by Kim Egan
Late last month, only three days before Christmas, FDA released a draft guidance document regarding lead in cosmetics. FDA recommends a maximum lead level of 10 parts per million (ppm) in lip products and externally applied cosmetics.
FDA allows lead in cosmetics and as a result, the substance is ubiquitous in the American market. Over the last decade, FDA has tested 479 different lipsticks and 412 externally applied cosmetic products and found lead in all of them. The highest concentration of lead in lipstick was 7.19 ppm; the average was 1.09 ppm. The highest concentration of lead in externally applied cosmetics was 14 ppm, with an average of 4.6 ppm. The two products with the most lead were Clarins’s Paris Mono Couleur 19 Ice Blue eye shadow and blush and L’Oreal Lancome’s Blush Subtil 8 Brun Roche.
The United States permits lead in cosmetics even though there is no safe level of exposure for humans. As the World Health Organization explains, lead accumulates in the body over time and travels to the brain, liver, kidney and bones. Lead exposure can cause miscarriages and stillbirths, respiratory ailments, cognitive difficulties, cardiovascular disease, cancer, and death.
Lead is sufficiently unsafe that it is among the over 1,300 toxins that the European Union bans entirely in cosmetics. It is thought by some historians that England’s Queen Elizabeth I died of blood poisoning caused by the heavy white lead paste she used on her face.
FDA’s justification for allowing lead in cosmetics is that “dermal absorption of lead from cosmetic lip products is negligible” and occurs “primarily by incidental ingestion.” FDA says that “only a very small amount (0.41%) of the lead present as an impurity in an externally applied cosmetic is absorbed by the skin.”
Having said that, “FDA is prepared to take enforcement action against any cosmetic lip product or externally applied cosmetic containing lead at levels that may harm consumers.”
Contact us if you wish to participate in this rulemaking.
Comments are due February 21, 2017.
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Kim Egan, Esq., is a principal in Saltbox Consulting and a member of Chesapeake PSR's advisory group. This post first appeared on and was reprinted with permission from Saltbox Consulting.