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The FDA Needs More Power to Regulate Toxic Chemicals in Cosmetics

Laws need to change to allow the FDA to protect people

Julia Breckenreid

Earlier this year a group of more than a dozen health advocacy groups and individuals petitioned the U.S. Food and Drug Administration to ban lead acetate from hair dyes. The compound, a suspected neurotoxin, is found in many hair products—Grecian Formula, for example. Lead acetate has been outlawed for nearly a decade in Canada and Europe. Studies show it is readily absorbed through the skin and can cause toxic levels of lead to accumulate in the blood.

How is it possible that this chemical is still being sold to U.S. consumers in cosmetic products? The main reason is that petitions such as the one calling out lead acetate are one of the few ways, under current law, that the agency charged with ensuring food, drug and cosmetic safety can even start to limit dangerous chemicals used on our faces and in our bodies. We need to do better.

Under the Federal Food, Drug, and Cosmetic Act and the Fair Packaging and Labeling Act, the FDA can regulate cosmetic chemicals. But it only steps in if it has “reliable information” that there is a problem. In practice, that has often meant that nothing is done before a public outcry. Years can pass while the FDA investigates and deliberates. Aside from these situations, the safety of cosmetics and personal care products is the responsibility of the companies that make them. The law requires no specific tests before a company brings a new product with a new chemical to market, and it does not require companies to release whatever safety data they may collect.


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The result is that several chemicals with realistic chances of causing toxic effects can be found in everything from shampoo to toothpaste. One is formaldehyde, a carcinogenic by-product released by the preservatives used in cosmetics. In 2011 the National Toxicology Program at the Department of Health and Human Services declared formaldehyde a known human carcinogen, demonstrated by human and animal studies to cause cancer of the nose, head, neck and lymphatic system. Other research indicates it can be dangerous at the levels found in cosmetics, and nearly one fifth of cosmetic products contained the chemical. Other risky substances include phthalates, parabens (often found in moisturizers, makeup and hair products) and triclosan, which the FDA banned from hand soaps in 2016 yet is still allowed in other cosmetics. At exposures typical of cosmetic users, several of these chemicals have been linked to cancer, impaired reproductive ability and compromised neurodevelopment in children.

A recent study published online by Ami R. Zota of George Washington University and Bhavna Shamasunder of Occidental College in the American Journal of Obstetrics & Gynecology showed that women of color are at especially high risk of exposure. In an attempt to adhere to Caucasian beauty ideals, the researchers found, women of color are more likely to use chemical hair straighteners and skin lighteners, which disproportionately expose them to high doses of phthalates, parabens, mercury and other toxic substances.

The U.S. should protect its citizens. One worthwhile approach is to emulate the European Union's directive on cosmetics, which has banned more than 1,300 chemicals from personal health or cosmetic products. In some cases, the E.U. has acted after seeing only preliminary toxicity data. This is a prime example of the “precautionary principle” that has guided U.S. health agencies in setting acceptable levels of exposure to other potentially hazardous substances, such as lead.

Right now the number of studies on cosmetics is limited, and the FDA does not have the resources or directive to initiate broad tests. This past May senators Dianne Feinstein of California and Susan Collins of Maine reintroduced the Personal Care Products Safety Act in Congress. The bill would require, among other things, that all cosmetics makers pay annual fees to the agency to help finance new safety studies and enforcement—totaling approximately $20 million a year. With that money, the FDA must assess the safety of at least five cosmetics chemicals a year. The bill also gives the agency the authority to pull products off the shelves immediately when customers have reported bad reactions, without waiting for a review that can take multiple years.

Consumers should not be forced to scrutinize the ingredient lists in their medicine cabinets and report adverse reactions. That should be the FDA's job. The Feinstein-Collins bill empowers the agency to make efficient determinations from sound science.

Scientific American Magazine Vol 317 Issue 5This article was originally published with the title “Get Toxic Chemicals Out of Cosmetics” in Scientific American Magazine Vol. 317 No. 5 (), p. 10
doi:10.1038/scientificamerican1117-10