November 30, 2010
Ms. Jamie Silberberger Director of Programs and Policy
Women’s Voices for the Earth
114 W. Pine Street Missoula, Montana 59802
Dear Ms. Silberberger:
Thank you for your letter, dated November 5 and 8,2010, in which you expressed concerns about Brazilian Blowout hair products. In your letter, you asked that the Food and Drug Administration’s (FDA) Office of Cosmetics and Colors request a recall ofthis product (or “issue a voluntary recall”). issue a health advisory, and use the agency’s “statutory authority to ensure Brazilian Blowout does not continue to make false claims and is penalized for misleading salon workers and consumers regarding the formaldehyde content in its products. II You also asked that FDA “take immediate action to protect consumers and workers from these unsafe products.” FDA shares your concerns and is actively investigating Brazilian Blowout and other similar products on the market.
As you are aware, FDA regulates cosmetics under the authority ofthe Federal Food, Drug, and Cosmetic Act (FD&C Act, or the Act). Under the Act, cosmetics must be safe f(x consumers under labeled or customary conditions of use, and they must be properly labeled. The U.S. Occupational Safety and Health Administration (OSHA) is responsible tQr regulating workplace safety, including air quality. In the case of salons, some state and local authorities also exercise regulatory authority. We recommend that you direct questions and concerns about workplace safety to the agencies with authority in that area.
FDA is working with state and local organizations, as well as OSHA, to determine whether products such as Brazilian Blowout would be likely to cause health problems \’v’hen used as intended. For example, we are working with other regulatory agencies to evaluate the levels offQrmaldehyde that are released into the air after the product is applied to the hair and heated. In addition, we are evaluating the methodology used and the data reported by the Oregon OSHA and other authorities. The composition of the products and the labeling, including use instructions and any warning statements, also will be factors in determining safety.
As you know, FDA has no authority under the FD&C Act to “issue” a recall of a cosmetic, although we can request that a firm voluntarily recall a product if we have solid evidence of a violation of the FD&C Act. We also can take other regulatory action against products marketed in violation of the Act and against the firms and individuals who market them. 110wever, we would need to determine the appropriate steps based on a full examination of all the relevant facts. As a matter of policy, FDA does not announce in advance its intent to carry out enforcement action.
Regarding your request that FDA “immediately issue a health advisory,” we posted “FDA Receives Complaints Associated With the Use of Brazilian Blowout” on our website at http://w\vw.fda.gov/Cosmetics/ProductandlngredientSafety/ Productlnformationlucm228898.htm on October 8, 2010. We have featured this resource on FDA’s home page, \vwwJda.gov; on FDA’s cosmetics home page, www.fda.gov/cosmetics; and elsewhere on the FDA website. Subscribers to FDA news on cosmetics have received email notification of its availability (see “Get Email Updates” at http://www.fda.gov/ AboutFDA/ContactFDA/Staylnformed/GetEmaiIUpdates), and a link to the article was posted on FDA’s Facebook page. We have updated this resource and intend 10 do so again as new information becomes available.
We at FDA appreciate and share your concern about the safety of cosmetics marketed in this country, and take our public health mission seriously.
Office of Cosmetics and Colors
Center for Food Safety and Applied Nutrition