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SJG:,V4 5th September 1 4
NOTS ON THE CURRMiT STATUS OF SUBSTITUMS
AND POLICY
Current trends In tobacco prices gives added t1ve
to exploring further use of reconstituted tobacco
and non-tobacco,
substitutes.. B.A.T. poLicy on the use of
subst:Ltutes has been
stated since 1962 as follows:
"We wlll not- use substitutes unless there
is a demonstrable advantage on health
grounds't.
Since that time our policy has been modified in
some respects
laxgely by the interpretation of what we mean by
"demonstrable
advantage". The present position. is that we
regard a =a;tQxia6L
as having a demonstrable advantage if it g1ves
cigarettes with
lower tax and lower rLicotine and with carbon
monoxide 'no higher
and shows no increase, in biological activity. The
11unter
Co=mittee Gdideli-mes have now helped us to
clarify what we 72eaa
by biological activity: this should cover an
examination of the
chemistry of _,-ka including mate=j,,ia such as
benzpyrana,
nitrosamines, hydrogency-anide, etc., it should
coven te3ts for
tumorigerLicity both by skin palnt:Lng and by
-inhalation, It, should.
also involve some general inhalation toxicology.
R=ter, Of coursev
is developing his Guidelines further to include
clinical and other
human studles. B.A.T. could go further than Hunter
in one respect:
we could take cognizance of the Initiat
on/promoticii hypothesis-
and aim to get both a reduction in total
tumorigenicity and in
promotion activity.
A list of substitutes and their present statu-s is
attached. . TO MY knowledg2 only tnwo of these are
likely at
present to shour a demonstrable advantage on
health grounds
that would satisfy us: these axe CYTIREL and NSM.-
Presumably We Would only use tobacco substlt7ates
if
they prove to be profitable in the broadest sense,
1.e. acceptable
to the consumer, acceptable to the cigarette
manufacturer, .-
available at the right price, etc. One other
condition, of'
coUrsQ, is that they would not contravene the law
in the market
for which the use is Intended. Before they are
used in any.
particul_-~r ma ket careiul consideration would
also have. to be
given to any change in the legal position with
respect to
consumers.
In my v wi the fact that tobacco substitutes have
been accepted 3For sale by the German Federal
Health 'Ministry
does not necessarily constitute a demonstrable
advantage on
health grounds or provide a basis for use in any
other country.
ihe tests carried out under the German law by
Professor Xrdle
consists only of simple pyrolysis tasts and
benzpyrena determin-
ation, on thi-s basis 13ATFL~~LKMI CYTIRET, and
NS4 have all. been cleared.
Equally although the Hunter Guidelines are ve-ry
=uch mora extensive
it dops not follow that clearance by Hunter 7tould
be satisfactory
for clearanca either by 3-A-T. or for use in
another country.
Cjatd-
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BATCo document for Province of British Columbia 5
November 1999


2 -
This last raises important questions. If - as for
promotion -we regard Run-ter Guidelines as
1nadequate should we
do our utmost to get the Guidelines enlarged or
-should we be
grateful for SM-11 Mercies. Should we insist on
more stringent.
requirements to satisfy B.A.T. than axe required
to satisfy
Hunter, or for that matter Kxdle'.'. In my view we
should get
the best legal advice we cam w:Lth regaxd to
potentlal maxkets
and our respon_,;i1b:LlitiQs as manulacturers.
Tb:Ls adv:Lce will
almost certainly require us to act responsibly and
it may be
necessary to gat independent medical advice.
SuggQsted actlons are as follows-
1. We should get legal advice on our posLttlon if
we usa~
substitutes j= the United Kingdom. Fer haps si mi
larly
opinions could be sought in U.S.A., Canada and
Au3tx-"-ia-
2.' We have promised to proposs to American
Celanase a draft
agxee=ent for the purchase of CYTREM. This would,
if
accepted, -convait -us to buying a given quantity
of CYMML
contingent upon CYTREL r-i-i-g in substantial
quantjtle~
in cigarettes on sale'ln the U.K. This would cover
both
consumer acceptance and any revision in Hunter
requirements
or reversal after testing on hu--ns.
3. We should aim to get a similax- understanding
with IDL fox
I'TSM.
4. We should opatlnue to press on with BATFLAXZ
development
and a propo-sal will be mitt to the Tobacco Boaxd
in tb-is
respect an the. 20th September.
5. We should make an approach to Cauxtaulds to
explore the
possibility o1 some co-operation or a phased joint
venture.
The main. attraction here is that it is likely
that they
could quick-ly engage in large scale product-ion.
6. We should diligently inform ourselves -,vith
respect to.the
other materials, particulaxly Ecusta which is
being t2st2d
by the H.C.I. in America.
7. We will mak-a a poiat of exam-ini-ng the Sayer
material where
it aooears in Reemtsmals cigarattes and thus
becomes
ava'IaDle to us, at least for laboratory work.
3. We should continue the development of
reconstituted
substitutes wita lower biological activity.
S. J. G.7ZZClr
Enc:
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BATCo document for Province of BritiSh Columbia 5
November 1999


APPENDIX I
BATFLAXE B.A.T. product based on chalk and sodium
carboxymethyl cellulose.
Approaching, decision stage for sem:L-commercial.
plant.
Weak but useful patent position.
Probably~'id per 1b.
N.S.M. Product of Imperial Developments Ltd.
Full scale 20 - 30 million lbs/year plant under
construction.
Partially oxidised-*cellulose-
Useful patent protection.
Expensive - probably over 9 I/lb.
CYTRSL Product of American Celanese Corporation.
Full scale 10 million lbs/year plant under
construction.
Inorganic additives with cellulose bondet
probably carboxymethyl cellulose.
Useful patent protection - not impregnable.
Pric2 at present values about 75 d/lb.
ECUSTA Product of Ecusta.
Believed at pilot plant scale but probably no
problem in production as is essentially cellulose.
No patents.
Probably 50 V /lb.
No biological claims but under test by N.C.I.
COURTAULDS No public iagormation. Probably
viscose.
No patents known.
Price - not to be offered for sale but cost
is probably around 60 v~ /lb.
Could be produced readily.
BAYER No information but will be on test in
German_v
and samples can then be examined.
Almost certainly c9llulose based.
'
B & W alurainium
Batflake type product based on
co=Dounds.
Laboratory stage.
11 sulls Vegetable reconstitution. No biological
information.
May be on sale in U.S.A. in 1974.
DUPONT No knowledge
SHUAL4 PRODUCT Presumed dead - Was reconstituted
vegetabl-a waste
but eff2ctive17 flavoured.
SUTTON RF-SF-A2CH Turned down by IDL,.B&W and SAT.
Patented.
Cellulose based.
SJG:,IIW
5.9.74
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BATCo document for Province of BritiSh Columbia 6
November 1999