Cosmetics and the future 653 immediate impact on an important class of cosmetic products as defined by the Cosmetic Products Directive that are also 'medicinal products' as defined by the Medicines Act. The trend is to judge and treat them more as medicinal products than as cosmetics in regard to safety, efficacy, quality and good manufacturing practice as well as labelling and advertising. I foresee, moreover, an increasing tendency to bring the generality of cosmetics within the same kind of regulatory framework, and here I think that it is extremely important for you all to be very much on the alert in the years ahead. We live at a time when safety evaluation is a major growth industry worldwide. Large organisations have been established in order to carry out tests prescribed by an army of functionaries and their advisers. A comment by Dr Yale Gressel at the 1976 Cosmetic, Toiletry & Fragrance Association Scientific Conference seemed to me very much to the point: once there was only one kind of toxicology--the science of that name--but now we have several. Consumer toxicology is the art and science of maxi- mising the impact of possibly adverse findings in the supposed interest of the general public and so ensuring an effective ban on any questioned compound or product on minimum or no evidence. The leaders in media toxicology are expert in generating headlines from a minimum of data. The successful grant toxicologist makes sure of a steady flow of funds to his laboratory from a grateful public by following a policy of positive results at all cost. Political toxicologists see 'safety' as a stepping stone to high office. Legal toxicologists thrive on the impossibility of proving a negative. It is not surprising that an increasing number of useful compounds have been banned or made politically unusable on grounds that owe more to emotion than science. I believe that it is the duty of the scientific community to stand up and be counted on this issue when a ban is threatened that is based on inadequate evidence, or on data obtained by in- appropriate test procedures unrelated to ordinary conditions of use. The US National Cancer Institute has several hundred compounds on test for what is called their 'carcino- genic potential'. The extremely high levels of exposure used in this programme are based on the maximum tolerated dose of the compound being investigated, and are calculated to cause so much tissue damage at the cellular and sub-cellular levels that carcinogenic effects are elicited that might never occur in real life. There are scientists in industry as well qualified to generate, handle and interpret toxicological data as any in academic and official life, but all too often in the past they have seemed reluctant to express their doubts and criticisms in public. Last year, with some colleagues, I tried to interest the Society of Toxicology in initiating some public debate on what was going on: I failed. Your Society in particular has a special duty in regard to the relationship between risk and benefit. I urge you all to resist at every opportunity the allegation that there is no 'benefit' from the use of cosmetics. This is how the argument runs: some risk must remain even after the most exhaustive testing benefit by definition -- 0 therefore risk/benefit = infinity. You can put it another way: if the social acceptability of the products of an industry is defined as safety x benefit then if benefit = 0 the future of the industry is to say the least somewhat doubtful. Don't be persuaded, either, that the products of the consumer protection industry are beyond question or reproach and not themselves in need of safety evaluation. In August 1973 an Oklahoma paediatrician reported to the newly established Consumer Products Safety Commission in Washington that there was a higher incidence of damaged chromosomes in ten persons who had used a spray adhesive than in twelve who hadn't. He had also seen two deformed children born to parents who had used the sprays during or shortly before the pregnancies. The Commission acted in a matter of days in a blaze

654 R. J. L. Allen of nationwide publicity to 'persuade' manufacturers to stop production and then formally to ban these products. Later it was found that the original allegations were wholly without foundation and that these adhesive products were completely harmless and the ban was quietly withdrawn in January 1974. No publicity has been given by professional consumerists to the results of an enquiry conducted the following May by Hook and Healy of the New York State Department of Health and the Department of Paediatrics, Albany Medical College among medical genetic centres throughout the US (4). They found that the centres had received no less than 1100 enquiries as a result of widespread publicity in the media and that nine women had actually procured abortions, so terrified were they of giving birth to malformed babies. It is easy for us, as scientists, to under- estimate the effect on the ordinary man or woman of scare headlines that can arise from the false identification of an environmental agent as toxic, whether these relate to cyclamates, aspirin, amaranth, hairdyes, saccharin or whatever. Perhaps the nine unfortunate women in Oklahoma were only the tip of an iceberg? The efficacy--or rather the lack of it--of cosmetics is another favourite consumerist theme. As I have said, with products at the borderline between cosmetics and medicines we are moving towards a requirement to demonstrate efficacy by double blind clinical trials just as rigorous in design and meticulous in execution as with a potent therapeutic agent. There are already problems with trials that require the use of human volunteers, and these will increase. Prior demonstration of safety is tending to become more rigorous, and the withholding of therapy in a placebo group may conflict with the code of ethics for human experimentation enunciated in the Declaration of Helsinki (5). With the great majority of cosmetics, however, efficacy must lie in the eyes of the user and the beholder, but this will not prevent increasing demands by regulatory authorities for objective and statistically valid evidence in support of claims made for product classes traditionally promoted by harmless puffery alone. In this situation, it will be particularly important to insist on an interpretation of efficacy wide enough to take account of the imponderable product characteristics that determine consumer satisfaction or otherwise. When the Directive was going through the Economic & Social Committee, suggestions were made that the interests of the consumer could only be adequately assured by a fully fledged system of product licensing. The French system of dossiers available for government inspection might be regarded as a step in that direction. I have described how product licensing has developed for pharmaceuticals. I do not see how the cosmetics industry as we know it could survive in that kind of strait-jacket, so be on your guard! The first effective Act to regulate the food industry (Sale of Food & Drugs Act, now Food & Drugs Act) was passed as long ago as 1875 but reinforcement of the general provisions of the Act by compositional standards and lists of approved food additives did not start in earnest until the 1940s. It has taken half a century to establish a system of permitted lists for some 300 food additives and even now flavourings (the analogues of fragrances) have yet to be tackled. There are said to be 13 000 compounds in use in cosmetics (6). How long will it take to marshal these in the positive lists to which the authorities are apparently committed? The course of events in the food industry shows how limited, in reality, is the scope for speedy action. We must continuously remind Government of the facts of the situation, and especially perhaps the consumerists, of the stifling effect on initiative of a rigid system of permitted ingredients in an industry which lives by rapid change. I have discussed elsewhere (7) the minimum safeguards that the industry must seek to have built into the system. The record of the consumer representatives in debate on the Directive in the Economic & Social Committee and the