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Marcia G. Yerman

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What Price Beauty? New Legislation Seeks Safety Regulations

Posted: 09/19/10 03:23 PM ET

2010-09-19-cosmetics.jpg

Most Americans would be astonished to learn that of the approximately 12,500 individual chemical ingredients in personal care products, the overwhelming majority has never been reviewed for safety by any governmental or "publicly accountable body." It is estimated by the Campaign for Safe Cosmetics that Americans generally use ten personal care products daily--which can expose them to more than 126 "unique" chemicals. More than 500 products sold in the United States utilize ingredients banned in Canada, Europe, and Japan. Hormone disruptors have been found in perfume; chemicals have been identified in umbilical cord blood. Are American consumers being adequately protected?

Rep. Jan Schakowsky (D-IL) doesn't think so. A long time consumer advocate, Schakowsky is spearheading a move to revamp the obsolete federal law from 1938. She has introduced House Resolution 5786, with current co-sponsors Rep. Ed Markey (D-MA) and Rep. Tammy Baldwin (D-WI).

In 2001, Schakowsky introduced the Safe Notification and Information for Fragrances Act. At that time, she reached out to Janet Nudelman, who serves as both the legislative coordinator for the Campaign for Safe Cosmetics and the Director of Program and Policy for the Breast Cancer Fund. Nudelman outlined how fragrance was only a small part of the larger problem--toxic chemicals throughout the spectrum of cosmetics and personal care products. When I interviewed Nudelman she said, "Rep. Schakowsky looked to the Campaign for Safe Cosmetics as a resource when she was developing her legislation. We helped her identify the key issues that needed to be addressed. The result was the Safe Cosmetics Act of 2010."

The premise of the Safe Cosmetics Act is to secure legislation that would terminate those loopholes in federal law that currently allows companies to use any ingredients--even those known to have an adverse effect on human health and the environment. Chemicals in products shown to have a link to cancer, birth defects, and learning disabilities would be eliminated.

Statistics show that 80 percent of all personal care products can be tainted with "cancer causing pollutants." As Schakowsky pointed out, "It's not just a women's issue." In a teleconference about the Resolution, Markey said, "Men just don't think of themselves in terms of cosmetics." Yet they are at risk from the unregulated formulations in shaving creams, aftershaves, and deodorants.

Included on the call was actress and cancer activist Fran Drescher, who spoke about her concerns. "The cosmetics industry can no longer be a self-regulating industry," she opined. A repeated premise was that safety standards had to be uniform. Markey emphasized, "The details are important."

There would be big changes for the fragrance industry. Previously shielded by invoking "confidentiality" in the categories of "fragrance, flavor, and color," they would have to disclose and label their products with the chemicals that are used as preservatives.

Jane Houlihan, Vice President for Research at the Environmental Working Group (EWG), weighed in on the proposed bill commenting, "The legislation would give [the] FDA real authority to ensure that personal care products sold in the United States met a basic standard of safety." The EWG has put together the "Skin Deep" database with over 60,000 product entries that allows consumers to research the levels of toxicity in the beauty items they use.

Two previous attempts at putting regulations into place in 1973 and 1988 failed. Markey made clear, "We intend on insuring that cosmetics will no longer fall into a regulatory back hole that winds up hurting people."

The proposed bill has nine key provisions. They are:

Registration of Cosmetic Companies and Registration Fees: Cosmetics companies would be required to register with the FDA and pay registration fees.

Cosmetic and Ingredient Testing and Safety: The FDA would establish a list of ingredients prohibited from being used in cosmetics. Manufacturers would be required to conduct safety assessments and submit information to the FDA.

Cosmetics and Ingredient Statements: Companies would have to submit ingredient statements for every product they manufacture to the FDA.

Ingredient Labels on Cosmetics: The label on each package of cosmetics would be required to list the name of each ingredient, including the components of fragrance.

Post Market Testing: This requires the Secretary of Health and Human Services to conduct annual random sample tests for pathogens or contaminants in cosmetic products.

Mandatory Reporting of Adverse Health Effects: Cosmetic Manufacturers, packagers, and distributors would have to submit a report to the FDA on any serious adverse events associated with the use of a cosmetic.

Market Restrictions: For products that fail to meet the safety standard, HR 5789 would provide the FDA with recall authority, the ability to request a voluntary recall, or to order a halt to distribution.

Worker Issues: This requires companies that distribute cosmetics for salon use to provide information on health hazards listed by authoritative bodies, or found in scientific studies.

States Rights: This allows states to set more stringent standards.

I contacted Stacy Malkan, spokesperson for the Campaign for Safe Cosmetics. She has been involved in chemical safety policy reform for ten years and is also the author of Not Just a Pretty Face: The Ugly Side of the Beauty Industry".

Malkan reeled off more numbers supporting her belief in the need for legislation. She told me that only 13 percent of cosmetic chemicals have been publicly reviewed for safety: more than 70 percent of all personal care products may contain phthalates, which are linked to birth defects and infertility: there is also evidence that some baby soaps contain the cancer causing chemical 1,4 dioxane, formaldehyde, or both.

Having checked the Skin Deep database, I was discouraged to learn that some of the items I use, advertised as "natural" or "eco-friendly," had problems. Malkan explained, "Even if an ingredient comes from a plant or is organic, it needs to be accessed for safety." Therefore, it is important to also take into account that the labels "safe" and "natural" have no legal definitions.

Speaking about how big brands were working to capitalize on consumer interest in greener alternatives, Malkan referenced name players who were either creating alternative lines to their regular cosmetics or buying pre-existing "green" labels, while still using toxins in their other products. She singled out Estée Lauder for specific criticism. Malkan suggested, "If they can use less parabens or formaldehyde releasing toxins in the Origins line, why don't they extend that to their other products? How can they support breast cancer research and at the same time have carcinogens in their makeup?"

Malkan described how cosmetic chemicals in shampoo, toothpaste, hand soap, and bath products wash down the drain into the national waterways--and end up in the fish that we eat. Admitting that the big picture could be overwhelming, Malkan suggested that simple steps could reduce chemical exposure. Her advice to individuals was to "start by cutting a few things out" of your beauty routine. "Less is more. Simpler is better." Top advice was to avoid synthetic fragrance, and use fewer products overall--especially on babies and young children.

I asked her for a list of what she considered the most toxic components to avoid. They are:

Parabens: Widely used as a preservative in a range of personal care products. They are suspected endocrine disruptors that can mimic estrogen in the body. Higher lifetime exposure to estrogen is a known risk factor for breast cancer.

Ethoxylated chemicals: Chemicals such as sodium laureth sulfate, PEGs, ceteareth-20 and other chemicals with "eth" in the name are often contaminated with 1,4 dioxane, a probable human carcinogen that may also be toxic to the kidneys, brain and respiratory system, according to the California EPA.

Triclosan in anti-bacterial soaps: This pesticide is found in a range of products including anti-bacterial hand soaps, dishwashing liquids, and toothpaste. Triclosan is associated with carcinogenic byproducts, and is linked to disruption of the thyroid hormone. The U.S. FDA has found there is no evidence that triclosan soaps are more effective in killing germs than regular soap and water.
Hydroquinone in skin lightening and face creams: Banned in the European Union but legal in the United States, hydroquinone is a suspected carcinogen.

Coal tar-based hair dyes: Several coal tar-based ingredients have been found to cause cancer in lab animals. Studies of humans link long-time hair dye use with cancer, including bladder cancer, non-Hodgkin's lymphoma, and multiple myeloma.

Formaldehyde-releasing preservatives: Found in bath products and shampoos. Formaldehyde, is a known allergen and probable human carcinogen.

Fragrance: Studies have found that many fragrances contain sensitizing chemicals that can trigger allergic reactions such as headaches, wheezing, and asthma attacks. Many fragrances contain diethyl phthalate, a chemical linked to sperm damage in adult men and abnormal reproductive development in baby boys.

On a positive note, Malkan referred me to a list of companies that have already signed a pledge to make safe products, available at The Compact for Safe Cosmetics. Addition resources include: the EWG's 2010 Sunscreen Guide; the Whole Foods program tied to their Premium Body Care seal; the OPI nail company--which has reformulated its line of Nail Lacquers, Nail Treatments, and Nail Hardeners to eliminate DBP (dibutyl phthalate) and Toluene. (They have an "OPI Cares" link on their site).

Malkan sees the bill as an "incredible opportunity"--a once in a generation possibility to put "health protective environmental regulations in place for the cosmetics industry." She is aware that not everyone sees it that way. She told me, "The bill has certainly stirred up a lot of passion, which was to be expected since this is the first attempt to regulate an industry that has had very few regulations to deal with." She continued, "My view is that there are some legitimate questions about the bill, but there is a desire on the part of environmental groups to work together with small businesses to come up with a final bill that is meaningful and workable." She noted, "There are already people who are spreading disinformation about the bill and about environmental health science, which is not helpful to the debate on how to make the beauty industry as safe as it can be."

Optimistically Malkan concluded, "I think people's behavior is already changing. The sales of green personal care products are growing faster than that of conventional products."

"We don live in a bubble. Home use, food packaging, air and water pollution--we're being doused with chemicals. Cosmetics are the tip of the iceberg. If we can do something about it, why not?" Nudelman underscored. At the Breast Cancer Fund, the organization's mission is to prevent breast cancer by identifying and eliminating the environmental links to the disease. "Consumers have the right to know," Nudelman emphasized, pointing to transparency as the goal. "Why do companies use harmful ingredients when they can do a product without it?" Nudelman asked rhetorically. Her answer was, "Because they can, and there is no standard definition of safety. It's business as usual. It's what they have always done."

The Personal Care Products Council, based in Washington, D.C., doesn't agree. They describe their organization as the "leading national trade association representing the $250 billion global cosmetic and personal care products industry...whose member companies are global leaders committed to product safety, quality and innovation." They issued a statement in reaction to the Safe Cosmetics Act on July 21, through Lezlee Westine, the President and CEO of the Personal Care Products Council.

I spoke by telephone with Kathleen Dezio, Personal Care Council spokeswoman, to get a clearer perception of her organization's position. She told me, ""We think our proposals are more rooted in practicality and efficacy in terms of product safety. A regulatory regime for cosmetics that is stricter than the regulations for food, drugs, or medical devices is costly, unnecessary, and it's impractical." I asked her if she would define the Personal Care Products Council as a lobbying organization. She responded, "We do lobby like other trade associations, but that's a small part of what we do. The largest part of our operations is scientific services for our member companies."

Dezio did believe that "the FDA cosmetics regulatory structure should be contemporized," saying, "And we have put forward a proposal we believe would effectively accomplish that. We have also lobbied for several years to secure more funding for FDA's cosmetics office. Yet she made clear, "I think that a lot of the allegations being made about cosmetic ingredient safety are misrepresentations of what the scientific community thinks." She pointed to a study conducted by the FDA published in July/August 2009 about lead in lipstick. The FDA responded to the question, "Is there a safety concern about the lead found by FDA in lipsticks?" with the answer, "Lipstick, as a product intended for topical use, is only ingested incidentally and in very small quantities. The FDA does not consider the lead levels that it found in the lipsticks to be a safety concern." Nevertheless, the FDA went on to state that it will "continue to test for lead in a wider range of lipsticks, including lipsticks similar to those recently assessed for lead content by another laboratory.4"

Nudelman believes that "for the last seventy years they [the council] have been lobbying against regulation of the industry." She told me, "We want companies to step up to the plate and say we want to be part of the solution, not the problem."

The battle has just begun. Annie Leonard's seven-minute video, "The Story of Cosmetics", has already received over 300,000 hits on YouTube. Dezio, in turn, responded with a statement about the animated short saying, "The content in this harsh and unscientific 'shockumentary - genre' video bears no relationship to the 'real' story of cosmetics."

I contacted Rep. Schakowsky directly to find out how long it will take to move the legislation along. Her estimate was that it would get to the next stage "early on in the next [Congressional] session." When I questioned her about the likelihood of pushback from the cosmetic and fragrance industries her reply was succinct: "We will work with them, or not, to make sure what ends up on the shelf is safe."

This article originally appeared on the women's health site Empowher.

Image courtesy of RVR Associates.

 

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11:53 AM on 10/03/2010
I used to work in the pharmaceutical industry. Believe me when I say: don't believe a word from the cosmetics industry lobby. They are protecting assets of $250 billion. That is more money than most of the governments in our world are operating with. They are doing everything humanly possible to use barely tested, or not at all, ingredients in their products because it keeps costs way down. Part of their job is to legally keep from registering detailed chemical names and safety data for patents - why are they exempt from having to patent formulas for 17 years, but every other industry has this limitation? When you get sick from cheap fragrances used in laundry products and cosmetics, particularly the new ones marketed in the past year, companies are currently protected under the law to not provide you with any chemical names for medical investigation. They also provide NO safety data. The U.S. CPSC does not have chemical names or safety data for any of these products, nor does the FDA or EPA. Your only recourse is to sue the company. If you have problems with these products, there is a Facebook page about laundry problems. For all fragrance chemical related problems, search all over the web and there are blogs and groups forming. Thanks to the Cosmetics Safety Database, WVOE, and Rep. Jan Schakowsky for proposing this regulation. Please pass it! Write your congressional representatives!
06:49 PM on 09/23/2010
Let’s face it: no one wants personal care products that contain harmful toxins on our shelves. But there they sit. First, consumers need to be educated. Anyone can start by finding out more on the subject (i.e. what's in my lip gloss, anyway?) and making more conscious--and safe--choices about what purchases we make and what we put on their faces and bodies. I started by making the Campaign for Safe Cosmetics and EWG's Skin Deep sites my go-to sources of info (and I tell everyone who will listen to visit their sites). Second, we need to ask our legislators to step up to help protect us. If we're okay with rules for what we put in our bodies (food), why not rules for what we put ON our bodies? It’s really that clear to me. Simple action to take: go to Congress dot org to contact your rep about supporting the bill.
02:56 PM on 09/22/2010
Helpful article. There's a lot more info about the legislation (and the problem it addresses) at www.safecosmetics.org. Especially interesting to the small-business commenter might be the FAQ at http://www.safecosmetics.org/article.php?id=695, which may help clear up some misconceptions about the bill and how it will affect cosmetics businesses.
06:16 PM on 09/20/2010
The larger problem we are facing is that we have "tested" and deemed "safe" tens of thousands of chemicals on animals only to find that the many results are not accurate in humans. It's time to use human-relevant non-animal testing practices as outlined by the National Academy of Sciences report, "Toxicity Testing in the 21st Century: A Vision and a Strategy in 2007."

The potential for chemical reform is quite exciting, but it should be done in a way that doesn’t sacrifice millions of animals (for toxicity testing) in the name of better protection for human health. We need Congress to mandate and create market incentives to use nonanimal methods and tests.
03:42 PM on 09/20/2010
Just want to mention that at present, all ingredients ARE required to be listed on any cosmetics product--it's no different than food labels. Drugstore.com is a great resource as you can find ingredients for any product there. So you read the label & decide whether you want to buy/use the product.

Maybe what people are looking for is stricter government regulations about what ingredients can be used.
11:58 AM on 10/03/2010
You are incorrect. When you say "fragrance," there is no regulation stating that the manufacturer has to tell me exactly what that is. There are literally, thousands of synthetic fragrances concocted by chemists in whatever form or shape. For food, you can't just say "color", you have to state exactly what the color number is, and that information is available. For example, blue#1 - I can get an MSDS telling me plenty of information about that color.
03:26 PM on 09/20/2010
Thank you for this important article about a public health issue that has been left unaddressed by the federal government for far too long. I commend Rep. Shakowsky for her efforts regarding the Safe Cosmetics Act. These safety issues cannot be left to the cosmetics industry/'market' to regulate, because under current regulations too many important health details are not provided to the consumers. It can take a little extra effort at times, but it is worth the effort to seek out safe products and support cosmetics companies that care about our health.
01:42 PM on 09/20/2010
The air we breathe, the water we drink - both have been improved radically over the last few decades due to regulation (not fixed, but Id rather drink and breathe now than in the 70s.) In food we have choices, I can choose USDA organic or Certified Humane labeling. With personal care products it is completely and unreasonably on the consumer to decipher, and with out all the information. I applaud the Safe Cosmetics Act for standing up and being our national voice. If others dont like how it is spelled out then lets get active and involved. Id love for the world to be discussing this. As other countries protect their citizens, not having the regulation is no longer an option for the US.
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J David Auner
01:26 PM on 09/20/2010
Accurate labels are extremely important. My idea of a label would be thus: Company updated web site regulated by FDA on label. Contents: 6 published studies,5 expert opinions,25 opinions from other scientists and the public. 7 positive for safety/29 negative. Container:22 published studies,546 expert opinions,4567 comments from scientists and public. 2 positive for safety,5133 negative. Method product is used:2 published,1 expert opinion,256 comments from scientists and public. 3 positive for safety,256 negative. Problems with use of expired product:0 studies,1 expert opinion,3 comments. 0 positive,4 negative. Whistle blower rules for fraudulent company posts should apply.
11:15 AM on 09/20/2010
I have a small hand-made soap & bath & body business. I started it because I believe in making products that are as close to natural as possible--I grow some of my ingredients, buy from local farmers, & always from small suppliers that I have a personal relationship with. I' m exactly the person who desires greater safety & transparency in ingredient regulation. Yet this Act will most likely put me out of business. As written, each time I get an order of goats'milk for my soap from my friend Rebecca I would have to test and report. Would this make my soap safer?--I doubt it, but I know I can't raise the price of my soap to cover the cost of testing. There are frightening statistics being quoted in articles about this Act. They really aren't very accurate, unfortunately, but unless you take the time to do the reading on the research you won't know that. I really wish that we could work holistically on the many huge problems of contamination & pollution in this country--the chemicals that we use for cosmetic purposes are pretty minuscule compared to what we get from the air we breathe , the water we drink & the food we eat--planes flying overhead, fertilizers, pesticides, smokestacks, methane from animals, oil spills--I could go on all day----an Act to address the overall problem would be a huge accomplishment--I could support that.
10:00 PM on 09/21/2010
I too own a hand made soap/personal care product business and you are correct. These "fees & registration fees" they talk about number in the thousands and will put people like us out of business.

I am also a Holistic Nutritional Consultant & Master Herbalist (in training) that is obtaining my BSHH.

There are good things about this...but there are also bad things. They need to adjust this law to where it does not alienate those of us who went into the business to create natural products & already have honesty in labeling.

We soap makers etc need to get together & put our 2 cents in on this or we are going to be "legislated" out of business.
12:03 PM on 10/03/2010
You brought up an excellent point. I was thinking that naturally occurring substances are not regulated by the FDA. Maybe an exclusion for naturally occurring excipients? The problematic sources for medical problems, like asthma, headaches, and wheezing, are usually related to the synthetic fragrances. These newer fragrances are longer lasting, and cannot be broken down easily with heat or common household chemicals. They literally "stick". We know that people have "allergies" to naturally occurring ingredients, but just listing them on the side of the container should be enough. I disagree with the wording in the cosmetics act about annual review of the microbiology. As a microbiologist, I don't think necessary, and certainly would be a burden on a small company like yours.
11:07 AM on 09/20/2010
One of my concerns with the The Safe Cosmetics Act of 2010 is the testing requirements, I am a small company and if you read SEC. 614. COSMETIC AND INGREDIENT TESTING AND SAFETY of The Safe Cosmetics Act of 2010 I would be required to test every shipment of supplies as well as my water, that was deemed good enough to drink! can you imagine the expense for a small company to test all the supplies and another concern is the labeling requirements that would require me to list an ingredient that I use extensively, Olive Oil like this (can you imagine how long the labels would be?); (Tri-Glycerides of Palmitic, Di-Glycerides of Palmitic, Palmitoleic, Stearic, Oleic, Linoleic, Arachidic Acid, Linolenic Acid, Squalene, Beta Carotene, Campesterol, Methylenecholesterol, Stigmasterol, Sitosterol, Fucosterol, 28-Isofucosterol, Stigmadienol, Brassicasterol, 7-Cholestenol,Ergostadienol, Avenasterol, Triterpene Alcohols, Tirucallol, Taraxerol, Dammaradienol Beta-Amyrin Germanicol, Butyrospermol, Parkeol, Cycloartenol, Tirucalladienol, 24-Methlene 24-Dihydroparkeol, 24-Methlenecycloartanol, Cyclobranol, 4-Methyl Sterols, Esters of Tyrosol, Esters of Hydroxytyrosol, Vitamin E (Tocopherols), Carotenoids, Oleuropein)
12:30 PM on 09/20/2010
ha--we were writing at the same time, i think....
10:33 AM on 09/20/2010
I know people all over the world that suffer from cosmetics, fragrance, soaps, detergents, dryer exhaust, cleaning products, etc. Why would other countries eliminate these chemcials and the US lets these issues drag on for years. I am not aloud to go around and poison anyone-- why should companies be permitted to do so?

If they don't want to ban chemicals causing suffering, they should compensate those that cannot work and have begged for years for regulation. I can buy safe products for my home, but it is the products other use that cause illness.

I have written of these issues for many years, You should take the time to listen to the hearings, you would be surprised how much our leaders do not know what is in our products-- nor does the EPA, etc.

Crazy way of doing business. Make the product then later find out if it is safe. Or did they know of the dangers from the start-- but went ahead and made the product anyway? What do you think?

It is sad that people need to see it on tv that many of these products cause cancer, asthma, migraines, etc. but will still ignore the info provided.
12:06 PM on 10/03/2010
You are right on. I personally don't use these toxic products, but my neighbors do, and the toxins from their dryer exhaust are actually coming into my house and getting me sick. I agree - why are these large corporations allowed to poison people, but I could get arrested for doing that?
10:07 AM on 09/20/2010
There are parts of this law that we really need, but other parts are simply not thought out. The requirement, if you read the law, is for companies to submit "publicly available safety information". This is because the EPA does not have the authority to require the chemicals companies to submit full safety data - so how is FDA going to make this decision? What will it cost to set up a system in which there is no real accountability between agencies?

I want to see the US have the safest consumer products in the world. I'm not so sure that this focus on cosmetics will accomplish that - it seems to avoid the real issue of analysis and a comprehensive chemical policy for the US. I'd like to see the regulation be smarter and I'd like to see all consumer products be safer.