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This article is from the In-Depth Report Chemistry for a New Era

Saving Face: How Safe Are Cosmetics and Body Care Products?

The government knows just about as much as you do about what you're putting on your skin—that is to say, not much
cosmetic makeup safety regulation ingredients



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Editor's Note: This story is part of an In-Depth Report on the science of beauty. Read more about the series here.

Cosmetics—makeup, creams, fragrances—have been around for thousands of years. Ancient Egyptian and Roman women famously caked on lead-based foundation. (Lead, a metal, can cause nerve, muscle and organ damage.) But surely lead-laden cosmetics have been phased out along with lead-lined water pipes, right? Not necessarily.

Today, the U.S. Food and Drug Administration (FDA) oversees the multi-billion-dollar-a-year cosmetics industry but it lacks the power to approve products or ingredients before they hit store shelves, even though their contents have been shown to enter the body.

According to the FDA, a cosmetic is anything used for "cleansing, beautifying, promoting attractiveness or altering the appearance." An average U.S. consumer uses about 10 cosmetic products every day, including makeup, soap, shampoo, lotion, hair gel and cologne, says Lisa Archer, the national coordinator for The Campaign for Safe Cosmetics (CSC), a nonprofit advocacy group based in San Francisco and financed in part by the Breast Cancer Fund, a nonprofit organization. As a result, she says, people are exposed to roughly 126 different chemicals daily, many of which haven't been thoroughly tested.

"We're operating in a vacuum in terms of safety," Archer says. "The FDA doesn't even define what 'safe' is, so it's totally up to the discretion of cosmetic companies."

Soaking it in

Slathering, powdering, spritzing. The skin is the body's largest organ and its shield against the surrounding environment. But it is a porous protector, allowing some substances in and others—most notably moisture—out. Some compounds that are applied to the skin's surface can be absorbed into the body, including the estimated four pounds (1.8 kilograms) of lipstick an average lipstick-wearer consumes in a lifetime, according to the Environmental Working Group (EWG), a nonprofit public interest organization based in Washington, D.C.

As chemistry has ramped up in the past century, ingredients in cosmetics have become increasingly complex and cutting-edge. But "there's no need," Archer says, for some potentially harmful chemicals now in cosmetics to be in the mix. Among those that should be nixed, the CSC says: formaldehyde (a known carcinogen that's used as a preservative) and 1,4-dioxane (an industrial solvent or foaming agent that is a suspected carcinogen).

Archer notes that some other ingredients in cosmetics may be benign in one state but toxic in others. For example, titanium dioxide (a naturally occurring mineral often used as a pigment or thickener) is considered to be safe when put into a viscous mixture, such as in sunscreen or toothpaste. But in powder form, such as in mineral makeup powders, it can cause cancer when inhaled, according to the International Agency for Research on Cancer (part of the World Health Organization).

Still on the cusp of regulation, phthalates, chemicals used in everything from nail polish to household cleaners, have recently been garnering negative headlines because of growing concerns about their possible link to health issues. Originally developed in the 1920s, phthalates help make plastics, including food containers and baby bottles, more pliable. Earlier this year Congress banned the use of some phthalates in toys amid mounting evidence that they disrupt the production of hormones, especially in boys, possibly causing reproductive disorders. But John Bailey, chief scientist at the Personal Care Products Council (PCPC), a cosmetic industry organization, says that phthalates are a large class of compounds and that not all of them are associated with health issues.

He points out that one common phthalate, diethyl phthalate used in fragrances, is still legal in the U.S. as well as in the E.U.—where there are much stricter cosmetic safety standards. He says another cosmetic-based phthalate, dibutyl phthalate, which is in nail polish and is a suspected endocrine disruptor, is not risky in the low doses in which it's used. Nevertheless, some companies have removed it from their products voluntarily.

Want to avoid some of the iffy chemicals? Reading cosmetic labels may not be enough. Under the Federal Food, Drug and Cosmetic Act of 1938, cosmetic firms are required to list the so-called intended ingredients in products. That means that contents, such as 1,4-dioxane and lead, might not make it onto labels because they are considered "unintended" by-products (or impurities) of the manufacturing process or of contaminated constituents.

The components of scents also bypass the labeling process. The law requires only that these complex cocktails, which may contain hundreds of ingredients—including phthalates—be listed as "fragrance." From an industry standpoint, the rule guards trade secrets and simplifies packaging. It "wouldn't be practical to list all of them," Bailey says, maintaining that, "consumers basically have the information they need to make [purchasing] decisions."

Regulation after the fact
The Food, Drug and Cosmetic Act authorized the FDA—which also oversees food and drug safety—to make sure that cosmetics do not contain toxic or contaminated ingredients or provide false or incomplete label information. But cosmetics do not have to be approved by the FDA before they hit stores or the Internet. "It's the [cosmetic] firm's responsibility to assure that its cosmetic products and ingredients are safe and properly labeled," explains the FDA's Web site. Under current law, cosmetics makers also aren't required to register with the FDA or give the agency information on ingredients or cosmetic-related injuries. An FDA spokesperson says, however, that the agency monitors the market for potential dangers.

The FDA will step in "if we start noticing that there are a lot of adverse reports coming in" from consumers, says Linda Katz, director of the FDA's Office of Cosmetics and Colors division. "If we find out that there is a product out there [that's] unsafe, we can gather data and contact the distributor or manufacturer." Recalls of a product, however, are the prerogative of the company that makes or distributes it. If the FDA believes a product to be unsafe, it "may request a recall," but it cannot require one, it notes on its Web site.

"The system for regulating cosmetics [in the U.S.] is virtually nonexistent," Archer says. "Other countries are far ahead." The E.U., for example, has banned the use of more than 1,000 substances in cosmetics; in contrast, the FDA has barred the use of eight substances for use in cosmetics: bithionol, chloroflurocarbon propellants, chloroform, halogenated salicylanilides, methylene chloride, vinyl chloride, zirconium-containing complexes, and prohibited cattle materials (to prevent the spread of mad cow disease).

Other chemicals are restricted to certain uses and require special labeling. Earlier this year, for example, the FDA concluded that carmine, an extract from insects used as coloring in some makeup and food, was a common allergen. As a result, it ruled that beginning next year carmine must be listed as an ingredient rather than simply as "color added" on cosmetic and food labels.

Another government group, the Federal Trade Commission (FTC), can take legal action if it discovers that companies are making false advertising claims. But its power doesn't extend to some of the most popular buzzwords of today's market. Claims such as "natural," "organic" or "hypoallergenic" have no specific legal definition in the cosmetic world. Rather, the terms such as hypoallergenic "mean whatever a particular company wants [them] to mean," the FDA's Web site says.

Consequently, consumers should beware, Archer says. "Unfortunately… people see these words and associate them with a better product," she notes.

Is the fox guarding the henhouse?
A patchwork of voluntary organizations have cropped up in the absence of more robust government regulation.

In an attempt to track ingredients and stave off widespread harm, the FDA runs the Voluntary Cosmetic Regulation Program. Participating cosmetic makers and distributors file lists of products and their ingredients with the agency. The FDA can then notify companies in the database if a certain ingredient is found to be potentially troublesome.

The industry-backed Personal Care Product Council (PCPC)—whose membership covers about 15 to 20 percent of U.S. cosmetics companies, which make more than 80 percent of products on the market—encourages companies to do substantial testing before introducing products to the market. Bailey says that most companies perform computer modeling and will run ingredients through a database of toxins. Beyond that, he notes, "finished products typically go through a battery of testing…[and]…usually there will be in-market monitoring, as well" to watch for complaints. He says that the best way to ensure safety is for companies to stick to ingredients that have proven safety track records.
 
Cosmetic companies have also been receiving guidance from the Cosmetic Ingredient Review (CIR), which was started (and is funded) by PCPC in 1976 to evaluate ingredients in beauty products. The CIR's Web site promises that "review processes are independent from the Council and the cosmetics industry," noting they are conducted by a nine-member panel that includes a toxicologist, a dermatologist and a consumer representative as well as nonvoting FDA and industry officials. The CIR has reviewed about 1,500 ingredients to date, which Bailey says account for more than 80 percent of the ingredients commonly used in cosmetics.

The CIR's findings, however, are nonbinding. "Their decisions and whatever conclusion they make need to be reevaluated by the FDA to see if we concur," the FDA's Katz says. When tipped off by the CIR, the FDA will go back to the raw data—including toxicology analyses and adverse-reaction reports—and conduct its own analysis before ruling on whether to limit or ban a certain ingredient or suggest recalls.

But Archer says voluntary compliance is not enough—and that companies should be required to meet certain safety criteria. "Unfortunately, it's a case of the fox guarding the henhouse," she says. "We need actual federal authority and regulations to guide companies as to what safe is…so consumers don't have to have a degree in chemistry to figure out what's safe to use on their families."

In the meantime, she recommends that consumers look for fragrance-free cosmetics with short lists of ingredients.

Need some help? The Compact for Safe Cosmetics, promoted and run by the Campaign for Safe Cosmetics, is a voluntary group of companies that pledge to keep products in line with (or beyond) E.U. standards and to avoid using ingredients that are known or suspected to be hazardous to human health. It currently has a membership of about 1,000 mostly small and midsize U.S. companies. Additionally, the Environmental Working Group's Skin Deep cosmetic safety database allows users to search ingredients of more than 42,000 products.

"I think the good news for consumers," Archer says, is that "there are many companies in the industry that are waking up to the fact that…consumers want safer products."

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