FDA FOIA Re: Brazilian Blowout

Attn: FDA FOIA Officer Food and Drug Administration Division of Freedom of Information (HFI-35) Office of Shared Services Office of Public Information and Library Services 5600 Fishers Lane Rockville, MD 20857

Re: Freedom of Information Act Request

Dear Sir or Madam:

I am writing you on behalf of the Environmental Working Group (EWG) to make a request pursuant to the Freedom of Information Act, 5 U.S.C. § 552, and corresponding Food and Drug Administration (FDA) regulations, 21 C.F.R. §§ 1401.1-1401.13.

EWG is a non-partisan, non-profit organization dedicated to using the power of information to protect public health and the environment. EWG provides useful resources to consumers and advocates policies that promote conservation and mitigate health risks.

In keeping with that mission, EWG has been monitoring reports from Oregon regarding the discovery of formaldehyde in test samples of Brazilian Blowout – despite claims that the products are “formaldehyde free.”¹ Oregon health officials found concentrations of formaldehyde that were more than 50 times greater than industry’s recommended 0.2 percent limit.² They conducted tests after receiving complaints from hair stylists who experienced “eye irritation, nose bleeds and difficulty breathing” shortly after using Brazilian Blowout’s products.³

EWG is troubled by these events because it suggests that there may be cosmetics manufacturers that are imposing unnecessary health risks on consumers. This case is particularly serious because formaldehyde can cause respiratory problems and “severe allergic reactions.”⁴ Medical experts also suspect that formaldehyde is a “human carcinogen.”⁵

Because of the public’s interest in this matter, EWG requests copies of all FDA records (including but not limited to electronic records) regarding health concerns about Brazilian Blowout products and any other hair-straightening product sold in the past two years.

1. All consumer complaints about adverse events potentially caused by Brazilian Blowout products or any other hair-straightening product brought to the FDA’s attention in the past two years; and
2. All correspondence between FDA staff and cosmetics manufacturers regarding health concerns about hair-straightening products such as Brazilian Blowout in the past two years.

EWG acknowledges that it filed a FOIA request with the FDA on Oct. 30, 2010, in which EWG asks for all adverse event records related to cosmetics. However, EWG would like to stress the fact that this letter constitutes an entirely separate request and in no way should affect other ones pending with the FDA.

EWG will accept the requested records with all Privacy Act-protected information redacted.

EWG asks the FDA to waive search or review fees related to this FOIA request in accordance with 5 U.S.C. § 552(a)(4)(A)(iii) and 21 C.F.R. § 1401.13. Granting a fee waiver is in the public interest because this request will help the public more fully understand the risks associated with certain consumer products and how government agencies are addressing them. EWG’s interest in the requested documents is purely non-commercial. If the FDA cannot grant a fee waiver, EWG is willing pay up to $100 so that the FDA may conduct the requested search in a timely fashion.

If you require further clarification about this FOIA request or anticipate any problems with releasing the requested documents, please contact me at (202) 667-6982.

EWG looks forward to your reply to this request within 20 business days, as provided under 5 U.S.C. § 552(a)(6)(A)(i) and 21 C.F.R. § 1401.7.

Sincerely,

Thomas Cluderay
Stabile Law Fellow
Environmental Working Group

¹ Press Release, Or. Health & Science Univ.’s Ctr. for Research on Occupational and Envt’l Toxicology (Sept. 30, 2010), http://www.orosha.org/admin/newsrelease/2010/nr2010_24.pdf. ²See id.; see also COSMETIC INGREDIENT REVIEW, 2009 CIR COMPENDIUM 83 (2009). ³ Andrea Canning, et al., Brazilian Blowout Hair-Straightening Product Under Fire, ABC NEWS, Oct. 1, 2010, http://abcnews.go.com/GMA/Consumer/brazilian-blowout-hair-straightening…. ⁴ OCCUPATIONAL SAFETY AND HEALTH ADMIN., OSHA FACT SHEET: FORMALDEHYDE 1 (2002), http://www.osha.gov/OshDoc/data_General_Facts/formaldehyde-factsheet.pdf. ⁵Id. ⁶ FOIA Request Letter from Sonya Lunder, Senior Analyst, EWG, to FDA (Oct. 30, 2010) (no reference number yet).