J. soc. cos. CHEM. 15, 155-159 (1964) PRETESTING OF COSMETICS FOR CONSUM ER PROTECTION By DAVID J. MILLER, B.S.* Presented September 24-25, Z963, Seminar, Boston, Mass. ABSTRACT Recently proposed legislation contains a provision which requires cosmetics to be tested for safety before marketing. The require- ments for such safety testing of cosmetics and the effect of the Color Additive Amendments of the law on cosmetics in interstate commerce are discussed. Finally, it is emphasized that the Color Additives Regulations limit the coal tar hair dye exemption of the Food, Drug and Cosmetic Act to those hair colorings having sensitivity reaction only. This discussion will be concerned with over-all problems of pre- testing of cosmetics as they relate to safety considerations. Some members of the industry still recall the controversies and discussions that took place during the developmental period that led to the Food, Drug and Cosmetic Act of 1938 and may remember the vivid illustrations of dan- gerous cosmetics that were used during that period in supporting new cos- metic legislation. That Act contained provisions for pretesting of safety of drugs but did not contain a similar requirement for foods or cosmetics. Under that law, it was necessary for the Food and Drug Administration to demonstrate and to be prepared to prove in court that a cosmetic was dangerous before it could be removed from interstate commerce. All of us are aware, of course, of the Food Additives Amendment of 1958 which simulated the new drug requirement of 20 years earlier in establishing the requirements for pretesting of chemical substances used in foods prior to their being marketed. It is also likely that all of us are aware of the more recent legislation enacted in 1960 which requires the pretesting of the class of cosmetics which may be defined as color additives. Final regulations relating to color additives were published on June 22, 1963, and set forth the conditions that must be met in the marketing of cosmetics of this class. It may be recalled that in the regulations the term "color additive" is defined as "Any material.. that is a dye, pigment or other substance made by a process of synthesis or similar art}rice, or extracted, * Food and Drug Administration, Dept. of Health, Education, and Welfare, Washington 25, D.C. 155

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