314 JOURNAL OF THE SOCIETY OF COSMETIC CHEMISTS and evidence was obtained that it was hydrolyzed by esterases from fungi, serum and skin the hydrolysis rate became vanishingly small as the freed acid created a pH in the region of 4 to 5. Clinical reports and a limited literature on the subject suggest a very low order of toxicity for glycerol triacetate. REFERENCES (1) Ochs, Irving L.,/lrch. Otolaryngol., 52, 1 (1950). (2) Ludwig, F. E., Surgery, 19, 486 (1946). (3) Adkins, H., Royals, H. E., and Wilds, A. L., O•ce of Scientific Research and Development Report No. •t•t19, Dec. 2 (1944). (4) Nicolaides, N., and Wells, George C., •7. Invest. Dermatol., 29, 423 (1957). (5) Rothman, Stephen, "Physiology and Biochemistry of the Skin," 1st edition, Chicago, University of Chicago Press (1954), p. 224. (6) Burack, Adele M., and Knight, S. G., •7- Invest. Dermatol., 30, 197 (1958). (7) Bernstein, Eugene Traugott, and Herrmann, Franz, N.Y. State y. Med., 42, 436 (1942). (8) Li, R. C., Sah, P. P. T., and Anderson, H. H., Proc. $oc. Exptl. Biol. Med., 46, 26 (1941). (9) Cox, W. M., Jr., •7. Biol. Chem., 103, 777 (1933). (10) Rothman, Stephen, op. cit., 38. DRUGS IN COSMETICS--SHOULD THEY MIX? By A. J. LEHM^* Presented February ¾, 1959, New York Chapter DURINO THE PAST thirty or forty years cosmetics have become almost a necessity and are probably no longer considered as a luxury. Synthetic chemistry has aided greatly in popularizing cosmetics, and the demand for incorporating the newer materials into cosmetic products has outstripped research in the fundamentals of skin physiology and related problems in skin pharmacology and toxicology. Claims for the new products frequently have taken them beyond the realm of cosmetics into the category of drugs. The terms "cosmetic" and "drug" as defined in the law are not mutually exclusive. An article may be both a cosmetic and a drug. The Food, Drug, and Cosmetic Act states that the term "cosmetic" means: (1) arti- cles intended to be rubbed, poured, sprinkled, or sprayed on, introduced into, or otherwise applied to the human body or any part thereof for cleans- ing, beautifying, promoting attractiveness, or altering the appearance and (2) articles intended for use as a component of any such articles, except that soap is excluded. * Div. Pharmacology, Bureau of Biological and Physical Sciences, Food and Drug Ad- ministration, U.S. Dept. of Health, Education, and Welfare, Washington 25, D.C.

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.