Source: Environmental Working Group
The Food and Drug Administration has no authority to require companies to test cosmetics products for safety. The agency does not review or approve the vast majority of products or ingredients before they go on the market
Myth – If it’s for sale at a supermarket, drugstore or department store cosmetics counter, it must be safe.
Fact – The Food and Drug Administration has no authority to require companies to test cosmetics products for safety. The agency does not review or approve the vast majority of products or ingredients before they go on the market. FDA conducts pre-market reviews only of certain cosmetics color additives and active ingredients that are classified as over-the-counter drugs.
Myth – The government prohibits the use of all dangerous chemicals in personal care products, and companies wouldn’t risk using them.
Fact – With the exception of color additives and a few prohibited substances, cosmetics companies may use any ingredient or raw material in their products without government review or approval (FDA 2005). Whereas the European Union has banned more than 1,000 ingredients from use in cosmetics, the FDA has only prohibited the following (FDA 2000a):
Halogenated salicylanilides (di-, tri-, metabromsalan and tetrachlorosalicylanilide)
Prohibited cattle materials (including material from non-ambulatory cattle, material from cattle not inspected and passed and mechanically separated beef).
Myth – The cosmetics industry effectively polices itself, making sure that all ingredients meet a strict standard of safety.
Fact – Since FDA does little to regulate ingredient safety, it has authorized the cosmetics industry to police itself through its Cosmetics Ingredient Review panel. In its more than 30-year history, the industry panel has declared only 11 ingredients or chemical groups to be unsafe (CIR 2012). Its recommendations on restricting ingredients are not binding on companies (FDA 2012).
Myth – Cosmetic ingredients are applied to the skin and rarely get into the body. When they do, the amounts are too low to matter.
Fact – People are exposed to cosmetics ingredients in many ways: breathing in sprays and powders, swallowing chemicals on the lips or hands or absorbing them through the skin. Biomonitoring studies have found that cosmetics ingredients – such as phthalate plasticizers, paraben preservatives, the pesticide triclosan, synthetic musks and sunscreen ingredients – are common pollutants in the bodies of men, women and children. Many of these chemicals are potential hormone disruptors (Gray 1986, Schreurs 2004, Gomez 2005, Veldhoen 2006). Cosmetics frequently contain enhancers that allow ingredients to penetrate deeper into the skin. Studies have found health problems in people exposed to common fragrance and sunscreen ingredients, including increased risk of sperm damage, feminization of the male reproductive system and low birth weight in girls (Duty 2003, Hauser 2007, Swan 2005, Wolff 2008).
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. The FDA says descriptions such as “hypoallergenic” or “natural” can “mean anything or nothing at all,” and while most of these terms “have considerable market value in promoting cosmetic products to consumers… dermatologists say they have very little medical meaning” (FDA 2000b).
Myth – Natural and organic products are always safer.
Fact – Products labeled natural or organic often contain synthetic chemicals, and even truly natural or organic ingredients are not necessarily risk-free. The global market for organic personal care products was valued at more than $7 billion in 2012, capturing the attention of consumers who prefer more natural or plant-based products (Cosmetics Design 2013). Products labeled “organic” or “natural” can contain petrochemicals, and those certified as organic can contain as little as 10 percent organic ingredients by weight or volume (Certech 2008). FDA tried to establish an official definition for the term “natural,” but this initiative was overturned in court (FDA 1998).
Myth – FDA promptly recalls any product that injures people.
Fact – FDA has no authority to require recalls of harmful cosmetics. Furthermore, manufacturers are not required to report cosmetics-related injuries to the agency. FDA relies on companies to report injuries voluntarily (FDA 2005).
Myth – Consumers can read ingredient labels and avoid products with hazardous chemicals.
Fact – Federal law allows companies to leave some chemical ingredients off their product labels, including those considered to be trade secrets, components of fragrance and nanomaterials (FDA 2011). Fragrance may include any number of the industry’s 3,100 stock chemicals (IFRA 2010), none of which is required to be listed on labels. Tests of fragrance ingredients have found an average of 14 hidden compounds per formulation, including ingredients linked to hormone disruption and sperm damage
(EWG & CSC 2010).
Myth – Cosmetics safety is a concern for women only.
Fact – An EWG 2004 consumer survey showed that while on average women use 12 personal care products daily, men use an average of six a day, exposing themselves to more than 80 unique ingredients.
Certech Registration Inc. 2008. International organic standard – Natural and natural organic cosmetic certification. IOS Cosmetics. Issue 01. April 2008. http://www.certechregistration.com/IOS_cosmetics_standard.pdf.
CIR (Cosmetic Ingredient Review). 2012. Ingredients found unsafe for use in cosmetics (11 total, through February 2012). http://www.cir-safety.org/sites/default/files/U-unsafe%202-02-2012%20final.pdf, last viewed November 2013.
Cosmetics Design. 2013. Global market for organic personal care expected to continue rapid growth. July 9, 2013. http://www.cosmeticsdesign.com/Market-Trends/Global-market-for-organic-personal-care-expected-to-continue-rapid-growth
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. Environmental Health Perspectives 111(9): 1164-9.
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
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.
FDA (U.S. Food and Drug Administration). 2000a. Ingredients prohibited & restricted by FDA regulations. June 22, 1996; Updated May 30, 2000. http://www.fda.gov/Cosmetics/ProductandIngredientSafety/SelectedCosmeticIngredients/ucm127406.htm.
FDA (U.S. Food and Drug Administration). 2000b. Hypoallergenic Cosmetics. http://www.fda.gov/cosmetics/cosmeticlabelinglabelclaims/labelclaimsandexpirationdating/ucm2005203.htm.
FDA (U.S. Food and Drug Administration). 2005. FDA authority over cosmetics. http://www.fda.gov/Cosmetics/GuidanceComplianceRegulatoryInformation/ucm074162.htm
FDA (U.S. Food and Drug Administration). 2010. Regulation of non-prescription products. http://www.fda.gov/AboutFDA/CentersOffices/OfficeofMedicalProductsandTobacco/CDER/ucm093452.htm
FDA (U.S. Food and Drug Administration). 2011. Guidance for Industry: Considering Whether an FDA Regulated Product Involves the Application of Nanotechnology (Draft Guidance). http://www.fda.gov/RegulatoryInformation/Guidances/ucm257698.htm
FDA (U.S. Food and Drug Administration). 2012. How FDA Evaluated Regulated Products: Cosmetics. Last updated April 4, 2012.
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.
Gray TJ, Gangolli SD. 1986. Aspects of the testicular toxicity of phthalate esters. Environmental Health Perspectives 65: 229-23.
Hauser R, et al. 2007. DNA damage in human sperm is related to urinary levels of phthalate monoester and oxidative metabolites. Human Reproduction.22(3):688-95.
IFRA (International Fragrance Association). 2010. Ingredients. IFRA survey: Transparency list. http://www.ifraorg.org/public/index_ps/parentid/1/childid/15/leafid/111.
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.
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. Environmental Health Perspectives113(8):1056-61.
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.
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. Environmental Health Perspectives. Aug;116(8):1092-7.
Wu X, Bennett DH, Ritz B. 2010. Usage pattern of personal care products in California households. Food and Chemical Toxicology 48: 3109–3119