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Medicines (Cyanogenetic Substances) Order 1984

Volume 448: debated on Tuesday 14 February 1984

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3 p.m.

rose to move, That the draft order laid before the House on 18th January be approved.

The noble Lord said: This order will effect a small but important extension of the scope of controls under the Medicines Act 1968. As the name of the order indicates, it is concerned with certain consumer products—and two particular chemical substances—which liberate cyanide within the human digestive system and are therefore highly toxic when a large quantity is eaten.

The Medicines Act provides the foundation for a comprehensive system of control of the production and marketing of medicinal products. The Act defines medicinal products as, broadly, products which are clearly intended to be used wholly or mainly for a medicinal purpose. It follows that the Act imposes no controls on products marketed in such a way that there is no evidence that they are intended to be used for a medicinal purpose. For instance, many vitamin pills and similar products are sold simply as food supplements, with no medicinal claims made for them, and products such as these (whatever they contain) lie outside the direct scope of the Medicines Act.

They can however be brought within its scope. It was realised at an early stage in the Act's preparation that there might be products falling outside its ambit which it would later seem highly desirable to control, and Section 104 of the Act therefore empowers the health Ministers by order to apply selected parts of the Act to substances which are not strictly medicinal products but which appear to Ministers to be manufactured and put on sale at least partly for a medicinal purpose. There are probably quite a number of ordinary and harmless substances on sale today which could possibly be brought under Medicines Act control by such an order, if there were need for such order; but in the Government's view this is a power whose use can only be justified where there is clear evidence of a risk of serious harm, for instance to consumers of home remedies.

The cyanogenetic substances order is designed to eliminate just such a risk. It brings within the scope of the Medicines Act "non-medicinal" products containing—or purporting to contain—amygdalin or laetrile or the so-called "Vitamin B17". These names are variously used to describe two substances which, although different, are very closely related chemically. Their chemical names are printed in the order.

Amygdalin is a naturally occurring substance found especially in the kernels of apricots, peaches and plums. When it is eaten, especially in conjunction with certain other foods, cyanide is set free by means of enzyme activity within the body. In America several deaths from cyanide poisoning have been attributed to it. Normally accepted foodstuffs, such as marzipan, containing small amounts of amygdalin present no problem. But there are some preparations on sale in this country, presented simply as food supplements, which contain enough amygdalin to be potentially dangerous. In tablet form, they are easily swallowed. Although no deaths or serious cases of poisoning have been recorded in this country, the ready availability of these preparations must give rise to concern.

So far as likely purchasers are concerned, amygdalin has been widely publicised in the United States as an unorthodox treatment for cancer. Its use for this purpose is also openly advocated in the United Kingdom, for instance in magazine articles. It has no apparent nutritive value, and we can therefore reasonably assume that purchasers of amygdalin preparations have more often than not a medicinal purpose in mind. These preparations are currently being sold, often in health food shops or by mail order, simply as food supplements in packaging which carries no advice or warning about their possible toxicity, and it is open to anyone to buy them off the shelf.

Ministers asked the Committee on Safety of Medicines last year to advise them about the safety issue. The committee concluded that the potential risks to the general public were such that these products ought no longer to be available for purchase over the counter. However, they saw no justification for any ban on supply which would prevent doctors treating patients with amygdalin, as some indeed do. If a doctor believed that, taking full account of the risks, he ought to prescribe the substance for a particular patient, then the committee thought it should be available for him to do so. So they advised that all products containing amygdalin should be brought within the ambit of the Medicines Act and should be restricted to sale only on a doctor's prescription. Since then we have consulted a wide range of representative organisations about our proposal to act upon that advice and their reaction has been overwhelmingly favourable.

The scope of the order is limited to preparations containing more than 0.1 per cent. of amygdalin or laetrile. Fruits or seeds in their natural state are excluded. The significance of 0.1 per cent. is that it corresponds with the maximum level of cyanide the Government regards as acceptable to any foodstuff The parts of the Act which are being applied by the order to these products are in the main those concerned with sale, supply, importation, packaging and promotion. Should the draft order be approved by your Lordships, it would be made and brought into operation without delay, and these products would then speedily be categorised as prescription only medicines by means of another order. These proposals have, as I said, been generally welcomed in the consultations we have undertaken, and I hope that your Lordships will feel able to agree to the making of the order. I beg to move, my Lords.

Moved, That the draft order laid before the House on 18th January be approved.—( Lord Glenarthur.)

My Lords, we are grateful to the noble Lord the Minister for his explanation. Let me say straight away on behalf of these Benches that we support the Government in the decision they have taken to bring within the scope of control under the Medicines Act substances that are not now controlled and which, though they can be bought over the pharmacist's counter, contain chemicals which can be very harmful to health. As the noble Lord said, we are dealing mainly with amygdalin, though also with one or two other substances. He has explained—which I certainly had not realised until I looked at the order—the way in which amygdalin can become a dangerous product, found naturally in the kernels of various types of fruit, which can be converted by enzymes into something that is dangerous to the human body. There have been a number of deaths in the United States due to cyanide poisoning which have been attributed to amygdalin. I know that in the United States it has been widely publicised as a cure for cancer.

These substances, as the noble Lord said, can be obtained in Britain without prescription, without the containers carrying any warnings, and quite clearly action had to be taken quickly. I am certain the Government were right in acting on the advice of the Committee on the Safety of Medicines, for which I have very great respect, though of course doctors will be free to prescribe within certain very strict limits the material itself if it falls within their clinical judgment.

There are only two points that I should like to raise with the Minister. First, what action will be taken to alert the public in Britain to the dangers which at present exist until the order comes into effect? Secondly, what provision will there be for warnings on the packagings of these substances which are at present sold over the counter?

Before the noble Lord the Minister replies. I wonder whether he can tell me whether there is any relationship between these cyanogenetic substances and hydrocyanic acid, which we all know as prussic acid?

My Lords, I can answer the noble Lord, Lord Leatherland, first of all by saying, yes, they are exactly the same substance. If I can explain a little bit further, the kernels of these various fruits contain substances which, when extracted, are dangerous. If you were to eat the equivalent of about 50 apricot stones I believe you would probably be taking a fatal dose, or it might well be a fatal dose especially if eaten in conjunction with certain other foods. It is as bad as that. That is why it is necessary to make this order. People are extracting the substance, putting it into pill form and selling it over the counter.

As regards the points raised by the noble Lord, Lord Ennals, about action to alert the public and packaging, some publicity will be given to the making of a prescription only order, and I hope that that will meet the very real fears expressed by the noble Lord. We will of course bear in mind the difficulty of trying to put this over to the public and will be keeping it under review at all times.

On Question, Motion agreed to.