Fact: The Food and Drug Administration (FDA) has no authority to require companies to assess ingredients or products for safety. FDA does not review or approve the vast majority of cosmetic products or ingredients before they go on the market. The agency conducts pre-market reviews only for certain color additives and active ingredients in cosmetics classified as over-the-counter drugs.1,2

Myth: The cosmetics industry effectively polices itself, making sure all ingredients meet a strict standard of safety.

Fact: In its more than 30-year history, the industry’s safety panel (the Cosmetic Ingredient Review, or CIR) has assessed fewer than 20 percent of cosmetics ingredients and found only a handful of ingredients or chemical groups to be unsafe.3,4 Its recommendations are not binding on companies.5

Myth: The government prohibits dangerous chemicals in personal care products, and companies wouldn’t risk using them.

Fact: Cosmetics companies may use any ingredient or raw material, except for color additives and a few prohibited substances (such as vinyl chloride and cow parts), without government review or approval. 1,6

• More than 500 products sold in the U.S. contain ingredients banned in cosmetics in Japan, Canada or the European Union.7

• Nearly 100 products contain ingredients considered unsafe by the International Fragrance Association.8

• A wide range of nanomaterials whose safety is in question may be common in personal care products. 9

• 22% of all personal care products may be contaminated with the cancer-causing impurity 1,4-dioxane, including many children’s products. 10,11

• 60% of sunscreens contain the potential hormone disruptor oxybenzone that readily penetrates the skin and contaminates the bodies of 97% of Americans.12,13

• 61% of tested lipstick brands contain residues of lead. 14

Myth: Cosmetic ingredients are applied to the skin and rarely get into the body. When they do, levels are too low to matter.

Fact: People are exposed by breathing in sprays and powders, swallowing chemicals on the lips or hands or absorbing them through the skin. Studies find evidence of health risks. Biomonitoring studies have found cosmetics ingredients – like phthalate plasticizers, paraben preservatives, the pesticide triclosan, synthetic musks, and sunscreens – inside the bodily fluids of men, women, children and even the cord blood of newborn babies.15–22 Many of these chemicals are potential hormone disruptors that may increase cancer risk.23–26 Products commonly contain penetration enhancers to drive ingredients deeper into the skin. Studies find health problems in people exposed to common fragrance and sunscreen ingredients, including elevated risk for sperm damage, feminization of the male reproductive system, and low birth weight in girls. 27-30

Myth: Products made for children or bearing claims like “hypoallergenic” are safer choices.

Fact: Most cosmetic marketing claims are unregulated, and companies are rarely if ever required to back them up, even for children’s products. A company can use a claim like “hypoallergenic” or “natural” “to mean anything or nothing at all,” and while “[m]ost of the terms have considerable market value in promoting cosmetic products to consumers,… dermatologists say they have very little medical meaning.” 31 An investigation of more than 1,700 children’s body care products found that 81 percent of those marked “gentle” or “hypoallergenic” contained allergens or skin and eye irritants. 32

Myth: FDA would promptly recall any product that injures people.

Fact: FDA has no authority to require recalls of harmful cosmetics.1 Furthermore, manufacturers are not required to report cosmetics-related injuries to the agency. FDA relies on companies to report injuries voluntarily.1

Myth: Consumers can read ingredient labels and avoid products with hazardous chemicals.

Fact: Federal law allows companies to leave many chemicals off labels, including nanomaterials, contaminants, and components of fragrance.25 Fragrance may include any of 3,163 different chemicals,33 none of which are required to be listed on labels. Fragrance tests reveal an average of 14 hidden compounds per formulation, including potential hormone disruptors and diethyl phthalate, a compound linked to sperm damage.34

Myth: Cosmetics safety is a concern for women only.

Fact: Surveys show that on average, women use 12 products containing 168 ingredients every day, men use 6 products with 85 ingredients, 35 and children are exposed to an average of 61 ingredients daily.24 The large majority of these chemicals have not been assessed for safety by the industry-funded CIR safety panel. 3,4Authors: Jason Rano, Legislative Analyst Jane Houlihan, Senior Vice President for Research, Environmental Working Group, Washington DC.

Stacy Malkan, Campaign for Safe Cosmetics, 202-321-6963, stacy@safecosmetics.org; Alex Formuzis, Environmental Working Group, 202-667-6982, alex@ewg.org

1. FDA (U.S. Food and Drug Administration). 2005. FDA authority over cosmetics. http://www.cfsan.fda.gov/~dms/cos-206.html.

2. FDA (U.S. Food and Drug Administration). 2010. Regulation of non-prescription products. http://www.cfsan.fda.gov/~dms/cos-206.html.

3. FDA (U.S. Food and Drug Administration). 2007. Compliance Program Guidance Manual. Program 7329.001. Chapter 29 – Colors and Cosmetics Technology. http://www.fda.gov/downloads/cosmetics/GuidanceComplianceRegulatoryInformation/ComplianceEnforcement/ucm073356.pdf.

4. CIR (Cosmetic Ingredient Review). 2009. Ingredients found unsafe for use in cosmetics (9 total, through December, 2009). http://www.cir-safety.org/findings.shtml.

5. Houlihan, J. 2008. Statement of Jane Houlihan on Cosmetics Safety: Discussion Draft of the ‘Food and Drug Administration Globalization Act’ Legislation: Device and Cosmetic Safety. Before the Subcommittee on Health of the Committee on Energy and Commerce, United States House of Representatives. May 14 2008. http://www.ewg.org/node/26545.

6. FDA (U.S. Food and Drug Administration). 2000. Ingredients prohibited & restricted by FDA regulations. June 22, 1996; Updated May 30, 2000. http://www.fda.gov/Cosmetics/ProductandIngredientSafety/SelectedCosmeticIngredients/ucm127406.htm.

7. EWG (Environmental Working Group). 2007b. Cosmetics with banned and unsafe ingredients. Table 1 – Banned in other countries. Accessed June 21, 2010. http://www.ewg.org/node/22624.

8. EWG (Environmental Working Group). 2007c. Cosmetics With Banned and Unsafe Ingredients. Table 2 – Unsafe for use in cosmetics, according to industry. Accessed June 21, 2010. http://www.ewg.org/node/22636.

9. EWG (Environmental Working Group). 2006. EWG Comments to FDA on Nano-Scale Ingredients in Cosmetics. Docket: FDA Regulated Products Containing Nanotechnology Materials. Docket number: 2006N-0107. http://www.ewg.org/node/21738.

10. EWG (Environmental Working Group). 2007d. EWG research shows 22 percent of cosmetics may be contaminated with cancer-causing impurity. http://www.ewg.org/node/21286. •

11. CSC (The Campaign for Safe Cosmetics). 2009. No more toxic tub. http://www.safecosmetics.org/downloads/NoMoreToxicTub_Mar09Report.pdf.

12. EWG (Environmental Working Group). 2010. EWG’s 2010 sunscreen guide. Nanomaterials and hormone disruptors in sunscreens. http://www.ewg.org/2010sunscreen/full-report/nanomaterials-and-hormone-disruptors-in-sunscreens/.

13. Calafat AM, Wong LY, Ye X, Reidy JA, Needham LL. 2008. Concentrations of the sunscreen agent benzophenone-3 in residents of the United States: National Health and Nutrition Examination Survey 2003–2004. Environ Health Perspect. 2008 Jul;116(7):893-7.

14. CSC (Campaign for Safe Cosmetics). 2007. Lead in lipstick. http://www.safecosmetics.org/article.php?id=223.

15. CDC (Centers for Disease Control and Prevention). 2005. Third National Exposure Report. http://www.cdc.gov/exposurereport/report.htm.

16. Darbre PD, Aljarrah A, Miller WR, Coldham NG, Sauer MJ, Pope GS. 2004. Concentrations of parabens in human breast tumours. J Appl Toxicol. 2004 Jan-Feb;24(1):5-13.

17. Ye X, Bishop AM, Reidy JA, Needham LL, Calafat AM. 2006. Parabens as urinary biomarkers of exposure in humans. Environ Health Perspect. 2006 Dec;114(12):1843-6.

18. Müller S, Schmid P, Schlatter C. 1996. Occurrence of nitro and non-nitro benzenoid musk compounds in human adipose tissue. Chemosphere. 1996 Jul;33(1):17-28.

19. Eisenhardt S, Runnebaum B, Bauer K, Gerhard I. 2001. Nitromusk compounds in women with gynecological and endocrine dysfunction. Environ Res. 2001 Dec;87(3):123-30.

20. Sathyanarayana S, Karr CJ, Lozano P, Brown E, Calafat AM, Liu F, Swan SH. 2008. Baby care products: possible sources of infant phthalate exposure. Pediatrics. 2008 Feb;121(2):e260-8.

21. EWG (Environmental Working Group). 2008. Adolescent exposures to cosmetic chemicals of concern. http://www.ewg.org/reports/teens.

22. EWG (Environmental Working Group). 2009. Pollution in minority newborns. http://www.ewg.org/minoritycordblood/executivesummary.

23. Gray TJ, Gangolli SD. 1986. Aspects of the testicular toxicity of phthalate esters. Environmental health perspectives 65: 229-23.

24. Schreurs RH, Legler J, Artola-Garicano E, Sinnige TL, Lanser PH, Seinen W, et al. 2004. In vitro and in vivo antiestrogenic effects of polycyclic musks in zebrafish. Environmental science & technology 38(4): 997-1002.

25. Gomez E, Pillon A, Fenet H, Rosain D, Duchesne MJ, Nicolas JC, et al. 2005. Estrogenic activity of cosmetic components in reporter cell lines: parabens, UV screens, and musks. Journal of toxicology and environmental health 68(4): 239-251.

26. Veldhoen N, Skirrow RC, Osachoff H, Wigmore H, Clapson DJ, Gunderson MP, et al. 2006. The bactericidal agent triclosan modulates thyroid hormone-associated gene expression and disrupts postembryonic anuran development. Aquatic toxicology (Amsterdam, Netherlands) 80(3): 217-227.

27. Duty SM, Singh NP, Silva MJ, Barr DB, Brock JW, Ryan L, et al. 2003. The Relationship between Environmental Exposures to Phthalates and DNA Damage in Human Sperm Using the Neutral Comet Assay. Environ Health Perspect 111(9): 1164-9.

28. Hauser R, et al. DNA damage in human sperm is related to urinary levels of phthalate monoester and oxidative metabolites. Hum Reprod. 2007;22(3):688-95.

29. Swan SH, Main KM, Liu F, Stewart SL, Kruse RL, Calafat AM, et al. 2005. Decrease in anogenital distance among male infants with prenatal phthalate exposure. Environ Health Perspect 113(8):1056-61.

30. Wolff MS, Engel SM, Berkowitz GS, Ye X, Silva MJ, Zhu C, Wetmur J, Calafat AM. 2008. Prenatal phenol and phthalate exposures and birth outcomes. Environ Health Perspect. 2008 Aug;116(8):1092-7.

31. FDA (U.S. Food and Drug Administration). 1998. Clearing Up Cosmetic Confusion” by Carol Lewis. FDA Consumer magazine. May-June 1998. http://www.pueblo.gsa.gov/cic_text/health/cosmetic-confusion/398_cosm.html.

32. EWG (Environmental Working Group). 2007a. Safety Guide to Children’s Personal Care Products. http://www.cosmeticsdatabase.com/special/parentsguide/summary.php.

33. IFRA (International Fragrance Association). 2010. Ingredients. IFRA survey: Transparency list. http://www.ifraorg.org/public/index_ps/parentid/1/childid/15/leafid/111.

34. EWG & CSC (Environmental Working Group and Campaign for Safe Cosmetics). 2010. Not so sexy. Hidden chemicals in perfume and cologne. http://www.safecosmetics.org/article.php?id=644.

35. EWG (Environmental Working Group). 2004. Exposures Add Up – Survey Results. http://www.cosmeticdatabase.com/research/exposures.php.