468 JOURNAL OF THE SOCIETY OF COSMETIC CHEMISTS tion with respect to the incidence of adverse effects found but not accurately assessed as to incidence during the investigational period. Over the years responsible manufacturers have promptly submitted such information to this Administration on a wholly voluntary basis. In some cases this had led to labeling changes with respect to conditions of use, such as dosage, indications, precautions, and the disclosure of ad- verse effects. In other cases it has been necessary to remove the drug from the market. We think the prompt reporting of such adverse information with respect to a drug is essential. We are very much concerned with evidence that in some cases it is not being done. We have encountered from time to time information with respect to untoward reactions with new drugs in reports in the literature or through correspondence with physicians. We have followed up these leads only to learn in some cases that these reactions, and even additional cases, were known to the manufacturer but were never submitted as part of his new drug application. We view the failure to: submit such information as a serious violation of the intent and the pur- pose of the entire new drug application procedure. If information going to the very essence of the safety question is not made available to users of the product through informative labeling or is not used to remove the drug from the market, the essential purpose for the existence of the new drug provision of the Act is completely defeated. A supplement is not an entity in itself but only a part of the new drug application which it incorporates. The failure to disclose any vital inform- ation available to the applicant, such as an adverse reaction, an unstable lot, or difficulty with an assay, is indeed, in our opinion, sufficient grounds for an application to be suspended on the basis that it contains an untrue statement of a material fact. I hope I have clarified the requirements in the field of new drugs by this brief description of our activities in handling new drug applications. Many of the areas discussed are open to a diversity of opinions. I would remind you that we welcome your opinions in this new drug area and recognize that an exchange of ideas is the healthiest atmosphere for all of us. (Received May 8, 1962)

TOXICOLOGICAL PROPERTIES OF SEVERAL COMMERCIALLY AVAILABLE SURFACTANTS By K. J. OLsoN, P•.D., R. W. DUPREE, B. S., E. T. PLOMEP., B.S., and V. K. RowE, M.S.* Presented May 8, 1962, New York City SURFACTANTS are used in formulations varying in purpose from in- dustrial floor cleaners, to compositions for cleaning the most delicate nat- ural or synthetic fibers, to cosmetics. When one is considering a surfactant for a new formulation or for any purpose, he has a myriad of commercially available products from which to choose. It is of primary importance, of course, that he select a product that will do a good job from a functional point of view. Since there may be a num- ber of acceptable products in this regard he may wish to consider the one which will offer him the greatest margin of safety from the standpoint of the health of his customers and employees. The matter of health and safety will be influenced to a great extent by the application for which his formulation is intended. If his product is a cosmetic, for example, it is likely that his prime concern will be that of safety. The tests herein reported were designed to provide pertinent information about the effects on the skin and eyes and about the toxicity by acute in- gestion of several commercially available surfactants. Aqueous dilutions of 1 per cent, 5 per cent and 25 per cent were chosen for study to represent the range of concentration employed in most formulations. SOURCE AND FEEDING OF ANIMALS The albino rats used for the acute oral feeding studies were females ranging in weight from 135 to 180 g. and were raised in this laboratory of stock originally obtained from the Wistar Institute of Anatomy and Biology in 1938. They were maintained on Famo Laboratory Ration. The animals used for eye and skin studies were albino rabbits of hetero- geneous stock raised in this laboratory and fed Famo Rabbit Starter and Breeder Pellets. * The Dow Chemical Co., Biochemical Research Laboratory, Midland, Mich. 469