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.

158 JOURNAL OF THE SOCIETY OF COSMETIC CHEMISTS (7) Data bearing on the safety of the diluent or the final mixture. In the case of well-known diluents which the manufacturer has good reason to believe are generally recognized as safe--no matter how used or in what quantity--some of this information could be omitted. If it is not possible to be assured of the safety of a color additive which colors the human body by a consideration only of the straight color and diluents (and again using a lipstick as an example), then the lipstick is subject to listing and must have a regulation indicating approval of the petition submitted to show its safety. The question arises as to whether, under such circumstances, a petition must be filed for each lipstick which varies only in shade. The answer is a qualified "no"--qualified because a final decision cannot be made without examination of the formulas involved. It is apparent that, under certain circumstances, the safety of a color additive, such as a lipstick, may be evaluated on the basis of the safety of its components. The question has been asked whether or not the safety of a cosmetic other than a color additive may be evaluated on the same basis in place of a pharmacological test of the finished product. The answer is probably yes, but each formulation must be studied by the pharmacologist for a final decision in the matter. Consideration will include not only the safety of the individual components but possible inter- action of those components. Hair dyes, which are also color additives which color the human body, fall into a special class. When Congress passed the color additive amend- ments, it retained Section 601(a) exactly as it appeared in the 1938 Act. Section 601(a) reads: "A cosmetic shall be deemed to be adulterated- (a) If it bears or contains any poisonous or deleterious substance which may render it injurious to users under the conditions of use prescribed in the labeling thereof, or under such conditions of use as are customary or usual: Provided, That this provision shall not apply to coal-tar hair dye, the label of which bears the following legend conspicuously displayed thereon: "Caution--This product contains ingredients which may cause skin irritation on certain individuals and a preliminary test according to accompanying directions should first be made. This product must not be used for dyeing the eyelashes or eyebrows to do so may cause blindness," and the labeling of which bears adequate directions for such preliminary testing. For the purposes of this paragraph and paragraph (e) the term "hair dye" shall not include eyelash dyes or eyebrow dyes." It has been concluded that the coal tar hair dye exemption was intended to apply only to those hair colorings the only toxicity of which was that of producing sensitivity reactions which could be detected by the "patch" test. It is the responsibility of the Food and Drug Administration to take action against a product should adverse reactions, other than that of sensi-