Industry Press Conference Sets the Record Straight
Let’s jump right to the best part. Of all the strange things I heard yesterday from the cosmetics industry, this quote from doctor-for-hire Richard Adamson was most bizarre. “We humans are all chemicals put together and formatted in a very sophisticated manner by our maker and by evolution.”
Yes he really said that, at a press conference. What does he mean? Maybe he’s trying to say that only God can give you cancer? He certainly doesn’t think cosmetics will, according to his testimony at yesterday’s hastily organized press event put on by the Personal Care Products Council (to which they neglected to invite certain top reporters who are following the story — guys, come on.)
The event was billed as “setting the record straight” about the Story of Cosmetics and the Safe Cosmetics Act of 2010. (Click here for MP3 audio of the press conference put on earlier in the day by bill sponsors Rep. Jan Schakowsky and Rep. Edward Markey, actress Fran Drescher, EWG and Breast Cancer Fund.)
Key points made at the industry conference: They are really eager to get to work with Reps. Markey and Schakowsky and already have a meeting scheduled on the Hill. (John Bailey and lobbyist John Hurson had to leave midway through the event for a meeting with bill sponsors, but weirdly, when a reporter asked them specifically who they were meeting with, they wouldn’t say and told the reporter to “look at the bill.”)
Bottom line, they don’t like this bill: it will dump an unnecessary amount of data on FDA, they couldn’t deal with it, they’d have to build a new building to put all the researchers. Safety standard would ban a glass of water. Ridiculous to require everyone in supply chain to register with FDA. Would make it virtually impossible to put products on market. Removing trade secrets is huge problem. Bill is not scientifically responsible.
They don’t like the movie either. “They’re really mad about the movie,” says my source. According to a statement read by press person Kathleen Dezio (former beverage industry apologist for benzene in soda), the film is a “harsh unscientific shockumantary that bears no resemblance to the real story of cosmetics. It is repugnant and incredibly offensive to suggest that cosmetic companies would manufacture, and FDA would allow them to market, products that are dangerous or contain toxins that cause cancer or any other disease.”
They took special exception to the “cheap attack” in the video about the industry’s philanthropy efforts to raise money for cancer. “In fact, through its Look Good. Feel Better program, the industry has helped 700,000 women in the U.S. overcome the appearance-related side effects of cancer treatment,” Dezio said.
“The ‘real’ story of cosmetics is that of an industry with a proven, lengthy track record of responsibility and safety and a strong commitment to making the lives of consumers better.”
So there.
NEW: Great NYT blog by David Herzenhorn The Nanny and the Senators
July 22nd, 2010 at 9:59 am
Great work Stacy and team!! The amount of press this is getting is very exciting. The video is really clever and I have the sense it is buzzing around the internet at top speed. It is so great to see this conversation rising to the level of national attention that is deserves.
July 22nd, 2010 at 12:46 pm
To say that chemicals are dangerous is ridiculous because all matter on earth is made of chemicals; be it human, plant, mineral or synthetic. The truth is that this bill would put small cosmetic businesses out of business. The truth is that the CFSC considers things like coffee and olive oil (because of phytoestrogens) as cancer agents. So the bill would also close down the business of Natural Cosmetics because all natural ingredients are tainted somewhat with lead and other toxins at minute but measurable levels. Only highly processed and synthetic chemicals could be lead free. I think many people supporting the bill have not really read the bill or the lists of chemicals considered ‘carcinogenic’.
July 23rd, 2010 at 6:03 am
[...] that the other BIG cosmetics news this week is the Safe Cosmetics Act of 2010. (The industry is fricking mad about that too.) So I’m working away on a kind of Price Check on Steroids post to tell you [...]
July 23rd, 2010 at 9:26 am
Cindy, please! I’m tired of these comments that toxic chemicals are just like salt or that these laws would ban coffee — sorry but it is not true, and not a good comparison to relate 1,4 dioxane, petroleum distillates, formaldehyde, phthalates, hydroquinone, etc., to salt and coffee.
July 26th, 2010 at 5:28 pm
Stacy,
I’m concerned about some of the reporting requirements as proposed in the bill for small scale manufacturers – I’m talking the mom’n'pop, kitchen table, type people that you see at your Farmer’s Markets. I see that there is no fee for small cosmetic companies (thank you) but am worried about the paperwork hassle for the part time, home crafter who is literally making like 1000 lip balms a year and selling them for extra holiday money. Is there a possibility of a sliding paperwork scale as well as the fee scale?
Thanks.
July 26th, 2010 at 5:58 pm
Thank you Stacy for making sense in an area of so much nonsense. It isn’t a coincidence that women use twice as many cosmetic ingredient as men and also suffer more from certain types of cancer, hormone disorders, etc… all the while the rise in these health problems coincide with the usage rate of chemicals in cosmetics. Chemicals not proven to be safe by any standard! Big and small companies continue to use ingredients that are unsafe, some even hiding behind the handmade and natural label. Several small companies are also guilty of not researching the ingredients they use, instead relying on this broken system where we have incorrectly believed that an ingredient must be safe or it wouldn’t be available. The safe cosmetic act isn’t perfect as currently written and although I don’t support it in entirety I fail to see another alternative to this industry that is so unregulated! Keep up the good work you do on behalf of the people!
July 27th, 2010 at 6:03 am
Stacy, I believe that you miss the point about salt. It IS dangerous in sufficient quantities – and that is an indisputable fact. What should also be indisputable is that many of the “toxic chemicals” that get certain people hysterical are not present in sufficient quantities in cosmetic products to pose any significant risk to human health. But, instead, too many people get too focussed on the hazard, rather than the risk posed. I know you and I have been here before, but this is for the benefit of others readintg this who did not see the previous discussion.
I don’t see why the supporters of the new bill have to always be insulting to thiose who disagree – using words like “apologist” and (on another site) “goons”, and always have to suggest that there is some sort of conspiracy and that anyone posting contrary comements is paid by “The Chemical Industry” to do so. We all have varying degrees of interest, vested or otherwise; none more so than the paid employees of the EWG, luxuriating in their salaries significantly greater than $100,000, who have the cheek to accuse people like me (typing this during my lunch hour, because my employer does NOT pay me to do this) of vested interest.
In actual fact, we all want the same thing – safe cosmetics – the disagreement comes on the analysis of the current regulatory situation, and the true nature of the risk to which consumers are currently exposed.
I am mystified why Anne-Marie asks you to introduce a sliding scale as though the regulation is within your gift to do as you will. I suppose I should congratulate you on the success of your propaganda when you have managed to convinve people that you are in charge here!
July 27th, 2010 at 6:41 am
Hey Stacy -
It’s great to see you are allowing comments that disagree with your point of view. I, for one, would like to see the science the Campaign for Safe Cosmetics has on ‘toxic chemicals’ in personal care products. Provide links to support your stance. I have an open mind and would love to see your findings. Correct me if I’m wrong though, didn’t Susan Roll state in Colorado back in March that you didn’t have the science?
I find it quite interesting that you would be slightly rude to Cindy in your comments. Cindy happens to be very knowledgeable and is not making her comments just to read her words. Cindy actually knows what she’s talking about, with a Ph.D. in Biochemistry to back up her knowledge.
We’ve definitely come a long way since our discussion in March about finding common ground. I just have to ask myself if the olive branch you extended was really ‘toxic’.
Have a great day!
Lisa
July 27th, 2010 at 9:39 am
I think Anne Marie has a good idea here to have some kind of sliding scale paperwork provision. And it seems to me like that’s the most productive type of discussion to be having here — how to work within the system with this bill (which still has to undergo a lengthy democratic process) to make sure the Safe Cosmetics Act achieves its goal of safer products and fewer hazardous chemicals, without burdening small businesses.
I believe it can be done, and yes Lisa I still believe there is a lot of common ground between the independent business community, even those who are opposed to the bill, and the environmental health community. I was disappointed though to see the inaccuracies on your website Personal Care Truth, such as that the FDA rigorously regulates products and that toxic chemicals are just like salt. Talk about rhetoric (borrowed straight from the Personal Care Products Council). Of course, I do understand that salt can be dangerous in high quantities. It’s also true that the “dose makes the poison” phrase was coined in the 1700s, and the more recent science refutes it as a credible framework from which to make sound decisions about chemicals. We now know it’s not just the dose that makes the poison, but also the timing of the dose, the unique vulnerabilities of the person exposed (for example, a fetus versus the 200 pound male that most risk assessments are based on), the potential for enhanced toxicity of chemical mixtures (i.e., phthalates can have an exponential toxicity when combined with other anti-androgens), and the fact that low-dose exposures can be more harmful than higher doses in some cases (such as with endocrine disruptors). The science is a lot more complicated than the salt comparison, obviously. Point taken, though, that the tone of my earlier response to Cindy was not helpful – I retract it and invite serious discussions about the science for those who would like to have them.
July 27th, 2010 at 11:09 am
Hello Stacy,
It is clear, like so many others in your group that visit the Personal Care Truth Website, when asked to present the science, they spin the conversation away from what is asked and deflect their rationale of accusations to our inaccuracies.
Did you miss Lisa’s request for the science or the fact that susan roll stated you didn’t have the science but let’s ban ingredients based on precautionary principle?
Furthermore Phthalates as shown in 60 minutes, did not need to be banned and there was no incontrovertible evidence that phthalates caused any of the problems based on the claims made by Dr. Swan. This law was based on precautionary principle and served to destroy small toy manufacturers which could not afford the testing, this also included testing for lead, something small indie toy companies were not using in the first place….same scenario here.
And my final question, is why do we need regulation for making “safer cosmetics” as you so enjoy coining a phrase? Since many companies are already doing this, then why regulation at all? It is still about consumer choice…and this is America when I last checked. Educate the public if you will but do it on science, not propaganda and scare tactics like in the Story Of Cosmetics!
I noted at the very end of this unscientific video that she stated the choice would be made for us through federal government regulation. No thanks! I don’t need government control over my business because CFSC or EWG think the American public doesn’t have enough intelligence to make their own choices.
July 27th, 2010 at 11:13 am
Stacy,
granted, some of the things you want prohibited may have some evidence of danger to humans. But, have you even read the list of IACR that you want banned???? I doubt it. Carcinogens are a natural part of plants that exist in balance with things that are beneficial to us. For you to make 1, 4 dioxane equal in danger to coffee and ban both is just ridiculous. Before you say you want all carcinogens banned, try to understand what a carcinogen is.
July 27th, 2010 at 11:21 am
“I noted at the very end of this unscientific video that she stated the choice would be made for us through federal government regulation. No thanks! I don’t need government control over my business because CFSC or EWG think the American public doesn’t have enough intelligence to make their own choices.”
Excuse me I made an error in this last remark…she did not actually state the obvious, but was inferred!
Just needed to clarify my statement!
July 27th, 2010 at 12:40 pm
Cindy, The Safe Cosmetics Act as I read it doesn’t ban chemicals from any specific list but rather sets up a system for FDA to evaluate chemicals over time and make decisions about what’s safe to use.
To Katherine’s question, where is the science? There are many resources to point you to, including books like “The Secret History of the War on Cancer,” by Dr. Devra Davis; “Generations at Risk: Reproductive Health and the Environment,” by Dr. Ted Schettler and Dr. Gina Solomon; “Our Stolen Future” by Dr. Theo Colborn, Dianne Dumanoski, and John Peterson Myers and Myer’s website that tracks the latest science and media stories on environmental health issues at http://www.environmentalhealthnews.org/. The recent President’s Cancer Panel Report (written by two Bush-appointed MDs) issues a strong warning that the cancer cases caused by environmental factors such as chemicals are vastly underreported, and said there is an urgent need for more regulation and study of chemicals. The panel also recommended that pregnant women and people planning families should avoid contact with endocrine disrupting chemicals when possible. http://www.nytimes.com/2010/05/06/opinion/06kristof.html. The American Cancer Society just issued a report about the need to further investigate possible causes of cancer such as formaldehyde, lead, titanium dioxide and acetaldehyde. http://www.reuters.com/article/idUSTRE66E5AS20100715
Regarding phthalates, nobody said that Dr. Shanna Swan’s research provides incontrovertible proof that phthalates cause harm. Rather her studies increased the concerns about a set of chemicals that scientists have been raising concerns about for decades. As quoted in my book, Dr. Earl Gray, a top researcher at U.S. EPA, testified at a legislative hearing in California: “For 25 years, we’ve known that phthalates disrupt the production of testosterone critical for the masculinization of the male species.” For a review of the science, see Dr. Ted Schettler’s report, “Aggregate Exposure to Phthalates in Humans” http://www.safecosmetics.org/downloads/AggregatePhthalatesReport_HCWH.pdf and the article “Male Reproductve Effects of Phthalates: An Emerging Picture,” by NIEHS scientist Jane Hoppin http://journals.lww.com/epidem/Fulltext/2003/05000/Male_Reproductive_Effects_of_Phthalates__An.2.aspx.
Keep in mind that both these reports were written before the recent human studies by Dr. Swan showing decreased anogenital distance (a marker of maleness) in male babies and by Dr. Phil Landrigan of Mt. Sinai showing increased ADHD in children whose mothers were exposed to higher levels of diethyl phthalate (the fragrance phthalate) while pregnant; and by Harvard researchers Dr. Russ Hauser and Susan Duty showing DNA damage in the sperm of adult men exposed to diethyl phthalate. For references on all those studies, see page 21 and 22 of this report, http://www.safecosmetics.org/downloads/NotSoSexy_report_May2010.pdf.
It is amazing to me that 25 years into the research on phthalates, people are still arguing that it’s OK to put these chemicals into toys and fragrances, where they are not even disclosed on labels, and expect the American people to “have enough intelligence to make their own choices.” It is the responsibility of companies to stop using these chemicals.
July 27th, 2010 at 1:20 pm
For those asking where the science is to prove these chemicals are dangerous, one of the main problems is that the science doesn’t exist, because testing for safety has never been required for many of these.
If I want to know whether salt is dangerous, it’s very easy for me as a layperson to find that data, and make my own fact-based decisions on how much salt I should ingest and expose myself to.
If, on the other hand, I want to find out what the safety risk is to me in personal care products, I won’t even be able to find that data at all for many ingredients, and it will be incomprehensible to a layperson in most other cases. Some ingredients, like “fragrance” won’t even give me the information I would need to look up that data.
As a consumer, I want to know that simple, replicable toxicity testing has been done on any ingredient that I’m going to put on my body. I want a governmental agency to have determined safe levels of every chemical used in these products, and I want manufacturers to be required not to produce anything with amounts in excess of that level. This is in no way an unreasonable expectation, it is common sense. Anyone arguing otherwise has a larger stake in selling people untested and potentially hazardous products than in ensuring safety.
July 27th, 2010 at 1:41 pm
Okay in reviewing your links you provided, there was not a single scientific study in any of them, just more news reporting propaganda on something scientists state. Perhaps the term scientific study is confusing, but this mean show us the actual study, not more hyperbole disseminated through the media.
Furthermore your premise on phthalates is also off the mark and a link back to your site is not an unbiased researched study being presented, but your side of equations as though this lends credibility.
Dr. Richard Sharpe, the leading phthalates researcher in the world, performed studies on pregnant rats by feeding or injecting them with phthalates. And of course the studies showed the abnormalities similar to Dr. Swan’s findings.
However, when tested on pregnant Marmoset Monkey’s in similar fashion, all of their babies were normal. And as was pointed out by 60 minutes, we are more closely related to primates and not rats so why don’t we lean toward the results of the monkey study as being the more accurate? Clearly the monkeys’ offspring were still normal…a very telling fact and very important information since it goes to credibility of the study and proof of or lack of harm.
Also research in Phthalates over the past 25 years is meaningless since no clear human studies have shown phthalates to be the problem. Animal studies do not extrapolate to humans as Annie Leonard tried to do in her Story of Cosmetics. Furthermore, the medical colleagues of Dr. Swan do not support her in her findings since they do not see the science that phthalates have proven to be harmful.
And using books published as being sound science is only open to one viewpoint and designed to sell books through scaring the public as you did with your own.
This fact alone is scary for me, that Congress would have a knee jerk reaction to unsubstantiated data and override the FDA and the Consumer Product Safety Commission where they conducted repeated tests of products containing phthalates, including having volunteers chew directly on the toys to see if phthalates leaked from them. The EPA isn’t even thoroughly convinced as to any probability they are a danger to the public since the current human studies are in their infancy of research data provided. This is why Dr. Swan was awarded a $5,000,000.00 grant for further study on phthalates. Pretty much she needs to make the claims she makes in order to keep her funding coming, but yet she stated she can not state for sure that phthalates cause these conditions.
So you still have not provided actual case studies, nor have you addressed the pointed question about Susan Roll conceding you don’t have the science to back up your claims, nor have you addressed the need for added regulation when we are already making safer cosmetics if this isn’t about control, let alone allow your organization or EWG to be one of the governing bodies…when you simply don’t have the science but only supposition and by the Story of Cosmetics own admission, precautionary principle is what this is about and there is no denying this fact.
I invite you view the rebuttal to this ridiculous video as it is quite telling and sticks with fact and not scare tactics. They also make reference to many of your so-called scientific studies which are directed back to CFSC’s site where the version CFSC presents appears to make their argument more credible.
http://www.youtube.com/watch?v=RxO3bPNyWzo&feature=player_embedded
July 27th, 2010 at 2:34 pm
Katherine,
Your comments would actually be kind of humorous if we weren’t dealing with such a serious topic as the health of our families and future generations. There are literally thousands of scientific studies documented in the books and websites I mentioned, conducted by the world’s leading independent researchers. On the other hand, you invite people to watch a video that mentions no actual scientific studies (with the exception of completely false account of the science in the FDA’s lead in lipstick report) and relies 100% on the writings of a newsletter editor who works for a university that is heavily funded by oil companies.
I invite you to read the studies on phthalates and talk to the researchers about the abundance of animal and human evidence that phthalates are a problem (and ask them about how marmocets react quite differently to testosterone disruptors than humans, whose endocrine systems are much more similar to those of rats). As for case studies, read my book for stories including the story of Olivia James, a former model whose son was born with a birth defect of the penis called hypospadias — a condition that has increased dramatically over the past 30 years in industrialized countries, and is linked in many animal studies to the dibutyl phthalate that was used in the nail salon where Olivia visited each week of her pregnancy. Tell her the two aren’t related.
I expect we won’t agree no matter how long we go on with this debate, but I am being fully sincere in my suggestions to read the science and talk to the researchers as I have spent the last 10 years doing. Yes there is uncertainty in science, but that is no excuse for not taking action to make the best choices and use the safest ingredients.
Stacy Malkan
Co-founder, Campaign for Safe Cosmetics
Author, “Not Just a Pretty Face: The Ugly Side of the Beauty Industry”
http://www.newsociety.com/bookid/3966
July 27th, 2010 at 2:44 pm
Stacy,
This bill, as the Colorado bill uses lists of carcinogens from the FDA, EPA, IARC and more. Although the Colorado bill was much more specific about which lists were to be used. Please read these lists so you too can see how silly this is. It amazes me that you are part of writing both the Federal and the CO State bill but have no idea what substances it wants to ban. YES, COFFEE is on the list compiled by the IARC!!! READ THE LISTS BEFORE YOU WRITE A BILL!!
Section 614, page 17
“USE OF AUTHORITATIVE INFOR
MATION.—The list under subparagraph
3 (A) shall contain ingredients that are
4 known to be carcinogenic, mutagenic, or
5 have reproductive and developmental tox6
icity, based on information from the Envi7
ronmental Protection Agency, the Inter8
national Agency for Research on Cancer,
9 the National Toxicity Program through the
10 National Institutes of Health, the Cali11
fornia Environmental Protection Agency,
12 and other authoritative international, Fed13
eral, and State entities (as determined by
14 the Secretary).”
July 27th, 2010 at 2:59 pm
Cindy, my point was that the bill doesn’t outright ban chemicals based on lists – it sets up a process for FDA to review the best available science and make determinations about what’s safe to use in cosmetics. You will see that the section you reference is called “use of authoritative information” — yes I do happen to think it’s a good idea to use scientific information that has already been compiled by authoritative bodies as part of the decision making process.
July 27th, 2010 at 3:39 pm
Yes we agree to disagree and I still don’t see a single study attached for viewing. Plus you completely discounted the report from Dr. Sharpe, who clearly states there is no actual evidence that phthalates are the cause of these problems. Furthermore, anecdotal evidence is not science so the fact that an individual visited a nail salon during her pregnancy is not established proof.
If you don’t care for the beauty industry then don’t buy beauty products, say you don’t like a companies ingredients by voting with your dollar.
And in terms of making choices to use the safest ingredients, then we completely agree on this point, yet your organization doesn’t want us to have choice. Your organization along with EWG wants to remove choice and forcefully ban ingredients based on precautionary principle through regulation, something you still do not address or the fact that these two entities are listed as the governing bodies in the Safe Cosmetics Act Draft. Every ingredient I use in my products, Skin Deep can or will find some problem with, even though much of it is organic or natural….plus I really love their data gaps of 80% or higher when giving an assessment of an ingredient with a rating score of 5 or higher…how does that work? (rhetorical)
And for every study you claim is in these books, there are those that can dispute them such as the case of parabens. Personally I don’t pay attention to books since the information can become seriously antiquated since ongoing studies can bring fresh perspective. The video is attached in direct contradiction to your video and was not about presenting all the science at all since your video didn’t have any to refute, but thank you for making that point, while ignoring the fact that all your case studies refer back to your site. I have many documented studies which I have provided within my blog, and you are free to research them since I don’t write open ended articles on my opinion, but provide links to the actual studies of any research I perform.
Plus I love it when it is always the CFSC’s stance that if funding comes from companies you despise, like big oil, the science must be biased…well I go back to government funding on the backs of taxpayers to Dr. Swan. So let’s see, her funding source makes her more or less credible in her research on phthalates?….this vested interest argument is bogus and tired.
It is clear that when we are able to dispute your claims you come back with pat answers and deflect with making my argument seem humorous…glad I entertain you, but it still does not deflect from the truth…show your science I state once again, because if you had it then Susan Roll would not have made the remark she did but presented it during the Colorado hearings which she couldn’t do because….you didn’t have the science….and again why the precautionary principle in dictating regulations to private sector businesses without the irrefutable proof of harm, instead of fundamentally through decades of research and use there has been no reports of anyone dying from personal care products?
The right to choose is the important point here and equating skincare products with environmental issues is off base. Something you slather on your skin versus what we drink or breathe are very different levels of exposure since unless we are dealing with nano particles like in birth control or smoking patches, skincare ingredients are not absorbed past the epidermis layer much less into the blood brain barrier as you propose. You may want to research nano technology further since you also made this claim in some of your CFSC materials equating skin absorption of skincare products to skin patches, and this is absolutely false.
Plus you and others you associate with love to spread that over 1200 ingredients have been banned by the EU in cosmetics when approximately 6 on that list have ever been used in cosmetics. You even have Fran Drescher repeating the same tired mantra. Don’t recall diesel fuel or metaldehyde (slug bait) being used in a skincare product as an example. Have you even looked at the EU list of ingredients banned?
But hey it’s been nice chatting with you.
July 27th, 2010 at 3:43 pm
Hmm I find it interesting that I am unable to place any more links within my last post to you giving you plenty of science, but unfortunately I am no longer allowed it seems….Odd!
Too bad since those that follow this blog will not have the actual science provided to them about what I state.
ah well C’est la vie! Cheers Stacy!
July 27th, 2010 at 6:28 pm
The science is documented with references and links provided in the footnotes of all the books and reports I mentioned, as well as this link which tracks the emerging science on environmental health, http://www.environmentalhealthnews.org/archives.jsp?sm=fr4%3btype6%3b5Study18%3bScientific+Studies. To see the studies you’d actually have to open the links and look at them. Regarding Dr. Sharpe’s work on phthalates, I suggest again that you read his studies rather than characterizing his work by the quotes that made it into the 60 minutes story.
I do appreciate the dialogue, even if we do have deep philosophical differences about how to look at the science, about whether “absolute proof” should be required to make choices about chemicals (which is a strange one, given that absolute proof isn’t even possible with the current capabilities of science), and about whether we should stick with the “trust the companies” regulatory systems currently in place in the U.S. or instead create policies that shift American industries in the direction of sustainability. On that positive note of imaging the future we want to create, here is a great new post by Elizabeth Grossman about the great potential of green chemistry. http://www.huffingtonpost.com/elizabeth-grossman/can-green-chemistry-get-u_b_660191.html
Cheers,
Stacy
July 28th, 2010 at 6:30 am
Stacy -
Thank you for your reply to my comments. “I was disappointed though to see the inaccuracies on your website Personal Care Truth, such as that the FDA rigorously regulates products and that toxic chemicals are just like salt. Talk about rhetoric (borrowed straight from the Personal Care Products Council)”.
The FDA does regulate products and salt is toxic when consumed in high quantities. I’m sorry you are disappointed to see this on Personal Care Truth. Are you bothered because we are providing truthful information based on science? We don’t follow the precautionary principle. The truth of the matter is the fundamental principle of toxicology, attributed to 16th century scientist Paracelsus – the dose makes the poison.
I’m disappointed that you believe the Safe Cosmetics Act of 2010 will not harm the small cosmetic manufacturer. I’m disappointed at the implication that cosmetic manufacturers add ‘toxic chemicals’ to their formulations without telling consumers. It’s simply not true. I’m disappointed that you promote The Story of Cosmetics, a video that is fear mongering at its best.
Cindy is correct that coffee is on the IARC list of group 1 carcinogens. It’s on page 7 of http://monographs.iarc.fr/ENG/Classification/ClassificationsAlphaOrder.pdf
We will have to agree to disagree. You will continue on your path of the precautionary principle, since Susan Roll admitted you don’t have the science. I will continue on my path of providing the links and articles on Personal Care Truth that are backed by scientific facts.
Thanks,
Lisa
July 28th, 2010 at 9:53 am
Lisa,
Yes FDA does regulate cosmetics, but even the Personal Care Products Council is now admitting that the FDA authority over cosmetics is inadequate and needs to be strengthened. Yes salt is toxic in high doses, and what’s the point of trying again to point out to you that the scientific evidence gathered in this century completely refutes what you are saying about the “dose makes the poison.” Yes Cindy is correct that coffee is on the IARC list of carcinogens, and she is incorrect that IARC chemicals would be banned under the new law (but I’m guessing that is not going to stop you from saying it).
There is a lot of misinformation and inaccuracies circulating about the bill – not it would not ban coffee or cause thousands of $$$ in new testing or crush small businesses. See the real story here: http://www.safecosmetics.org/article.php?id=695#small-business. The bill has provisions that will actually help small businesses by giving consumers the tools they need to make informed decisions about products. As I just heard from a small business owner, “Our businesses has taken a big dive due to big companies playing the green game.” Does he think the Safe Cosmetics Act will help fix that problem? “Absolutely yes.”
Lisa, you are doing a great job, I’ll give you that, of defending the rights of large corporations to continue making “pure and gentle” baby products that contain chemicals like formaldehyde, 1,4 dioxane, quaternium 15, toxic dyes, and other chemicals that under no circumstances should ever be applied to a baby’s skin — and making it out to look like you are somehow “defending the little guy.”
Stacy
July 28th, 2010 at 11:37 am
You keep saying we small manufacturers will not be harmed by this and that ingredients like coffee will not be banned. Yet the bill is so vague that it is really up to future interpretation what will or will not be banned isn’t it? We have yet another sloppy piece of legislation being pushed through with the plan to hammer out the details later.
No small business in the country would be satisfied with your assurances that these natural extracts and ingredients will NOT be banned until you put it in the bill. To be honest, we just don’t trust your assurances, since even you have stated that you have tried to reason with the EWG about naturals being rated more harshly on the Skindeep database, to no avail. Once you open the door to over-regulation it is nearly impossible to close it again.
In my opinion simply enforcing the regulations in place would greatly improve the safety of cosmetics. All ingredients are already required to be labeled on the ingredients deck. Contaminants, potential contaminants and trace elements clogging up the ingredients list is not going to assist consumers in making informed decisions about the products they want to buy. It will basically negate any value listing the ingredients even has for people. The ingredients deck of all products will be a tiresome list of useless information. Currently my consumers depend on my ingredients list to make their decisions, the list is complete and meets all FDA regulations. My customers always are thanking me for giving the easy to find and valuable ingredient listings. This legislation will take that benefit away from the consumers. They will not be able to easily compare lists across brands and there will be so much inconsequential garbage on the listing that has absolutely nothing to do with what the cosmetic is made up of, that it will become futile for a customer to even waste the time reading it. This will seriously harm consumers as they will have an even harder time figuring out what ingredients their skin prefers or does not agree with. As a manufacturer I have only had a very small percentage of consumers come to me with a reaction to a product I make. Every time it has been a slight clogging of the pores and by discussing with the customer their skin care regimens and product choices we were always able to solve the problem. With trace elements and potential ingredients listed we will never be able to pinpoint problem ingredients again.
All of this I have discussed is of course ignoring the fact that if this legislation passes I will be out of business and will not be helping consumers anymore anyway. They will be left trying to get a Customer Service Rep from Loreal or MAC to contact them about why there skin is breaking out. Which if you have ever tried to get a decent response or advice from a large corporation is a useless endeavor.
What you seem to refuse to acknowledge is that thousands of small companies that have been created for the sole purpose of creating safer cosmetics will be out of business. While you sit here gloating about how “the jig is up” for the cosmetics industry (according to Fran Drescher), you are in fact helping the very corporations you eschew by eliminating their competition. You may think there has been a shift by large corps to safer and more natural ingredients because of your work, but in reality it was the small cosmetics companies edging in on their market share that has made the difference. So go ahead and pat yourself on the back, but don’t be too surprised when the small natural cosmetics industry is gone and the big corps are once again ignoring you.
Unintended consequences can be avoided if you just listen us.
July 28th, 2010 at 2:17 pm
Hey Stacy -
Oh wait, I’m confused. You said, “As I just heard from a small business owner, “Our businesses has taken a big dive due to big companies playing the green game.” Does he think the Safe Cosmetics Act will help fix that problem? “Absolutely yes.”
So you think the Safe Cosmetics Act will help by “spurring the innovation of green chemistry”? How is this different than what you quote above about the big company playing the green game? Is there a difference between “green chemistry” and the “green game”?
I appreciate you taking the route of accusing me of representing the big guy while posing as a “little guy defender”. That’s rich! I guess it means the information posted at Personal Care Truth is starting to resonate, especially with the small businesses that have asked to be removed from the compact because they don’t like the direction the Campaign for Safe Cosmetics is going.
Make no mistake. My interest is for the small business owner and those that know me can attest to my determination to have our voices heard. The Campaign for Safe Cosmetics, along with the Environmental Working Group, can continue to mislead consumers and scare them to death. I, on the other hand, will continue to provide consumers all the information I can gather that provides scientific facts on personal care products and let consumers judge for themselves.
Just out of curiosity, if the Campaign for Safe Cosmetics has always been a supporter of the small business owner then why only now are you voicing your support by supplying that crafty link? For the life of me, I couldn’t find any pages that referenced you are supporting the small business owner when I looked up the Campaign for Safe Cosmetics site on the Internet Archive Wayback Machine.
Thanks Stacy. I believe I’ll pass on the Kool Aid.
Lisa
July 28th, 2010 at 3:36 pm
The “green game” refers to greenwashing — for example, those “pure and gentle” baby shampoos “for sensitive skin” that contain formaldehyde-releasing preservatives, or the “FDA-approved, hypoallergenic” kids’ face paint that contains some of the worst known allergens such as nickel and chromium. There is a huge segment of consumers who want to buy green products and think they are when they reach for the Aveeno and St. Ives. That is the point the small business owner was making, with the observation that the legislation will make it harder to greenwash.
Green chemistry is a new approach to chemistry that is about designing substances from the molecule on up that are benign and non-toxic. Scientists know how to do that now, but the research is happening in only a handful of universities. The report I mentioned from UC Berkeley makes the point that good government policies are needed to spur the development of green chemistry, which holds great promise for new approaches in product development (for safer hair dye and relaxers, for example). But as long as you can put any set of chemicals on the shelves and call it safe and natural, there is no incentive for the big companies to invest their R&D money in that direction.
I still do think we have common ground — we both believe in the power and importance of small businesses, and that consumers should have the full facts and then judge for themselves. The Safe Cosmetics Act is mostly about ensuring that consumers and companies have the information they need to make the best decisions about product safety, and it will also give FDA the power to ban the most harmful chemicals and to order recalls when necessary (for example, the recent Chicago Tribune study that found illegal levels of mercury in skin lightening creams).
More information about how the bill will impact companies is posted on our website here: http://www.safecosmetics.org/article.php?id=695. The Campaign for Safe Cosmetics has been in communication for several years with our community of 1,000-plus signers of the Compact for Safe Cosmetics about legislative approaches, with twice-yearly meetings. Yes it’s true that some companies have dropped off the list. But we are encouraging them to stay with it and work together with us through the democratic process to ensure that the goals of the Safe Cosmetics Act are met without burdening small businesses. I wholeheartedly believe it can be done.
Thanks,
Stacy
July 28th, 2010 at 3:51 pm
I know this is from a few posts back but you mentioned the Personal Care Products Council and I wanted to circle back.
I read the post by the Personal Care Products Council on their ideas of adding transparency to the current FDA regulatory system.
http://www.personalcarecouncil.org/newsroom/20100715
When I read their post, I see a measured desire to improve the system for all (including dealing with trace elements, putting the CIR directly under FDA purview, mandating registration) that seems to be a middle ground compared to what we have right now and the legislation you are currently advocating.
As I mentioned earlier, I am concerned about the paperwork requirements on small businesses and in general, I’m concerned about small business. There are so many women out there who depend on the $500-$1000 they make per month selling their handmade soaps and lotions and more and I worry about them, especially since there are no jobs out there.
Might there be a middle ground within the Personal Care Products Council suggestions that your team could work with?
July 28th, 2010 at 4:05 pm
Lauren,
I assure you that we completely agree that preserving the opportunities of small businesses is important not only for the personal care products industry but for the entire U.S. economy. People ask me every day for my advice about finding safer products, and I tell them that I buy products only from small, independent companies (locally if possible) that I know I can trust. The small business community is where the true innovation is happening in the industry right now, thanks to the many small companies that have already figured out how to make great products without toxic chemicals, and who are already being transparent with their customers as you stated.
Please check out our post about how the Safe Cosmetics Act will impact companies: http://www.safecosmetics.org/article.php?id=695. Yes, you are correct that there are details still to be worked out, such as which chemicals would be banned under the FDA review system, and which contaminants would have to be labeled. The point of the bill is that it will set up an independent government review of chemical risk assessments and good manufacturing practices under FDA — rather than leaving it up to the companies to decide for themselves, and frankly, rather than having an NGO like Environmental Working Group do the government’s job for it via the Skin Deep database. The new law will set up a government database that will make chemical safety data transparent and available to everyone — which will benefit everyone.
Regarding the listening, I am listening and so are the environmental and health groups I work with. The bill will follow a public process that will give all sides a chance to state their views. As I’ve said, I fully believe the Safe Cosmetics Act can achieve its goals of a safer and more informed cosmetics industry without burdening small businesses — and that it’s in all of our best interests to make sure that happens.
Thank you,
Stacy
July 28th, 2010 at 4:19 pm
In reply to Anne-Marie, I’ve looked at their proposal and it doesn’t include the most important provisions. I think the time is past for allowing the Personal Care Products Council and the huge corporations to decide how to set up safety programs. I’ve tracked the this trade group for years, and have written extensively in my book and elsewhere about how their true intentions are to keep the industry self-regulating and to keep doing businesses as usual. They admit this openly (see my book chapters 8 and 9 for more on that – I hope to have the excerpts available online soon).
July 28th, 2010 at 8:57 pm
Wonderful exchange of ideas and opinions. One of the issues that seems to be overlooked or purposely avoided is how in the world could the FDA even carry out something of this magnitude? I would imagine they’re thinking that themselves. They’re so understaffed now that our food supply is dangerous and people on Capital Hill now want to add on the burden of additional cosmetic regulations and testing? This is how the new health care reform got passed – it got slammed down our throats and that is what this bill (I can’t call is safe cosmetics bill – sorry) is looking like. Where do you think the money is going to come from? Yep, not only will it put me, a small manufacturer quickly out of business, but it will raise my taxes – again. Somewhere, somehow, our friends in government and their friends didn’t learn the basics principles of problem solving skills. Yes, there are issues and questions about the safety of ingredients, but this entire bill has not been thought through to the ramifications of implementing said bill. Thank you Lauren for your very well thought out discussion about some of these. Truthfully, at this point, I’m wondering if the “science” is academic at this juncture and someone needs to take a good close look at how this could possibly be implemented regardless of whether it’s right or wrong.
July 28th, 2010 at 9:46 pm
Stacy…like many others, I am very concerned about safety”testing” that would be required as specified in the proposed legislation. It is so vague, that no one could possibly know with any certainty what it really means. In one of your posts on CFSC, there is a mention that data would be shared so that duplicate testing would be unnecessary or avoided (I am paraphrasing). My interpretation of this would mean that we would be able to get all of the necessary documentation on toxicology, etc., from our contract manufacturers or their suppliers, and therefore not have to incur exhorbitant testing fees (I am a compact signer) ourselves? Is this correct? The problem right now is that much of the language is so vague that it doesn’t really mean anything meaninful that we can count on….except a ton of paperwork that would ratttle any sane mind. If you can be more specific on this issue, I would appreciate it. I think this is at the crux of the matter when small business owners state that they would be put out of business.
July 28th, 2010 at 10:39 pm
Anne-Marie brought up a good point about the reporting requirements as proposed in the bill for small scale manufacturers, and Stacy’s response was encouraging. I expect that if the bill is passed as written, it would put me out of business.
I don’t say that to be pessimistic or fear-mongering, just as a realistic assessment. It’s not the one-time registration, it’s the reporting of every formulation for every product sold. I make small batches, frequently “tweaked” for a particular event or customer. Sometimes less than 100 units are made from a particular formulation for a product. Were I to have to report every change to every formulation I make, including a full array of testing and other information, it would be sufficiently burdensome as to make it impossible for me to produce the specialized formulations and customized products that are the a key factor in the success of my business.
The new definitions of “ingredient” are also problematic: “(E) contaminants present at levels above technically feasible detection limits”; and “(F) contaminants that may leach from container materials or form via reactions of the shelf life of a cosmetic that may be present at levels above technically feasible detection limits”. The wording pre-supposes there MAY be detectable contaminants and therefore implies a necessity to test for them. What determines “feasible detection limits”? What’s feasible for Proctor and Gamble and their manufacture of millions of units of a single product is considerably different than what’s feasible, both technically and financially, in my small business for my small batch production.
I originally started out with the desire to make “natural” products, which I defined as “using ingredients that were as close to those found in nature as possible.” Most of my ingredients are considered GRAS for food products (although they may not be food grade). I don’t have the capability to test every incoming product, so I rely on my suppliers to provide unadulterated ingredients – similar to the standard acceptable in the food industry.
I hope that these issues will be taken into account as the bill is reviewed and discussed as part of the legislative process. It would seem to defeat the purpose and intent of the act if only the “big guys” are able to play by the new rules and the smaller companies like mine, that don’t use synthetic ingredients and aren’t inventing new chemicals, end up being forced out of the marketplace.
Marie Gale
July 29th, 2010 at 12:34 am
I don’t have the time to add my usual lengthy diatribe, but shouldn’t the prime purpose of the legislation be to ensure consumer safety in a manner that is acheivable without overburdening ANY business, irrespective of size, avoiding uneccessary demands and without needlessly removing ingredients that are acceptably low risk?
The differentiation between “big” companies and small ones is a false one, because the products should be acceptably safe irrespective of the size of the manufacturing company. Morover, the much maligned “big” companies spend millions of dollars and use expert toxicologists to assess the safety of their products – far more than smaller companies are able to do. The value of their brands to these companies is so massive that they dare not take the risks that they are being accused of by the chemophobes; losing brand value by using provenly dangerous formulations is not an option for them. The whole basis of “that video” is wrong.
You cannot talk about safe chemicals, because there is no such thing as a safe chemical (natural or synthetic). I could easily design a study on any given substance that would demonstrate a hazard, given the right (wrong) route of exposure and a high enough concentration. Given the criteria used by the supporters of this bill, I can forsee the possibility of such studies being designed and carried out simply to get a competitor’s product banned.
There has to be a sensible, risk-based approach – the Precautionary Principle is so grossly misused (almost completely ignoring risk) that no legislation should ever be based on this premise.
July 29th, 2010 at 10:04 am
Lisa,
You named the problem exactly. Sure it is possible to design a study to demonstrate hazard, likewise it is possible to design a study to demonstrate safety — it is quite easy, especially given the fact that there are no required safety assessments and no standards for these assessments, to manipulate the exposure or hazard calculations to rig the equation to show “safe levels.” I’ve heard it straight from the risk assessors that this happens all the time.
Plus, most of these studies conducted by the big companies are geared to look at short term health effects, not long term effects like cancer risk to children from repeated exposure over time to the chemicals in children’s products.
So no, I don’t think it is sensible or reasonable that we’re supposed to trust the companies to do their own science with no review. If they are spending millions on risk assessments, those studies should be publicly available and they should be reviewed by independent government scientists. The Safe Cosmetics Act will make that happen, and the fees from the large corporations will fund the FDA to do the job it is supposed to be doing. If you think such fees would be a problem for the big companies, I ask you to look at how much they are paying the Personal Care Products Council for the purpose of lobbying against regulations (and if you are so interested in people’s salaries, Lisa, you might want to check out the million-dollar salaries going to the top brass over there).
July 29th, 2010 at 11:58 am
Dene, sorry for calling you Lisa (and Lisa sorry for confusing you with Dene). Dene, we can’t continue to go around in circles with the same arguments on this blog. I will respond to and post comments from others shortly.
July 29th, 2010 at 2:11 pm
Stacy, the posts of mine that you have just failed to publish were not circular arguments; they were new points that actually presented you with a new dilemma that you were unable to answer without compromising your entire stance. I challenge you to show the courage to permit me to engage in open debate with you, rather than you act as a censor, and publish those two comments! (and this one!).
July 29th, 2010 at 2:14 pm
Dene,
The thing is, I don’t have time to sit around all day engaging in debate with you. I will respond to some of those new critiques at a later time. Thank you,
Stacy
July 29th, 2010 at 3:45 pm
[...] course, the $50 billion cosmetics industry doesn’t want to change, as that’ll cost money, which is exactly why this video is great—hopefully it’ll serve to [...]
July 30th, 2010 at 8:34 am
Hi Teri,
The data transparency and data sharing parts of the bill are important for the reasons you bring up — yes small companies would be able to get a lot more information than is currently available to them about toxicology and safety data, from suppliers and also from having access to the studies that have been conducted by other companies that are currently kept secret. There would be a lot more information available from which to make decisions. There may be cases where no information is available and safety data would need to be provided but this doesn’t mean every company will need to conduct assessments on their own (the bill specifies that duplicative testing needs to be avoided), and a data sharing system could be put in place (with a central agency conducting assessments, for example).
It’s true that some of the language is vague and needs to be worked out by FDA and also through the public process — that will definitely happen. When’s the last time we saw a bill sail from introduction to law with no debate? It’s why I’m perplexed by the hysteria that is being perpetuated out there. This bill is a solid framework that will absolutely enhance the safety of cosmetics by setting some standards in the industry, while also providing many benefits to small companies — with some important details to be worked out. The best way to approach that is to work together through the process to ensure the final bill achieves the goals of safety without hurting small businesses. I’m glad to hear you are a Compact signer – the Campaign for Safe Cosmetics will be inviting Compact Signers to a teleconference very soon to discuss these details and make a plan. I hope you can make it!
Thanks,
Stacy
July 30th, 2010 at 12:45 pm
The company I work for represents many of the major (and quite a few minor) suppliers of ingredients for cosmetics. If ANY customer requests toxicity data for one of the suppliers ingredients, it is supplied, if it exists. The data is NOT secret, so this bill will make absolutely no difference to that situation. I fail to understand why you would think that any supplier would spend money on safety testing and then not share the information with customers. Why would they spend the money in the first place if they are going to lock up this information in a secret vault?
I think you will find that very little data exists exclusively in the domain of the big companies. The only likely advantage for gaining new data is if the FDA requests specific studies in order to make a better assessment of the safety of specific ingredients.
I believe that some form of bill to regulate cosmetics is a good idea, but not this one – it is unworkable in its present form, for many reasons that you will discover once the lobbying process begins (I don’t want to spoil your fun just yet!)
Talking of the CFSC, I wonder how many participants you will get involved in your teleconference. Not many, I suspect, because I am picking up information that suggests that many of the signatory companies listed are no longer even in business, and of those that still trade there are several (at least) who are trying to get their names removed – and with some difficulty, I might add. I know of one specific company that has made FIVE separate requests to have the company name removed from the Compact Signers list. Apparently, the fifth request also included a legal document threatening action if the request continued to be ignored. This request actually generated a response! Sounds to me like the CFSC isn’t so popular as some may think. Continuing to list defunct signatories, and making it extremely difficult to disassociate disaffected signatories sounds to me as though there is some desperation to make the list look longer than it really is! I wonder why . . .
July 30th, 2010 at 2:08 pm
Hi Stacy,
With regard to Dene’s comments above, would you please read http://bit.ly/9SxrBN and respond, either here or there? I hope that you will see that you are causing the very small companies you claim to advocate for burdensome requirements that will truly put many of us out of business. Surely you are aware of the unintended consequences of the CPSIA legislation, that put thousands of ethical toy manufacturers and retailers out of business. I look forward to your response, and I mean that sincerely.
Thanks.
July 30th, 2010 at 2:27 pm
Dene, that’s good to hear. Perhaps you can supply me with studies showing whether workers are exposed or environmental contamination occurs from the use of ethylene oxide (a known breast carcinogen) during the ethoxylation process of cosmetic chemicals. I’d like to see if the industry has any data about how much phthalates are absorbed into the body from fragrance — or if it is only Harvard University that has done such studies (and found that a single application of cologne dramatically increases the body burden of phthalates). Come to think of it, when the Cosmetics Ingredients Review Panel reviewed diethyl phthalate, they were calculating the exposure numbers on the back of a napkin. Not a risk assessment that inspires much confidence!
I wonder if L’Oreal has consumer reports about allergic reactions and deaths from PPD exposure, and whether they are conducting long-term health studies of workers who are exposed to hair dye chemicals every day. I heard about the PPD problem not from L’Oreal or the FDA but from people who have been severely affected by exposure, including a reporter whose doctor advised her never to use PPD hair dyes under any circumstances. This reporter was quite pissed off, by the way, to go to the Personal Care Products website and see PPD is described as safe with no problems.
Ok, it’s all safe, we trust you.
To your point about suppliers, many small business owners have told me they have a hard time obtaining information from suppliers such as a full list of fragrance chemicals, and that their own product testing contradicts what suppliers have promised them about contamination issues. Perhaps your company avoids these problems, and if so that’s great, but the problem is that companies are making very different safety decisions in an environment with no safety standards.
Yes I agree, regulations are a good idea, and we will get there one way or another.
Stacy
July 30th, 2010 at 4:58 pm
Marcia, I will be posting my response online yes.
Stacy
August 4th, 2010 at 4:11 pm
Hi Ann,
It’s true that FDA is so understaffed at the moment that we are in a dangerous situation. A good article on that topic from the former head of FDA is here: http://www.washingtonpost.com/wp-dyn/content/article/2006/05/07/AR2006050700907.html (He claims that the budget for the agency in charge of the safety of the nation’s entire supply of food/drugs/medical devices/cosmetics is the same as the budget for the school district of Fairfax County Virginia! I’m not sure if those numbers hold, but anyway, the point is taken.)
FDA used to be the gold standard consumer protection agency in the world, but no longer. I believe it can be revived and that it has to be, and that it’s important to build up the scientific infrastructure of our public agencies like EPA and FDA. The Safe Cosmetics Act would put more funding to FDA but not through raising taxes. It would require fees from the big companies. I think this is fair. The current safety system, the Cosmetics Ingredients Review, is paid for by industry already and the proposed system would eliminate the industry panel and bring the science under the independent review of FDA.
Thanks,
Stacy
November 10th, 2010 at 11:21 pm
know i’m a little off topic, but i just wanted to say i love the layout of your blog. i’m new to the blogegine platform, so any suggestions on getting my blog looking nice would be appreciated.
November 21st, 2010 at 1:23 pm
What I would like to see is less personal opinion on this topic and more documented evidence. I’m trying to do a speech on this this for class and I’m going crazy because people are so caught up with arguing against the other side that they circumvent the actual facts. Forget opinion–if you want to help, give us well-documented facts that WE can use to make our own opinions. What we need to know is: 1) exactly how the government does and doesn’t regulate the cosmetics industry–on state and national levels 2) what chemicals are known to be hazardous, and at what levels 3) the levels at which these are commonly found in beauty products 4) The pro AND con arguments as to the safety of using multiple products with these ingredients, fairly represented, and 5) the honest truth about what opinions simply don’t have much evidence either way. Statements of fact or research need to be properly footnoted or linked to reputable sources, such as the FDA or independent scholarly research organizations. Otherwise it can only be passed off as a personal impression, which tells us nothing.
After the appropriate evidence is presented, by all means make your case. But don’t leave us entirely at the mercy of your personal opinion on the matter. If your purpose is to inform, you should be able to do just what I’ve asked without hurting your cause. The truth stands up to scrutiny. If someone could do that, I would be very impressed and very thankful–I sure haven’t seen it yet.