Executive Summary

FDA cannot require companies to do safety testing of their cosmetic products before marketing.

— FDA Office of Cosmetics and Colors (FDA 1995)

Most consumers would be surprised to learn that the government does not require health studies or pre-market testing for cosmetics and other personal care products before they are sold. According to the government agency that regulates cosmetics, the FDA's Office of Cosmetics and Colors, "...a cosmetic manufacturer may use almost any raw material as a cosmetic ingredient and market the product without an approval from FDA" (FDA 1999).

The toxicity of product ingredients is scrutinized almost exclusively by a self-policing industry safety committee, the Cosmetic Ingredient Review (CIR) panel. Because testing is voluntary and controlled by the manufacturers, many ingredients in cosmetics products are not safety tested at all. Environmental Working Group's analysis of industry and government sources shows that:

• Eighty-nine (89) percent of 10,500 ingredients used in personal care products have not been evaluated for safety by the CIR, the FDA, nor any other publicly accountable institution (FDA 2000, CIR 2003).

The absence of government oversight for this $35 billion industry leads to companies routinely marketing products with ingredients that are poorly studied, not studied at all, or worse, known to pose potentially serious health risks.

The Environmental Working Group's (EWG's) six-month computer investigation into the health and safety assessments on more than 10,000 personal care product ingredients found major gaps in the regulatory safety net for these products. To help people use what we learned we developed an online rating system that ranks products on their potential health risks and the absence of basic safety evaluations. The core of the analysis compares ingredients in 7,500 personal care products against government, industry, and academic lists of known and suspected chemical health hazards.

Our analysis shows that ingredients in cosmetics range from essentially harmless components like table salt and oatmeal, to chemicals known to cause cancer in humans. Notably, natural ingredients are no more likely to have been assessed for safety than synthetic chemicals. Individual ingredients vary tremendously in their ability to soak through the skin. Some absorb in only miniscule amounts, while others can quite easily penetrate the skin to the blood vessels below. Few individual ingredients pose excessive risks, but most people use many products in the course of a day, so it well may be that these risks are adding up. A survey of 2,300 people conducted as part of this research effort shows that the average adult uses 9 personal care products each day, with 126 unique chemical ingredients. More than a quarter of all women and one of every 100 men use at least 15 products daily.

Little research is available to document the safety or health risks of low-dose repeated exposures to chemical mixtures like those in personal care products, but the absence of data should never be mistaken for proof of safety. The more we study low dose exposures, the more we understand that they can cause adverse effects ranging from the subtle and reversible, to effects that are more serious and permanent.

Overall, our investigation of product safety shows cause for concern, not alarm. Much more study is needed to understand the contribution of exposures from personal care products to current human health trends.

Findings. Our safety assessment of 7,500 personal care product labels, documented in this web-based review, shows that:

• Just 28 of the 7,500 products we analyzed have been fully assessed for safety by the cosmetic industry's self-regulating panel, the Cosmetic Ingredient Review (CIR). All other products — 99.6 percent of those examined — contain one or more ingredients never assessed for potential health impacts by the CIR. This panel, run and funded by the cosmetic industry's trade association, is billed as the organization that "thoroughly reviews and assesses the safety of ingredients used in cosmetics" on behalf of the industry (CIR 2004). The government does not systematically review the safety of personal care products and has banned or restricted just nine of the more than 10,000 ingredients used in personal care products.
• One of every 100 products on the market contains ingredients certified by government authorities as known or probable human carcinogens, including shampoos, lotions, make-up foundations, and lip balms manufactured by Almay, Neutrogena, Grecian Formula, and others. An astonishing one-third of all products contain one or more ingredients classified as possible human carcinogens.
• Seventy-one hair dye products contain ingredients derived from carcinogenic coal tar. These products have all been granted a specific exemption from federal rules that deem products to be adulterated when they contain ingredients that can harm human health. Coal tar containing products include dyes made by Clairol, Revlon, L'Oreal, and others. Coal tar hair dyes are one of the few products for which FDA has issued consumer advice on the benefits of reducing use, in this case as a way to potentially "reduce the risk of cancer" (FDA 1993).
• Fifty-five percent of all products assessed contain “penetration enhancers,” ingredients that can increase a product's penetration through the skin and into the bloodstream, increasing consumers' exposures to other ingredients as well. We found 50 products containing penetration enhancers in combination with known or probable human carcinogens.
• Nearly 70 percent of all products contain ingredients that can be contaminated with impurities linked to cancer and other health problems. Studies by FDA and European agencies show that these impurities are common, in some cases occurring in nearly half of all products tested (FDA 1996, DTI 1998). Some manufacturers buy ingredients certified by an independent organization called United States Pharmacopeia (USP). These ingredients may contain lower levels of harmful impurities, but the criteria for certification are not public. There are no federal standards for ingredient purity. While it seems likely that some companies purchase or manufacture refined, purified ingredients, it is equally likely that many do not. Consumers and government health officials have no way to know.
• Fifty-four products violate recommendations for safe use set by the industry's self-regulating Cosmetic Ingredient Review board. Most of these products contain ingredients found unsafe for the intended use of the product they are found in. Examples include ingredients found unsafe for use in baby products but used in diaper cream, ingredients found unsafe for use on injured or damaged skin contained in products marketed specifically for use on chapped and injured skin, and ingredients not safe for sprays but found in spray products. Brand name products found in violation of industry recommendations include Neutrogena, Desitin, Herbal Essences, and Rite Aid.
• In its 67-year history of monitoring cosmetic safety, FDA has banned or restricted just nine personal care product ingredients (FDA 2000). In its review of 1,175 ingredients, the industry's safety panel has found just nine ingredients (a different nine) unsafe for use in cosmetics (CIR 2003). By contrast, 450 ingredients are banned for use in cosmetics in the European Union, although the vast majority of these have never been used by the industry. The regulatory vacuum in the U.S. gives cosmetic companies tremendous leeway in selecting ingredients, while it transfers potentially significant and largely unnecessary health risks to the users of the products.

Table 1. Many leading cosmetics companies may have failed to formulate their products with customer health as a top concern. According to an EWG Safety Assessment Rating for personal care products, the products with the highest health concerns in 25 different product categories contain ingredients linked to cancer, pregnancy problems, and other potential health issues (scores range from 0 to 10, with 10 being of highest health concern):

Recommendations. Because the FDA has no legal authority to require safety assessments of cosmetics, products safety is by default the responsibility of the industry and its own appointed Cosmetic Ingredient Review panel. This voluntary policing arrangement has been a failure. EWG's analysis of 7,500 personal care product labels found that some cosmetic companies use known human carcinogens in products, manufacture scores of products containing ingredients in direct contraindication of industry hazard assessments, widely use chemicals that are likely to be contaminated with harmful impurities, and add to thousands of products ingredients that industry assessments show lack basic information needed to support their safety.

To improve the safety of personal care products EWG recommends that manufacturers:

• Remove from products all chemicals classified as known or possible human carcinogens, reproductive toxins, and developmental toxins. Manufacturers are currently reformulating products in Europe to comply with this restriction.
• Certify that ingredients do not have impurities classified as known or probable human carcinogens, reproductive toxins, or developmental toxins.
• Conform with the recommendations of the CIR and reformulate products to eliminate ingredients that are deemed unsafe for the intended use of the product.

In addition to these actions by industry we also strongly recommend that:

• Congress amend the Federal Food Drug and Cosmetic Act to provide FDA with clear and unencumbered authority to request any and all safety studies that it deems necessary to assess the safety of cosmetics and other personal care products.

Cosmetics Ingredient Review (CIR) (2003). 2003 CIR Compendium, containing abstracts, discussions, and conclusions of CIR cosmetic ingredient safety assessments. Washington DC.

Cosmetics Ingredient Review (CIR) (2004). CIR information available at http://www.cir-safety.org, accessed May 6 2004.

Department of Trade and Industry, UK (DTI) (1998). A survey of cosmetic and certain other skin-contact products for n-nitrosamines.

Food and Drug Administration (FDA) (1993). Hair Dye Dilemmas. FDA Consumer. April 1993. Accessed online May 6 2004 at http://vm.cfsan.fda.gov/~dms/cos-818.html.

Food and Drug Administration (FDA) (1995). FDA Authority over Cosmetics. Center for Food Safety and Applied Nutrition. Office of Cosmetics and Colors Fact Sheet. February 3 1995. Accessed online May 6 2004 at http://www.cfsan.fda.gov/~dms/cos-206.html.

Food and Drug Administration (FDA) (1996). Are nitrosamines in cosmetics a health hazard? Accessed online May 6 2004 at http://vm.cfsan.fda.gov/~dms/qa-cos25.html. Updated November 1996.

Food and Drug Administration (FDA) (1999). Diethanolamine and Cosmetic Products. Office of Cosmetics and Colors Fact Sheet. Dec 9, 1999. Accessed online May 6 2004 at http://vm.cfsan.fda.gov/~dms/cos-dea.html.

Food and Drug Administration (FDA) (2000). Prohibited Ingredients and Related Safety Issues. Office of Cosmetics and Colors Fact Sheet. March 30, 2000. Accessed online May 20 2004 at http://www.cfsan.fda.gov/~dms/cos-210.html.