From the second century until well into the 19th century, wealthy European women faithfully, and sometimes fatally, used a lead-containing cosmetic known as “ceruse” to make their faces look fashionably pale. Fortunately, no current cosmetic approaches ceruse’s deadliness. Today, consumers annually spend approximately $35 billion on cosmetic products; most of them without giving thought to how safe those cosmetics are because safety is assumed. Serious injuries from using cosmetics are “pretty rare events” but how risky is the use of cosmetics? Is moist skin or the perfect shade of powder worth any risk at all?
The Cosmetic Ingredient Review (CIR) was established in 1976 as a mechanism for the cosmetics industry to effectively assess cosmetic safety while also relieving the Food and Drug Administration (FDA) of a direct regulatory burden. By most accounts, this has been a successful program, enabling industry growth without sacrificing product safety. Although FDA experts are CIR liaison members, and are present at CIR meetings, recent years have seen increased criticism of the cosmetics industry’s attentiveness to safety concerns.
In June 2004, a citizen watchdog group petitioned FDA to recall, or issue warning labels on, many personal care products whose ingredients have not been determined by CIR to be safe as used. Through a computer investigation, the watchdog group reported finding 356 personal care products containing ingredients that lack adequate safety information as determined by CIR. They cited an additional 19 products with ingredients that may be harmful when used as directed on the label.
FDA’s 2004 Program Priorities listed, among its enforcement and compliance goals, the development of draft regulatory guidance on warnings for cosmetics formulated with ingredients lacking adequate safety data. Although FDA assigned this initiative a secondary, Level B priority, the citizen’s petition may serve to elevate this priority to Level A in 2005. The pressure on the cosmetics industry to adequately substantiate safety for all ingredients would be a departure from past cosmetics industry practices. FDA is expected to publish their 2005 Program Priorities in Fall 2004.