THURSDAY 18 NOVEMBER 1999

PROFESSOR LIAM DONALDSON, DR DAWN MILNER, MR TIM BAXTER AND MR PAUL LINCOLN

  80. I am sorry, I was not clear on the date of the previous paper that you have in front of you.
  (Mr Lincoln) This research was produced in July this year.

  81. That report is about consumer perception?
  (Mr Lincoln) This one is.

  82. That is, I think, an important part of the argument but at what stage did it generally become accepted that lighter or milder tar content cigarettes were not safer?
  (Professor Donaldson) I do not know that all scientists would completely agree with it but I would have said that it has been established over the last couple of years, particularly as the nature of the incidence of a different type of lung cancer has emerged.

  83. Would you agree that, therefore, this is one of the most important and key messages that needs to be got out?
  (Professor Donaldson) Yes, I do, but I see a big opportunity with the possibility of a European Directive which would be quite wide-ranging, encompassing this and many other areas, including additives, which I think is an area which does need a great deal of attention.

  84. Chairman, I was going to try to explore the additives. May I, first, put on the record—and I am not proud of the fact—that I still smoke my pipe from time to time, but this, of course, also gives me an interest in what actually happens to tobacco because we all accept that nicotine is a very harmful substance but I read in your submission that there are some 600 additives which can be used to tobacco and the only control that I have seen to date is a voluntary agreement on the approval of new additives. What work has been done to establish what the old and the new additives do in the way that tobacco and tobacco combustion products actually get absorbed, because the root of absorption is infinitely more effective than the oral route which is very well regulated by the Medicines Control Agency and others?
  (Professor Donaldson) As far as I see things in the area of health, which we need to be concerned about, not all of the science is very well established because we have not had information over the years on the detail of the additive. I think there are eight reasons to be concerned. One is that specific ingredients amongst the additives might be hazardous to health in their own right. Secondly, the additives may affect the smoke chemistry and in this respect I think we would be particularly concerned about carbon monoxide and cadmium, both of which are dangerous components of smoke. Thirdly, some additives may create what has been described as free-based nicotine, in other words it releases more nicotine which makes the cigarettes more addictive. Fourthly, additives used to make cigarettes more palatable might make cigarettes more desirable. Fifthly, sweeteners and chocolate, which some people say have been added, could make cigarettes more palatable to children. Sixthly, cocoa, which can be used as an additive, may, according to some scientists, dilate the airways and make larger amounts of tar enter the lungs. Seventhly, additives may mask the smell of smoke making it more socially acceptable and, finally, additives may increase susceptibility to illnesses. For example, it has been suggested that ammonia predisposes people to more respiratory illness. In my view that is the range of issues which need to be looked at. The science is not established in all of those areas. The position over the years has been that the use of additives has been permitted over the years and when the first voluntary agreement came in in March 1977 a number of additives that had been in historical use were consolidated and then the further voluntary agreements related only to new additives and I think that is a very unsatisfactory position because we do not have a comprehensive list of what additives are used by cigarette brand and therefore we cannot even amass the science which is necessary to look at the health hazards of those particular additives, if there are any health hazards. That brings me back to the importance and I think the ideal way would be through the European Directive because at the moment we are obliged to accept additives that may have been agreed in another European country, so that creates a further difficulty for getting a grip of this situation. I hope that through the pursuance of a new European Directive this whole matter might be sorted out. As I said earlier, I have been very impressed by the action taken in British Colombia which has allowed comprehensive information on precise additives by a brand of cigarettes to come out and for scientists to start to assess the health impact.

  85. I cannot understand why the tobacco industry appears to have a God-given right to produce what it likes to produce and to sell it. Any other industry, the food industry, the medicine industry, would have to justify what it puts in its products and to demonstrate whether or not it harms. People can then make up their minds about whether they are going to eat eggs with salmonella or not. We have also got a situation where filters, over-wrappers and bits of paper and printing ink does not appear to be regulated in any way. I am really very surprised that this has not been tackled before. I would really like Dr Milner's evidence as to how far the European Directive might take us towards having some binding legislation so that a consumer can look to see what is in a particular product before they make a decision to use it or not.
  (Dr Milner) My first point would be to draw your attention to the fact that the product is lethal. Tobacco itself is a lethal product. Additives you could view as a relatively minor issue in the whole scheme of things. The product itself is lethal. It kills half of its regular users. Taking it a little bit further than what the Chief Medical Officer said, the need for an additives list was identified at the time of the first independent Scientific Committee on Smoking and Health. The Second report listed the additives which had been in use, it was a "grandfather" list. We have variable amounts of information about those additives, some in quite great detail because they were well known substances on which there was a lot of research and a lot of information on the chemistry. At the time of the Second report of that independent Scientific Committee on Smoking and Health we acquired a considerable amount of detail on the new additives that have come forward. I could refer you to the voluntary agreement which you have perhaps read in the report of the Scientific Committee on Tobacco and Health which followed on from the previous committee. We asked for the chemical structure of the additives, we asked for the purpose of use, we asked the status of that additive in food and tobacco and drug laws, we asked for the usage level, the quantitative data on transference to smoke, information on destructive distillation pyrolysis and the formation of potentially noxious components and biological studies. We are now no longer able to ask for inhalational studies because of difficulties in getting licences to do work on animals from the Home Office, but we can ask for genotoxicity studies and that information is all assessed very carefully. That is where we are now. It has been mentioned that we do not know what additives there are by brand. Earlier this year we were given limited disclosure via solicitors to the Tobacco Manufacturers' Association information on additives by coded brand of all the UK cigarettes and we now know a bit more but not enough because we do not know the market share, for example, of the brand, we do not know the brand name and we still do not have details of the flavourings that are used. This information is commercially confidential to the industry and the flavouring companies and these flavourings are used in very very minute amounts, but certain steps have been taken and we are beginning to see more disclosure. Separate to that, two tobacco companies have given us increased disclosure and one company has told us the list of additives by brand name. I would like to draw your attention to the fact that the majority of cigarettes smoked in the UK contain mainly Virginia tobacco which does not require the use of sugars and cocoa in the way that the Burley tobacco requires, which is the main ingredient of American cigarettes, for example.

  86. You mentioned that some of this information came from lawyers acting on behalf of the companies. Was this in the context of the litigation that was taking place at that stage earlier in the year or was this separate from that? Why would they disclose this information at that point?
  (Dr Milner) The context was that we meet with the industry every six months to look at the workings of our 1997 voluntary agreement and we started explaining to them how we cannot go any further with our assessment of this product until we have this information. We asked that question first, a year before we finally were given this disclosure from the industry. We asked that at meetings and then we asked in writing and then we had a response in February of this year with further information, and then we had the disclosure in, I think, October this year, and we had a large amount of paper material submitted by the industry.

  87. Is there any reason why this particular version has been only so recently obtained when there has been debate around the additives issue for a long time?
  (Dr Milner) Partly because perhaps we have only recently been starting to ask for it. As I said, we asked the previous June, we asked at the meeting.

  88. Why were not these requests put forward a lot earlier when the knowledge clearly was there about this issue?
  (Mr Baxter) I think, Chairman, it is fair to say that, going back to Dr Milner's earlier point, tobacco itself is lethal and there is a judgment to be made how far you pursue the issue of additives. I think it is a very fair question and it is also before our time, so whether there were any discussions with the industry we do not know. It might be helpful to refer you to the proposed EC Directive in this area. This is the proposed draft: "Not later than 31 December 2003 the Member States shall require all manufacturers and importers of tobacco products to submit to them a list of all the non-tobacco ingredients, including additives and quantities thereof, used in the manufacture of their tobacco products by brand name. This list shall be accompanied by a statement setting out the reason for the inclusion of such ingredients and constituents in their tobacco products. Member States shall also require manufacturers and importers to provide all data on these non-tobacco ingredients in burnt and unburnt form and to demonstrate that the said ingredients are safe for the health of the consumer when used as intended in their tobacco products," and then they have to submit information. That goes a long way to meeting many of the flaws in the current voluntary agreement.

  89. I appreciate that tobacco is lethal but that does not mean that additives may not be quite an important factor. Dr Milner, you mentioned flavourings and you said these are in small amounts. Any cook, anybody who has cooked, knows that that is the essence of flavourings, but it makes a massive difference to the finished product, and flavourings are bound to be being put in in order to make the thing more attractive. So it is important if people put into a product that is lethal something, however small the amount, which increases its attractiveness, and that is even more so when the product itself is addictive because that can mean that the initial thing is the attractiveness of the flavouring while addiction kicks in, and to say small amounts I think is totally irrelevant. Think of anything without salt and how much salt you put in something. It is absolutely inherent and I would like your opinion as to whether these are being judged on the inherent safety or otherwise of the additive or on the effect, because these additives may be perfectly safe but if they increase the propensity to smoke then they are totally unsafe. So from what point of view is it being looked at?
  (Professor Donaldson) Could I say, Chairman and Mrs Wise, that I hope I made clear that I thought the present situation was very unsatisfactory and if we look back at the comprehensiveness and tenacity of action to control tobacco as a whole in this country and many other countries in the past, it has been highly unsatisfactory as a whole. I think a way forward is needed on this. I completely agree with the comments you have made and I think the European Directive does offer that opportunity. I agree with Dr Brand's point; I think it is not right that consumers do not have access to comprehensive information and, as I mentioned earlier, the government of British Columbia in July 1988 was the first jurisdiction in the world to require tobacco companies to both reveal additives and ingredients in each brand of cigarettes and to provide a detailed chemical analysis of the smoke of each brand of cigarette. That is the sort of approach that I think would be necessary to deal with this.

  90. I am quite sure that the Committee has taken great note of the British Columbia situation and it is very helpful to have had it brought to our attention, but I am still worried about the answers to the previous questions because it does seem to me to be a fundamental flaw that we are told that the flavouring is only used in small amounts. If that is the kind of view which is prevalent in the Tobacco Unit, then I worry about that and I do recommend that you look at any recipe and look at how small the quantity of flavouring gets.
  (Mr Baxter) I think we said that we do need more disclosure, that is absolutely right, before we can make an informed judgment, and I think what we said was that additives may or may not be a big public health issue and we do not know yet because we do not have the disclosure and the disclosure is key.
  (Dr Milner) I would like to take you back a little bit to the rationale of why we have gone along with a series of voluntary agreements and these controls as they are on additives. It is because it was decided on very good scientific evidence that to make this lethal product safer we would have to reduce the tar. To get smokers to adjust to a lower tar cigarette, the argument which was accepted by the scientific committees from the tobacco industry was that we have to add flavour in some way to this product to persuade the customers to adjust down to a lower-tar cigarette, and since we thought it was right to reduce tar, we went along with this idea that we kept the flavour, otherwise the smokers just would not switch or they would switch back, so this was the rationale at that time.

  91. Of, course, they may then have been more open to the argument thinking there is nothing safer or that the safer thing was not worth smoking and, therefore, they might have stopped. These are not very scientific arguments, if I may say so, and I think that we are told a lot about waiting for scientific and evidence-based and all of that but then we are told that attempts at scientific evaluation through measuring by machines do not actually properly replicate human behaviour. So I think that a certain injection of commonsense into this would not come amiss and the Department's own evidence says that there has been strong evidence, and convincing evidence that smoking is extremely harmful emerged in the 1950s and has been widely available since the 1960s, and I think we are still told, "We cannot do this, we cannot do that," for lack of scientific evidence, whereas the essential scientific evidence is there. Then we are told things are commercially confidential. What effort is being put in by the medical people in the Department to say to Government: "Commercial confidentiality should have no place when we are talking about the production and marketing of lethal products," or do you just accept that commercial confidentiality is a valid argument?
  (Professor Donaldson) No, I do not think it is that. I hope I have made clear my position on this whole issue in the last ten minutes or so. I do not accept that argument but we have an opportunity now to try and get this right through a European Directive. That is the main vehicle for doing it. We could revisit the history of this. I was not there at the time, some of the officials were not there at the time. For whatever reason a more cautious approach was taken in the past to the tobacco companies in this regard. I do not think it was the right approach but that is the position we are in now.

  92. I appreciate the European Directive would be ever so useful. The trouble with European Directives, though, is that they take forever to get on the map and to get implemented even longer.
  (Professor Donaldson) At the very least we have a big loophole at the moment in that we are obliged to accept additives that are being approved by others and that has to be put right and the opportunity to have a comprehensive look at it is being deliberated on at the moment.

  93. And are you confident that the Government will be shouting very loudly in Europe about these things?
  (Professor Donaldson) They are certainly issues that we want to see pursued, yes.
  (Mr Baxter) The White Paper Smoking Kills did welcome very strongly the European action in this area. So it is published government policy that supports this Directive.

  94. Mr Chairman, anything that hassles the tobacco company must be a good thing and therefore the more regulations you have may well mean that that will have more of an effect on them than current policies. We have just established in this place a Food Standards Agency which has statutory powers to take samples, to look at effectiveness and regulates and does not take commercial confidentiality as an excuse for doing its work. Should there not be a nicotine regulatory authority which looks at the availability of the nicotine and at the additives and actually require the tobacco companies to be more open? Could that not be a domestic step we could take in this country which would enhance the work being done by the European Directive? In food standards, for instance, we have got a lot of European regulation and the Food Standards Agency is there to help interpret it for this country.
  (Professor Donaldson) I do not think this is something we have given any thought to. I cannot think through on the spot the implications of limiting it to nicotine and whether that would comprehensively deal with the sorts of issues that we have talked about.

  95. Was there no discussion when the Food Standards Agency's proposals were put forward about the issue of tobacco?
  (Professor Donaldson) Calling it a food and adding it into that responsibility? I do not think so, no. I would have to check.
  (Mr Baxter) The parallel with the Food Standards Agency is everybody eats, but only 30 per cent or less of the population smoke.

  96. But there is a Medicines Control Agency which insisted until quite recently on looking at herbal remedies and nutritional supplements which are not taken by everyone. Going back to my original question to Dr Milner, how is tobacco classified? Is it classified as a drug? Under the food legislation it certainly would be classified as a drug. It has got physiological effects and therefore it is a drug. Is it a food or is it a toxic substance and come under the health and safety legislation or does it have no status at all as far as control is concerned? This is the point I was making. We seem to have given the tobacco companies carte-blanche in the past to produce something and leave it up to the individual whether they respond to it or not.
  (Mr Baxter) Tobacco products are excluded from the Consumer Protection Act 1987, but there is provision there for secondary regulations to control tobacco products. I think one would have to admit it is a pretty unique situation.

  97. Could I ask why?
  (Mr Baxter) I do not think it is sensible to ask me.

  98. It seems to have special privileges for some reason.
  (Mr Baxter) I was not in the Department at the time. I think it would be an unfair question to ask me.

  Mr Austin: It is certainly fit for the purpose, i.e. it sets out to kill you and it does.

  99. It would be helpful to have a written memorandum on that because I really would like to know what the status of the control mechanism is on the tobacco companies other than voluntary agreements and whatever.
  (Mr Baxter) I can expand on our written evidence.