By Carolina M. Wirth As 2016 comes to an end, the Food and Drug Administration (FDA or agency) is turning its attention to cosmetics by issuing a draft guidance on December 21, 2016 recommending a limit of “no more than 10 parts per million (ppm) of lead as an impurity in cosmetic lip products (such as lipsticks, lip glosses, and lip liners) and externally applied cosmetics (such as eye shadows, blushes, compact powders, shampoos, and body lotions).[i]” This is the first guidance since 2014,[ii] that the agency has published involving cosmetics. The draft guidance is in part a response to a 2011 Citizen Petition by the Personal Care Products Council (PCPC) requesting that the FDA establish a limit of 10 ppm for lead in lipsticks and other types of externally applied cosmetics. After completing its own testing of cosmetics products and conducting exposure analysis, the FDA decided to grant the PCPC’s Petition. The draft guidance does not apply to “topically applied products that are classified as drugs or to hair dyes that contain lead acetate as an ingredient.[iii]” According to the draft guidance, FDA scientists have been developing tests and analyzing the levels of lead in various types of cosmetics since 2007. The most recent testing, conducted between 2012 and 2013, showed lead levels from “0.0084 . . . to a maximum of 14 ppm in one eye shadow and one blush.[iv]” Therefore, because the surveys conducted by FDA showed that levels of lead in cosmetic lip products and other externally applied cosmetics were for the most part well below 10 ppm, the agency concluded that the recommended level of 10 ppm can be achieved by all manufacturers of these types of products, as long as the manufacturers “source their ingredients appropriately and use good manufacturing practices.[v]” Moreover, the agency noted that “[m]odern analytical capabilities permits determination of lead at ppm levels, thus enabling 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.[vi]” FDA explained that exposure to lead from incidental ingestion (e.g., a consumer licks her lips) of cosmetic lip products “is very small and cannot be measured in routine blood testing.” With regard to externally applied cosmetics, the agency also concluded that the amount absorbed by through the skin is very small[vii]. “This means that exposure to lead from a product such as [an] eye shadow or body lotion is even lower than exposure from a lipstick or other lip cosmetic, and also cannot be measured in routine blood testing.” Therefore, FDA concluded that “up to 10 ppm” lead in a cosmetic lip product and externally applied cosmetics would not pose a health risk to consumers. What does this mean for the cosmetic industry? Guidance documents represent the agency’s thinking on a topic and the recommendations are not “law;” however, the agency is informing the industry of what it considers to be the maximum acceptable level of lead in lipsticks and other externally applied cosmetic products. Thus, this should serve as guidance to manufacturers of cosmetics products concerning the level of lead the agency may consider harmful to consumers and, as such, levels above this threshold could prompt the agency to take enforcement action against a product. In the draft guidance, the FDA noted that it is “prepared to take enforcement action against any cosmetic lip product or externally applied cosmetic containing lead at levels that may harm consumers.[viii]” The agency will also consider several other facts in determining whether to bring enforcement action such as “the level of lead present, the particular product, and the conditions of use for the product[ix].” Given that FDA found that a large number of cosmetic lip and externally applied cosmetic products on the market today are well below the recommended 10 ppm for lead, this draft guidance should be most useful to new companies looking to enter this market. FDA is accepting comments on the draft guidance here. Comments should be submitted by February 21, 2017 to make sure they are considered by the agency before they finalize the draft guidance. [i] See FDA Constituent Update FDA Issues Draft Guidance Recommending a Limit on the Amount of Lead in Lipstick and Other Cosmetics, available here http://www.fda.gov/Food/NewsEvents/ConstituentUpdates/ucm534120.htm [ii] The last guidance issued by the agency addressed the safety of nanomaterials in cosmetics. See http://www.fda.gov/Cosmetics/GuidanceRegulation/GuidanceDocuments/ucm300886.htm. [iii] See Draft Guidance entitled “Lead in Cosmetic Lip Products and Externally Applied Cosmetics: Recommended Maximum Level Guidance for Industry” (December 2016) (Draft Guidance), at p. 3, available at http://www.fda.gov/Cosmetics/GuidanceRegulation/GuidanceDocuments/ucm452623.htm [iv] Id. at 5. [v] Id. [vi] Id. [vii] See “Limiting Lead in Lipstick and Other Cosmetics,” available at http://www.fda.gov/cosmetics/productsingredients/products/ucm137224.htm . [viii] Draft Guidance at 7. [ix] Id.
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