JOURNAL OF THE SOCIETY been classified with the precancerous lesions of the skin, yet it is favorably influenced by estrogens and may completely regress in the course of prolonged topical application." Dodds (24:): "(Lacassagne's re- sults) do not constitute a contrain- dication to the clinical use of estro- gens, since the doses given to human beings are fractional compared with those administed by Lacassagne to mice." Eller and Eller (5): "Particular attention was paid to the cytologic character of the epidermal cells of the patients showing a response to estrogen. It can be stated unequiv- ocally that no abnormalities were observed. There was no increase in the number of mitoses, or any suggestion of changes other than those of simple regeneration." Davis (18): "An estrogen be- comes a carcinogenic factor only when used on a strain of mice that have a strong hereditary tendency toward the formation of cancer." Mazer and Israel (25): "The authors have observed the develop- ment of uterine cancer in only 2 of 1000 climacteric women who had re- ceived as much as 10,000 rat units of estrogen every fourth day for pe- riods varying from six months to two years. According to the law of averages, more of these patients will eventually develop breast or uterine cancer, but its relationship to estro- gen treatment of two or more years previously would be more than doubtful." Dunbar (26): "There has been a considerable amount of work on the OF COSMETIC CHEMISTS carcinogenic properties of these ma- terials. In highly susceptible strains of rats under very special conditions, the administration of the estrogens has apparently produced carcinoma, but with ordinary laboratory ani- mals and in all studies so far on hu- man beings there is no evidence whatsoever that these products are carcinogenic. "We have in- vestigated the files of a number of firms producing these products searching for evidence of injuries. We have not found such evidence." The latter reference deserves par- ticular attention since it is based upon information gathered by the Food and Drug Administration. It should be noted, in this con- nection, that no quantity of estro- gen administered for therapeutic purposes can produce a concentra- tion in the blood stream comparable to that during the second half of ges- tation. As shown by Salter, Hunam, and Oesterling (27), also by Jailer (28), the excretion of natural estro- gen in the urine of the normal fe- male, at its peak, amounts to an es- trone equivalent of 600 to 1000 I.U. daily. (Between the peaks the vari- ation is from 50 to 200 I.U. daily.) Nevertheless uterine and mammary carcinomas do not occur in child- bearing women more often than in nulliparous women of the same age and hereditary background. In any case, because of the great difference in the comparative sizes of dosage, it is hardly admissible to con- sider the relevance of the carcino- genic aspects of estrogenic hormone

COSMETIC ASPECTS OF ESTROGENIC HORMONES 417 •? i:i:therapy to the cosmetic application of •?these materials. The cosmetically •!•i:}!!11applied "dose" of a correctly for- :•!?mulated hormone cream is but a }i•?::"fraction of the "therapeutic" dose :!:?whereas the latter is administered to i{i !!i produce systemic action, affecting ?particularly the functioning of the !i?feminine gonadal apparatus, the :iiii:.'i.former almost surely is without :5:•any systemic action, its effect being }•}•'topical and restricted to the skin. •?::In this latter connection reference •:•' •:may be made to a statemelt, by ?-Schwartz (29) to the effect that ? Section of Dermatoses Inuestiga- •.?tions of the U.S. Public Health :•::" Service has no record of skin damage , }•: •resulting from the use of hormon •:}: creams." Cosmetic hormone preparations '•}:haue been on the market for over j::•.thirteen years during which time .'?:millions of jars have been used by •::•:: the consuming public. There is no ?.Published or other medical record as to any harmful results attributed to the use of properly compounded hormone cosmetics. REGULATORY ASPECTS There exists no federal state or municipal regulation or ordinance prohibiting the sale of hormone cos- metics. True, there have been sev- eral instances of some restraining ac- tion being considered however, upon investigation of the pertinent evidence, such action was either dropped directly or it resulted in some form of amended procedure. Thus the New York State Board of Health which, some time ago, had started to restrict the sale of hor- mone creams, dropped its action to this effect. The states of Virginia, Kentucky, and Massachusetts re- scinded their proposed restrictive regulations upon review of the facts involved. Perhaps the most pub- licized case is that of the State of Louisiana which terminated with the promulgation of the following regulation: "No cosmetic or beauty prepara- tion containing as one of its ingre- dients estrogenic hormone, or any of its derivatives, or any synthetic chemical product possessing prop- erties similar to those of estrogenic hormone, may be manufactured, processed, packed, sold, or distrib- uted in Louisiana unless its label bears adequate directions for use and a statement of the quantity, in units, of such products." As to the labeling of hormone cosmetics, it must be borne in mind that their mode of action is such as to make them fall in the category of drugs (in addition to that of cosmet- ics) within the definition of the term "drug" given by the Federal Food, Drug and Cosmetic Act. This classification calls (among other things required by this stat- ute) for a statement of the active ingredients upon the "labeling" of the hormone-bearing product. If the latter is to be sold in a state or a country having special labeling or selling requirements, due cognizance must be taken of them before plac- ing the product on the respective market.