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Antiperspirants have been widely used since the mid 1960s. In 1978, the US Food and Drug Administration (FDA) issued a draft monograph (finalized in 1993) on the category, listing these products as drugs—defined as an over-the-counter (OTC) drug when applied topically to reduce production of underarm sweat (perspiration).1 Antiperspirants and deodorants are considered drugs because they can affect the function of the body by reducing the amount of sweat that reaches the skin surface. In the United States, OTC drugs are subjected to monograph rules, which define standards and requirements, pre-market approval process, acceptable actives and allowable formulation percentages of actives. Other countries’ regulations vary in content and scope. Even though most countries have not adopted equal FDA regulatory restrictions, they have adopted some type of general regulatory guidelines that define acceptable safe antiperspirant actives and how to substantiate claims. Even though non-US antiperspirant products are not confined to strict rules, because the FDA monograph has become a template of acceptable antiperspirants, there has been limited innovation in the category globally.
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