A nine-member review panel of health experts, established by the cosmetics industry with the FDA’s support, disputed GIB's claim in a report last year. Methylene glycol in the products is continuously converted to formaldehyde, and vice versa, the panel said last year. The panel concluded that "hair smoothing products containing formaldehyde and methylene glycol are unsafe" at the levels found.
Representatives of the Personal Care Products Council, a trade group representing Revlon, Procter & Gamble and 600 other companies, agreed with the review panel's conclusion. “The industry supports the determination made by CIR (Cosmetic Ingredient Review) that methylene glycol/formaldehyde when used in hair straighteners is not safe,” said Halyna Breslawec, chief scientist at the Personal Care Products Council.
Also, the American Chemistry Council, which represents chemical manufacturers, supports the panel's finding. However, it opposes the classification of formaldehyde as a known carcinogen, calling the science uncertain.
Industry representatives say that formaldehyde can be used safely in cosmetics, including nail hardeners, as long as the levels don't exceed limits set by the review panel. “Ingredients are safe, depending on their dose. The amount of formaldehyde that is used as a preservative or in other cosmetic uses is safe,” Breslawec said.
In the United States, more than eight billion personal care items, mostly cosmetics, are sold annually for an estimated $54-$60 billion. From 2004 to 2010, cosmetics imports nearly doubled, according to FDA and industry officials.
In California, where manufacturers must report chemicals in consumer products that are known or suspected of causing cancer or reproductive effects, 700 companies reported 17,060 cosmetic products as containing one or more hazardous chemical ingredients.
“Insulated behind burden of proof”
Unlike drugs and medical devices, cosmetics are not subject to pre-market approval or notification. A manufacturer may use any ingredient provided it doesn't adulterate the product and it is properly labeled – except for 10 types of ingredients, including chloroform, methylene chlorine and mercury, according to FDA regulations.
Under the Food, Drug and Cosmetic Act, the FDA doesn't have recall authority; instead it must start enforcement proceedings in federal court to prove harm, according to FDA's Landa in his congressional testimony in March.
Joseph H. Guth, a lawyer and biochemist at University of California, Berkeley, said the cosmetics industry “is insulated behind the burden of proof” required under the law.
Guth said the burden of proof should shift to the manufacturers to present testing information before products go on the market instead of making the government prove harm to get them off the market.
“People think cosmetics are tested for safety. They are not. It's not like pharmaceuticals or even pesticides where some data are required. All the same, people slather cosmetics directly on their bodies, and absorb them in creams, deodorants, fragrances and shampoos, and ingest them in lipstick and gloss,” said Guth, who serves on two science advisory panels for the California Environmental Protection Agency.
“The industry is highly resistant to regulation, and it provides zero information on the chemicals in products,” he said.
Breslawec of the industry group said that pre-approval of products is unnecessary. “If you look at the safety record of cosmetics, you will see the existing controls are sufficient because cosmetics have a record of being very safe."