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

460 JOURNAL OF THE SOCIETY OF COSMETIC CHEMISTS an article which is an antiperspirant is a drug because it affects a structure or function of the body relating to perspiration. If the cosmetic-type article meets the definition of a new drug it is sub- ject to the new drug procedure, in spite of the fact that no such require.- ment exists for a new cosmetic. The Federal Food, Drug and Cosmetic Act prohibits the shipment in interstate commerce of any new drug until an application is effective for it. This gives the distributor of a cosmetic, when it is a new drug, a responsibility to acquire an effective new drug application before he markets the article. The purpose of this requirement of law is to insure that a new drug is adequately tested for safety before marketing. It is not sufficient for the distributor of a new drug to satisfy himself that it is safe, although this is an obvious first step. It is equally necessary under the law to satisfy the Food and Drug Administration that the new drug is safe. The term "new drug," as defined in the Act, may be paraphrased as any drug whose composition is such that it is not generally recognized, by ex- perts qualified by training and experience to evaluate safety of drugs, as safe for use as suggested in the labeling. The definition also includes a drug which has gained recognition of its safety as a result of studies but which has not otherwise been used for a material time or to a material ex- tent under the conditions suggested in its labeling. Under this definition safety may be recognized to the extent that one firm has an effective new drug application for a drug but, until it has been used to a material extent and for a material time, it is still a new drug, and other firms wishing to manufacture and distribute it must also obtain an effective new drug application. Now that we have considered the why and when to submit a new drug application, we may explore more fully the purpose and substance of an application. The Act provides that an application shall contain (1) full reports of investigations that have been made to show whether the drug is safe for use (2) a full list of the articles used as components of the drug (3) a full statement of the composition of the drug (4) a full description of the methods used in, and the facilities and controls used for, the manu- facture, processing, and packing of the drug (5) required samples of the drug and its components and (6) specimens of the proposed labeling for the drug. The significant purpose for the processing of new drug applications is contained in section 505(d) of the Act, which provides that an application may be refused, after giving the applicant notice and opportunity for a hearing, if it is found (1) that the submitted reports of investigations do not include adequate tests by all methods reasonably applicable to show whether the drug is safe for use or (2) the tests show that the drug is un- safe or fail to show that it is safe or (3) the methods, facilities and con-