cosmetic safety

Let’s Talk The Same Language

March 11, 2011 By denegodfrey 4 Comments

When it comes to cosmetics, there seems to be two camps, broadly speaking. One camp believes that the majority of cosmetic ingredients are sufficiently safe to be used in cosmetics, the other believes that cosmetics are full of “toxins” and that most cosmetics manufacturers (and certainly the larger ones) do not care about the safety of their consumers, preferring to use “cheap fillers”, with an eye only for increased profits, etc, etc.

The second camp has a tendency towards the use of hyperbole (not always the case, but extremely common), using phrases such as “full of toxins”, “toxic soup” and similar.

The use of the words “toxin” and “toxic” are constantly repeated throughout the verbiage coming from this camp. The issue I would like to highlight here is that both words are being grossly misused in many cases, partly because most of the people using them don’t actually know what they mean. They often THINK they do, but that is very different.

TOXIN

A favourite word used often and, in almost every case, misused. It sounds good. It sounds dangerous, which is entirely the point of its use. The problem is that “toxin” doesn’t mean “toxic”; they are related, but are not interchangeable. A toxin is a naturally occurring substance that is produced by a plant or animal as part of its defence mechanism against attack by predators.

tox·in (tŏkˈsĭn)

noun

A poisonous substance, especially a protein, that is produced by living cells or organisms and is capable of causing disease when introduced into the body tissues but is often also capable of inducing neutralizing antibodies or antitoxins.

The American Heritage® Dictionary of the English Language,  4th edition
Copyright © 2010 by Houghton Mifflin Harcourt Publishing  Company.
Published by Houghton Mifflin Harcourt Publishing Company. All  rights reserved.

Just for emphasis – toxins are natural. Toxins do not occur in cosmetic products. The word “toxin” should never be seen in any discussion on cosmetics (other than to say that it should not be seen in any discussion on cosmetics). Anyone campaigning for the removal of toxins from cosmetics can pack up and go home, with the satisfaction of having been successful (even though removal was not actually necessary, there having been none present in the first place).

I am aware that I could be accused of arguing pure semantics, and I know that these people mean “toxic chemicals”, but the use of the wrong word is indicative of the lack of knowledge and understanding, and throws some doubt over the capabilities of the person in question being in possession of sufficient science to be able to put forward a meaningful case. A classic case of this is a book written by Philip and Alice Shabecoff, the title of which is “Poisoned For Profit”, and the subtitle, ”How Toxins Are Making Our Children Chronically Ill”.

Even leaving aside the somewhat apocalyptic title, this error doesn’t bode well for an informed, fully scientific case to be made.

TOXIC

The chemophobes other favourite word!

tox·ic (tŏkˈsĭk)

adjective

1. Of, relating to, or caused by a toxin or other poison: a toxic condition; toxic hepatitis.

2. Capable of causing injury or death, especially by chemical means; poisonous: food preservatives that are toxic in concentrated amounts; a dump for toxic industrial wastes. See Synonyms at poisonous.

noun

A toxic chemical or other substance.

Origin: Late Latin toxicus, from Latin toxicum, poison, from Greek toxikon, poison for arrows, poison, from neuter of toxikos, of a bow, from toxon, bow, from Old Persian *taxša-, an arrow.

Related Forms:

toxˈi·cal·ly adverb

The American Heritage® Dictionary of the English Language, 4th edition
Copyright © 2010 by Houghton Mifflin Harcourt Publishing Company.
Published by Houghton Mifflin Harcourt Publishing Company.

As with “toxin”, “toxic” is often misused, and even more frequently misunderstood. There are different types of “toxic”. The word itself refers to the ability to kill, and many substances have the ability to kill. In fact, it could be argued that most substances have the ability to kill, given a sufficiently high dose, and an appropriate (or inappropriate!) route of application. There are many cases where long distance runners have died from drinking too much water. Water is, therefore, toxic. This is NOT a trick, nor is it any kind of play on words – in the broadest meaning of the word, WATER IS TOXIC. Logically, therefore, those who would regulate all “toxic chemicals” out of cosmetics would also have to demand the removal of water (and virtually everything else – natural AND synthetic!).

There are 3 potential routes for a substance to be toxic:

1) By ingestion

2) By inhaling

3) By skin absorption

Some substances can be toxic by more than one route.

Given that the majority of substances may be toxic in some way, there needs to be some kind of guideline to determine relative toxicity. Some substances are more toxic than others, i.e. it takes a lower quantity to kill.

In the European Union, within the depths of the regulations governing the classification and labeling of substances, there are prescribed definitions of these 3 routes, in terms of what is considered toxic for labeling purposes, and what is not.

For oral toxicity (i.e. by ingestion), the classifications are thus:

Any substance with a figure of 400 – 2,000mg/kg bodyweight for the LD₅₀ (rat, oral) – the dose that will kill 50% of the number of animals in the study – is designated “harmful by ingestion”.

An LD₅₀ (rat, oral) – 50 – 400mg/kg is designated “toxic by ingestion”

An LD₅₀ (rat, oral) – <50mg/kg is designated “very toxic by ingestion”.

The other 2 routes have different criteria, but are equally clear in terms of what constitutes “toxic” by each route. I do not intend to get bogged down in a discussion on the relevance of animal studies to humans; nor on the morality of animal testing (but I WILL stress that this classification applies to ALL substances in the EU and is not specific to any use in cosmetics), but I simply wish to make the point that there is a clear definition of what is “toxic” by any of the 2 routes, and that there are different levels of toxicity.

At this point, I would like to give a classic example of someone who doesn’t understand the meaning of “toxic”. It comes from a discussion about an article on cosmetics in the Huffington Post: (previously discussed in my earlier article on PCT.

BzzzE 03:06 AM on 2/24/2011

There’s a reason they’re [cosmetics] shipped as Toxic Chemicals.

Dene62 02:57 AM on 2/28/2011

There is not one single cosmetic product shipped as a “toxic chemical”. This comment just goes to show the danger of free speech without constraint – anyone can say any old rubbish and pass it off as fact. Where DO you get your information from, BzzzE? This one certainly needs some proof – that is not possible to provide.

BzzzE 12:27 PM on 2/28/2011

For someone who has worked at UPS and seen cosmetic boxes pilled (sic) high with the “hazardous material in a limited quantity” label. Unpossible (sic) you say? You might be wrong.

http://en.wikipedia.org/wiki/ORM-D

Dene62 12:44 PM on 2/28/2011

This is a different type of classification. You clearly stated that you had seen cosmetics shipped as a “toxic chemicals” – this ORM-D classification is NOT toxic, but is described as hazardous – very different. “Toxic” means it will KILL! No cosmetic product is classified (either legally, or scientifically) as “toxic”.

I am NOT wrong – you have misquoted, or simply misunderstood what “toxic” actually means..

I will also point out the BEER is also on the list of ORM-D classified materials. Are you also suggesting that beer is toxic?

Dene62 6 minutes ago (4:19 AM)

I am still waiting for some sort of response – either an admission that it was YOU that got it wrong, or statement that you believe beer is toxic.
If you cannot distinguish between “toxic” and “hazardous material in a limited quantity”, you should confine your comments to things you actually understand, as others will read your comments and think that you know what you are talking about.

My last comment was actually posted over a week later (7 March); I have still received no response at the time of writing. I make no apologies for the terse tone of my comments in that thread because, as I said above, people should confine their comments to things they actually understand (or have the civility to apologise if they have been proved wrong). Yes, I am a little intolerant at times, but “toxin” and “toxic” are words that are tossed around carelessly and without regard for the true meanings. I have said elsewhere that the more times either of these words are used, the less informed the user, and the less credible the information on offer.

“Toxic” describes a hazard. Similarly “corrosive”, “irritant” etc are hazards. As I have made clear in other posts, ‘Skin Deep – Scratching Below The Surface‘, the hazard is only part of the picture. Exposure completes the picture and enables the risk to be assessed. RISK is the real issue, NOT HAZARD. Out of the 17,000+ cosmetic ingredients listed in the INCI Dictionary, there may be several hundred, or even thousands of ingredients that are classified (in regulatory terms) as “toxic” (I have not, and nor do I intend to actually count the number – this is for illustrative purposes only), but the point is whether or not they are used at concentrations in cosmetics that are high enough to be truly toxic to the consumer (i.e. KILL!). To the best of my knowledge, there are no documented cases of a consumer being killed due to the use of cosmetics.

I appreciate that this piece is a fairly simplistic approach to the toxicity of cosmetics and cosmetic ingredients – it does not consider any possible cumulative or environmental effects (and these are often mooted by chemophobes). The environmental angle is not directly relevant to this discussion, but on the subject of accumulation, I am not aware of any studies showing true accumulation of any cosmetic ingredient, with the possible exception of triclosan and, in this specific case, there is no evidence that it is actually harmful to humans at the concentrations apparently detected (in human breast milk). It is typical of the Environmental Working Group that they make much capital out of almost 200 different substances having been detected in a study of umbilical cords, without any consideration of the risk posed by these substances. They are, of course, all “toxic”.

If the water doesn’t get you, try breathing pure oxygen – it will kill you – oxygen is toxic.

Do Chemicals in Cosmetics Accumulate in Your Body?

August 31, 2010 By Guest 56 Comments

I have spent a lot of time over the last week looking at the coverage of the Story of Cosmetics video in the blogosphere, and sometimes challenging stuff written there. I have to say it wasn’t a particularly productive thing to do. For a start, not many of the things I posted ever appeared. It seems that a lot of them are happy to criticise without having any kind of debate about it. I also noticed that the same things get said time and again, almost as if there is only a small group of people actually writing this stuff.

However not all my posts vanished without a trace. One blog I found that did seem to be having a discussion was Organic Mania. This seems to be run by a woman called Lynne who seems to be both passionate and well informed. And although she was broadly sympathetic to the EWG, she had obviously got some doubts about their methods.

She also was very interested in the question of the effect of long term accumulation of cosmetic chemicals in the body. And she seems to have pursued the question with some tenacity. I cannot improve on her own account of her attempts to get industry figures to answer questions on the subject so I suggest you simply follow the link to it at the bottom of this post. But her basic point was that nobody in the industry knows what is the long term effect of accumulation of cosmetic ingredients in the body.

I did reply at some length. My reply never appeared, but in this case the explanation was probably not censorship. I simply had more to say than her blogging software could cope with.

But it is a good point. Even if the materials in personal care products are used at safe levels according to the data which we have available – which they are, with Google and a bit of patience you can check this for yourself – isn’t there a risk that over time the levels in your body will grow until they reach an unsafe level?

Posing this question shows a much better understanding of the way risk actually works than most of the critics of cosmetic safety you find online.

But who would know the answer to this one? There isn’t any particular reason why the people who manage cosmetic companies, or sell cosmetics and personal care products should know any more about the safety of the formulations themselves than the average person in the street. They hire scientists like me to handle that side of things. So when you hear a spokesman on the media responding to a scare story, they are basically trusting what the guys in their labs have told them. Lynne did not get a satisfactory answer from industry insiders. I think that is because us guys in the labs are insiders inside the industry.

So to answer her question.

Do we know what the cumulative effect of the chemicals used in cosmetics in the body is? Well compared to what you eat, it is pretty obvious that cosmetics can only make a tiny contribution to what is in your body. The most dedicated of beauty junkies is not going to apply more than a few grammes of product a day. Even if was all absorbed it would not even equal a mouthful of food.

However most of what you apply is simply not absorbed. Rest assured the skin is an extremely good barrier. That is why diabetics have to inject insulin rather than letting it soak through the skin and why snakes have to bite you in order to poison you. This is actually a great shame for the pharmaceutical industry because transdermal patches would be a great way of delivering drugs if the skin didn’t do such a great job of keeping stuff out.

Even if they did get through the skin the bulk of chemicals used in cosmetics are not very different to those you eat in any case. A chemical like say glyceryl monostearate might sound scary if you don’t know what it is. But it is simply a fraction of a vegetable oil with a very slight chemical modification – and modification that your body carries out too. The next time you eat some fried food you will probably be eating more glyceryl monostearate than would get into your body from a lifetime of applying skin creams.

Most cosmetic ingredients are derived from natural sources. This has always been the case. If they do get into your body, you have enzymes that can deal with them. Your liver’s main reason for existing is to deal with toxins and it has plenty of tools to do the job. This is just as well because even a very organic diet has plenty of toxins in it (or maybe especially an organic diet). Fortunately we have evolved to deal with them.

I have said that the skin is a good barrier, but there are some chemicals that have the right properties to go through it. But there aren’t many. Nicotene is one, which is why you can buy nicotine patches. Caffeine is another. But very few drugs are available as patches because very can be made to penetrate the skin. Very very few of the materials used in cosmetics will get through the skin. But even then, just getting through the skin is not enough for a chemical to accumulate. If it is metabolised then the body will get rid of it quickly. We are all familiar with how quickly the body deals with caffeine. I am writing this late at night and I am well aware that my last dose is in need of replacement.

So it is far from obvious that any cosmetic raw material accumulates in the body. I can only think of a handful of materials that even have a chance to do so. Of those only the parabens are not metabolised extremely quickly. (I don’t want to talk about parabens again, after 8 recent blog posts my regular readers must be fed up of them by now.)

I have done some work trying to deliberately improve penetration through the skin. It is an extremely hard thing to accomplish. So in a nutshell, the answer to Lynne’s question about studies of the long term effects of accumulation of cosmetic raw materials in the body is that we don’t know because it doesn’t happen.

None of this means that cosmetic formulators are complacent. There are a few materials that are absorbed into the skin and we need to be vigilant. Previously unknown risks might come to light at any time. We also have to have in mind that it is in the nature of cosmetics that most of them end up in water courses. (This is the downside of the fact that they don’t actually get absorbed much.) We need to keep an eye on what is going on and keep an open mind for risks that nobody has predicted.

For instance, I recently picked up on people criticising triclosan. My first reaction was that it was yet another groundless scare story, but when I looked into it it turned out that there is a recently identified problem with triclosan interfering with water treatment plants. I was really grateful to the environmental activist on Twitter who drew my attention to it. But that also illustrates the way the world really is. You need to look at data and use your brain to spot the problems. And problems usually turn out to be something nobody is expecting. The black and white world portrayed in the Story of Cosmetics seems to be emotionally satisfying to a lot of people. But the real world is a lot more complicated and interesting. And I am more than happy to listen to anyone with a passion for making it a better place, especially if they have thought of something that I haven’t.

_____________________________

From the UK, Colin Sanders has been a formulator of cosmetic and topical pharmaceuticals for 27 years. Over that time he has formulated nearly every category of product including shampoos, cosmetic skin creams, pharmaceutical skin creams, face masks, lip balms and so on. He has been an active member of the Society of Cosmetic Scientists since 1985 and in 1999 organised the first of the Formulate shows. His degree is in environmental science and he continues to take a keen interest in the impact of human activities on the planet. He regards himself as an environmental activist and all round green. When not in the lab, he writes a blog, Colin’s Beauty Pages with the intention of entertaining and hopefully informing users of cosmetic and personal care products with some insider insights, a bit of science and his own opinions.

The Safe Cosmetic Act of 2010 is Not the Solution

July 27, 2010 By Kristin Fraser Cotte 68 Comments

I’m taking a moment to update you all on new proposed cosmetic legislation that will ultimately impact everyone, from large cosmetic companies, to small, green indie manufacturers (like me), to anyone who sells personal care products and cosmetics, to you, the consumer.

HR 5786 The Safe Cosmetics Act of 2010 was released last week. I’ve had a chance to read through the document multiple times and have huge concerns and questions with the bill as drafted. The entire bill can be downloaded by clicking the link above. In attempt to share my personal experience and not turn this post into a novel, I’m directing you to check out these posts that summarize and highlight just some of the many issues with the Safe Cosmetic Act of 2010 draft. I urge you to read the bill as well.

Comments & Concerns Regarding The Safe Cosmetics Act 2010

Safe Cosmetics Act 2010

Interestingly enough, the Campaign for Safe Cosmetics (CFSC) released The Story Of Cosmetics, a “shockumentary” on cosmetic safety on the very same day this proposed new legislation was released…

This was no coincidence.

It’s time to tell my own personal story, something I have been a bit hesitant to do publicly up until this point. An important note to all those who support CFSC and the new bill, the signers of the Campaign For Safe Cosmetics Compact were not notified in any way shape or form as to the lobbying and orchestrated release of the CFSC video with the proposed legislation draft.

I know this first hand because The Grapeseed Company is still listed as a Compact Signer… even though I have asked multiple times to be removed due to the detrimental direction the Campaign was heading in squashing small businesses, along with the lack of science behind their agenda. I last attended an annual compact meeting at Expo West in March 2009 where I was threatened if I did not update my products in the Skin Deep system, my company would be removed as a Compact Signer. That was 17 months ago. I have not updated my products in their system, and have not been removed from the Compact. I have chosen to register with the FDA Voluntary Cosmetic Registration Program (VCRP) and have always listed our complete ingredient decks on my company’s website. I have sent multiple emails asking to be removed from CFSC completely, the latest sent just last week asking for confirmation that my company is removed.

I still have not been removed as a Campaign For Safe Cosmetics Compact Signer.

Lisa Rodgers, my co-founding partner at PersonalCareTruth.com and I have directly tried to work with the CFSC. After the proposed Colorado Cosmetic Bill failed, the co-founder of CFSC left multiple comments at Green Skincare Blog. Following our online interaction, Lisa and I had a conference call with Stacy Malkan, co-founder of the CFSC, about our concerns with the Campaign and lobbying for legislation that would hurt the small, innovative, natural companies. Stacy commented during our conversation, and in writing on my blog that her “view on Skin Deep is that it is not a perfect system and never can be, because of what it is trying to do — analyze an entire industry based on available data, which is very limited due to the historic lack of safety regulations for chemicals.”
I am still perplexed by the fact that co-founder of CFSC herself is pointing out flaws with the Skin Deep rating system CFSC Compact Signers are required to register their formulas in! I do not want my business associated with an organization lobbying to put me out of business based on fear mongering and lack of science. I support safe cosmetics based on scientific research. CFSC has not shown the science to back their rating system in Skin Deep. The way this bill is written would impose huge fees on companies big and small which we will all end up seeing when we purchase our daily essentials, from soap to mascara.

So while CFSC is touting support for this bill from their Compact Signers, I must ask:

How many other companies are there out there like me who have asked to be removed and the CFSC has not complied?
Why haven’t they complied? (I think I know the answer to this one… but what do you think?)
How many of the companies on their signer list have gone out of business and are still listed as compact signers?
How many are just plain scared to be removed due to the obvious power this “nonprofit” currently has over our government and pending legislation? (if you’re wondering why “nonprofit” is in quotes, read The Revealing Truth of the Money Trail of EWG)

We all want to make sure the personal care products we use are safe, but do we want our government to create a paperwork nightmare that regulates down to nanoparticles when we don’t have the science (ironically from the words of Susan Roll, a founding member of CFSC) to back it? You can listen to Ms. Roll’s live statement from the Colorado hearing by clicking the link above. There may be room for improvement in FDA regulations concerning cosmetics, but The Safe Cosmetics Act of 2010 in it’s current form is is not the solution.

I urge you all to voice your opinion, write your representatives, sign the petition and oppose The Safe Cosmetics Act of 2010 in it’s current draft. If you’re interested in learning more about the science behind what’s in your skin care products, check out more articles under ingredients and science here at Personal Care Truth.

This bill will not ensure your body is safer.

It will make the price tag on your personal care and cosmetic products much higher.

It will squash small businesses paving the way in innovation and green cosmetics right out of the industry.

We need to be vocal, not scared. We need to tell our stories. We need to stand up to the CFSC and make sure they are not using our businesses as “numbers” to show support of this bill. You may feel the impact in your wallets if you don’t. No matter how green you consider yourself, we all use personal care products daily. This bill will impact everyone.

Perhaps this post will finally get me removed from the CFSC Compact Signers list?

As I step off my soap box, I have one last thought that has been lingering in the back of my mind for months… why is the government targeting the cosmetic industry? We have a proven track record of safety. What you apply to your body doesn’t affect your system in the same way as what you put into your body… if we’re concerned about health issues, cancer and safety, shouldn’t we be scrutinizing diet, fitness and lifestyle choices first? Things that are actually scientifically proven to affect health? We have no legislation in place to cover what we eat or our lifestyle choices… why is the target pointed at the cosmetics industry?

Nation’s Cosmetics Industry Calls for Greater FDA Role in Oversight of Ingredients in Personal Care Products

July 16, 2010 By Kristin Fraser Cotte 9 Comments

Press Release from The Personal Care Products Council:

Groundbreaking Initiative from Personal Care Products Council Would Establish an Additional Layer of Federal Oversight & Enhance Existing Consumer Safeguards

WASHINGTON, July 15 /PRNewswire/ — In a groundbreaking initiative intended to enhance existing protections for millions of American consumers, the nation’s cosmetics industry today announced plans to support legislation that would strengthen and modernize regulatory oversight of the industry and create a greater role for the U.S. Food and Drug Administration (FDA) in assessing ingredient safety for personal care products.

The proposal represents the culmination of more than three years of planning and research by the Personal Care Products Council (the Council), the cosmetics industry’s trade group, which has consistently advocated for more FDA funding to support additional regulatory oversight. The Council detailed its proposal in a letter to key health policy leaders in Congress. The proposal would enhance current FDA and industry safety initiatives.

The Council is seeking to create formal processes for FDA to review ingredients for safety at the request of the public and stakeholder groups and to review all safety determinations made by the Cosmetic Ingredient Review (CIR) Expert Panel. No such FDA processes currently exist.

“For decades, the industry has had an impeccable safety record under the existing requirements implemented by FDA under the Federal Food, Drug, and Cosmetic Act. Our products remain among the safest in the marketplace,” said Lezlee Westine, the Council’s president and chief executive officer. “Nonetheless, we believe it is time to develop a more contemporary approach that includes a greater federal regulatory role. In fact, for the last 30 years, we have aggressively implemented numerous safety initiatives and processes to strengthen industry safety practices. Our consumers deserve multiple layers of protection and transparency.”

Westine emphasized the proactive nature of today’s announcement, which is being made in the absence of any specific public health risk or legislative mandate involving personal care products, which remain safe to use. Rather, the industry is responding to American consumers who are requesting and deserving more transparency from government and industry while ensuring their ability to keep pace with continued demand for innovative products.

“From Wall Street to the Gulf of Mexico, we have seen what can happen when there is a breakdown in the relationship between government and the private sector,” said Westine. “Our initiative recognizes the need to establish a more collaborative and constructive relationship with federal regulators.”

Toward that end, the Council’s five-point plan includes mandatory industry reporting and mandatory Good Manufacturing Practices, two provisions currently in HR 759, the Food and Drug Administration Globalization Act of 2009, introduced by Congressman John Dingell (D-MI), and three additional provisions that industry is seeking.

The Council plan includes:

(1) Enhanced FDA Registration. It requires that personal care products manufacturers who market their products in the United States comply with the following:

* Register with FDA all facilities where those products are manufactured.
* File with FDA product ingredient reports disclosing all of the ingredients used in those products; and
* Report to FDA any serious unexpected adverse event with a personal care product experienced by consumers.

(2) New Process to Set Safety Levels for Trace Constituents. When requested or on its own initiative, FDA would be required to establish safe levels for trace constituents in cosmetic ingredients and products;

(3) New FDA Ingredient Review Process. Once a request has been made, or FDA unilaterally determines action is warranted, the agency would be required to review the safety of any ingredient intended for use in a personal care product and set safety use levels for such ingredient on a specified timetable;

(4) New FDA Oversight of CIR Findings. FDA would be required to review current and future findings on the safety of cosmetic ingredients by the Cosmetic Ingredient Review (CIR) Expert Panel and determine if these findings are correct. If there are instances in which it determines a CIR finding is not correct, FDA would determine by guidance or regulations if, or under what conditions, the ingredient can be used safely in personal care products;

(5) FDA-Issued Good Manufacturing Practices. FDA would establish industry-wide “Good Manufacturing Practices” requirements.

“The current process has served the public well for decades, but the time has come for us to advocate for additional safeguards as science and technology evolve. Today’s consumers have even higher expectations for the products they choose for themselves and the companies that provide them,” said Westine. “Our companies commend Rep. Dingell for his ongoing work to better protect consumers and increase transparency. We look forward to working with the current and next Congress to ensure these changes are meaningful and attain the full force of federal law.”

For more information about cosmetic and personal care products, visit www.cosmeticsinfo.org.

Based in Washington, D.C., the Personal Care Products Council is the leading national trade

association representing the global cosmetic and personal care products industry. Founded in 1894, the Council’s more than 600 member companies manufacture, distribute, and supply the vast majority of finished personal care products marketed in the U.S. As the makers of a diverse range of products millions of consumers rely on every day, from sunscreens, toothpaste and shampoo to moisturizer, lipstick and fragrance, personal care products companies are global leaders committed to product safety, quality and innovation.

SOURCE: Personal Care Products Council

Lipstick and Lead: Questions and Answers

May 15, 2010 By LMRodgers Leave a Comment

The following is taken directly from the FDA website:

“The Food and Drug Administration (FDA) has received a number of inquiries regarding reports of lead contamination in lipstick. The following information is drawn from responses to those inquiries, along with information on our latest findings”.

What is FDA’s legal authority over cosmetic safety?

FDA regulates cosmetic safety under the authority of the Federal Food, Drug, and Cosmetic Act (FD&C Act). The FD&C Act requires that cosmetics marketed in interstate commerce be safe when used as directed in the labeling or under customary conditions of use. Cosmetics are not subject to pre-market approval by FDA. However, pre-market approval is required for the color additives used in cosmetics (including those in lipsticks) and other FDA-regulated products (with the exception of coal-tar hair dyes). To learn more on this subject, please refer to FDA Authority Over Cosmetics¹.

Has FDA set limits for lead in cosmetics?

No, FDA has not set limits for contaminants, such as lead, in cosmetics. However, FDA does set specifications for impurities, such as lead, for color additives used in cosmetics. FDA approval of color additives is based on safety evaluations that consider the color additive’s intended use(s) and estimated consumer exposure resulting from those uses. FDA-approved color additives are listed in Title 21 of the U.S. Code of Federal Regulations (CFR). To learn more about FDA-approved color additives, please refer to Color Additives².

What are FDA’s limits for lead in color additives?

FDA limits lead in color additives to maximum specified levels, typically no more than 20 parts per million (ppm) for color additives approved for use in cosmetics. Some color additives listed under regulations in 21 CFR Parts 74 and 82, such as D&C Red No. 6 and D&C Red No. 7, are required to be batch-certified by FDA before they may be used in cosmetics. Part of the FDA certification process for such color additives includes testing each batch of the color additive for lead. Other color additives listed under regulations in 21 CFR Part 73, such as mica, titanium dioxide, and iron oxides, are not required to be batch-certified by FDA, although cosmetic manufacturers are still responsible for ensuring that the color additives used in their products meet FDA’s specifications.

Has FDA been aware of concerns about lead in lipstick?

Yes, reports about lead in lipstick are not new. In the 1990s, reports of analytical results from a commercial testing laboratory suggested that traces of lead in lipstick might be of concern. Subsequent evaluation by FDA of that laboratory’s test results determined that the method used had not been validated for the analysis of lipsticks. More recently, in October 2007, the Campaign for Safe Cosmetics (CSC) reported finding lead in a selection of twenty-five lipsticks on the market. FDA was not able to determine if a method validated for the analysis of lipstick was used to generate the data in the CSC report. Because reports regarding lead in lipstick have surfaced periodically and because of the amount of time that had elapsed since FDA last examined data and other information on lipsticks in the marketplace, FDA decided that further follow-up was needed.

How has FDA followed up on the latest reports?

FDA scientists developed and validated a highly sensitive method for the analysis of total lead content in lipstick and applied the method to the same selection of lipsticks evaluated by the CSC. FDA found lead in all of the lipsticks tested, ranging from 0.09 ppm to 3.06 ppm with an average value of 1.07 ppm. FDA concludes that the lead levels found are within the range that would be expected from lipsticks formulated with permitted color additives and other ingredients that had been prepared under good manufacturing practice conditions.

An article on FDA’s testing method³⁴ was published in the July/August 2009 issue of the peer-reviewed Journal of Cosmetic Science.¹ The article includes results for lead in all the lipsticks we tested. FDA’s testing method is now available for use by any suitable analytical laboratory for the determination of total lead in lipstick.

Is there a safety concern about the lead found by FDA in lipsticks?

No. FDA has assessed the potential for harm to consumers from use of lipstick containing lead at the levels found in its testing. Lipstick, as a product intended for topical use, is only ingested incidentally and in very small quantities. FDA does not consider the lead levels that it found in the lipsticks to be a safety concern. FDA also notes that the lead levels that it found are lower than limits recommended by other public health authorities for lead in cosmetics, including lipstick. ²^,3

It has been reported that levels of lead in certain lipsticks exceed those for candy. Is this a fair comparison?

No. The FDA-recommended upper limit for lead in candy is 0.1 ppm⁵. It is not scientifically valid to equate the risk to consumers presented by lead levels in candy, a product intended for ingestion, with that associated with lead levels in lipstick, a product intended for topical use and which is ingested in much smaller quantities than candy.

Does FDA intend to continue investigating lead in lipstick?

Yes. FDA does not believe that the lead content found in its recent lipstick analyses is a safety concern. However, the agency is planning to investigate a wider range of lipsticks than has been tested so far, including lipsticks similar to those recently assessed for lead content by another laboratory.⁴ If FDA determines that a safety concern for lead in lipstick exists, the agency will advise the industry and the public and will take appropriate action under the authority of the FD&C Act in protecting the health and welfare of consumers.

FDA Analyses of Lead in Lipsticks

The following results for lead content in a selection of lipsticks were obtained by scientists at the U.S. Food and Drug Administration (FDA) and reported in the Journal of Cosmetic Science⁶^[1] Exit Disclaimer ⁷. FDA purchased lipsticks from retail stores between October and December 2007.

Brand name	Parent company	Lipstick Line and Shade^a	Lot numbers^b	Lead (Pb)^c (ppm)^d
Cover Girl	Procter & Gamble	Incrediful Lipcolor 964 Maximum Red	7241S1	3.06
Cover Girl	Procter & Gamble	Incrediful Lipcolor 964 Maximum Red	5188S1	3.05
Revlon	Revlon, Inc.	ColorStay Lipcolor 345 Red Velvet	Composite^e	2.91^f
Revlon	Revlon, Inc.	ColorStay Lipcolor 345 Red Velvet	07298	2.38
Cover Girl	Procter & Gamble	Queen Collection Q580 Ruby Remix	7136	2.24
Body Shop	L’Oreal	Lip Colour 22 Garnet	C274EA	1.79
Cover Girl	Procter & Gamble	Continuous Color 435 Cherry Brandy	7228	1.76
L’Oreal	L’Oreal	Colour Riche 315 True Red	FD261	1.47
Revlon	Revlon, Inc.	Super Lustrous 660 Bed of Roses	07208 1508 53	1.37
Maybelline	L’Oreal	Moisture Extreme F315 Cocoa Plum	WD2891	1.21
Revlon	Revlon, Inc.	Super Lustrous 725 Love That Red	07284 1508 59	1.04
L’Oreal	L’Oreal	Colour Riche 752 Classic Wine	FD064	0.79
L’Oreal	L’Oreal	Colour Riche 752 Classic Wine	FD234	0.67
Clinique	Estee Lauder Companies Inc.	Long Last FJ Merlot	AA7	0.55
Clinique	Estee Lauder Companies Inc.	Long Last F9 Paprika	A87	0.48
Estee Lauder	Estee Lauder Companies Inc.	Pure Color 1A3 Maraschino	B55	0.43
Burt’s Bees	Clorox Company	Lip Shimmer Merlot^g	1840701	0.33
Maybelline	L’Oreal	Moisture Extreme E215 Midnight Red	WD3041	0.23
PeaceKeeper	PeaceKeeper	Paint Me Compassionate^g	h	0.17
Dior	LVMH	Replenishing Lipcolor 752 Red Premiere	7A01	0.15
Dior	LVMH	Addict Ultra-Shine 750 Shiniest Sexiness	7D01	0.12
MAC	Estee Lauder Companies Inc.	Matte Lipstick Viva Glam I	A67	0.10
Avon	Avon	Ultra Color Rich U250 Cherry Jubilee	h	0.09
Average				1.07

^a Lipsticks selected are the same brands and shades analyzed by the Campaign for Safe Cosmetics (http://www.safecosmetics.org/your_health/poisonkiss.cfm⁸ ⁹).
^b Lot numbers embossed or printed on lipstick cases or end labels.
^c Results are for total lead content determined by FDA’s validated method [Reference 1].
^d Reported in units of µg Pb/g in Reference 1.
^e Combination of several lots.
^f Result not used for determining average value of lead content by FDA’s validated method.
^g No shade number on lipstick.
^h No lot number on lipstick.

References:

¹ Hepp, N. M., Mindak, W. R., and Cheng, J., “Determination of Total Lead in Lipstick¹⁰: Development and Single Lab Validation of a Microwave-Assisted Digestion, Inductively Coupled Plasma–Mass Spectrometric Method,” Journal of Cosmetic Science, Vol. 60, No. 4, July/August, 2009.

² Letter from Edmund G. Brown, Jr., Attorney General, State of California to J. L. Sean Slattery, David Lavine, and Laralei Paras regarding Proposition 65 claims concerning lead in lipstick, March 3, 2008.

³ Health Canada, Draft Guidance on Heavy Metal Impurities in Cosmetics¹¹. ¹²

⁴ Al-Saleh, I., Al-Enazi, S., and Shinwari, N., “Assessment of Lead in Cosmetic Products,” Regulatory Toxicology and Pharmacology, Vol. 54, pp. 105-113, 2009.

December 27, 2007; updated June 25, 2009, September 2, 2009, and November 3, 2009