156 JOURNAL OF THE SOCIETY OF COSMETIC CHEMISTS isolated or otherwise derived with or without intermediate or final change of identity, from a vegetable, animal, mineral, or other source, and that, when added or applied to a food, drug or cosmetic, or to the human body or any part thereof, is capable (alone or through their action with other substance) of imparting a color thereto. This includes all diluents." The definition continues with other qualifications, but the point to em- phasize here is that the color additive section of the law includes spe- cifically those cosmetics that impart color to the human body or any part thereof. It is common knowledge, of course, that there is pending before the Congress a bill, HR 6788, introduced by Mr. Harris, which would extend the premarketing clearance of cosmetics for safety. It is premature to discuss the provisions contained in this bill. Hearings on it have not been held by the Committee on Interstate and Foreign Commerce, and there is no way to predict the final form of the bill, should it be enacted. It is not profitable to anticipate the kinds of provisions that eventually will apply to all cosmetics. However, responsible firms dealing in manufac- ture of new cosmetics or new formulations of old cosmetics would be well advised to carry out a responsible program of testing for safety the com- ponents and, in some cases, final formulations of cosmetics that are being offered to the consumer. Of course we know that, without any legal requirement of pretesting, there has been a great deal going on by re- sponsible manufacturers who most certainly do not wish to market a prod- uct unless and until there is a demonstration that the product will not cause injury to consumers. This includes a consideration of the pro- posed use of the article as well as the use to which it would normally be put. The responsible firm knows that the directions for use must be reasonable and recognizes that under the law as it now stands, a component which would be deleterious to the eyes, for example, could not be justified for inclusion in a shampoo with the caution statement on the label, "Do not get into eyes." It should be pointed out again that the law as it stands now does provide for seizure of dangerous cosmetics but only after the Government has proved that they are dangerous. The law provides for criminal action against or the enjoining of the manufacturer charged in such cases. This is of little comfort, of course, to the consumer who has been used as a guinea pig and has been injured. Rather than this kind of inhibition of the distribution of dangerous cosmetics, F.D.A. has urged that, just as in the case of new drugs, food additives, and color additives, there be a requirement for pretesting of all cosmetics. The kind of pretesting that is now encouraged or that would be required by new legislation depends largely upon the formulation, how it is to be used, how often it is to be used, upon what part of the body it is to be used, and upon the likely misuse to which it may be subjected. Reasonable

PRETESTING OF COSMETICS 157 scientific tests are essential. Where there is a long history of use this will be considered. The F.D.A. has always had an open-door policy for dis- cussion of the kinds of tests that are desirable and meaningful in the evalua- tion of safety of foods, drugs, or cosmetics. Before undertaking an ex- tensive program of testing, it is usually advisable to discuss with F.D.A.'s scientific people the adequacy of the experimental plan. The opportunity to have such discussions is available for the asking. It may be profitable to consider briefly some of the conditions set forth in the interpretive and procedural color additive regulations published on June 22, 1963. In these, the F.D.A. made clear that a cosmetic such as a lipstick, rouge or eye shadow, which directly or through reaction, colors the human body is to be regarded as a color additive. It does not necessarily foil ow, however, that each color additive which colors the hum an body must be individually listed by a regulation. It is F.D.A.'s intention to prepare a list of diluents which may safely be used in these color ad- ditives. If a manufacturer then uses a straight color which has been listed and suitable diluents on this diluent list, in a lipstick for example, then individual listing of the lipstick is not required. How is a safe diluent list established? By a notice published in the Federal Register July 6, 1963, the Commissioner of Food and Drugs re- quested manufacturers of foods, drugs and cosmetics, to propose (by January 1, 1964) safe diluents for listing in various categories, i.e., for coloring foods, ingested drugs, externally applied drugs, cosmetics which do not directly color the human body, and those that do. In this notice, it was stated that, to avoid duplication, no additional information is needed for certain specific diluents in each category. We believe that there is sufficient safety data about these specific diluents, but it should not be inferred that every one will necessarily be listed in a "diluent" regulation. It is apparent that few, if any, final cosmetic products could be prepared from the few diluents mentioned in the notice of July 6. Therefore, manufacturers were encouraged to submit as much information as necessary to warrant listing all possible diluents on the "safe" list. The following kinds of information were required: (1) The chemical name of the diluent or, if it is a compound diluent, the chemical names of its components. (2) Where available, official or trade specifications. (3) The type of product in which it is used, e.g., lipstick, rouge, eye shadow, etc. (4) The amount used in a formulation. (5) The qualitative and preferaNy quantitative composition of the formulation. (6) Information as to reactions with other components including the straight color.