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Purely Cosmetic?

A New Report Gives Risk Ratings to Thousands of Personal Care Products. It
Reveals How Little Is Known About Them -- but Not Whether There's Really
Much to Fear


by Jennifer HugetThe Washington Post
June 22nd, 2004

You're already counting calories or carbs, measuring your weight and your
BMI, monitoring your blood pressure and cholesterol. Do you really need
another health-related number to reckon with?
The Environmental Working Group (EWG), a nonprofit public-interest research
group known for making connections between chemical exposure and adverse
health conditions, thinks you may. The Washington-based organization has
made it easy to calculate your risk of exposure to potentially harmful
substances through the personal care products you use. In its new "Skin
Deep" study, funded by the Heinz Family Foundation, the Beldon Fund and the
John Merck Fund, EWG uses a complex formula to assign a health-risk rating
to each of 7,500 personal-care products.
In EWG's assessment, Just For Men Brush-In Color Gel for Mustache, Beard &
Sideburns, Natural Real Black merits a whopping 9.5 score (on a scale of 0
to 10, the top end reflecting the highest risk). Rite Aid Pure Baby Oil
comes in for a tiny 1.1 rating. In between are Crest Rejuvenating Effects
Liquid Gel Toothpaste (4.3) and Speed Stick Deodorant Solid, Fresh Scent at
5.3. EWG says all those products impose a cumulative chemical load about
which too little is known.
The rating system offers a means of quantifying the answer to a
controversial question: Just what are we doing to ourselves when we slather
stuff on our bodies? At first blush, the numbers may scare you. Dig deeper
and you'll find much that could temper your fear -- or, depending on your
point of view, fire your temper.
People like Rep. Diana DeGette (D-Colo.) applaud EWG's work, saying it's
time for the cosmetics industry to change. "Consumers need better
information about the ingredients used in their personal care products,"
said DeGette. "Providing consumers with better access to this information is
an important first step."
But the industry says the public shouldn't fear its products. Gerald McEwen,
vice president for science of the Cosmetic, Toiletry, and Fragrance
Association (CTFA), maintains that "cosmetics really are safe. There are not
a huge number of complaints, and no evidence of a lot of health problems
from their use."
In any case, the context for any possible risks need to be taken into
account. Michael Thun, head of epidemiology for the American Cancer Society,
says that "evidence doesn't support the view [that cosmetics are major
contributors to cancer risk] at all. If cosmetics pose any [cancer] risk at
all, that risk is very small compared to known major risks like smoking,
[poor] nutrition, obesity and physical inactivity and sunlight."
EWG itself encourages a moderate response to the data. EWG project director
Jane Houlihan says Skin Deep's findings are "cause for concern, but not
alarm."
Calculating Risk
Finding your cosmetics risk rating is easy and even kind of fun: Just go to
the "Skin Deep" report (www.ewg.org/reports/skindeep/) and type in the brand
name of your deodorant, toothpaste, soap, shampoo and whatever else you use.
(EWG research shows the typical adult uses nine such products per day.) The
site will tell you how many ingredients the products collectively contain
(the average adult load is 126 unique chemicals, says EWG), and rate the
aggregate health threat those ingredients may pose.
Each product is ranked according to its ingredients' potential to cause
cancer, trigger allergic reactions, interfere with the endocrine (hormonal)
system, impair reproduction or damage a developing fetus; any harmful
impurities in the product are also considered. Containing unstudied
ingredients or a "penetration enhancer" that helps chemicals get absorbed
through the skin also enter into the equation, as does any violation of
industry safety recommendations surrounding its use.
EWG compiled a master list of ingredients in personal-care products and
compared those components with known and suspected chemical health hazards
on government, industry and academic lists.
Not all sources carry equal weight in the EWG formula. The presence of
progesterone on the federal government's list of known or suspected
carcinogens helps bump the rating for DDF Organic Sunblock, SPF 30, to 8.5.
Meanwhile, said Houlihan, less weight is given to a list offered by authors
of the controversial book "Our Stolen Future" (OSF), which examines
synthetic chemicals' potential threat to the endocrine system. And so the
presence of the so-called parabens chemicals (butyl-, methyl, ethyl-, and
propyl-) had less of an effect on the rating of Peter Thomas Roth Titanium
Dioxide Sunblock SPF 30, which received a 7.0 score. OSF-supplied data show
the parabens may alter hormone levels, but the industry's safety review
panel calls them "safe as used."
Industry, Police Thyself
One of the key data sources of the EWG report is the Cosmetic Ingredient
Review (CIR) panel, the industry's voluntary oversight body. Cosmetics
aren't subject to the same federal regulation that drugs and foods receive;
the Food and Drug Administration (FDA) doesn't conduct pre-market reviews or
safety checks of cosmetics or their ingredients.
In the absence of such controls, the CIR conducts reviews of scientific data
regarding ingredients that have come to its attention, usually because their
use is becoming more widespread or because published research raises safety
concerns. The group conducts a few dozen reviews each year. The CIR doesn't
conduct scientific studies of its own but relies on research done by others,
including manufacturers.
The CIR maintains a list of chemical ingredients and guidelines for their
use, based on available data, which in many cases is scant. Some are
considered "safe as used," others are deemed safe to use under set
circumstances, and some are labeled unsafe. Cosmetics manufacturers are
supposed to consult this list and follow its instructions when formulating
their products. Consumers are welcome to check the list, too: it's online at
www.cir-safety.org/findings.shtml.
By FDA regulation, items whose ingredients haven't been shown to be safe are
supposed to say so on their labels. According to the EWG, none of the
products in the Skin Deep database bore such a label, despite the fact that
356 products contained ingredients for which the CIR had insufficient data
to support their safe use in cosmetics.
Other products draw EWG's fire for containing ingredients that are used in
ways other than those dictated by the CIR. For instance, Pond's Clear
Solutions Overnight Blemish Reducers -- which are applied directly to the
skin -- pull an 8.8 rating for containing butyl methacrylate, a substance
for which CIR's instructions are to "avoid skin contact."
The study "revealed major gaps in the regulatory safety net for consumers,"
Houlihan said. "When only 11 percent of the ingredients in personal care
products have been assessed, that leaves a large room for unknown risk."
Houlihan said the EWG is particularly concerned about the risks posed by
cosmetics ingredients over time and in combinations.
McEwen of the CTFA said "the FDA has ample authority to be able to take
action" if ingredients are misused. Those actions include seizing products
found to be unsafe or misbranded and to prosecute those who sell them. "The
law is absolutely clear. Companies are not allowed to put on the market a
product that's not safe or has unsafe ingredients," he said. FDA action can
include "throwing [violators] in jail."
"I'm sure that someone looking at that would not allow themselves to be
placed in that position," McEwen said.
But Linda Katz, director of the FDA's office of cosmetics and colors, said
the agency's lack of authority to require pre-market safety testing makes it
difficult to enforce the law.
"Since we don't do pre-market approval, we don't necessarily know" whether a
company has conducted tests to establish ingredient safety or not. If the
agency does find out -- usually through adverse-event reports -- that a
dangerous ingredient is present without a warning label, "we can say the
item is misbranded and take action."
Killing Me Softly With Lip Balm?
Searching the EWG report's Web site can be discomfiting. The usual suspects
-- such as hair dyes, long under scrutiny for the health risks they might
pose -- take a hit here. For instance, Clairol Natural Instincts Haircolor,
Level 2, Sahara 02 gets a 10 for its potentially cancer-causing ingredients.
But more unsettling are high ratings attached to such apple-pie products as
Neutrogena, whose Transparent Skin Care Bar scored high at 8.1, and
ChapStick, whose mint lip balm scored 7.4.
But digging deeper into the site can muffle your alarm. Neutrogena
Transparent Skin Facial Bar's bad rating, for instance, is based in part on
the carcinogenic potential of a chemical called triethanolamine, which the
report found in 987 products. Follow the link to learn that this substance's
connection to cancer is ill-defined and of concern only when this chemical
is combined with another and left on the skin rather than washed away. It's
considered safe for rinse-off use by the CIR panel.
The scores of 535 products are adversely affected by the presence of
petrolatum -- basically good ol' petroleum jelly, which in its pure form is
considered safe. But petrolatum's varied and unregulated manufacturing
procedures make the goop vulnerable to contamination by foreign elements,
which may -- or may not -- pose cancer risks or other health concerns.
Fifty-six percent of the products in EWG's database contain penetration
enhancers, widely used in FDA-regulated drugs as well as in cosmetics to
help active ingredients get through the skin. EWG notes that penetration
enhancers can be troublesome if they help other chemicals -- including
possible carcinogens -- get under your skin, too. But in EWG's database, the
presence of a penetration enhancer worsens a product's score whether or not
there's another worrisome chemical present in the formula. Having both a
penetration enhancer and a possible carcinogen brings the score even closer
to 10.
Nor is the Skin Deep system entirely rational: RID Lice Shampoo, which
contains pyrethrins, pesticides suspected of causing neurological damage,
has a modest 5.9 rating. This is far "safer" than TIGI Bed Head, Dumb Blonde
Shampoo, which gets its 8.5 mark for having lots of unstudied chemicals,
penetration enhancers and potential harmful impurities. (No word on whether
the product's name influenced its score.)
Acknowledging that in this case something "fell through the cracks,"
Houlihan says the inconsistency will be addressed in updated versions of the
report.
In the end, the study's main message is less about what we know can hurt us
than about the vast universe of unknowns. The rating system yields high
numbers not only for products whose chemical makeup is likely to do harm but
for those containing lots of possibly benign ingredients that consumers have
no way of distinguishing from the nasty stuff. A product label listing
"silica," for example, gives the consumer no guidance as to whether the
ingredient is the carcinogenic crystalline silica or another form of the
substance not thought to cause harm.
A Call for Regulation
EWG has garnered much attention, both from the media and from government
agencies, for calling attention to the presence of arsenic in playground
equipment and deck wood, and PCBs in farmed salmon. Their findings have been
disputed by the industries they target, but some have led to changes in
federal regulations. For instance, the group's work with arsenic in wooden
play sets helped encourage a federal ban on arsenic's application to wood
used in backyard structures.
A week after releasing its "Skin Deep" report, the EWG petitioned the FDA
to, among other things, order recalls of cosmetics that contain ingredients
that haven't been established as safe and yet don't carry a warning label.
It has also asked the agency to require manufacturers to stop using
ingredients that contain toxic impurities or that might combine with other
ingredients to form such impurities.
The Skin Deep site offers a link by which you can send an adverse-effect
report to the FDA if you have a bad reaction to a cosmetic.
"We need fundamental changes in the way cosmetics are regulated in this
country," said Richard Wiles, EWG's senior vice president. "First, we need a
definition of what 'safe' is. And cosmetics need to conform to the same
safety standards as other chemicals" in foods and drugs that are regulated
by the FDA.
The FDA's Katz said she couldn't comment on the EWG petition because it is
currently before the agency. Nor had she or her colleagues fully digested
the EWG report in time to comment on it in detail for this article.
But she did say that "the bottom line is that cosmetics have been used in
this country for a very long time, and their ingredients are generally
safe." Still, she said, "We will carefully look at the [EWG] report to make
an assessment as to whether there are ingredients that need further study.".
Jennifer Huget is a regular contributor to the Health section.