Cosmetic regulatory activities in the United States: past, present and future

Abstract

To protect consumers from unsafe or decptively labeled cosmetics, the Food and Drug Administration promulgates regulations, conducts factory inspections, investigates mardeted products, evaluates consumer complaints, maintains registries of voluntarily submitted formulation and adverse reaction information, and carries out analytical, microbiological and toxicological studies. There has been a significant shift in program priorities from surveillance activities to scientific research and the determination of systemic hazards to health. Major scientific efforts involve studies to determine the dermal toxicity of cosmetics, develop methods for predicting the efficacy of preservatives, and answer questions about the skin penetration and carcinogenicity of nitrosodiethanolamine. A further issue of concern is the carcinogenic hazard of hair dyes.

Studies on the dermal toxicity of p‐phenylene diamine

“…P-phenylcne diamine is a common ingredient of hair dyes, and is known to cause dermatitis, contact allergy, photosensitization, purpuric eruptions, mutagenicity and carcinogenicity after prolonged use (1)(2)(3)(4). The seriousness of the dermal toxicity of p-phenylenc diamine is evident from the fact that 8 % of the dermatitis patients are sensitive to it (5).…”