Cosmetics and safety

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

By Katherine Harmon

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

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

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

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

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

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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