vitamin K and thus associated with childhood cancer, but in the other hospital there was no association between type of delivery and cancer, regardless of whether or not intramuscular vitamin K had been given. Consequently it is unlikely that type of delivery will explain the link between intramuscular vitamin K and childhood cancer. We note the response from D Kaiser and PA Hooper of Roche. As they indicate in their letter, the second vitamin K study was indeed funded by them. This funding was only agreed after they had submitted our proposed design for appropriate peer review. The exact design of the study was discussed at length with Roche before it was started and so it is difficult to interpret their statement that they believe this to be seriously flawed. Kaiser and Hooper also criticise the statistical methods. The data have been analysed in two different ways, and although possibly some of their criticisms may apply to the use of logistic regression, they do not apply to the Mantel-Haenszel test that we used. The fact that both methods produced almost identical results is a refutation of their claim of bias in the statistical techniques. The MantelHaenszel results were published in detail so that it could be seen that these were not unduly influenced by any one particular year. J&OLDING
Association already not only adhere to recognised standards of good manufacturing practice but also submit pack copy and advertising for expert approval. These two associations account for 95% of the food supplements sold in Britain. Professor John Garrow and Dr Mark Rayner are drawing attention to the irresponsible activities of a tiny minority. Over the past four years I have personally given dossiers of advertisements that are illegal under present British law to the Ministry, the Department of Health, and, indeed, John Garrow. No action of any consequence has been taken, and we are told that because of budgetary restraints future action is unlikely unless there is a danger to public health. Food legislation demands that claims be accurate, and safety assured. The laws are in place to take action where and when it is needed. There is no scientific reason why products that adhere to our safety guidelines and submit to our advertising controls should be taken off the market, and we are working closely with the European Commission to bring about this result. Anything less would be an unwarranted restriction of consumer freedom. MAURICEItANSSEN
(Health Food Manufacturers' Association, ames Ditton, OLT
Surre)KT7
RE.ENWOOD)
I Richards T. Vitamins face control worldwide. 491. (29 August.)
Institute of Child Health, Royal Hospital for Sick Children, Bristol BS2 8BJ 1 Handel J, Tripp JG. Vitamin K prophylaxis against haemorrhagic disease of the newborn in the United Kingdom. BMJ _C991;303: 1109. -W
Vitamins face control worldwide EDITOR,-The news item by Tessa Richards' does little to help present a balanced and accurate picture. The Health Food Manufacturers' Association has advised safe upper limits for nutritional supplements since 1985 and these are adhered to by more than 95 per cent of the supplements on sale in the United Kingdom. The European Commission's discussion paper of December 1991 on the subject states that "there are relatively few cases of proven harm arising from the consumption of these products"-this was a European overview. The fact is that the commission's proposals have not been finalised; that the British government has prepared a draft directive which seems perfectly reasonable in its approach to upper safe limits as being the criteria for judging their suitability as foods and that the restrictive proposals of the other member states have far more to do with protecting the monopolies of pharmacies. These shops traditionally supply such products and in France, Germany, and Italy are almost twice as numerous as in the United Kingdom. There is also a substantial legal difficulty in categorising food supplements as medicines at relatively low doses. Just what do you claim to prevent, treat, or cure with 200 mg of that extremely safe vitamin, E? That is 20 times the recommended daily allowance; yet the French are saying that more than one time is obviously medicinal. The Medicines Control Agency withdrew a licence from a 500 mg vitamin E product on the grounds that it was not a medicine. It would hardly be reasonable to ask the manufacturer to now pay a £12000 fee to obtain a licence on bureaucratically created grounds. The Ministry of Agriculture, Fisheries, and Food is currently spending £1 65 m on trying to establish optimal levels for antioxidant nutrients. It is likely that vitamins C and E will be well above any "Euro RDA," and 3 carotene does not even possess one. Members of the Proprietary Association of Great Britain and the Health Food Manufacturers'
BMJ
VOLUME
305
19 SEPTEMBER 1992
BMJ
1992;305:
EDITOR,-The article by Tessa Richards is misleading. The British health food industry is not, neither manufacturers nor retailers, in conflict with the European Commission. At a recent meeting of EC ministers the British government presented a position paper calling for product safety, on the basis of published scientific research, to be the only criterion for upper limits which may be placed on vitamins and minerals available for general sale. This proposal was accepted and supported by the commission but opposed by other member states. In many cases, those who oppose us do so from an apparent desire to protect entrenched commercial interests rather than consumer safety. With the support of the Ministry of Agriculture, Fisheries, and Food and the Department of Health our trade associations are now working hard to have the high standards of product safety, with freedom of choice, currently enjoyed by British consumers accepted by the rest of Europe. The health food industry, in common with many other industries, does have a small number of "cowboy" operators who make outrageous claims. It is perhaps significant that these claims are usually made through advertisements in the national press. These products are rarely seen in genuine health food stores. There, proprietors and staff-many of whom are professionally trained and hold recognised certificates and diplomas in health food retailing-have to meet their customers face to face. They simply could not survive commercially unless the honesty and credibility of their products and service was.beyond question. It is a pity that Professor Garrow and Tessa Richards make no atfempt to differentiate between "cowboys" and those who have a real concern for the welfare of consumers-on whose continued health and satisfaction we all ultimately depend. RICCHARD)MISTHIN N National Association of Health Stores,
L
Boston, Lincolnshire PE2 1 9HG 1 Richards T. Vitamins face control worldwide. BMJ 1992;305: 491. (29 August.)
EDITOR,-There has been much confusion about whether vitamin pills are dietary supplements or drugs. This confusion seems to stem from the fact that a specific nutritional product may be sold as a
licensed medicine, while an identical product is sold as a supplement. Faced with what seems to be a highly irregular situation, many people who are unaware of the reasons for it may logically assume that the unlicensed products are in some way escaping proper control through some loophole of the law, and therefore that the forthcoming directive of the European Commission, which proposes to set a limit below which a product is a food and above which it is a medicine, is perfectly logical and indeed good. What may not be understood is that in Britain the legal difference between a food or food supplement and the same food or supplement sold as a drug is essentially whether or not the manufacturer -makes a medical claim for it. Thus a product licence would have to be sought for oat bran if the makers went all the way in their advertisements and claimed that their products actually lower blood cholesterol. It is against the law in Britain to make a medical claim for a food supplement that is not licensed as a medicine. We suggest that Professor John Garrow, who was quoted in Tessa Richards's article,' should encourage the government to enforce this law more effectively rather than support an EC directive which could result in the disappearance of up to 95 per cent of vitamin products in this country. As a nutritionist I am sure he would not like to see this happen. The loss of the products will occur because most manufacturers say they do not have the extensive funds and facilities required for licence applications. The fact is that, as Dr Mark Rayner says, few nutritional products are suitable candidates for medicinal claims. This only proves that they are not medicines, and therefore that they should not be classified as such. There are other ways of controlling dosages sold over the counter to the public. LINDI LAZARIDES Society for the Promotion of Nutritional Therapy, Heathfield, East Sussex TN2 1 8AE 1 Richards T. Vitamins face control worldwide. BMJ 1992;305: 491. (29 August.)
EDITOR,-The implications of the European Commission's decision to consider introducing legislation banning the free sale of vitamins, minerals, and other known nutrients' are quite astonishing. The whole adult population of Europe is free to purchase, in almost every corner shop, one of the most habit forming and toxic drugs known to humans. Even when the advertising of tobacco is eventually banned, no one would seriously suggest that the commission should ban its free sale. Films showing violence and sadistic cruelty are a regular part of the fare broadcast by many of Europe's television stations. Despite growing evidence on the behavioural effects of that kind of visual diet, our legislative freedom to pay to watch such material is not likely to be restricted. Yet the innocent practice by vast numbers of people, of purchasing nutrients in tablet or capsule form, is likely to be virtually ended by decree of our European bureaucrats. Far from removing trade barriers, this will be a grave restriction on trade. Even if the dubious argument that these tableted and encapsulated nutrients have no effect whatsoever is accepted, it is surely people's freedom to waste their money as they think fit. Buying vitamin supplements is a much healthier way of using money than is drinking, smoking, betting, or other forms of legitimate entertainment that often have a high cost in human health. Arguments about the "danger" of swallowing these nutrients are risible. In the United States the reporting of side effects of drugs and nutrients is mandatory. Compared with an annual total of hundreds of deaths and many times that number
711
Association already not only adhere to recognised standards of good manufacturing practice but also submit pack copy and advertising for expert approval. These two associations account for 95% of the food supplements sold in Britain. Professor John Garrow and Dr Mark Rayner are drawing attention to the irresponsible activities of a tiny minority. Over the past four years I have personally given dossiers of advertisements that are illegal under present British law to the Ministry, the Department of Health, and, indeed, John Garrow. No action of any consequence has been taken, and we are told that because of budgetary restraints future action is unlikely unless there is a danger to public health. Food legislation demands that claims be accurate, and safety assured. The laws are in place to take action where and when it is needed. There is no scientific reason why products that adhere to our safety guidelines and submit to our advertising controls should be taken off the market, and we are working closely with the European Commission to bring about this result. Anything less would be an unwarranted restriction of consumer freedom. MAURICEItANSSEN
(Health Food Manufacturers' Association, ames Ditton, OLT
Surre)KT7
RE.ENWOOD)
I Richards T. Vitamins face control worldwide. 491. (29 August.)
Institute of Child Health, Royal Hospital for Sick Children, Bristol BS2 8BJ 1 Handel J, Tripp JG. Vitamin K prophylaxis against haemorrhagic disease of the newborn in the United Kingdom. BMJ _C991;303: 1109. -W
Vitamins face control worldwide EDITOR,-The news item by Tessa Richards' does little to help present a balanced and accurate picture. The Health Food Manufacturers' Association has advised safe upper limits for nutritional supplements since 1985 and these are adhered to by more than 95 per cent of the supplements on sale in the United Kingdom. The European Commission's discussion paper of December 1991 on the subject states that "there are relatively few cases of proven harm arising from the consumption of these products"-this was a European overview. The fact is that the commission's proposals have not been finalised; that the British government has prepared a draft directive which seems perfectly reasonable in its approach to upper safe limits as being the criteria for judging their suitability as foods and that the restrictive proposals of the other member states have far more to do with protecting the monopolies of pharmacies. These shops traditionally supply such products and in France, Germany, and Italy are almost twice as numerous as in the United Kingdom. There is also a substantial legal difficulty in categorising food supplements as medicines at relatively low doses. Just what do you claim to prevent, treat, or cure with 200 mg of that extremely safe vitamin, E? That is 20 times the recommended daily allowance; yet the French are saying that more than one time is obviously medicinal. The Medicines Control Agency withdrew a licence from a 500 mg vitamin E product on the grounds that it was not a medicine. It would hardly be reasonable to ask the manufacturer to now pay a £12000 fee to obtain a licence on bureaucratically created grounds. The Ministry of Agriculture, Fisheries, and Food is currently spending £1 65 m on trying to establish optimal levels for antioxidant nutrients. It is likely that vitamins C and E will be well above any "Euro RDA," and 3 carotene does not even possess one. Members of the Proprietary Association of Great Britain and the Health Food Manufacturers'
BMJ
VOLUME
305
19 SEPTEMBER 1992
BMJ
1992;305:
EDITOR,-The article by Tessa Richards is misleading. The British health food industry is not, neither manufacturers nor retailers, in conflict with the European Commission. At a recent meeting of EC ministers the British government presented a position paper calling for product safety, on the basis of published scientific research, to be the only criterion for upper limits which may be placed on vitamins and minerals available for general sale. This proposal was accepted and supported by the commission but opposed by other member states. In many cases, those who oppose us do so from an apparent desire to protect entrenched commercial interests rather than consumer safety. With the support of the Ministry of Agriculture, Fisheries, and Food and the Department of Health our trade associations are now working hard to have the high standards of product safety, with freedom of choice, currently enjoyed by British consumers accepted by the rest of Europe. The health food industry, in common with many other industries, does have a small number of "cowboy" operators who make outrageous claims. It is perhaps significant that these claims are usually made through advertisements in the national press. These products are rarely seen in genuine health food stores. There, proprietors and staff-many of whom are professionally trained and hold recognised certificates and diplomas in health food retailing-have to meet their customers face to face. They simply could not survive commercially unless the honesty and credibility of their products and service was.beyond question. It is a pity that Professor Garrow and Tessa Richards make no atfempt to differentiate between "cowboys" and those who have a real concern for the welfare of consumers-on whose continued health and satisfaction we all ultimately depend. RICCHARD)MISTHIN N National Association of Health Stores,
L
Boston, Lincolnshire PE2 1 9HG 1 Richards T. Vitamins face control worldwide. BMJ 1992;305: 491. (29 August.)
EDITOR,-There has been much confusion about whether vitamin pills are dietary supplements or drugs. This confusion seems to stem from the fact that a specific nutritional product may be sold as a
licensed medicine, while an identical product is sold as a supplement. Faced with what seems to be a highly irregular situation, many people who are unaware of the reasons for it may logically assume that the unlicensed products are in some way escaping proper control through some loophole of the law, and therefore that the forthcoming directive of the European Commission, which proposes to set a limit below which a product is a food and above which it is a medicine, is perfectly logical and indeed good. What may not be understood is that in Britain the legal difference between a food or food supplement and the same food or supplement sold as a drug is essentially whether or not the manufacturer -makes a medical claim for it. Thus a product licence would have to be sought for oat bran if the makers went all the way in their advertisements and claimed that their products actually lower blood cholesterol. It is against the law in Britain to make a medical claim for a food supplement that is not licensed as a medicine. We suggest that Professor John Garrow, who was quoted in Tessa Richards's article,' should encourage the government to enforce this law more effectively rather than support an EC directive which could result in the disappearance of up to 95 per cent of vitamin products in this country. As a nutritionist I am sure he would not like to see this happen. The loss of the products will occur because most manufacturers say they do not have the extensive funds and facilities required for licence applications. The fact is that, as Dr Mark Rayner says, few nutritional products are suitable candidates for medicinal claims. This only proves that they are not medicines, and therefore that they should not be classified as such. There are other ways of controlling dosages sold over the counter to the public. LINDI LAZARIDES Society for the Promotion of Nutritional Therapy, Heathfield, East Sussex TN2 1 8AE 1 Richards T. Vitamins face control worldwide. BMJ 1992;305: 491. (29 August.)
EDITOR,-The implications of the European Commission's decision to consider introducing legislation banning the free sale of vitamins, minerals, and other known nutrients' are quite astonishing. The whole adult population of Europe is free to purchase, in almost every corner shop, one of the most habit forming and toxic drugs known to humans. Even when the advertising of tobacco is eventually banned, no one would seriously suggest that the commission should ban its free sale. Films showing violence and sadistic cruelty are a regular part of the fare broadcast by many of Europe's television stations. Despite growing evidence on the behavioural effects of that kind of visual diet, our legislative freedom to pay to watch such material is not likely to be restricted. Yet the innocent practice by vast numbers of people, of purchasing nutrients in tablet or capsule form, is likely to be virtually ended by decree of our European bureaucrats. Far from removing trade barriers, this will be a grave restriction on trade. Even if the dubious argument that these tableted and encapsulated nutrients have no effect whatsoever is accepted, it is surely people's freedom to waste their money as they think fit. Buying vitamin supplements is a much healthier way of using money than is drinking, smoking, betting, or other forms of legitimate entertainment that often have a high cost in human health. Arguments about the "danger" of swallowing these nutrients are risible. In the United States the reporting of side effects of drugs and nutrients is mandatory. Compared with an annual total of hundreds of deaths and many times that number
711
