JOHN F. CORBETT, RAJ K. SHARMA, WILLIAM E. DRESSLER
Bristol-Myers Squibb Worldwide Beauty Care, Stamford, Connecticut
INTRODUCTIONCOSMETIC SAFETY REGULATIONDecorative cosmetics and fragrances have beenpart of almost every culture for many thousands ofyears but a formal approach to the toxicological eval-uation of cosmetic products has only evolved duringthe 20th century. Initially; the evaluation involvedonly dermal, ocular, and, in some cases, mucousmembrane irritation toxicity and allergenicity via theDraize eye and skin tests in rabbits and guinea pigs.This was sometimes followed by clinical studies inhumans.The recognition that the skin was not an imperme-able barrier to topically applied materials requiredthat systemic toxicity, including both acute andchronic effects, also be taken into account. For themost part, and for obvious reasons, ingredients usedin products subject to incidental ingestion, such aslipstick, have received particular attention, followedby those used in the eye area and products applied toand left on the skin, while rinse-off products, exceptfor hair dyes, have been of least concern.This chapter will consider the scope of testing thatis generally accepted as desirable for cosmetic prod-ucts, together with the chemical nature of the activeingredients used in selected specialized hair productssuch as dyes, bleaches, permanent waves, andstraighteners. For other varied types of cosmetic prod-ucts, use experience and some general principles re-garding safety evaluation and risk assessment will bediscussed. In addition, reference will be made to theparticular requirements for and methods of reviewsof safety data in the European Union, the UnitedStates and Japan.
The United States
In the U.S., the Food, Drug and Cosmetic Act des-ignates the Food and Drug Administration as theagency responsible for cosmetic safety.For this purpose, the FDA has defined cosmetics as"articles to be rubbed, poured, sprinkled, or sprayedon or introduced into, or otherwise applied to thehuman body or any part thereof for cleansing, beau-tifying, promoting attractiveness, or altering the ap-pearance, and articles intended for use as a compo-nent of any such articles; except that such term shallnot include soap." The exemption for soap appliesonly to a composition consisting of an alkali metal saltof a fatty acid that is intended only for cleansing.Certain cosmetic products that are "intended foruse in the diagnosis, cure, mitigation, treatment orprevention of disease" are classified by FDA as drugs.This category includes sunscreen products, anticavitytoothpastes, antiperspirants (as opposed to deodor-ants, which are "cosmetics"), antidandruff prepara-tions, "medicated" skin lotions and liquids, skin pro-tectants, and hair restorers.Under the regulations, the active ingredients in cos-metic drug products must be safe and effective ac-cording to the appropriate monograph covering theclaimed indication.The only category of cosmetic ingredient subject toFDA approval is colors used for purposes other thandyeing the hair. There are only 36 "certified colors"and 23 "permitted" colors available for general use incosmetics, and a further 7 that are permitted only for
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