Lead is a bluish-gray, heavy metal that occurs naturally in the Earth’s crust and is present in trace amounts in the environment, in numerous foods and in some natural products.
Lead is part of the Earth and occurs at an average level of 0.0013 % (13 parts-per-million (ppm)) in the Earth’s crust. It is found in the air, water, and soil at levels that are usually below any concentration that would raise health concerns. Lead can be present in nearly all things that we use and consume on a daily basis, including food and cosmetics.
Consumers should be aware that lead is never used as an intentionally added ingredient in makeup products. However, because lead is a naturally occurring metal, it is routinely detected in the air, water and soil. Consequently, it may be found at extremely low levels as a trace contaminant in some raw natural ingredients that can be used to formulate products such as lipstick.
Reports about lead in lipstick are not new. Indeed, there have been reports over the years about the presence of lead being detected in some lipsticks. Usually, these reports allege that the levels found are at are dangerously high levels. These reports are unfounded internet rumors without scientific merit that have been circulating for many years.
The U.S. Food and Drug Administration (FDA) regulates cosmetics under the Federal Food, Drug, and Cosmetic Act (FD&C Act) and the Fair Packaging and Labeling Act (FPLA). These laws require that cosmetics marketed in the United States be safe under their intended and customary conditions of use, and be properly labeled. Cosmetic regulations require pre-market approval for the color additives used as ingredients in cosmetics. FDA has set limits for lead as an impurity in color additives as part of the requirements for the safe use of color additives. Typically, the allowed levels are 10 to 20 parts-per-million (ppm). FDA has a regular testing program to determine compliance with these specifications.
In December 2016, the FDA issued draft guidance, in response to the personal care product industry’s citizen petition, on the recommended maximum level of lead in cosmetic lip products (such as lipsticks, lip glosses, and lip liners) and externally applied cosmetics (such as eye shadows, blushes, shampoos, and body lotions). The guidance supports FDA efforts to limit human exposure to lead in finished products by recommending a maximum level of 10 parts-per-million (ppm) lead as an impurity or trace contaminant in cosmetic lip products and externally applied cosmetics marketed in the United States.
Numerous in-market product surveys conducted by FDA between 2007 and 2013 indicated that levels of lead in cosmetic lip products and externally applied cosmetics are for the most part (99%) well below 10 ppm. They concluded that a maximum level of 10 ppm for lead as an impurity in cosmetic lip products and externally applied cosmetics should be readily achievable by manufacturers that source their ingredients appropriately and use Good Manufacturing Practices (GMPs). Furthermore, FDA felt that this guidance was consistent with lead limits set by other international regulatory bodies. Additionally, the International Cooperation on Cosmetics Regulation (ICCR) a voluntary international group of cosmetics regulatory authorities from Brazil, Canada, the European Union, Japan and the United States that promotes regulatory convergence, has also endorsed a limit of 10 ppm lead as an impurity in cosmetics based on considerations of scientific risk assessment, Good Manufacturing Practices, technical feasibility, and appropriate analytical methods. In addition, Health Canada has issued Guidance on lead impurities in cosmetics, also setting a limit of 10 ppm.Get more information on lead in cosmetic products.