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-

PRETESTING (')F COSMETICS 159 tization, occur. Under such circumstances, however, in the opinion of F. D. .4. the manufacturer could not successfully invoke Section 60Z(a) of the `4ct as a defense against such action. A prudent manufacturer will wish to know that his hair coloring, if it does not cause sensitivity, is free from any other toxic effects. What is the status of a hair coloring containing certified colors only combined with certain diluents? This product must be considered a color additive mixture which would be exempt from certification only if it con- tained those diluents which appear on a safe list. If this were not the case, then the product would require listing and an effective regulation following the demonstration of safety by appropriate tests. There are other combinations and formulations that raise complex questions under the present laws and regulations. An attempt has been made here to cite only a few examples of the situations in which exemption, listing and pretesting may be required. As indicated above, I have made clear that many of these problems will require discussion with F.D.A.'s ad- ministrative and scientific staffs to make certain that the conditions require testing and if so, to clarify and agree upon the kinds of tests and the experi- mental designs that will provide the necessary information for listing. (Received October 1, 1963)