Annals of the Royal College of Surgeons of England (I980) vol 62

'The nature, substance and quality demanded'

Sir Frank Hartley CBE FPS FRIC FRCPFormerly Vice-Chancellor of the University of London

Mr President, ladies, and gentlemen,The phrase I have chosen as the title of my

talk, 'The nature, substance and qualitydemanded', is derived from successive Foodand Drugs Acts and in part from the Medi-cines Act i968. It therefore serves as a textfor me to talk about food, drink, and medicinesand also about analysis.

After-dinner speeches are not appropriateoccasions for erudite lectures and so I will en-deavour to remember that part of the objectof your monthly dinners is to provide stimulusto good fellowship and to encourage subsequentconversation.

In John Hunter's time-that is, before wehad any synthetic organic chemicals-medi-cines were of animal, vegetable, and mineralorigin. The pepperers and spicers had providedmany of the spices and flavouring agentshandled by the grocers and the vegetable drugshandled by the apothecaries for their food andmedicinal use respectively. It was duty of the'garbler' to clean the drugs and spices beforeweighing or sale. Garblers were originallychosen by the Mistery of Grocers, but laterapothecaries were chosen to become the King'sGarbeler. The word 'garble' is derived fromthe Arabic kirbal, meaning a sieve, and hencethe Arabic garbal, to sift, and later, in relationto handling spices, the Italian garbellare. Itwas the task of the garbeler or his deputy toseparate out the adulteration from the genuinearticle.We now use the word 'garble' in a totally

different sense-as making usually unfair ormalicious selections from facts or statements ormutilating messages in order to misrepresentor unintentionally to distort or confuse suchfacts, statements, or messages. So today'sgarbler is one who, whether carelessly or in-tentionally, adulterates the truth, whereas inJohn Hunter's time the garbler was the author-ity for detecting adulteration of foods anddrugs.

But if you go away from this dinner tonight

with a garbled version of what I talk about thatwill not necessarily mean that you have eatenadulterated food or drunk factitious wine. Itwill more probably mean that you are suf-ficiently sophisticated not to be bothered aboutthe nature, substance, or quality of the ex-cellent food we have eaten and the delectablewine we have drunk. As we are told in St Mat-thew's Gospel, 'Sufficient unto the day is theevil thereof. But is it?An old lady having enjoyed the sermons of

a young new clergyman is said to have toldhim: 'I think you are wonderful. I never reallyknew what sin meant until you came'. Or an-other quip I recently heard is that when wetalk about checking adulteration we often callthat 'vetting' the product. But when a veter-inary surgeon present objected to this mis-representation of the function of his professiona physician present observed that vetting theproduct is better than doctoring the product!

In these days of advanced techniques for thedetection of impurities new meanings areneeded for the word 'purity'. As an absoluteconcept purity really does not exist. It is arelative term. How then does it apply to 'thenature, substance and quality demanded?'The Food and Drugs Act prohibited the sale

of any food or drug not of the nature, substanceor quality demanded if it was to the prejudiceof the purchaser. Cream, for example, meantthat portion of milk rich in milk fat which hasbeen separated by skimming or otherwise andis intended for human consumption. Its natureis defined by its origin-it must have beenseparated from milk. Its substance is definedby its composition-it must be rich in milk fat.Its quality is defined by its milk fat contentand freedom from other ingredients not to befound naturally in cow's milk. When creamwas prepared by skimming after milk had beenallowed to stand overnight in a cool place itcontained about 25 per cent of milk fat butstill quite a lot of fat remained in the skimmed

A talk given after a College Dinner held on 13th June I979

'The nature, substance and quality demanded'

milk. By centrifuging instead of skimming theresultant cream contains much more fat, 45 to65 per cent.

So you can see the scope for dilution ofcream obtained by centrifuging to make itequal in fat content to that from skimmingafter standing. To deceive the purchaser asto its fat content recourse was often had to theaddition of thickening agents such as gelatin,starch paste, alginates, or even condensed milk.Other fats could also be added so that therewas need for specific identification of fats otherthan milk fat. There was also need to restrictand determine the preservatives of all kindsthat were added to cream before improvedsterilisation processes were developed and re-frigerated storage became more commonlyavailable. Boric acid even was formerly usedto preserve cream!But after cream came 'artificial cream',

which in the first instance was a reconstitutedcream prepared by emulsifying fresh butter,dried skimmed milk, and water. And it wasdefined in the Food and Drugs Act I938 as anarticle of food which, though not cream, re-sembles cream and contains no ingredientwhich is not derived from milk, except water.But it could only be sold for human consump-tion provided the word 'cream' was precededby the word 'artificial'. Since the Food andDrugs Act I955 we now have not only 're-constituted cream' but also 'imitation cream'.With the development of synthetic ana-

logues of milk fats, of edible thickening agentslike carboxymethylcelluloses, and of syntheticsweetening and colouring agents the modemfood scientist and technologist can preparebetter-tasting and better-keeping, quite accept-able, yet less nutritious substitutes for creamand artificial cream. What then of 'the nature,substance and quality demanded?' Plainly wedo not now know what we mean by the term'cream' when we order it. Nor indeed doi theCommissioners of the European EconomicCommunity, who sought to ban the use of theword 'cream' in 'ice cream' unless that productwas in fact made from natural fresh cream.But they took an awful lot of words to attemptto define cream in a draft directive. That isan example of what I described as 'verbalinflation' in the Oxfam publication 'Pass thePort.' I was in fact then referring to caramelrather than cream, but no matter. I said that

I did not want to make a long speech becausethe more important principles can be brieflyexpressed. The Lord's Prayer has 56 words;the Ten Commandments have 297; the Amer-ican Declaration of Independence has 300; butthe EEC Directive on the Import of Carameland Caramel Products requires 26 9II words.No wonder we can't easily convey what wemean by the term 'cream', when we order it,in one or even two words! We assume it tobe bacteriologically safe for consumption. Wepossibly gain in weight-control terms from itsnon-nutritious nature.

So does a little of what you fancy any longerdo you good? Some wag has said that it is nogood having a little of what you fancy be-cause it is certain to be either illegal, immoral,or fattening. But it is surely still true that alittle of what you fancy ought to do you goodbecause only in that interpretation can we con-tinue to be concerned with safeguards againstharmfulness.How far should we pursue concepts of

harmfulness? It is no longer merely a matterof common sense and rational approach. Ourcolleagues in the USA seem to lead, if not toembarrass, the rest of the world in setting newcriteria for assessing harmfulness. From a stateof almost complete freedom for entrepreneurialactivity only 50 years ago the USA now seemsto some of us to take and advocate panic mea-sures at the slightest suspicion. Up to theI930S all sorts of medicines and potions wereavailable to consumers in the USA to cureeverything from impotency to cancer. Manyof the products were harmless but ineffective,while others posed severe hazards and at timeswere fatal in their use. Although severalefforts were made to strengthen the FederalGovernment's control over the marketing ofdrugs, it was not until the 'elixir of sulphanil-amide' disaster in 1937, when I05 persons diedfrom consuming a solution of sulphanilamidein diethyleneglycol, that attention was focusedon drug safety.

In I938 the US Congress passed the Fed-eral Food Drug and Cosmetic Act which gavethe Food and Drug Administration author-ity to rule on the safety of new drugs beforeallowing them on the market. We here didnot really have anything like the FDA exceptfor vaccines and sera in the Therapeutic Sub-stances Acts I925 and I 956 until after the

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thalidomide tragedy of I96I-62. That led tothe setting up of the Committee on Safety ofDrugs (now Medicines) in I963.

I will not weary you with all the develop-ments that have since occurred in drug regu-lations. But I would like to mention the de-vastating consequences of an amendmentmade to the American Act in 1958. This wasthe approval of a new clause, known as theDelaney Amendment, which states that nosubstance may be added to or sold for use asa food which on ingestion induces cancer inman or animals. Highly laudable, you mightsay. But of course it does not define what is tobe regarded as cancer in animals nor howmuch may have to be ingested to cause analleged cancerous growth in animals. It paysno regard to the state of knowledge aboutcocarcinogens or the effect of membrane irri-tants in activating viral effects.The consequence of the Delaney Amend-

ment has been to give unwarranted validationto faulty methodology in animal experimenta-tion even by the National Cancer Institute. Itled to the banning of cyclamates as sweeteningagents and to the proposal that saccharinshould also be banned. You may have noticedthat I used a saccharin tablet to sweeten mycoffee, as I do every day. That is becauseat the age of 68 I know I shall not live thefurther IOO years that would be required onmy present daily dosage to reach the amountused to produce tumorigenesis in the livers ofmice or the kidneys of male rats.

In April I976 the US Food and DrugAdministration baldly announced that it pro-posed that chloroform should be eliminatedas an ingredient in human drugs, cosmetics,and food packaging because of 'new evidenceindicating that it causes cancer in testanimals'. It went on to say that chloroformhad been used in small amounts as a flav-ouring agent in cough medicines, that it hadbeen used in liniments and in toothpastes andas a solvent to make adhesives and resins forfood packaging. The Commissioner said,'The experiments on animals by no meansprove that chloroform induces cancer inhumans. The amount fed to the test animalsexceeds by far the amount to which any per-son could be exposed with present products.But', he added, 'the benefits of chloroformare minimal and do not warrant any risk,

however small'. The use of chloroform is nowbanned from medicines, cosmetics, and foodpackaging in the USA, Canada, and Scandi-navia. But after receiving and reviewing allthe evidence available Australia decided not toban its use. Neither shall we in this country.To ban it would be to encourage the use aspreservative agents in mixtures and other pre-parations of alternatives which have been farless extensively studied in man and inanimals.The Chloroform Prohibition Order laid be-

fore Parliament on 28th March I979embodied the recommendations of the Medi-cines Commission after we had studied all theevidence and held hearings of interestedparties. There will be a transitional stage toallow clearance of stocks and reformulationof products to contain no more than thestrength of a saturated solution of chloroformin water-namely, 0.s57. This will allow itscontinued use as a flavouring agent in tooth-pastes and as a preservative in mixtures andelixirs. It may still be used as an anaestheticby a doctor or a dentist or in veterinary wvorkfor euthanasia. We do not acknowledge thevalidity of the US carcinogenetic studies, butwe do accept the need for some limitation tolessen the risk of liver damage that can occurfrom continued ingestion of substantialamounts of chloroform. We have avoided thepanic implications of alleged carcinogenicitythat banning would have seemed to implyand so in contrast to the sensational present-ation in the press in the USA in I976 and1977 the popular press in this country has notbothered to comment.

Requirements that the composition of medi-cines should be disclosed to help the user orprescriber have not ensured that they under-stand the nature and substance of the productsupplied or administered. The use of technicalterms often hides from users the real natureof products (as of course the use of Latin did,and was intended to do, in former times).Especially has this been demonstrated recentlyfor products containing aspirin or phenacetin.Despite the ban on the sale of products con-taining phenacetin except on a doctor's pre-scription, over a quarter of a million prescrip-tions per year are still being written for Com-pound Codeine Tablets, the composition ofwhich is widely publicised as that of earlier

'The nature, substance and quality demanded' I45

editions of the British Pharmacopoeia-namely, 250 mg of aspirin, 250 mg of phena-cetin, and 8 mg of codeine phosphate. Thewidely recognised dangers of gastric haem-orrhage from the continued use of substantialdoses of aspirin and the blood, kidney, andliver damage that can follow continued use ofphenacetin have failed to dissuade prescribersfrom using Compound Codeine Tabletsdespite provision in the British Pharmacopoeiaof an alternative formula containing para-cetamol instead of aspirin and phenacetin.

Labelling has not succeeded in conveying thenecessary information. But then experiencewith cigarettes shows that to advertise thateach packet carries a Government Health

Warning is now nearly regarded as a recom-mendation for the product.

So much for the nature and substance de-manded. It would need another talk of at leastthe present length to enthral you, I wouldhope, with the fascinating developments thathave occurred in analytical chemistry makingpossible the detection of impurities hithertounsuspected in products presumed to be of thehighest possible purity. It is the task of thechemist, the physicist, and the biologist to en-sure monitoring to meet the quality demanded.

So, Mr President, ladies, and gentlemen,when we think of 'the nature, substance andquality demanded' do not let us be like DrSpooner and say, 'I know your name but Ican't remember your face'.

COURT AND COUNCIL CRICKET TEAM v. STAFF XI,DOWNE, I4th JULY 1979

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Prom left to right: Dr S Forman, Mr A W F Lettin, Mr J S Mousley, Mr P Somerville, Mr J G Brice,Sir Reginald Murley, Professor G Slaney, Mr G C Lloyd-Roberts (Captain), Dr J Tinker, Mr NormanAddison, Mr R S Johnson-Gilbert.