I. Soc. Cosmet. Chem., 25, 99-107 (February 1974) The Scientific Basis for FDA Regulatory Activities in Cosmetics ALFRED WEISSLER, Ph.D.* Presented May 4, 1973, Seminar, Cincinnati, Ohio Synopsis-Increased safety for users of COSMETICS is the goal of Food and Drug Ad- ministration activities in cosmetics. In order for these activities to be effective, they must have a sound SCIENTIFIC BASIS. This paper surveys the scientific projects and capabil- ities at FDA in the field of cosmetics, in terms of their impingement on regulatory matters. It deserves note that the scientific basis for REGULATORY ACTIONS may involve not only facts, but also judgments as well the reason is that in some cases the available factual information is not complete or definitive. A brief discussion is given of recent examples, such as bubble baths, asbestos in talcum powders, and mercury prese•wa- fives in cosmetics. INTRODUCTION The goal here is to promote a better understanding of Food and Drug Administration's scientific work in cosmetics, as a basis for its regulatory ac- tivities. There are thrce broad areas that deserve discussion: the scientific re- sources at FDA, the operations and guidelines, and a few examples of the sometimes difficult transition from scientific knowledge to official regulations. SCIENTIFIC RESOURCES Approximately 1% of the overall FDA budget is allocated to cosmetics. Part of this is used to maintain about 16 people (mainly inspectors) in the re- gional offices. The balance is for the support of roughly 36 people plus over- head in Washington. Half of these are chemists, and there are also one medi- cal officer (a dermatologist), 2 microbiologists, 5 secretaries, 8 people in toxi- cology, and 2 in the Office of Compliance. The 18 chemists are divided just about equally into three groups: the voluntary registries group, the methods *Division of Color Technology, Food and Drug Administration, U.S. Department of Health, Education, and Welfare, Washington, D.C. 20204. 99

100 JOURNAL OF THE SOCIETY OF COSMETIC CHEMISTS development group, and the sample analysis group. Although space is at a premium in the FDA laboratory building and there is some crowding, we have good equipment for instrumental analysis. There are adequate gas chro- matographs and ir and uv spectrophotometers, as well as a fluorospectropho- tometer and a mercury cold vapor atomic absorption apparatus. We are also acquiring an automated X-ray powder diffractometer and a differential therm- al analysis instrument, for use in the determination of asbestos in talcum powders and for the identification of other crystalline materials. In addition, FDA cosmetics scientists have access to instruments for such specialized tech- niques as nuclear magnetic resonance, radioisotope counting, mass spectrome- try, and high-pressure liquid chromatography when the need arises. OPERATIONS AND (•IJIDELINES The operations, missions, and guiding philosophy in the cosmetics scientific program at FDA can be understood best by means of a historical perspective. For many years, FDA's work in cosmetic chemistry was shaped by the word- ing of Section 601(a) of the Federal Food, Drug, and Cosmetic Act of 1938, which states that a cosmetic shall be deemed to be adulterated "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 preliminary test according to accompanying directions should first bc made. This product must not bc used for dyeing the eyelashes or eyebrows to do so may cause blindness.', and the labeling of which bcm's adequate di- rections 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." Therefore, the main responsibility imposed on FDA by this law was to determine whether particular substances are present in cosmetic products, which are poisonous or deleterious in the amounts present. This led to pio- neering work at FDA on the analytical chemistry of cosmetics, under such notable figures as G. Robert Clark, John H. Jones, and Sylvan H. Newburger. Dr. Newburger's "Manual of Cosmetic Analysis"( 1 ) was published more than 10 years ago and is still the only book in its field. After having been out of print for several years, it was recently reprinted and is again available for purchase from the Association of Agricultural Chemists in Washington, D.C. We continue to do some methods development work. For example, a well- known ttuoromctric method for formaldehyde (2) was adapted for use in shampoos and other cosmetic products (3). This excellent procedure consists