FDA Issues Guidance on Lead in Lipsticks and Other Cosmetics

February 15, 2017

The U.S. Food and Drug Administration (“FDA”) has issued Guidance recommending a maximum level of 10 parts per million (ppm) of lead in certain cosmetic products. The guidance is for lip products—lipstick, lip gloss, and lip liners—as well as externally applied cosmetics like eye shadows, blushes, shampoos, and body lotions.

Lead is often present in cosmetics, as it is an element in many color additives. In large enough concentrations, lead can pose health risks. Lead can be absorbed through the skin and, in the case of lip products, through ingestion. The FDA has concluded that use of cosmetic products with less than 10 ppm of lead would not pose a health risk to consumers.

The FDA’s recent Guidance follows studies of lead levels in both cosmetic lip products and externally applied cosmetics, which found that these products generally contain less than 10 ppm lead. Thus, the FDA concludes that this maximum level is readily achievable through appropriate sourcing and good manufacturing practices. Moreover, the International Cooperation on Cosmetics Regulation has adopted the same standard, again indicating to the FDA the feasibility of its proposed ceiling limit on lead.

The FDA is accepting comments until February 21, 2017.

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