NCHR Testimony to FDA in Preparation for the International Cooperation on Cosmetics Regulation Meeting

Tracy Rupp PhD, National Center for Health Research, June 15, 2016

FDA meeting in preparation for the International Cooperation on Cosmetics Regulation (ICCR-10) Meeting

Thank you for the opportunity to speak today. My name is Dr. Tracy Rupp. Our research center analyzes scientific and medical data to provide objective health information to patients, providers and policy makers. I have no conflicts of interest.

We are concerned about the presence of endocrine disrupting chemical in cosmetics, and their effect on consumers’ health. This issue is not new for the International Cooperation on Cosmetics Regulation (ICCR). It was discussed in 2012 and 2013. It appears that the ICCR asked the cosmetics industry for additional information, but it is unclear whether that information was provided and discussed since 2013.

Meanwhile, research on the health impact of endocrine disruptors has continued and the risks of these chemicals in cosmetics have become more widely acknowledged.

Several different phthalates and parabens that disrupt hormones are found in a wide range of cosmetic products. Other endocrine disruptors are used in specific types of cosmetics, such as triclosan in toothpaste and antibacterial soap, and UV filters in sunscreen.

Low molecular weight phthalates such as DEP, DBP, DiBP, and DMP are still found in many cosmetics.[1] Early exposure to these phthalates prenatally and as a young child have been associated in later years with increased behavior problems, decreased cognitive function, and more attention problems.[2]

Parabens that are used in cosmetics as preservatives.[3] Parabens have been associated with health risks such as the generation of excessive free radicals from oxidative stress, DNA damage of sperm, altered thyroid hormones, and increase risk of allergies in humans. In addition, parabens are associated with breast cancer tumors and their growth. In at least some cases, the health effects are stronger when multiple parabens are present, as might be the case with the use of various cosmetic products.

Phthalates and parabens are found in virtually all adults.[4,5,6] They are transferred into human placenta, newborns, and milk, where they can harm fetal and infant development.

There is also evidence that cosmetics substantially contribute to overall exposure to endocrine disruptors. A 2016 study of adolescent girls found that just changing the cosmetics that they used reduced the amount of specific phthalates, parabens, and other endocrine disruptors by 27% to 45%.[7] This study needs to be replicated and extended, but the results suggest that cosmetics provide a measurable portion of human exposure to certain endocrine disruptors.

One of the problems with evaluating the impact of endocrine disrupting chemicals is that they can have an impact at very low concentrations and show a U-shaped dose response.[8] In some cases, smaller doses can have stronger effects than larger doses. This is particularly problematic in measuring the impact of exposure during critical developmental windows, such as during fetal development, as a young child, or during puberty.

We strongly urge the ICCR to have a thorough discussion about the issues of endocrine disruptors in cosmetic products as well as policies to reduce exposure. Not all phthalates and parabens are endocrine disruptors and eliminating all phthalates and parabens from cosmetics would not eliminate all exposure. Children and adults are exposed to many different soaps, creams and other cosmetic products every day and thus are exposed to multiple doses of different endocrine disruptors.

However, changing known or suspected endocrine disrupting chemicals to safer alternatives would reduce consumers’ overall exposure. In cases where cosmetics are the major source of exposure, such as parabens, triclosan, and some phthalates, it can greatly reduce exposure. In products where these chemicals are necessary, they should be clearly labeled so that consumers have the option to avoid them. These actions would reduce the risks of endocrine disrupting chemicals on consumers’ health.

The issues regarding the risks of endocrine disruptors are similar to the issues regarding lead in cosmetics in that exposures from individual cosmetics are lower than from other sources. However, the ICCR still specified a maximum limit for lead in cosmetics so that cosmetics do not unduly increase consumers’ daily exposures.

In summary, endocrine disrupting chemicals are present in cosmetics in the United States. Multiple types of endocrine disrupting chemicals are detected in almost all people due to their use of soaps, creams, and other cosmetics. These chemicals can harm the health of the people who use them. It is therefore essential for the FDA and the ICCR to consider the growing evidence for harm caused by endocrine disrupting chemicals in cosmetics.

Thank you for your time and consideration of our views.

References

  1. Guo Y, Kannan K (2013) A Survey of Phthalates and Parabens in Personal Care Products from the United States and Its Implications for Human Exposure. Environ Sci Technol 47(24):14442-14449.
  2. Ejaredar M, Nyanza EC, Eycke KT, Dewey D (2015) Phthalate Exposure and Childrens Neurodevelopment: A Systematic Review. Environ Res 142:51-60.
  3. Błędzka D, Gromadzińska J, Wąsowicz W (2014) Parabens. From environmental studies to human health. Environ Int 67:27-42.
  4. Philippat C, Bennett D, Calafat AM, Picciotto IH (2015) Exposure to select phthalates and phenols through use of personal care products among Californian adults and their children. Environ Res 40:369-376.
  5. Braun JM, Just AC, Williams PL, Smith KW, Calafat AM, Hauser R (2014) Personal care product use and urinary phthalate metabolite and paraben concentrations during pregnancy among women from a fertility clinic. J Expo Sci Environ Epidemiol 24(5):459-66.
  6. National Health and Nutrition Examination Survey (NHANES) (October 2014). Phthalates and Plasticizers Metabolites- Urine (PHTHTE_G); years of content 2011-2012. http://wwwn.cdc.gov/Nchs/Nhanes/2011-2012/PHTHTE_G.htm
  7. Harley KG, Kogut K, Madrigal DS, Cardenas M, Vera IA, Meza-Alfaro G, She J, Gavin Q, Zahedi R, Bradman A, Eskenazi B, Parra KL (2016) Reducing Phthalate, Paraben, and Phenol Exposure from Personal Care Products in Adolescent Girls: Findings from the HERMOSA Intervention Study. Environ Health Perspect In Press.
  8. Diamanti-Kandarakis E, Bourquioqnon JP, Giudice LC, Hauser R, Prins GS, Soto AM, Zoeller RT, Gore AC (2009) Endocrine-Disrupting Chemicals: An Endocrine Society Scientific Statement. Endocr Rev 30(4):293-342.