NCHR Comments on FDA Draft Guidance for Lead in Cosmetics

February 21, 2017

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National Center for Health Research’s Public Comments on Lead in Cosmetic Lip Products and Externally Applied Cosmetics: Recommended Guidance for Industry on Maximum Levels
[Docket No. FDA-2014-D-2275]

The National Center for Health Research is a nonprofit think tank that conducts, analyzes, and scrutinizes research, policies, and programs on a range of issues related to health and safety. We do not accept funding from companies that make products that are the subject of our work.

We support the efforts of the Food and Drug Administration (FDA) to provide a recommended maximum level of lead as in impurity in cosmetic lip products and externally applied cosmetics that are marketed in the United States. We are very concerned, however, about the FDA’s rationale for concluding that 10 parts per million (ppm) is an acceptable level of lead in these products and strongly encourage the FDA to hold cosmetics manufacturers to a safety standard based on solid scientific evidence.

The FDA’s 10 ppm limit is based on the recommended maximum level set by the International Cooperation on Cosmetics Regulation and by other countries, such as Canada and the European Union. In addition, the FDA evaluated lead levels in a sample of products currently on the U.S. market and found that about 1% of samples had lead levels that exceeded 10 ppm. As a result, the FDA concluded that the 10 ppm level is safe and achievable so long as manufacturers follow “good manufacturing practices” and seek to achieve even lower levels “whenever feasible.”1

There is no known level of lead exposure that is considered safe. With consumers’ health in mind, the first question the FDA should ask is: How much lead in one’s system is considered “safe?” The FDA proposal is linked to the Center for Disease Control and Prevention’s (CDC) threshold for lead in the blood of 5 micrograms per deciliter of blood (5µg/dL), above which children should be targeted for treatment. However, the CDC lead threshold is not based on evidence that 5µg/dL is the minimum lead level that causes harm, but instead it arbitrarily identifies children with the highest levels of lead exposure (i.e. the 2.5% of children aged 1 – 5 years with the highest levels of lead in their blood).2 This is particularly problematic because blood lead level tests do not measure lead’s total burden on the body but instead reflect recent or ongoing lead exposure. It should be unacceptable because blood lead level concentrations as low as 5µg/dL may result in decreased intelligence in children, behavioral difficulties, and leaning problems. The CDC and World Health Organization both state that there is no safe level of lead in the blood and that lead poisoning is preventable.3 4

Because of the serious risks of lead, the status quo should not be used to justify the proposed lead level for cosmetic lip products. The maximum level of lead in these products should be based on sound science. The FDA’s proposed maximum level of 10 ppm is not based on scientific safety data and instead on the status quo according to the FDA’s analysis of a sample of lip products sold in the U.S. and the CDC’s similarly questionable threshold.

When considering the maximum level, it is important to acknowledge that some women will use these lip products several times per day, seven days per week for years. One study found that women applied lipstick on average 2.35 times per day and an average of 10 mg of product at each use.5 Thus, researchers estimated that metal intakes for average use were 24 mg/day and 87mg/day for high use of lip products. In addition, many consumers begin using lip products as children or adolescents and continue using them for decades. These multiple exposures over time can lead to increased buildup of lead in the body.

No research has been conducted to determine whether or not the FDA’s proposed recommendation for cosmetic lip products and externally applied cosmetics is safe for consumers. Basing this recommendation primarily on the status quo in the U.S. and other countries creates a disincentive for the cosmetic industry to reduce lead levels in these products. The FDA has a responsibility to set high standards for manufacturers so that consumers are not inadvertently exposed to products that harm them. This is especially true for a guidance document that has no enforcement mechanism.

As the FDA draft guidelines state, the toxicity of lead is well documented.6 Lead is a toxic metal that disrupts brain development and causes problems with behavior, such as one’s ability to stop and think before acting.7 Lead exposure has been linked with reduced IQ and educational attainment as well as increased antisocial behavior. Furthermore, exposure to lead before birth increases risk for low birth weight.8 Early exposure to lead can increase risk for childhood obesity and diabetes, heart disease, or stroke in adulthood.9 As little as a 2µg/dL blood lead level is associated with increased death due to heart attack and stroke.10

Children, infants, and fetuses are particularly vulnerable to lead as their brains are not fully developed.11 Thus, smaller amounts of lead will have a greater effect than when compared to adults. Young children absorb 4-5 times the amount of lead that an adult ingests from the same source. Since lead stored in women’s bones and teeth may be released into the blood during pregnancy and lactation to expose the developing fetus and infants,12 women may cause significant harm to their children by ingesting lip products.

It is also essential to consider that some children, teenagers, and adults using lip products will be exposed to other sources of lead, including exposure to lead paint, water from leaded pipes, and lead-contaminated dust and soil.13 Though lead-based paints were banned for use in housing in 1978, approximately 24 million housing units in the U.S. still contain deteriorated lead paint and elevated levels of lead-contaminated house dust, and individuals living at or below the poverty line are at greater risk.14 A recent report found that 5,363 community water systems, serving over 18 million Americans, exceeded the established lead limits for water.15 The body accumulates lead over a lifetime and gets rid of it very slowly. It takes 28 to 36 days to remove about half of the lead from the blood of an adult.16

Lead has been identified as 1 of 10 chemicals of “major public health concern.”17 Researchers estimated that lead exposure resulted in $5.9 million in medical costs and an additional $50.9 billion in lost economic productivity resulting from reduced cognitive potential due to childhood lead exposure.18

In conclusion, although we support the FDA’s efforts to provide a recommended maximum level of lead as in impurity in cosmetic lip products and externally applied cosmetics, we reject the FDA’s rationale for the maximum level of 10 parts per million of lead in these products. Instead, the FDA should base this level on sound safety data. We believe that the maximum level of 10 parts per million is a reasonable temporary standard, but should be labeled as such in the guidance while the FDA requires research to determine what the level should be. This will ensure that the FDA accomplishes its stated goal to encourage companies to ensure that cosmetic lip products and externally applied cosmetics do not pose a health risk to consumers.

  1. Food and Drug Administration (2016, August). Draft Guidance, Lead in Cosmetic Lip Products and Externally Applied Cosmetics: Recommended Maximum Level Guidance for Industry (Docket No. FDA-2014-D-2275) Retrieved from https://www.regulations.gov/document?D=FDA-2014-D-2275-0002  
  2. Centers for Disease Control and Prevention (2012, October). What Do Parents Need to Know to Protect Their Children? Retrieved from https://www.cdc.gov/nceh/lead/acclpp/blood_lead_levels.htm  
  3. Centers for Disease Control and Prevention (2017, February). Lead. Retrieved from https://www.cdc.gov/nceh/lead  
  4. World Health Organization (2016, September). Lead poisoning and health: Fact sheet. Retrieved from http://www.who.int/mediacentre/factsheets/fs379/en  
  5. Liu, S., Hammond, S.K., & Rojas-Cheatham, A. (2013). Concentrations and Potential Health Risks of Metals in Lip Products. Environmental Health Perspectives, 121(6), 705-710  
  6. Agency for Toxic Substances and Disease Registry, U.S. Department of Health and Human Services (August 2007). Toxicological Profile for Lead. Retrieved from https://www.atsdr.cdc.gov/toxprofiles/tp.asp?id=96&tid=22#bookmark07  
  7. Environmental Protection Agency. EPA’s Report on the Environment: Blood Lead Level. Retrieved from https://cfpub.epa.gov/roe/indicator.cfm?i=63  
  8. Zhu, M., Fitzgerald, E.F., Gelberg, K.H., Lin, S., & Druschel, C.M. (2010). Maternal Low-Level Lead Exposure and Fetal Growth. Environmental Health Perspectives, 118(10), 1471-1475  
  9. Nye, M.D., King, K.E., Darrah, T.H., Maguire, R., Jima, D.D., Huang, Z., Mendez, M.A., Fry, R.C., Jirtle, R.L., Murphy, S.K., & Hoyo, C. (2016). Maternal blood lead concentrations, DNA methylation of MEG3 DMR regulating the DLK1/MEG3 imprinted domain and early growth in multiethnic cohort. Environmental Epigenetics, 2(1)  
  10. American Heart Association. (2016, September). ‘Safe’ Blood Lead Levels Linked To Risk Of Death. ScienceDaily. Retrieved from www.sciencedaily.com/releases/2006/09/060918192146.htm  
  11. Centers for Disease Control and Prevention (2017, February). Lead. Retrieved from https://www.cdc.gov/nceh/lead  
  12. Agency for Toxic Substances and Disease Regulation (2010, August 20). Lead Toxicity: How Are People Exposed to Lead? Retrieved from https://www.atsdr.cdc.gov/csem/csem.asp?csem=7&po=6  
  13. World Health Organization (2016, September). Lead poisoning and health: Fact sheet. Retrieved from http://www.who.int/mediacentre/factsheets/fs379/en  
  14. Centers for Disease Control and Prevention (2005, May). Childhood Lead Poisoning. Retrieved from https://www.cdc.gov/nceh/publications/factsheets/ChildhoodLeadPoisoning.pdf  
  15. Natural Resources Defense Council (2016, June). What’s In Your Water? Flint and Beyond. Retrieved from https://www.nrdc.org/sites/default/files/whats-in-your-water-flint-beyond-report.pdf  
  16. Agency for Toxic Substances and Disease Registry, U.S. Department of Health and Human Services (2007, August 20). Lead Toxicity: What is the Biological Fate of Lead? Retrieved from https://www.atsdr.cdc.gov/csem/csem.asp?csem=7&po=9  
  17. Nye, M.D., King, K.E., Darrah, T.H., Maguire, R., Jima, D.D., Huang, Z., Mendez, M.A., Fry, R.C., Jirtle, R.L., Murphy, S.K., & Hoyo, C. (2016). Maternal blood lead concentrations, DNA methylation of MEG3 DMR regulating the DLK1/MEG3 imprinted domain and early growth in multiethnic cohort. Environmental Epigenetics, 2(1)  
  18. Trasande, L. & Liu, Y. (2011). Reducing the Staggering Costs of Environmental Disease in Children, Estimated at $76.6 Billion in 2008. Health Affairs, 30(5): 863-870