Regulatory Status

The regulatory status of antiperspirants is somewhat different in various regions of the world market place.

United States

In the United States an antiperspirant is categorized as an over-the-counter (OTC) drug product and therefore subject to regulations by the Food and Drug Administration (FDA). In 1972 the FDA announced a proposed review of the safety, effectiveness, and labeling of all OTC drugs by an independent advisory panel. In 1978 the FDA announced the establishment of a monograph and notice of proposed rulemaking that would establish conditions under which OTC antiperspirants are generally recognized as safe and effective and not misbranded.

In 1982 the FDA issued a tentative final monograph for antiperspirants. In 1990 the FDA issued a rule that certain active ingredients which were used in antiperspirants are not generally recognized as safe and effective and are misbranded. Then in 2003 the FDA issued the final monograph for antiperspirant products. The final antiperspirant monograph became effective in December of 2004 and did not address foot antiperspirancy claims. In addition the monograph did not identify any OTC antiperspirant products to be effective in reducing problem or especially troublesome perspiration. However, there was no data submitted to support those claims. The agency remains open to those potential claims if data are submitted with individuals who perceive themselves to have problem perspiration (4).

Updated: June 21, 2015 — 9:18 pm