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 rocks, sediments, water, and soils at levels that are usually below any concentration that would raise health concerns. In fact, people are most likely to be exposed to lead through air pollution and the consumption of food and drinking water. Exposure can also occur by inadvertently ingesting contaminated soil, dust, or lead-based paint. Consumers should be aware that lead is never used as an intentionally added ingredient, or as an additive to any makeup product. 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 are used to formulate products.
Lead is a chemical element for which toxicity in humans has been well documented (CDC Tox Profile). It may occur as an impurity in ingredients used in cosmetic lip products and externally applied cosmetics due to its background presence in the environment.
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 regular 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 their safe use. 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In December 2016, the FDA issued draft guidance on the recommended maximum level of lead in cosmetic lip products (such as lipsticks, lip glosses, and lip liners) and externally applied cosmetics (such as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 in cosmetic lip products and externally applied cosmetics marketed in the United States. The FDA determined that a maximum level of 10 ppm in such products would not pose a health risk based on the available scientific data and research. However, the FDA noted that this guidance does not pertain to topically applied products that are classified as over-the-counter (OTC) drugs or to hair dyes that contain lead acetate as an ingredient.
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), which consists of the cosmetic regulatory branch of the FDA and its counterparts in Brazil, Canada, the European Union, and Japan 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 levels in cosmetics (10 ppm limit).
Because of the potential for lead to cause adverse health effects, other U.S. regulatory authorities have developed regulations to limit exposures to lead. The levels that are set take into account the toxicity of lead, the route of exposure (inhalation, oral or dermal), the anticipated amount of exposure, other sources of possible lead exposure, and then factor in a large safety margin. For water, the U.S. Environmental Protection Agency (EPA) has adopted a drinking water standard for public water supplies that limits lead content to 15 micrograms per liter (15 parts-per-billion [ppb]). For food, the Food and Drug Administration (FDA) has set a limit of 5 micrograms per liter (5 ppb) in bottled drinking water. FDA has also issued guidance recommending a maximum lead concentration of 100 ppb in candy likely to be consumed frequently by small children. There are FDA lead standards for other foods as well.