Antiperspirants: regulatory perspectives - marketing trends.

Antiperspirants

Regulatory Perspectives -- Marketing Trends

Most consumers still find antiperspirant and deodorant function somewhat confusing. However, personal care product formulators, processors and marketers must understand the specifics of the federal regulations encompassing antiperspirant and deodorant active ingredients and finished products. Within the context of this article, we will also provide an overview of the market and trends.

Historical Background

Regulation of personal care products in general commenced with the Food, Drug and Cosmetic Act of 1938[1] (FDCA) which defines the terms "drug" and "cosmetic."

In 1962, the Drugs Amendments Act required that drugs be found effective for their intended purpose, as well as safe. Previously, safety was generally the essential criteria. On January 5, 1972 a Federal Register Notice announced a proposed review of all OTC drugs for safety, effectiveness and labeling by independent Advisory Review Panels. The Final Regulations for the OTC Drug Review were published on May 11, 1972.

The first call for data on all active ingredients used in antiperspirant products was published on Sept. 7, 1973, followed by the convening of the first AP/OTC Panel on March 15, 1974. Industry collectively responded through the CTFA, via its Antiperspirant Task Force. Volumes of historical, technical, analytical, toxicological and efficacy data were submitted to the panel by industry and academia. After the trials and tribulations of the Drug Review, the FDA published a Proposed Rule on October 10, 1978.

The objective of the AP/OTC Drug Review Panel was to review the safety and effectiveness of all marketed antiperspirants; and to make recommendations to FDA regarding the active ingredients, packaging and labeling. This would enable FDA to establish a monograph which would include all acceptable criteria for continued marketing of the reviewed antiperspirant drugs. The monographs provide standards for all OTC drug products not covered by new drug applications (NDAs).

Antiperspirants have been formulated over the years with metal salts such as aluminum, zinc or magnesium chlorides, sulfates, acetates or sulfocarbolates.[2,3] However, it has been aluminum chlorohydrate in a variety of physical and chemical forms which continues to be used rather extensively.

The most efficient of the species was and still is considered to be aluminum chloride. Its applicability is limited because of its propensity for contributing to moderate to severe skin reaction and fabric damage.[4] These features were deciding factors in the development of the less acidic or more basic form of aluminum chloride--aluminum hydroxychloride[5] also known …