DRUGS IN COSMETICS--SHOULD THEY MIX? 315 The term "drug" means: (1) articles recognized in the official United States Pharmacopoeia, official Homeopathic Pharmacopoeia of the United States, or official National Formulary, or any supplement to any of them and (2) articles intended for use in diagnosis, cure, mitigation, treatment, or prevention of disease in man or other animals and (3) articles (other than food) intended to affect the structure or any function of the body of man or other animals and (4) articles intended for use as a component of any article specified in clause (1), (2), or (3) but does not include devices, or their components, parts or accessories. An article that is a drug as well as a cosmetic is subject to the labeling requirements of the drug section which are much more extensive than those of the cosmetic section. For instance, the label of a drug must state the common names of active ingredients and provide adequate directions for use and adequate warnings where necessary. And there are other labeling requirements not applicable to articles that are strictly cosmetics. Labeling statements that are false or misleading constitute misbrandings in the case of both cosmetics and drugs. We have not raised objection to such claims in cosmetic labeling as "beautifying, .... promotes attractiveness, .... lessens skin dryness, .... hides skin blemishes," and perhaps even "moisturizes the skin" or "makes the skin dewy." But labeling claims for growing hair, restoring natural hair color, and representations as skin foods, skin rejuvenators, nourishing creams, skin tonics, wrinkle eradicators, or contour creams place such articles in the class of drugs, and misbranded drugs at that because scien- tific evidence to support such claims is either nonexistent or entirely in- adequate. This discussion will deal largely with products that are merchandised and used in the manner of cosmetics, but, since they purport to affect a structure or function of the body, are drugs. They have been regarded as drugs and in general they are labeled in conformance with the drug re- quirements of the law. HORMONES Estrogens, progesterone, pregnenolone and extracts of placenta have been introduced into cosmetics allegedly to repair regressive or atrophic changes in older women, or in younger women with impaired ovarian function. Published reports of clinical studies on women with atrophic skin changes indicate that certain hormones (estrogens and lately, progesterone) effect responses. We have held that high potency hormone creams or lotions are drugs that should be dispensed on prescription only. Articles which pro- vide not over 20,000 I.U. of estrone equivalent as a total of daily doses in one month are not regarded as prescription drugs.

316 JOURNAL OF THE SOCIETY OF COSMETIC CHEMISTS In the case of laboratory animals we have not observed significant effects from external applications of hormone ointments in experiments conducted by our Skin Toxicity Branch. In one experiment an estrogenic ointment was inuncted daily using young virgin female albino rabbits as the test subjects. The dosages employed 250, 500, 1000 and 4000 I.U. estrone applied daily, five days a week for ninety days. Histopathologica] examination of the skin at termination of the experiment revealed a slight epidermal thickening which was no different than that exhibited in control animals treated in the same manner with the ointment base with no added estrone. In an attempt to determine if continued application of estrone would delay or prevent senile changes in the skin, another group of young animals were treated daily five days a week for eighteen months. The vehicles in this experiment were dimethyl phthalate and 70 per cent alcohol. Doses of 1000 and 5000 I.U. of each were employed in the above protocol. In these doses of massive estrone administration, the only skin changes ob- served were a slight increase in epidermal thickness and a slight reduction in numbers of hair follicles. These changes were overshadowed in the latter half of the experimental period by degenerative lesions attributable to old age and general debility. At these massive levels of estrone, uterine thickening and necrosis were observed also. Our conclusions from these experiments were: 1. No significant skin effects were obtained even from very large dosages of estrone. 2. At the levels at which minor skin changes did occur, systemic effects were also observed. 3. Skin deterioration (senile skin changes) were not prevented. VITAMINS A aND D These two vitamins are absorbed percutaneously in limited quantities. However, these are not absorbed in sufficient quantities by the percu- taneous route to produce changes in skin keratinization. It has been possible to alleviate conditions of vitamin A deficiency in man by topical application of the vitamin. Topical application of vitamin A has produced significant thickening of epidermis in rats, but this has not been duplicated in other species. ANTIBIOTICS Some of the more common uses of antibiotics in cosmetic type prepara- tions include: 1. Dentifrices 2. Antiperspirants 3. Mouth washes