The Cosmetic/Drug Dilemma: FDA Regulation of Alpha-Hydroxy Acids

W artykule wyjaśniono zagadnienia związane z występowaniem i zastosowaniem hydroksykwasów organicznych w fitokosmetykach rewitalizujących i zabiegach kosmetycznych. Dokonano charakterystyki budowy skóry oraz właściwości fizycznych i chemicznych alfa-(AHA) i beta-hydroksykwasów (BHA) (kwas glikolowy, kwas mlekowy, kwas cytrynowy, kwas jabłkowy, kwas winowy, kwas salicylowy). Scharakteryzowano sposoby oznaczania hydroksykwasów, a także przedstawiono regulacje prawne dotyczące stosowania hydroksykwasów w kosmetykach. Przedstawiono wskazania i przeciwwskazania do zastosowania zabiegów z kwasami owocowymi. Opisano czynniki warunkujące skuteczność działania biologicznego alfa-hydroksykwasów (AHA).

This paper traces the history of lipsticki?½s social and legal regulation in Western seats of power, from Ur circa 3,500 B.C. to the present-day United States. Sliced in this manner, lipsticki?½s history emerges as heavily cyclical across the Egyptian, Grecian, Roman, Western European, English, and American reigns of power. Examination of both the informal social and formal legal regulation of lipstick throughout these eras reveals that lipsticki?½s fluctuating signification concerning wearersi?½ class and gender has always largely determined the extent and types of lipstick regulations that Western societies put in place. Medical and scientific knowledge, however, has also played an important secondary role in lipsticki?½s regulatory scheme. Thus, lipstick status laws, primarily intended to protect men, long predated laws concerning lipstick safety. Safety laws, in turn, long focused solely on human safety before very recently also branching out into environmental and animal safety. In the future, Western societies should expect to see a continuation of lipstick status regulations, albeit probably informal social ones, as well as increasingly comprehensive lipstick safety regulations regarding human, environmental, and animal well-being.

In this article, I analyze the FDA's approach to regulating mehndi products. I draw on the cultural and historical uses of henna to suggest strategies for approaching the regulation of temporary tattooing products. These kinds of products have grown in popularity in the last few years. While the FDA has become concerned about the side effects caused by mehndi, it has not found a regulation strategy consistent with respecting cultural practices and protecting consumers against the greatest threats.

The Food and Drug Administration has completed a survey of consumer and salon/professional cosmetic products for glycolic and lactic acids, and product pH, to determine conformity with recommended levels established by the Cosmetic Ingredient Review (CIR). In twenty-five consumer products, concentrations of glycolic and lactic acid ranged from 1.1% to 8.7%. Two products had pHs lower than the recommended minimum of 3.5. In seventeen salon/professional products, glycolic and lactic acids were found at levels ranging from 0.9% to 28.5%. Two salon products had pHs significantly lower than the 3.0 recommended by the CIR. About half of the products contained either a sunscreen or a recommendation for the use of a sunscreen.

Enantiomer separation of α-hydroxy acids in high-performance immunoaffinity chromatography