 tobacco	 "Country	 Specific	 Experience	 In	 Tobacco	 Control	 –	 the	 status	 of	 tobacco	 regulations	 in	 3	 countries:	 	 Japan,	 the	 UK	 and	 Sweden"	 at	 the	 Swedish	 Embassy	 on	 27	 November	 2018.	 	 
This	 seminar	 will	 present	 and	 discuss	 the	 current	 status	 of	 tobacco	 regulations	 and	 trends	 
in	 new	 nicotine	 products	 that	 are	 replacing	 tobacco	 in	 three	 countries:	 Sweden,	 the	 UK,	 Japan.	 	 
In	 this	 regard,	 we	 would	 like	 to	 cordially	 invite	 you	 to	 participate	 in	 this	 event,	 as	 described	 below.	 	 	 [Date	 and	 Time]:	 27	 November	 2018	 (Tuesday)	 13:	 00-17:	 00	 seminar	 (reception	 from	 13:	 00),	 
18:	 00	 social	 gathering	 
[Registration	 fee]:	 Free	 [Place]:	 Embassy	 of	 Sweden,	 Alfred	 Nobel	 Auditorium	 (1-10-3,	 Roppongi,	 Minato-ku,	 Tokyo	 106-0032)“	 Two Japanese people will speak at this lecture, both of whom have relationships with the tobacco
industry, and as I previously appealed in a letter written to the honorable Mr. Adhanom of the WHO
director general, there is certainly a conflict of interest due to these people from the tobacco
industry. The expenses of the social gathering will also be paid by the tobacco industry.

Is it appropriate for such a meeting to be held at the Swedish Embassy, and moreover at thetraditional Alfred Nobel Auditorium?
Furthermore, at the COP 8 of the WHO Framework Convention on Tobacco Control (Geneva,Switzerland, 1-8 October 2018), it was resolved to “to prevent health claims from being made aboutnovel and emerging tobacco products”.
I humbly appreciate your reconsideration.
16 November 2018
General incorporated association Japan Society for Tobacco Control
Sakuta Manabu, Chairperson	  	  Dr	  Tedros	  Adhanom	  Ghebreyesus	  Director	  General	  World	  Health	  Organisation	  Avenue	  Appia	  20	  1202	  Geneva	  Switzerland	  Dear	  Dr.	  Adhanom	  Ghebreyesus	  1	  October	  2018	  Innovation	  in	  tobacco	  control:	  developing	  the	  FCTC	  to	  embrace	  tobacco	  harm	  reduction	  We	  write	  to	  express	  our	  hope	  that	  WHO	  will	  assume	  a	  leadership	  role	  in	  promoting	  effective	  and	  fast-­‐acting	  policies	  for	  regulating	  tobacco	  and	  nicotine.	  In	  this	  letter,	  we	  propose	  that	  WHO	  and	  related	  stakeholders	  adopt	  a	  more	  positive	  approach	  to	  new	  technologies	  and	  innovations	  that	  have	  the	  potential	  to	  bring	  the	  epidemic	  of	  smoking-­‐caused	  disease	  to	  a	  more	  rapid	  conclusion.	  
In	  the	  field	  of	  tobacco	  control	  and	  public	  health,	  the	  world	  has	  changed	  significantly	  since	  the	  Framework	  Convention	  on	  Tobacco	  Control	  was	  signed	  in	  2003.	  It	  is	  impossible	  to	  ignore	  or	  dismiss	  the	  rise	  of	  Alternative	  Nicotine	  Delivery	  Systems	  (ANDS).	  These	  are	  established	  and	  new	  technologies	  that	  deliver	  nicotine	  to	  the	  user	  without	  combustion	  of	  tobacco	  leaf	  and	  inhalation	  of	  tobacco	  smoke.	  These	  technologies	  offer	  the	  prospect	  of	  significant	  and	  rapid	  public	  health	  gains	  through	  ‘tobacco	  harm	  reduction’.	  Users	  who	  cannot	  or	  choose	  not	  to	  quit	  using	  nicotine	  have	  the	  option	  to	  switch	  from	  the	  highest	  risk	  products	  (primarily	  cigarettes)	  to	  products	  that	  are,	  beyond	  reasonable	  doubt,	  much	  lower	  risk	  than	  smoking	  products	  (e.g.	  pure	  nicotine	  products,	  low-­‐toxicity	  smokeless	  tobacco	  products,	  vaping	  or	  heated	  tobacco	  products).	  We	  believe	  this	  strategy	  could	  make	  a	  substantial	  contribution	  to	  the	  Sustainable	  Development	  Goal	  to	  reduce	  premature	  deaths	  through	  non-­‐communicable	  diseases	  (SDG	  Target	  3.4).	  
The	  concept	  of	  tobacco	  harm	  reduction	  is	  coded	  into	  the	  definition	  of	  ‘tobacco	  control’	  set	  out	  in	  the	  FCTC	  (Article	  1.d),	  and	  we	  believe	  it	  now	  needs	  to	  be	  fully	  expressed	  in	  the	  FCTC	  and	  by	  the	  Parties	  in	  their	  approach	  to	  implementation.	  To	  that	  end,	  we	  offer	  some	  guiding	  principles	  for	  your	  consideration	  for	  the	  development	  of	  the	  next	  phase	  of	  global	  tobacco	  control,	  starting	  from	  the	  next	  Conference	  of	  the	  Parties	  (COP-­‐8,	  1-­‐6	  October,	  Geneva).	  
•Tobacco	  harm	  reduction	  is	  integral	  to	  tobacco	  control.	  Harm	  reduction	  is	  a	  widely	  practiced	  strategy	  in	  public	  health	  (e.g.	  HIV,	  drug	  use,	  sexual	  health)	  and	  should	  become	  an	  integral	  component	  of	  tobacco	  control	  –	  helping	  smokers	  to	  quit	  smoking	  or	  diverting	  them	  from	  ever	  starting,	  and,	  in	  either	  case	  greatly	  reducing	  their	  risk.	   	  

•From	  a	  health	  perspective,	  the	  major	  distinction	  between	  nicotine	  products	  is	  whether	  they	  are	  combustible	  or	  non-­‐combustible.	  It	  is	  not	  whether	  they	  are	  tobacco	  or	  non-­‐tobacco	  products	  or	  whether	  they	  are	  established	  or	  novel.	  Given	  the	  principal	  focus	  of	  the	  FCTC	  is	  management	  of	  health	  risks,	  this	  distinction	  should	  be	  integral	  to	  the	  design	  and	  implementation	  of	  the	  FCTC1.	   	  1	   	  We	  recognise	  that	  poor	  production	  standards	  and	  the	  inclusion	  of	  slaked	  lime	  (calcium	  hydroxide),	  areca	  nut	  and	  other	  hazardous	  ingredients	  in	  some	  traditional	  tobacco-­‐containing	  products	  such	  as	  gutka	  and	  paan	  can	  make	  these	  products	  much	  more	  hazardous	  than	  other	  smokeless	  tobacco	  products.	  

•Tobacco	  harm	  reduction	  is	  supportive	  and	  synergistic	  with	  the	  ‘MPOWER’	  policies	  that	  underpin	  the	  FCTC.	  By	  providing	  more	  diverse	  options	  for	  users	  to	  respond	  to	  taxes	  or	  other	  measures,	  harm	  reduction	  can	  improve	  the	  effectiveness	  of	  conventional	  measures	  and	  mitigate	  the	  unintentional	  harmful	  consequences	  of	  such	  policies	  to	  continuing	  users,	  for	  example	  the	  impact	  of	  cigarette	  taxes	  on	  people	  who	  would	  otherwise	  continue	  to	  smoke.	   	  

•Stakeholders	  should	  give	  appropriate	  weight	  to	  the	  benefits	  and	  opportunities	  of	  tobacco	  harm	  reduction.	  They	  should	  not	  focus	  exclusively	  on	  unknown	  risks	  to	  health,	  especially	  when	  these	  are	  minor	  or	  improbable	  risks.	  A	  lost	  opportunity	  for	  a	  public	  health	  gain	  represents	  a	  real	  harm	  to	  public	  health,	  and	  should	  be	  recognised	  as	  such.	   	  

•Youth	  uptake	  of	  any	  tobacco	  or	  nicotine	  product	  demands	  a	  coherent	  and	  adaptable	  strategy	  focussed	  on	  reducing	  present	  and	  future	  harms	  to	  young	  people.	  Policies	  to	  address	  youth	  nicotine	  use	  should	  be	  based	  on	  an	  understanding	  of	  youth	  risk	  behaviours,	  the	  interactions	  between	  use	  of	  different	  products	  (for	  example,	  for	  some	  young	  smokers	  the	  potential	  displacement	  of	  smoking	  by	  low	  risk	  products	  may	  be	  beneficial),	  and	  due	  regard	  for	  the	  overall	  balance	  of	  harms	  and	  benefits	  to	  both	  adults	  and	  to	  youth	  arising	  from	  interventions.	   	  

•Uncertainty	  about	  long-­‐term	  effects	  should	  not	  be	  a	  reason	  for	  paralysis.	  It	  is	  true	  we	  will	  not	  have	  complete	  information	  about	  the	  impacts	  of	  new	  products	  until	  they	  have	  been	  used	  exclusively	  for	  several	  decades	  –	  and	  given	  the	  complex	  patterns	  of	  use,	  we	  may	  never.	  But	  we	  already	  have	  sufficient	  knowledge	  based	  on	  the	  physical	  and	  chemical	  processes	  involved,	  the	  toxicology	  of	  emissions,	  and	  biomarkers	  of	  exposure	  to	  be	  confident	  these	  non-­‐combustion	  products	  will	  be	  much	  less	  harmful	  than	  smoking.	  We	  also	  know	  with	  certainty	  that	  the	  incumbent	  product	  (cigarette)	  is	  extremely	  harmful.	   	  •FCTC	  and	  its	  implementation	  should	  embrace	  “risk-­‐proportionate	  regulation”.	  This	  means	  that	  the	  stringency	  of	  regulation	  or	  taxation	  applied	  to	  product	  categories	  should	  reflect	  risk	  to	  health.	  For	  example,	  there	  should	  be	  high	  taxes	  on	  cigarettes,	  but	  low	  or	  no	  taxes	  on	  vaping	  products.	  It	  is	  reasonable	  to	  ban	  all	  advertising	  of	  combustible	  products,	  but	  to	  place	  controls	  on	  advertising	  for	  non-­‐combustible	  products	  (to	  protect	  never-­‐smoking	  youth	  in	  particular)	  and	  so	  allow	  enough	  promotion	  so	  that	  smokers	  can	  still	  learn	  of	  alternatives	  and	  can	  be	  encouraged	  to	  switch.	  This	  risk-­‐proportionate	  approach	  should	  be	  adopted	  throughout	  the	  FCTC.	   	  

•WHO	  and	  Parties	  to	  the	  FCTC	  should	  be	  aware	  of	  and	  careful	  to	  avoid	  the	  harmful	  unintended	  consequences	  of	  prohibitions	  or	  excessive	  regulation.	  If	  WHO-­‐endorsed	  policies	  make	  non-­‐	  combustible	  alternatives	  to	  smoking	  less	  easily	  accessible,	  less	  palatable	  or	  acceptable,	  more	  expensive,	  less	  consumer	  friendly	  or	  pharmacologically	  less	  effective,	  or	  inhibit	  innovation	  and	  development	  of	  new	  and	  improved	  products,	  then	  these	  policies	  can	  cause	  harm	  by	  perpetuating	  smoking.	   	  

•The	  FCTC	  negotiations	  should	  become	  open	  to	  more	  stakeholders.	  There	  are	  many	  stakeholders,	  including	  consumers,	  the	  media	  and	  public	  health	  experts	  with	  pro-­‐harm-­‐reduction	  views,	  who	  should	  be	  part	  of	  the	  process.	  We	  are	  concerned	  that	  the	  FCTC	  has	  been	  excluding	  appropriately	  diverse	  perspectives	  and	  that	  its	  deliberations	  and	  decisions	  could	  be	  more	  robust	  and	  credible	  if	  its	  proceedings	  were	  more	  open.	   	  We	  are	  concerned	  that	  WHO	  and	  the	  Convention	  Secretariat	  are	  not	  embracing	  these	  principles	  and	  in	  many	  cases	  are	  doing	  the	  opposite.	  We	  have	  seen	  the	  more	  detailed	  letter	  to	  you	  of	  3	  September	  by	  Abrams	  et	  al	  regarding	  prohibition	  and	  excessive	  regulation2.	  We	  recommend	  that	  this	  letter	  be	  read	  carefully	  by	  everyone	  with	  an	  interest	  in	  the	  future	  of	  tobacco	  control.	  
We	  believe	  that	  it	  is	  time	  for	  tobacco	  control	  to	  embrace	  tobacco	  harm	  reduction.	  We	  hope	  that	  WHO	  and	  Parties	  to	  the	  FCTC	  will	  advance	  this	  agenda	  at	  the	  Eighth	  Conference	  of	  the	  Parties	  of	  the	  FCTC,	  starting	  today.	  We	  will	  share	  this	  letter	  with	  relevant	  stakeholders.	  
The	  authors	  of	  this	  letter	  confirm	  no	  conflicts	  of	  interest	  with	  respect	  to	  the	  tobacco	  industry	  and	  that	  no	  issues	  arise	  with	  respect	  to	  Article	  5.3	  of	  the	  FCTC.	  
Yours	  sincerely,	  Hiroya	  Kumamaru,	  MD,	  PhD	  Vice	  Director	  AOI	  International	  Hospital	  Kawasaki	  Japan	  Naohito	  Yamaguchi,	  MD	  Research	  Division	  Chief,	  Saiseikai	  Research	  Institute	  of	  Healthcare	  and	  Welfare	  Japan