Formaldehyde Containing Hair Straighteners Come Under Scrutiny, FDA Urged to Take Action

Jul 11, 2011   

On May 6, 2011, Rep. Jan Schakowsky, joined by nine other members of the U.S. House of Representatives, sent a letter to the FDA expressing concerns over the use of keratin hair-straightening products which contain high levels formaldehyde. Excess exposure to formaldehyde, a chemical classified by the EPA as a probable carcinogen, can irritate the skin, eyes, and lungs, and can cause breathing problems. Additionally, exposure has been linked to nose and throat cancer and leukemia. A copy of the Congresswomans letter can be read here.

Under the Federal Food Drug and Cosmetic Act, (“FDCA”), 21 U.S.C. § 301 et. seq., the FDA is granted the authority to regulate cosmetics. In accordance with 21 U.S.C. §§ 361 and 362, the FDCA, requires that cosmetics must be neither adulterated nor misbranded. However, unlike medical devices and drugs, cosmetics are not required to receive premarket approval from the FDA prior to marketing. Additionally, cosmetics marketed solely to professionals for salon use are not required to have labeling listing the products ingredients.

Rep. Schakowskys letter comes as formaldehyde based products have been under increased scrutiny. On October 5, 2010, Rep. Earl Blumenauer wrote a letter to the FDA urging it to investigate several hair straightening products labeled as “formaldehyde-free” for possible misbranding under the FDCA. Those products, while technically free of formaldehyde, contain chemicals such as methylene glycol which, when combined with water, creates and releases formaldehyde. In April 2011, the Federal Occupational Safety and Health Administration (“OSHA”) issued a Hazard Alert advising salons to discontinue use of formaldehyde and methylene glycol-based hair straightens. Additionally, in June 2011, the Cosmetic Ingredient Review (“CIR”), an independent industry-funded organization which reviews the safety of cosmetic ingredients, released a tentative conclusion that formaldehyde and methylene glycol are unsafe for use in hair smoothing products. A full study by CIR is expected this September.

Currently, FDA regulations do not prohibit the use of formaldehyde as a cosmetic ingredient and there are no set limits on the amount allowable in products. However, OSHA requires that if a formaldehyde based product is used which contains more than 0.1% formaldehyde, the manufacturer must list the substance on the label and address safe work practices on a material safety data sheet that accompanies the product. Additionally, CIR has recommended that formaldehyde or methylene glycol levels in hair straightening products be no greater than .074%. As a comparison, the products currently on the market which have been tested by OSHA for formaldehyde range from anywhere between 4.85 to 10.6 %.

Rep. Schakowskys letter requests that the FDA: 1) issue a voluntary recall of all formaldehyde based hair straighteners which have already been tested to have levels of formaldehyde greater than OSHA limits; 2) conduct testing of all hair straighteners available on the market to determine formaldehyde levels; and 3) require warning labels for any hair straightener that contains formaldehyde. The letter also asks the FDA to investigate hair straightening products labeled “formaldehyde free” for possible misbranding violations as well as to review and consider a ban on formaldehyde and formaldehyde releasing chemicals from hair straightening products.

Fuerst Ittleman will continue to monitor the progress of these issues. For more information, contact us at