1 4 3 6 U S t r e e t N W , S u i t e 1 0 0 W a s h i n g t o n , D C 2 0 0 0 9 T : 2 0 2 . 6 6 7 . 6 9 8 2 F : 2 0 2 . 2 3 2 . 2 5 9 2 September 26, 2007 Andrew C. von Eschenbach, M.D. Commissioner of Food and Drugs U.S. Food and Drug Administration 5600 Fishers Lane Rockville, MD 20857 Dear Dr. von Eschenbach: FDA regulators will attend a forum in Brussels this week in which cosmetic industry representatives and international regulators will discuss "ways to remove regulatory obstacles among the regions" and other issues related to cosmetic marketing and safety (FDA 2007a). Environmental Working Group (EWG) is writing to express deep concern that FDA officials are excluding public health, consumer, and environmental organizations from this meeting while allowing the regulated industry to participate. While such an unbalanced discussion of consumer safety issues is always unacceptable, this exclusion is even more problematic in light of our new analyses of product safety, which reveal that products sold in the U.S. frequently violate industry safety standards and contain ingredients banned in other industrialized countries. Our findings raise fundamental concerns about closed-door industry-regulator meetings that could further weaken international cosmetic policies. In a new investigation of the ingredients in more than 23,000 products, EWG found that nearly one of every 30 products sold in the U.S. fails to meet one or more industry or governmental cosmetics safety standards. We found nearly 400 products sold in the U.S. containing chemicals that are prohibited for use in cosmetics in other countries, and over 400 products containing ingredients that cosmetic industry safety panels have found unsafe when used as directed on product labels, including the U.S.-based Cosmetic Ingredient Review (CIR) and the International Fragrance Association. As you know, unlike for drugs and food additives, FDA has no authority to require that cosmetics be tested for safety before they are sold. An industry-funded panel (the CIR), not a government health agency, reviews the safety of cosmetic ingredients in the U.S. Our research shows that this largely self-regulated industry routinely fails to adhere to their own safety panel’s advice or to heed the health warnings inherent in cosmetic safety standards set in other countries. More than 750 personal care products sold in the U.S. violate industry safety standards or cosmetic safety standards in other industrialized countries. Our analysis of ingredients in more than 23,000 products finds that 751 different products fail to meet one or more industry or government safety standards, including: • 383 products containing ingredients that are prohibited for use in cosmetics in Canada, Japan, or the E.U. (Health Canada 2007; Japan Ministry of Health, Labour and Welfare 2006; EC 1999-2006; EWG 2007) (Table 1). • 447 products that industry safety panels have found unsafe when used as directed, including 86 found unsafe for all product applications by the CIR and the International EWG: THE POWER OF INFORMATION Dr. von Eschenbach page 2 of 9 September 25, 2007 Fragrance Association (Table 2), and 361 found unsafe by the CIR when used according to package directions (Table 3) (CIR 2007; IFRA 2007; EWG 2007). 98% of all products contain one of more ingredients never publicly assessed for safety. Our analyses also reveal that products sold in the U.S. routinely contain chemicals that lack basic safety data and that have not been found safe for use in cosmetics. These products contain chemicals that the industry’s safety panel determined lacked data necessary for a finding of safety in cosmetics, or they contain chemicals that have not even been reviewed for safety in cosmetics - by FDA, by the U.S. cosmetic industry’s safety panel, or by any other publicly accountable U.S. institution. We found: • 1,331 products containing ingredients for which the CIR panel said there is insufficient data to determine whether they are safe in cosmetics (CIR 2007; EWG 2007) (Table 4). • 22,697 products (98% of all products assessed) containing one or more ingredients for which FDA, the CIR panel, or any other publicly accountable U.S. institution have not conducted safety assessments (CIR 2007; EWG 2007) (Table 5). When the cosmetic industry trade association's current Executive Vice President for Science, John Bailey, was the head of FDA’s Division of Cosmetics, he noted that "The cosmetic industry is sensitive to the image of an uncontrolled market where anything goes[...] They counter this image with well-established self-regulation programs. Part of the incentive for such industry policy is to avoid increased regulatory authority," adding that "In the absence of the CIR program [the industry’s safety panel], there would be no systematic examination of the safety of individual cosmetic ingredients" (FDA 1995). Nothing has changed. The industry's "image of well-established self-regulation programs" stands in stark contrast with the many hundreds of products that violate governmental and industry safety standards. Our findings are particularly troubling in light of FDA's position on the upcoming meeting International Cooperation on Cosmetics Regulations Meeting in Brussels, Belgium. This meeting will be attended by FDA, cosmetic industry representatives, and regulators from Japan, Canada, and the E.U. As noted above, one stated purpose of this meeting is to "identify ways to remove regulatory obstacles among the regions" (FDA 2007a). Given the findings of our analysis, improving product safety should be a far higher priority than removing regulatory obstacles, which are already lacking to the point that products illegal for sale in other countries or not assessed for safety are common on store shelves in the U.S. We are particularly concerned that an FDA official appears to have misrepresented the terms of reference for this meeting in order to exclude representatives of public health and environmental organizations. On August 30, 2007 FDA denied a request made by the Campaign for Safe Cosmetics (of which EWG is a founding member) to attend the Brussels meeting, stating that, "Everyone has agreed that we should stick with our current Terms of Reference that provides for an industry association-regulator dialogue. If that changes at any point, we will certainly let you know" (FDA 2007b). Yet when we reviewed the Terms of Reference for the Brussels meeting (ICCR 2007), obtained by the Campaign for Safe Cosmetics from staff at the FDA Office of International Agreements and E W G : T H E PO W E R O F I N F O RMATION Dr. von Eschenbach page 3 of 9 September 25, 2007 Disclosure, Harmonization and Trade, we found that the document contradicts the official’s assertion. Instead of precluding attendance by anyone but regulators and industry representatives, the Terms of Reference provides that "[...]it is recognized that successful implementation requires the input of a constructive dialogue with the cosmetics’ industry trade associations and potentially other stakeholders"; and that the second day of the meeting can include dialogue with "in certain cases, interested parties." [emphasis added] Contrary to the exclusion asserted by FDA, the document provides ample leeway for public health, consumer and environmental groups to attend; the Campaign for Safe Cosmetics, EWG and other groups who research and advocate for the safety of personal care products certainly qualify as "interested parties” and “other stakeholders" in this process. FDA's misrepresentation of the Terms of Reference and its attempt to exclude consumers and the public from participating in this public health discussion is unacceptable and runs contrary to principles of open government. In 2004, EWG notified FDA of our findings of an analysis identifying hundreds of products either containing chemicals not proven safe for use in cosmetics, or containing ingredients that may cause harm when used according to package directions (EWG 2004). Three years later, with this new analysis, it appears that FDA has done little in the intervening time to improve product safety, and, worse, is now working to exclude public health, consumer and product safety advocates from international cosmetics safety policy decisions. We call on the FDA to: • Set a safety standard for cosmetics by clarifying the current regulatory requirement of "adequate substantiation of safety" in the Federal Food, Drug and Cosmetic Act (21 U.S.C. 301 et seq.). FDA should include guidance on whether it will consider cosmetics safe if they contain ingredients banned in other countries or in violation of CIR recommendations. • Ensure that all personal care products on store shelves are safe for consumers; and • Guarantee that meetings regarding cosmetics safety policy are open and accessible to the public, including the September 27th meeting and all subsequent meetings held by the ICCR. EWG thanks you for your prompt attention to this public health and safety matter. Sincerely, Richard Wiles Executive Director E W G : T H E PO W E R O F I N F O RMATION Dr. von Eschenbach page 4 of 9 September 25, 2007 APPENDED: TABLES 1-5 and ATTACHMENT References CIR (Cosmetics Ingredient Review). 2007. CIR Compendium, containing abstracts, discussions, and conclusions of CIR cosmetic ingredient safety assessments. Washington, DC. 2007. EC (European Commission of the European Union). 1999-2006. Enterprise Directorate-General Pharmaceuticals and Cosmetics. The rules governing cosmetic products in the European Union, Volume 1, "Cosmetics legislation." EWG (Environmental Working Group). 2004. Citizen Petition to U.S. Food and Drug Administration to Cease Unlawful Sale of Misbranded & Adulterated Cosmetics. Docket No. 2004P-0266/CPI. 14 Jun 2004. EWG (Environmental Working Group). 2007. Skin Deep. Last accessed: 24 Sept 2007.