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Deadline Looming For Comments About FDA Guidance on Lead in Cosmetic Products

Fashion-girl-makeup-paintBy Reena R. Bajowala

On February 21, 2017, the comment period closes for draft guidance issued by the Food and Drug Administration setting a maximum lead content of 10 parts per million (ppm) in cosmetic lip products and externally applied cosmetics.  The guidance also applies to shampoos and body lotions, but not to “topically applied products . . . classified as drugs or to hair dyes . . . contain[ing] lead acetate.”  The guidance is the FDA’s first foray into setting an acceptable limit for lead concentration in cosmetic products, though FDA scientists have been analyzing the issue for a decade.  In its most recent testing, the FDA found that lead levels were below 10 ppm for most of the 685 products tested.  The agency noted that modern testing capabilities “enable manufacturers to avoid the purchase of ingredients with unacceptably high levels of lead and to determine whether lead is introduced into their products during the manufacturing process.”  While the guidance is a recommendation and not a legally enforceable responsibility, the FDA noted that it is prepared to take enforcement action against cosmetic products that may harm consumers – which, according to the draft guidance, is at some level above 10 ppm.   What action the FDA takes with respect not only to enforcement, but to finalizing the guidance, depends on the new administration, which is signaling a possible period of decreased agency action. 

The proposed rule is Lead in Cosmetic Lip Products and Externally Applied Cosmetics: Recommended Maximum Level, Docket Number FDA-2014-D-2275.  Comments can be submitted electronically here.  Instructions on submitting comments using other methods can be found here.