Memorandum by the Department of Health
CURRENT DEBATE
56. The Government acknowledges that the
industry has cooperated with successive administrations in lowering
tar levels as measured in the standard method. However, there
is currently considerable debate as to whether the low tar regime
and the associated arrangements for the regulation and labelling
of tar, nicotine and additives, are adequate to protect the public
health.
57. To take additives first, as mentioned
above there are currently around 600 additives which may be used
in the European Union in the manufacture of tobacco products.
But there is no uniform regulatory framework for the approval
of new additives. Several countries within the European community
do not have an ongoing approval or rejection system akin to the
UK Voluntary Agreement. Belgium has a list of substances that
may be used and prohibits the use of any other ingredients or
additives not listed in an annex to a law dated 1990. France and
Germany also publish lists of permitted additives. France has
an advisory group on additives in tobacco products and these three
countries list similar products. The German tobacco ordinance
of 1977 contains a positive list of permitted ingredients which
was last updated in 1998. Ireland has enabling legislation which
gives the Minister of Health the power to make regulations to
control or prohibit the use of any material in tobacco products
other than water, tobacco or reconstituted tobacco sheet.
58. One perceived weakness of the United
Kingdom Voluntary Agreement is that it requires the Department
of Health to approve additives granted approval in other European
Member States. Another criticism is that there is no compulsion
for tobacco companies to reveal the purpose of the additive: this
is merely "desirable".
59. The concerns about tobacco product regulation
and labelling in Europe are addressed in a recent paper published
in "Tobacco Control" 38 which argues against the route
of requiring further reductions in tar and nicotine yields as
measured by the International Standards Organisation/Federal Trade
Commission (ISO/FTC) method. The authors state that the current
ISO/FTC methodology is misleading to customers and express concern
that the low tar cigarettes may be used by smokers as an alternative
to stopping smoking. The authors go on to call for disclosure
of additives by brand and establishment of a new basis for measurement,
regulation and labelling. In their view the new basis should include
upper limits and progressive reductions for concentrations of
known carcinogens and other toxins in smoke; a new measure of
total toxicity; a ratio of specific carcinogens and other toxins
to nicotine (this ratio to be reduced over time); and research
to examine the pros and cons of setting an upper limit for nicotine
yields. The paper states that it is not enough to assess the toxicity
of an individual additive but before permission is granted to
use an additive it should meet a test of public health or public
interest. Currently there is no evaluation of the overall public
health impact of the use of an additive.
60. In America the Federal Trade Commission
(FTC) has acknowledged that machine methods of testing tar, nicotine
and carbon monoxide yields are open to serious criticism and an
18 month period of review is necessary. During this current review
the FTC will be advising consumers of the significant limitations
in existing tar and nicotine yields. A press release from the
FTC in November 1998 stated "The National Cancer Institute
and US Food and Drug Administration stated in comments that new
data suggests that the limited health benefits, previously believed
to be associated with lower tar and nicotine cigarettes, may not
exist".
61. British Columbia in Canada is the first
jurisdiction in the world to require tobacco companies to reveal
additives and ingredients in each brand of cigarettes and to provide
detailed chemical analysis of the smoke of each brand of cigarettes.
This became law in July 1998. The authors of the Tobacco Control
paper draw attention to the British Columbia "The Tobacco
Sales Amendments Act" which requires companies to test their
products for the presence of 41 toxic chemical constituents of
smoke in addition to nicotine, tar and carbon monoxide. According
to the authors the British Columbia example is a good precedent
for full disclosure of ingredients, additives and smoke constituents
by brand which could be adopted in the European Union. Other concerns
that are discussed in this paper include the use of ammonia to
alter the pH of the smoke and increase the rate at which nicotine
is released for absorption into the bloodstream of the smoker;
the use of additives to make smoke more palatable to the teenage
palate; burn enhancers that keep cigarettes smouldering and compounds
such as cocoa which may produce substances which dilate the bronchial
passages.
62. ASH and the Imperial Cancer Research
Fund published a document "Tobacco Additives"39 in July
1999. This document draws heavily on evidence from tobacco industry
internal documents which have been released during recent litigation
in the United States and are now available on the internet or
in British American Tobacco's document depository in Guildford,
UK. The internal tobacco industry quotes give rise to concerns
that industry research, not in the public domain, has provided
their scientists with considerable knowledge of the role of additives
which have enabled them to perfect the engineering of the cigarette
which is a very efficient drug (nicotine) delivery system. It
is fair to add however that the internal industry documents do
not emanate from UK domestic tobacco manufacturers.
THE GOVERNMENT'S
POSITION
63. The Government takes the claim set out
in the Tobacco Control article referred to above very seriously.
It acknowledges that there is a debate in this area and officials
have initiated discussions with the industry. It takes the view
that improvements are necessary to the existing regulations on
the labelling and tar and nicotine content of cigarettes. Action
is also needed to give consumers more information on tobacco additives.
64. The Government stated the following
in "Smoking Kills", the White Paper on tobacco published
in December 1998:40
"The European Commission is currently examining
possible improvements to the existing directives governing the
labelling of tobacco products and the tar and nicotine content
of tobacco. We are keen to help the Commission develop effective,
practical proposals.
"Given the single market approach taken
by the EU on tobacco labelling, packaging, taxation and now advertising,
we believe it is sensible for developments in the regulation of
tobacco products within the EU to continue to be pursued on a
European-wide basis." [Paras 8.10-11.]
The White Paper went on to note that any new
directive should also cover additives. [Para 8.12.]
64. This remains the Government's position.
The Government looks forward to the European Commission bringing
forward a draft directive as soon as possible. The Government
would aim to negotiate a final directive that increased significantly
the information available to consumers about tobacco products.
October 1999
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