458 JOURNAL OF THE SOCIETY OF COSMETIC CHEMISTS rive effect. These calculated values were then compared to the actually measured values for the two glycerol-callus systems (Results--Table 1). TABLE 1--MoxsTUaE UPTAKE BY GLYCERoL-CALLUS SYSTEM 50 mg. callus & 50 mg. glycerol 50 mg. callus & 250 mg. glycerol Days Calculated Observed Calculated Observed 1 39 mg. water 33 mg. water 82 mg. water 73 mg. water 2 50 mg. water 47 mg. water 122 mg. water 114 mg. water 4 68 mg. water 65 mg. water 184 mg. water 173 mg. water 7 84 mg. water 81 mg. water 247 mg. water 237 mg. water 11 104 mg. water 100 mg. water 315 mg. water 303 mg. water 14 114 mg. water 111 mg. water 354 mg. water 342 mg. water 18 115 (?) mg. 124 mg. water 396 mg. water 388 mg. water 21 130 mg. water 131 mg. water 429 mg. water 419 mg. water 25 141 mg. water 145 mg. water 468 mg. water 464 mg. water 28 147 mg. water 151 mg. water 492 mg. water 490 mg. water As the results indicated, in neither case was a "potentiation" of water uptake seen. It should be noted that even after twenty-eight days, neither system had reached equilibrium. The reason for our inability to demon- strate the increased rate of water uptake reported by Flesch is not clear. It is most probably related to the fact that the size and shape of the vessels used by Flesch were better suited to increase the surface area of glycerol in the glycerol-ca]lus system than were the vessels used in this experiment. In any case, it is clear that the glycerol-callus system does not possess any enhanced ability to bind moisture over and above that which would be predicted on the basis of water uptake by glycerol alone and callus alone. Thus the functional role of glycerol on the skin, from a biological stand- point, has not clearly been established. Whether it has some specific biological action remains to be determined. (Received May 17, 1962) REFERENCES (1) Blank, I. H., y. Invest. DermatoL, 21,259 (1953). (2) Peck, S. M., and Glich, A. W., y. $oc. Cosmetic Chemists, 7, 530 (1956). (3) Shelmire, J. B., Jr., y. Invest. DermatoL, 26, 105 (1956). (4) Flesch, P., Proc. Sci. Sect. Toilet Goods Assoc. No. 35, 1 (1961). (5) Powers, D. H., and Fox, C., Ibid., No. 28, 21 (1957). (6) Powers, D. H., Rieger, M. M., and Fox, C., Ibid., No. 35, 4 (1961). NOTE: A recent publication by Fox, et al. [5*. Soc. Cosmetic Chemists, 13, 263 (1962)} has clearly shown that the enhanced water sorption of glycerol-callus systems, reported by Flesch, was a result of rate rather than equilibrium measurements.

NEW DRUGS AND THE COSMETIC CHEMIST By E^Rn L. Mvv.s, PH.D.* Presented May 8, 1962, New York City I SINCERELY appreciate this opportunity to have the privilege of taking part in your program. Many of you are interested in new drug applica- tion procedures as they pertain to your field, both from the theoretical and practical standpoints. It will be my purpose to present in a general way the introduction of new drugs under the legal requirements of the Federal Food, Drug and Cosmetic Act. I hope that this discussion may be help- ful. Today, as scientific knowledge advances, we find increasing use of quan- tities of synthetic materials developed in research laboratories. They are being employed for a wide range of purposes, extending from improved product appearance to responsive biological activity. These have in- cluded bacteriostats, hormones, vitamins, antiperspirants and even sub- stances claimed to change the texture of the skin. It has become common practice to incorporate these materials in cos- metic-type preparations (dentifrices, deodorants, shampoos, skin creams, soaps, etc.) and to make therapeutic claims in the labeling for them. It is important, therefore, that the cosmetic chemist recognize that the incor- poration of some components in his formulation or the use of therapeutic claims may cause an article regarded as a cosmetic to be a drug under the Federal Food, Drug and Cosmetic Act. Whether or not a product falls within the category of a drug or a cos- metic depends not only upon its composition but also upon its labeling. A cosmetic, as defined in the Act, is an article (except soap) "intended to be rubbed, poured, or sprayed on, introduced into, or otherwise applied to the human body or any part thereof for cleansing, beautifying, promoting attractiveness, or altering the appearance." The definition of the term drug includes "articles intended for use in the diagnosis, cure, mitigation, treatment or prevention of disease in man or other animals and articles (other than food) intended to affect the structure or any function of the body of man or other animals." It is evident that labeling with thera- peutic or prophylactic claims makes a cosmetic also a drug. For example, * Chief Chemist, Div. New Drugs, Bur. Medicine, Food & Drug Administration, Washing- ton 25, D.C. 459