Most people assume the government, in this case the Food and Drug Administration, regulates cosmetics the same way it does food and drugs to ensure they are safe. In reality, cosmetics are one of the least regulated consumer products on the market today.
Today's introduction of the Safe Cosmetics Act of 2011 should raise questions for all cosmetics and personal care companies -- will the passage of this act benefit or harm our industry, our business, and our customers?
I entered this industry because my family, the founders of Badger, believed in creating healthful products for people that we care about. For 16 years, our family business has been making safe, simple, and affordable products without using questionable ingredients or cutting corners for profit.
From what I have experienced as a small business owner, and after a close reading of the new Safe Cosmetics Act of 2011, I believe the Act will be good for small businesses for the following reasons.
The Safe Cosmetics Act of 2011 will:
1. Bring the USA in line with international cosmetic standards and regulations.
We sell our products in 26 countries, and other countries have more ingredient and product regulation than we have here in the United States. Under the Safe Cosmetics Act, cosmetics companies will need to register products with the FDA, follow the general guidelines of GMP (Good Manufacturing Practices) and provide safety substantiation for products and ingredients.
These may seem like big challenges for a small company to handle, and yet these challenges are dealt with routinely in most other countries. Countries such as Canada, the European Union, Japan, Australia and Russia all require the basic level of cosmetic regulation the Safe Cosmetics Act would require. In addition, this act will allow businesses with under $10 million in annual sales to be exempt from registration fees and very small businesses, less than $2 million in annual sales, will not be required to register their products at all.
2. Open up critical information flow.
This act will require suppliers, including fragrance and flavor manufacturers, to disclose ingredients. Under current regulations, such manufacturers are allowed to conceal this information as "proprietary."
At Badger, our core customers expect our full ingredient disclosure, which we can only provide if our suppliers are fully transparent. Yet, like most companies, we have had frustrating experiences trying to get basic information from suppliers.
This bill will fix that problem by requiring suppliers to disclose what they are selling us, and it will also enable us and the public to access to the extensive safety assessments of cosmetic ingredients that have been conducted by suppliers and other companies. These provisions will increase the flow of information so that everyone -- manufacturers and consumers -- can make the most informed choices.
3. Level the playing field.
Current industry standards allow companies to play by different rules. Some companies fully disclose their ingredients and others do not. I am constantly frustrated to see products on the shelves that are curiously not listing key ingredients such as emulsifiers or preservatives. This is because nobody is watching and enforcing ingredient labeling rules.
Hi Susan, thank you for your
Hi Susan, thank you for your comments.
I am happy to take the time to respond to your concerns because I believe that you are acting with good intentions. In the future, you might consider offering more constructive critique. The SCA is a work in progress and people like you could have a really positive impact in shaping the bill if you so choose. In my experience, the authors of this bill and the NGO’s that support it have very honorable intentions and are striving to balance cosmetic safety with the well being of small businesses. They have already taken a great deal of feedback from small businesses, and the bill authors are ready and willing to continue to shape this bill into the best piece of legislation that they can create. (**See my responses below)
"'Open up critical information flow.' - do you really think that a bill that will require companies to spend potentially hundreds of thousands of dollars testing individual ingredients, then turn those test results over for other companies to use for free, to support the safety of the same ingredient in their product, will ever pass?
But you are right...that will be good for small businesses; they can wait until someone else pays for all the testing then just trust their results and formulate away, with no costs of testing themselves!"
** This section of the bill refers to testing already conducted by suppliers. The supplier needs to be able to verify that they are selling a safe product - this is the cost of doing business. That information should then be shared with the manufacturer so that the manufacturer can ensure that they are using safe ingredients. Good suppliers are already doing this, and in all honesty, this is the relationship that we already have with most of our suppliers. If there is additional safety testing above and beyond what is required by law, we incur the testing costs ourselves. The supplier makes money by selling to manufacturers - they are not competing with us and thus it does not benefit them to keep their safety data in secret.
"This will require suppliers, including fragrance and flavor manufacturers, to disclose ingredients. Under current regulations, such manufacturers are allowed to conceal this information as proprietary.
Easy fix, stop formulating with synthetic fragrances and flavors, the essential oil and natural flavor industries are proud to tell you what their ingredients are made from."
** First of all, Badger has never and will never use synthetic fragrances or flavors. However, we believe this is an issue within the industry at large. While I applaud your faith in the natural flavor industry, I can assure you that most, with the very rare exception, natural and organic flavor and fragrance suppliers continue to keep their ingredients a secret, this is not just an issue with the synthetic fragrance and flavor industry. For this reason, Badger only uses pure organic essential oils and extracts to fragrance our products. Despite numerous requests for berry flavored lip balms, etc., we limit ourselves to using only ingredients that we can trace to full supply chain back to the source.
"As for formulating with other things you buy from suppliers and don’t know what’s in them…how does a company legally label their products with the correct INCI ingredients if they don’t know what they are formulating with?
Are you honestly saying that Badger has been selling products having no idea what is in them?"
** I am ABSOLUTELY NOT saying that Badger formulates with ingredients that we are uncertain of. We have had challenges in the past when suppliers would not disclose full information and we have chosen not to use those ingredients. We never use any ingredients that we do not have full disclosure on components of those ingredients and processes. That being said, there are many companies that use ingredients without full knowledge of the processes used, or of the actual nature of the ingredient itself. For example, many derivatives, even certified organic derivatives, are assigned INCI names; however the origin of the product and the processes used are completely proprietary. While I understand the importance of proprietary information, I always insist that we at least know the starting material and the basic processes used to create the end product. Even essential oils may be diluted or cut, and the supplier may not tell the customer of the true nature of the product. For this reason, we are very diligent in obtaining GC testing of essential oils and having all proper documentation in order for all ingredients that we use – including organic certificates, certificates of analysis, and MSDS.
"Currently, industry standards allow companies to play by different rules. Some companies fully disclose their ingredients and others do not.
This is not a factual statement. The FDA laws apply equally to all products sold, regardless of the size of the company. The fact that our current labeling laws are not enforced is a real issue – and should be addressed. But those laws already exist. They are broken every day… from the farmers market to Whole Foods, from Walmart to Target. New laws are not the answer, if the FDA fails to enforce the few that we have now I don’t understand how new laws to enforce will help the situation."
** You are partially correct – The FDA does have ingredient labeling laws in place, and as you wrote, these laws not enforced. However, current cosmetic ingredient labeling laws are far from ideal and exempt flavors, fragrances, and trade secret ingredients (as determined by the FDA based on the following three points: “1. Is the information publicly known? 2. Does the information have value? 3. Can the information readily be acquired or duplicated?” Consumer safety is not among these considerations). Any one of these exempt ingredients could contain harmful additives that the customer would be unaware of. The new cosmetics act would require full disclosure of ingredients so that consumers could make fully informed decisions about the products that they are choosing to purchase. In addition, the registration requirement would help the FDA to monitor and hold companies in compliance, thus minimizing the occurrence of mislabeled cosmetics. This mandatory transparency in combination with tighter monitoring would help to level the playing field, especially for companies like Badger, that already give 100% transparency in their ingredient declaration. Keep in mind, the SCA has provisions to support the FDA in regulating the cosmetics industry far more effectively than it has to capacity to now.
“'Require the disclosure of ingredient contamination.' That would be a good amendment to the FDA cosmetic regulations and that alone, might actually have a chance of passing. But buried and partnered with all of the other proposed laws I think this will be a missed opportunity to add something valuable to our regulations."
** I’m happy to see that you are recognizing some good in this bill. I think that if you look at the bill as a progressive move towards creating safe products, you could be offering constructive critique to help strengthen the bill instead of simply trying to shut down the whole idea.
“'Badger believes that all companies should be producing products that are unquestionably safe.' Of course…but the thing is…don’t you think the targets of this bill…the large corporations, already think they ARE producing products that are unquestionably safe? I do. I don’t think they are right, but I do believe they think they are."
** I agree in part - companies do not set out to make products that are unsafe. However, safety is not always the top priority for a company. At Badger, we put product safety first, and then we work towards meeting all of our other goals. But not all companies ensure that their products are unquestionably safe. Sometimes safety gets lost amongst more pressing concerns such as, efficacy, the bottom line, or aesthetics. Safety is certainly a consideration, but many companies do not put safety first and foremost above all else. If we cannot rely on companies to put safety first, who is responsible for ensuring public safety? I believe that when an industry does not successfully self regulate, our government needs to step in to ensure that companies are held to high safety standards.
"So, what I think will happen is, the corporate cosmetics companies will demonstrate the safety of ingredients, such as parabens or other “hot topic” ingredients, with their science. The secretary will review their submissions, and declare these questionable ingredients as safe. And we’ll be exactly where we are today. Only now the public will be told that science supports the safety of these “hot topic” ingredients and we’ll actually be headed backwards. Who will be spending money to refute the cosmetics company’s tests? No one. That’s not part of the bill. It’s a 'you show us you tested and if your tests show that it’s safe we’ll add it to the appropriate list.'"
** Firstly, the above statement is all speculation. You don’t know what will happen if this bill passes. Perhaps some of these “hot topic” ingredients will actually be found safe. That is not necessarily a bad thing if good science is there to demonstrate their long term safety. However, your assumption that big business will be the only ones studying these ingredients is more of an alarmist view than fact. There are already over 500 peer reviewed scholarly articles that have been published on the subject of parabens. There will be many sources of safety data, particularly for the “hot topic” ingredients. While this is far from a perfect system, this is a step in the right direction.
"Where is the requirement that everything be listed in the correct INCI language?"
** You are correct, the bill, as it stands, does not specify that INCI language must be used. That is because current federal regulation already requires INCI language should be used in the ingredient declaration. This bill is meant to complement current regulations and that is why it is silent regarding INCI labeling.
"Where is the requirement that any product formulated with fragrances, formulate to IFRA recommendations (though some are questionable recommendations, they are still the industry standard)."
** The bill does not address IFRA recommendations because they are a voluntary industry standard.
"And my biggest question---What about “cosmetic” products that are, thanks to their labeling, not legally cosmetics but sold as OTC drugs? Will those products be subject to the requirements of this bill, or will they get a free pass?"
** As you astutely observed, the determination of a drug vs. a cosmetic is largely based on the product labeling, i.e. the claims made and the function of the product. Products that make structure function claims are not considered cosmetics and fall under a different set of regulations. OTC drugs are far more firmly regulated than cosmetics at present. OTC drugs will not be getting a “free pass” but they will not be regulated by the same standards as cosmetics.
** I hope this helps to clarify some of your concerns.
Best wishes,
Rebecca Hamilton
++Your reply: ** This section
++Your reply: ** This section of the bill refers to testing already conducted by suppliers.
My reply: What testing already conducted by suppliers? The Campaign for Safe Cosmetics has said over and over and over again that these ingredients have never been tested for safety!!
Thank you for disclosing that "Good suppliers are already doing this, and in all honesty, this is the relationship that we already have with most of our suppliers."
I submit that MANY cosmetic suppliers are already doing this...not just a few. And if they are not...then I believe formulators should not buy from the suppliers who are not.
I am 100% certain because I have had more than a few heated debates with people, consumers believe based on the things the Campaign for Safe Cosmetics has said, that no suppliers ever test any of their ingredients for safety.
Never. Ever. None. And the mass hysteria they have created with their media campaigns of late, are dangerous, in my opinion. Because they create climate where people become desensitized to the issues, "The Boy Who Cried Wolf" -- and when the wolf really is at the door, no one will listen.
Just coming clean and clearing up that misinformation would go a long way in calming a lot of the fears generated by information to the contrary and put the issue of safe cosmetics in a more realistic perspective..
++Next, your reply: We have had challenges in the past when suppliers would not disclose full information and we have chosen not to use those ingredients. We never use any ingredients that we do not have full disclosure on components of those ingredients and processes.
My reply: Thank you for clarifying what I read in your article. And, once again, you are documenting facts which are the opposite of what the Campaign for Safe Cosmetics has said over and over and over again - that there is no way for manufacturers to obtain full disclosure on components of those ingredients and processes because such information does not exist.
"Cosmetic firms are responsible for substantiating the safety of their products and ingredients before marketing. Failure to adequately substantiate the safety of a cosmetic product or its ingredients prior to marketing causes the product to be misbranded unless the following warning statement appears conspicuously on the principal display panel of the product's label:
"Warning--The safety of this product has not been determined." (21 CFR 740.10)" (a)
If the FDA enforced the laws we already have on the books...every cosmetic company would have to formulate just like you do.
And if they do not have the safety information for their ingredients, and the FDA issued a warning letter to everyone who fails to list the "Warning", maybe cosmetic companies who don't follow the laws would take them more seriously.
And consumers faced with two like items in the store, would tend to buy the product without the warning about the safety being undetermined. And the market would police itself.
These companies who sell products with undetermined safety would start to lose business. I believe they would source new suppliers who WOULD provide the information they seek. Then those other suppliers would either need to change their business practices or go out of business.
The market really can regulate itself. But #1 consumers need to be given accurate information and not scare tactics; #2 the FDA actually needs to enforce the laws that already exist.
The government needs to do it’s JOB...and the work is already in their job description!! Will some people still choose toxic products with unproven safety? Sure. Just like people still smoke cigarettes in spite of the photos of people smoking through a hole in their neck!
People in this country do have the rights to be idiots and make bad choices...that's reality.
But what about the ingredients that are actually hazardous to our health?
I suggest we create a new law -- every single individual or business selling soap, cosmetics or OTC drug personal care products should be required to register and pay a fee for the privilege of selling these products.
Whether you sell $10 worth of melt and pour soap at the local farmers market or are a billion dollar international corporation -- you pay, on a sliding scale, based on gross sales. Start with $25 a year for selling $1 - $5,000. Scale up from there.
Then that money goes directly into funding independent research into the safety of cosmetic ingredients BASED on scientific factors such as the EPA's list of chemicals that are Persistent Bioaccumulative and Toxic (PBT). How about this group networks not only with the EPA but with the National Center for Complementary and Alternative Medicine as well; because medical professionals such as Naturopathic Doctors look at toxic exposure a different way than your average MD, and they may have valuable insight into where to start as far as what ingredients need to be researched first, with good, solid, scientific studies based on their experiences in actual medical practice.
Narrow down the list to a Top Ten chemicals a year. In ten years or so move on to those left among the "12,500 unique chemical ingredients are used in personal care and cosmetics products" which the Campaign for Safe Cosmetics claims "have not been required to undergo any type of formal safety assessments." (d)
The reality is, it takes more than a year to determine whether or not a chemical causes cancer! But start now!!
++Your next reply: "However, current cosmetic ingredient labeling laws are far from ideal and exempt flavors, fragrances, and trade secret ingredients ..."
My reply: I agree 100%; my objection to the Safe Cosmetics Act is because they have a loophole where these ingredients could STILL be kept secret!
"(c) Petition for Information To Remain Confidential- (1) IN GENERAL- The Secretary shall create a process for an entity to petition for nonconfidential information described in subsection (a) to remain confidential if the entity shows that there would be a serious negative impact to the entity’s commercial interests if such information were disclosed to the public."
Companies spend a small fortune creating fragrances for their products -- of course they will want to continue to keep them trade secret! This bill will allow them to continue to do so and is one of the major reasons I object to the bill!
I think every ingredient and the chemicals in each ingredient need to be disclosed, not necessarily on the product label, but in such a way that the public has access.
Example; I am highly allergic to lemongrass, the herb and the essential oil. So a product labeled with "Blend of 100% pure essential oils" and then a statement saying "lemon scented" does not give me sufficient information as a consumer. Are the essential oils lemon or lemongrass or lemon verbena or lemon thyme? I want to see the botanical name listed for the essential oil on the label. Do I need to know all of the constituents of the essential oil, no. But they should be accessible to me online. In Europe you have to list any of 26 allergens commonly found in fragrances and essential oils on the product label of any cosmetics (toiletries) & Detergents, and while I don't agree that all of these are actually allergens or need to be on the label itself, that information should be available so consumers in the USA who do wish to know about that information, have it accessible to them.
++You state: ** I’m happy to see that you are recognizing some good in this bill. I think that if you look at the bill as a progressive move towards creating safe products, you could be offering constructive critique to help strengthen the bill instead of simply trying to shut down the whole idea.
My reply: I am an honest person and once I am lied to, I am suspicious of that person/organization. I may forgive, but I never forget. The Campaign for Safe Cosmetics as it operates today is not the same organization I supported years ago when I was in the soap and cosmetics industry. They lie to try to get their agenda met. They allow misinformation to remain uncorrected if it serves their purposes.
As a result, I do not trust their intent with this bill. I think the lawmakers who are supporting it, have been conned. When I was banned from their Facebook page it became clear to me they are not engaged in fair play, they do not want to debate or discuss, they want to manipulate.
I have come to believe that this bill is written in such a way that it will never pass, it could never pass or the entire cosmetics industry would shut down. What is the result? The CFSC gets pats on the back for trying so hard, and they have another year of job security and of course, in the mean time since the FDA won't protect you...make sure you visit Skin Deep and make sure to donate while you are there because your LIFE may count on it!
They don't make cosmetics. They have nothing to lose but their jobs if the bill passes and the FDA is actually doing their job.
So you are right, I do want this bill completely shut down. 100%. That does not mean I want nothing done about hazardous ingredients in cosmetics.
Personally, I'd like to see petrochemicals banned for use in cosmetics. That would get rid of 95% (estimate) of synthetic fragrances as well. Just that - eliminate one class of chemicals in cosmetics and the entire industry would be geometrically safer.
Do I think the petrochemical industry lobby is strong enough to make sure that never happens? Sadly, yes.
My second choice would be to eliminate every single ingredient that does not biodegrade. That is a realistic goal. That alone would eliminate many of the ingredients that are currently "suspected hazards" but which lack the scientific proof of harm which would be necessary to result in them being banned.
When you start off claiming the entire industry needs a complete and total overhaul, you are going to fail. You pretty much know that it is impossible, so perhaps, it is designed to fail. Not unlike a lawsuit that you know you will not win, but which will bring an issue to light. I honestly do not believe the people behind this bill really think it will pass. I do believe a lot of the "not in charge" people are totally sincere in their wish for safer cosmetic -- but I also believe that - I know that - everyone I personally know who is opposed is equally passionate about wanting safe cosmetics. Those opposed simply do not believe this is the way, or more importantly that they result will BE safer cosmetics.
Logically, look at the recent media coverage for sunscreens. The FDA comes out with new regulations; the Campaign for Safe Cosmetics is all over them for being wrong. So explain to me why they are trying to give them MORE power and MORE responsibilities to the very organization they consistently find fault with? Is it just because they like playing ball and need a team to play against? Something just does not make sense.
++You say: " I believe that when an industry does not successfully self regulate, our government needs to step in to ensure that companies are held to high safety standards."
Me: I do not disagree but I don't see how a bill that requires those very same companies to be the ones who provide their safety information to the government, will result in safer cosmetics. The bill says to the cosmetic company and ingredients supplier: you test, you send us your test results, and we evaluate them, and then place your ingredients in lists for reference.
Are you old enough to remember when we had no safety information about cigarettes and second hand smoke? How'd that work out? Do you really think Revlon sending the FDA safety information on their ingredients and products is going to be any different from Marlborough sending safety information about the safety of their cigarettes to the FDA? I don't!
We need independent testing but with REALISTIC goals. If an ingredient has a history of safe use, put that ingredient at the bottom of the "to do" list!
I am sure there are many people who say this bill is great and they can't WAIT for it to get rid of Parabens, for example. Really? It won't. The industry has sufficient safety information that the same parabens that are used in Europe now will be used in the USA after this bill finishes with them.
In fact, name a SINGLE ingredient that will be banned as a result of this bill!!
Because if there was sufficient science to prove it is hazardous, then it is already illegal to use in cosmetics...and could be banned right now with no new laws.
++You: You are correct, the bill, as it stands, does not specify that INCI language must be used. That is because current federal regulation already requires INCI language should be used in the ingredient declaration.
Me: Specifically, where? Because it seems to me that it is suggested but not required. And if required by FDA or FTC law, then it is not enforced. And if something as simple as INCI language cannot be enforced...how will a single new requirement of this bill be enforced? If the FDA can't do this one thing right, I don't understand how adding a few dozen more things they should be responsible for will result in ACTUAL safer cosmetics.
++You: ** As you astutely observed, the determination of a drug vs. a cosmetic is largely based on the product labeling, i.e. the claims made and the function of the product. Products that make structure function claims are not considered cosmetics and fall under a different set of regulations. OTC drugs are far more firmly regulated than cosmetics at present. OTC drugs will not be getting a “free pass” but they will not be regulated by the same standards as cosmetics.
Me: So basically, I make a lotion...add some zinc, label it with a really low SPF, list zinc as the active ingredient - and get a free pass on following all the new laws that would be required for the very same exact lotion labeled with no SPF, and no active ingredient listed. That makes no sense to me.
And brings up another primary reason I object to this bill. Cosmetics. By definition...they don't really do anything but clean and make us "appear" better in some way. By contrast, personal care products with ingredients that actually absorb into the skin, ingredients that actually have an effect on the body, ingredients which "do" something in our personal care products -- the ones that are supposed to be manufactured, labeled and marketed as OTC drugs -- that is where I believe we should be looking as far as regulating safety.
Our country is in severe financial crisis. The FDA just had their budget cut by millions...MILLIONS of dollars. FDA -- Food and Drug Administration. Our top priority should be food safety. Every year "48 million food borne illness cases occur in the United States every year. At least 128,000 Americans are hospitalized, and 3,000 die after eating contaminated food." (b) Food safety is more important than cosmetic safety, in my opinion.
The Campaign for Safe Cosmetics constantly refers to "suspected hazards". We have real hazards that simply must take priority when finances are limited. If you can't feed your family you probably are not buying a new lipstick. The FDA needs to prioritize their resources as well.
So the cosmetic safety reform could function similar to health care reform, where the law sets up a nonprofit independent board with a multi-million $ budget, funded by the registration fee, where they study which cosmetic ingredients are not only are hazardous, but which are effective. (c)
I believe there are realistic risks out there, as a Mom, a consumer, I make choices accordingly. I never buy products with synthetic fragrances -- my child could have died from asthma as a baby and so for 20 years keeping my home free of synthetic fragrances has been important to me.
I also believe we are being poisoned by exposure to herbicides and pesticide residue in our foods, cosmetics and household products -- so I choose USDA Certified Organic whenever possible.
The wolf is at the door...but thinking we will get anywhere demonizing all 12,500 cosmetic chemicals is unrealistic.
And following what is basically the same process we followed when we started to suspect that cigarettes might be hazardous to our health is just plain stupid.
Thank you for allowing me to reply. Sue Sawhill Apito
(a) http://www.fda.gov/Cosmetics/GuidanceComplianceRegulatoryInformation/ucm...
(b) http://www.foodborneillness.com/
(c) http://apitoblogs.com/
(d) http://www.fuerstlaw.com/wp/index.php/11/house-representatives-propose-n...
Hi Susan, Thank you for your
Hi Susan,
Thank you for your reply. I will do my best to address your concerns, however, much of what you have written relates to the Campaign for Safe Cosmetics, not to me or to my company. While I fully support the mission and principles of the CFSC, I do not speak for them or work for them. In the future, please address these concerns directly to the CFSC.
(See *** for my comments)
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Your reply: This section of the bill refers to testing already conducted by suppliers.
My reply: What testing already conducted by suppliers? The Campaign for Safe Cosmetics has said over and over and over again that these ingredients have never been tested for safety!!
Thank you for disclosing that "Good suppliers are already doing this, and in all honesty, this is the relationship that we already have with most of our suppliers." I submit that MANY cosmetic suppliers are already doing this...not just a few. And if they are not...then I believe formulators should not buy from the suppliers who are not. I am 100% certain because I have had more than a few heated debates with people, consumers believe based on the things the Campaign for Safe Cosmetics has said, that no suppliers ever test any of their ingredients for safety. Never. Ever. None. And the mass hysteria they have created with their media campaigns of late, are dangerous, in my opinion. Because they create climate where people become desensitized to the issues, "The Boy Who Cried Wolf" -- and when the wolf really is at the door, no one will listen. Just coming clean and clearing up that misinformation would go a long way in calming a lot of the fears generated by information to the contrary and put the issue of safe cosmetics in a more realistic perspective.
***We don’t know how much safety testing has been conducted because much of it is not public. But there are still unregulated ingredients on the market that have known safety concerns. Many of the larger cosmetic companies and ingredient suppliers have conducted safety assessments - however this is not something that the public has access to. We also don’t know the extent of this safety testing, or the full results of these tests. A vast number of cosmetic ingredients have never been publically assessed, which is of great concern in determining the true safety of ingredients. Badger uses only certified organic food grade ingredients, which are generally recognized as safe, and common essential oils (with a long history of safe use) in our products because we feel that those ingredients create the safest products. We are very careful with our essential oils, and we always make sure to review all publically available safety data to determine safe percentages and usage. For our more complex ingredients, such as zinc oxide, there is extensive publically available safety data that we can draw on. We also only use zinc oxide that meets pharmaceutical standards. We ensure that our suppliers test all of our ingredients for purity and authenticity. When needed, we conduct additional safety assessments. When we sell our products in the EU, the entire product undergoes a safety assessment, which confirms that our products conform to the EU regulations.
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Next, your reply: We have had challenges in the past when suppliers would not disclose full information and we have chosen not to use those ingredients. We never use any ingredients that we do not have full disclosure on components of those ingredients and processes.
My reply: Thank you for clarifying what I read in your article. And, once again, you are documenting facts which are the opposite of what the Campaign for Safe Cosmetics has said over and over and over again - that there is no way for manufacturers to obtain full disclosure on components of those ingredients and processes because such information does not exist.
***Obtaining full ingredient disclosure would be difficult for many companies within our industry. Badger only makes simple products because we refuse to use the vast majority of ingredients that we would be unable to get full disclosure for. We cannot make shampoos and conditioners or many other commonly used cosmetic products because the ingredients needed to make those products effectively would not meet our standards. I personally use many products that we cannot make to our standards, which is part of the reason that I am in support of the SCA. I want to know that someone is ensuring that each of the products that I use is safe. I also want to be able to tell my customers that they can use any product out there on the market without concern for their safety. I don’t ever want people to choose my products because they are afraid of everything else. I want people to choose our products because the quality and efficacy that we provide fulfills their needs.
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"Cosmetic firms are responsible for substantiating the safety of their products and ingredients before marketing. Failure to adequately substantiate the safety of a cosmetic product or its ingredients prior to marketing causes the product to be misbranded unless the following warning statement appears conspicuously on the principal display panel of the product's label:
"Warning--The safety of this product has not been determined." (21 CFR 740.10)" (a)
If the FDA enforced the laws we already have on the books...every cosmetic company would have to formulate just like you do.
And if they do not have the safety information for their ingredients, and the FDA issued a warning letter to everyone who fails to list the "Warning", maybe cosmetic companies who don't follow the laws would take them more seriously.
And consumers faced with two like items in the store, would tend to buy the product without the warning about the safety being undetermined. And the market would police itself.
These companies who sell products with undetermined safety would start to lose business. I believe they would source new suppliers who WOULD provide the information they seek. Then those other suppliers would either need to change their business practices or go out of business.
The market really can regulate itself. But #1 consumers need to be given accurate information and not scare tactics; #2 the FDA actually needs to enforce the laws that already exist.
The government needs to do it’s JOB...and the work is already in their job description!! Will some people still choose toxic products with unproven safety? Sure. Just like people still smoke cigarettes in spite of the photos of people smoking through a hole in their neck!
People in this country do have the rights to be idiots and make bad choices...that's reality.
But what about the ingredients that are actually hazardous to our health?
***I don’t disagree with you here. I believe that consumers should have the right to choose, even if they are choosing a product that may not be as safe. I personally believe that certified organic products are safer than other natural products. This does not mean that I think all personal care products should be certified organic. The FDA does not currently have the resources to adequately regulate this industry or ensure that all products are truthfully labeled so that consumers can make informed choices. The bill would help give the FDA the resources they need to regulate cosmetics more effectively and would compliment current regulations.
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I suggest we create a new law -- every single individual or business selling soap, cosmetics or OTC drug personal care products should be required to register and pay a fee for the privilege of selling these products.
Whether you sell $10 worth of melt and pour soap at the local farmers market or are a billion dollar international corporation -- you pay, on a sliding scale, based on gross sales. Start with $25 a year for selling $1 - $5,000. Scale up from there. Then that money goes directly into funding independent research into the safety of cosmetic ingredients BASED on scientific factors such as the EPA's list of chemicals that are Persistent Bioaccumulative and Toxic (PBT). How about this group networks not only with the EPA but with the National Center for Complementary and Alternative Medicine as well; because medical professionals such as Naturopathic Doctors look at toxic exposure a different way than your average MD, and they may have valuable insight into where to start as far as what ingredients need to be researched first, with good, solid, scientific studies based on their experiences in actual medical practice. Narrow down the list to a Top Ten chemicals a year. In ten years or so move on to those left among the "12,500 unique chemical ingredients are used in personal care and cosmetics products" which the Campaign for Safe Cosmetics claims "have not been required to undergo any type of formal safety assessments." (d)
The reality is, it takes more than a year to determine whether or not a chemical causes cancer! But start now!!
***I agree with much of what you are saying here. The new law that you are suggesting is very much in line with the proposed SCA 2011. This would require cosmetic companies to pay fees on a sliding scale and those fees would go towards funding a committee that would assess the safety of cosmetic ingredients.
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Your next reply: "However, current cosmetic ingredient labeling laws are far from ideal and exempt flavors, fragrances, and trade secret ingredients ..."
My reply: I agree 100%; my objection to the Safe Cosmetics Act is because they have a loophole where these ingredients could STILL be kept secret!
"(c) Petition for Information To Remain Confidential- (1) IN GENERAL- The Secretary shall create a process for an entity to petition for nonconfidential information described in subsection (a) to remain confidential if the entity shows that there would be a serious negative impact to the entity’s commercial interests if such information were disclosed to the public."
Companies spend a small fortune creating fragrances for their products -- of course they will want to continue to keep them trade secret! This bill will allow them to continue to do so and is one of the major reasons I object to the bill!
I think every ingredient and the chemicals in each ingredient need to be disclosed, not necessarily on the product label, but in such a way that the public has access.
Example; I am highly allergic to lemongrass, the herb and the essential oil. So a product labeled with "Blend of 100% pure essential oils" and then a statement saying "lemon scented" does not give me sufficient information as a consumer. Are the essential oils lemon or lemongrass or lemon verbena or lemon thyme? I want to see the botanical name listed for the essential oil on the label. Do I need to know all of the constituents of the essential oil, no. But they should be accessible to me online. In Europe you have to list any of 26 allergens commonly found in fragrances and essential oils on the product label of any cosmetics (toiletries) & Detergents, and while I don't agree that all of these are actually allergens or need to be on the label itself, that information should be available so consumers in the USA who do wish to know about that information, have it accessible to them.
***I agree - this loophole is problematic. I believe that this section of the bill should be restructured so that all cosmetic companies are required to disclose ingredients that are considered allergens. This should be across the board with no loopholes. There can then be a clause that allows for some ingredients to remain trade secrets to the public, but these ingredients would still need to be fully assessed for safety so that the public does not need to be concerned that there are hidden allergens or harmful ingredients. Badger will always disclose our full ingredient lists because we believe that transparency is more important than proprietary knowledge. But I also recognize that the industry at large does not share this view.
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Personally, I'd like to see petrochemicals banned for use in cosmetics. That would get rid of 95% (estimate) of synthetic fragrances as well. Just that - eliminate one class of chemicals in cosmetics and the entire industry would be geometrically safer.
Do I think the petrochemical industry lobby is strong enough to make sure that never happens? Sadly, yes.
My second choice would be to eliminate every single ingredient that does not biodegrade. That is a realistic goal. That alone would eliminate many of the ingredients that are currently "suspected hazards" but which lack the scientific proof of harm which would be necessary to result in them being banned.
When you start off claiming the entire industry needs a complete and total overhaul, you are going to fail. You pretty much know that it is impossible, so perhaps, it is designed to fail. Not unlike a lawsuit that you know you will not win, but which will bring an issue to light. I honestly do not believe the people behind this bill really think it will pass. I do believe a lot of the "not in charge" people are totally sincere in their wish for safer cosmetic -- but I also believe that - I know that - everyone I personally know who is opposed is equally passionate about wanting safe cosmetics. Those opposed simply do not believe this is the way, or more importantly that they result will BE safer cosmetics.
***While Badger firmly believes in formulating our products with certified organic and natural ingredients, I don’t think that all synthetic ingredients are inherently bad or unsafe. Eliminating all non biodegradable or petrochemical ingredients would not likely solve the safety issues in our industry and would create other issues. The goal is to give cosmetic companies the diversity of ingredients that they need to create effective products while ensuring that none of those ingredients will cause harm.
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You say: " I believe that when an industry does not successfully self regulate, our government needs to step in to ensure that companies are held to high safety standards."
Me: I do not disagree but I don't see how a bill that requires those very same companies to be the ones who provide their safety information to the government, will result in safer cosmetics. The bill says to the cosmetic company and ingredients supplier: you test, you send us your test results, and we evaluate them, and then place your ingredients in lists for reference.
***This bill requires cosmetic companies to be responsible for providing safety data, but it also requires the FDA to be actively involved in reviewing all data, company submitted or other, to ensure that the data represents good solid science.
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We need independent testing but with REALISTIC goals. If an ingredient has a history of safe use, put that ingredient at the bottom of the "to do" list!
***The bill does specify that ingredients should be evaluated on the basis of risk. That means that ingredients with a safe history of use would be put at the bottom of the “to do” list.
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I am sure there are many people who say this bill is great and they can't WAIT for it to get rid of Parabens, for example. Really? It won't. The industry has sufficient safety information that the same parabens that are used in Europe now will be used in the USA after this bill finishes with them.
In fact, name a SINGLE ingredient that will be banned as a result of this bill!!
Because if there was sufficient science to prove it is hazardous, then it is already illegal to use in cosmetics...and could be banned right now with no new laws.
***There are ingredients on the market for which there is sufficient science to prove that they are hazardous and they have not been banned because the cosmetic regulations have not been updated to reflect current data. This bill would require ingredients to be reassessed based on all current available data and these ingredients harmful ingredients would be restricted or banned.
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You: You are correct, the bill, as it stands, does not specify that INCI language must be used. That is because current federal regulation already requires INCI language should be used in the ingredient declaration.
Me: Specifically, where? Because it seems to me that it is suggested but not required. And if required by FDA or FTC law, then it is not enforced. And if something as simple as INCI language cannot be enforced...how will a single new requirement of this bill be enforced? If the FDA can't do this one thing right, I don't understand how adding a few dozen more things they should be responsible for will result in ACTUAL safer cosmetics.
***This bill has provisions to support the FDA in regulating cosmetics. If products are registered and in the FDA database, then the FDA will have the ability to more easily regulate whether or not INCI labeling is being used.
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Me: So basically, I make a lotion...add some zinc, label it with a really low SPF, list zinc as the active ingredient - and get a free pass on following all the new laws that would be required for the very same exact lotion labeled with no SPF, and no active ingredient listed. That makes no sense to me.
And brings up another primary reason I object to this bill. Cosmetics. By definition...they don't really do anything but clean and make us "appear" better in some way. By contrast, personal care products with ingredients that actually absorb into the skin, ingredients that actually have an effect on the body, ingredients which "do" something in our personal care products -- the ones that are supposed to be manufactured, labeled and marketed as OTC drugs -- that is where I believe we should be looking as far as regulating safety.
***If a manufacturer adds zinc oxide or some other active sunscreen ingredient for the purpose of protecting people from UV rays, yes the product would then be considered an OTC drug and would then follow OTC regulations. If a manufacturer adds zinc oxide without making sunscreen claims, demonstrating that the product’s purpose is still cosmetic, then it would have to follow cosmetic regulations. This is not a flaw in the system, this is based on the intended use of the product and the regulations that are put in place to inform and protect people based on the end usage. If I took organic extra virgin olive oil and claimed that it was intended for use as a body oil, that product would have to follow cosmetic regulations not food regulations. Likewise, I could turn around and sell that exact same olive oil as a food product, in which case it would need to follow food regulations.
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***I know that I have not addressed all of your concerns. But keep in mind - I am a manufacturer, not the author of this bill. I am committed to giving constructive and supportive feedback to the bill authors in an effort to continue to improve this bill, and I believe that ultimately this bill will be good for the general public. As I have said before, this bill is not yet set in stone, which is why I feel that constructive feedback is incredibly important at this juncture. I believe that this country deserves to have solid cosmetic regulations that are reflective of current scientific knowledge and safety standards. I also believe that there is enough concern in this country that something will get passed within the next few years. I intend to be involved in this process because I believe that my customers deserve to have realistic legislation pass that will help to ensure their safety. Please keep my role in the process in mind when you direct comments, questions, and concerns to me. I know that you are as passionate about cosmetic safety as I am - which means that we are actually working from the same good intent. Let’s not lose sight of that.
Thank you for your feedback.
Best wishes,
Rebecca
"A vast number of cosmetic
"A vast number of cosmetic ingredients have never been publically assessed, which is of great concern in determining the true safety of ingredients. Badger uses only certified organic food grade ingredients, which are generally recognized as safe, and common essential oils (with a long history of safe use) in our products because we feel that those ingredients create the safest products. We are very careful with our essential oils, and we always make sure to review all publically available safety data to determine safe percentages and usage. For our more complex ingredients, such as zinc oxide, there is extensive publically available safety data that we can draw on. We also only use zinc oxide that meets pharmaceutical standards."
I really have no idea what this "vast number" of cosmetic ingredients represent, and whether the fact that the safety information is public or private really makes a difference in whether or not an ingredient is actually safe. I think what it is important for the public to know is that just because an ingredient's safety testing is not publically available, does not mean the safety is not established before adding to a cosmetic.
The public is led to believe there are vast numbers of ingredients that have never been tested by anyone and so that is the purpose of this bill, to right that wrong.
So you do it the right way, that's clear. Do you think it is realistic to expect you to also conduct testing on your entire product line to determine, in parts per billion, for any contaminants in your products (who knows where the bees have flown and what flowers they have contacted which may have been rained on by rainwater containing lead, for example and your beeswax may show positive for lead contamination); as well as testing each and every product to make sure that they do not present possibility of harm to anyone; including any vulnerable population (which includes people with immune deficiencies, allergies, sensitivities etc.).
Example, a person with a life threatening allergy to bee stings might react to beeswax...so it's possible beeswax would be categorized as a banned or restricted ingredient as a result of this bill.
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" I also want to be able to tell my customers that they can use any product out there on the market without concern for their safety."
And that is exactly why this bill will not work; and why any bill with that goal will not work - it is completely unrealistic. "In the United States, foodborne diseases have been estimated to cause 6 million to 81 million illnesses and up to 9,000 deaths each year." (http://www.cdc.gov/ncidod/eid/vol5no5/mead.htm). You can't walk into a restaurant and have that measure of safety. Why is it realistic to think that you can go to Whole Foods and walk out with cosmetics and have no concern for your safety but in your same shopping cart, have foods that potentially can kill you? It's an unrealistic goal. And realistically, there are people who WANT to smell like the potentially toxic synthetic fragrances make them smell, they don't CARE what the health risks are; they want inch long, brightly colored, fake fingernails and they don't care what those treatments do to their health; they want bleached blond, perfectly straight hair and really don't care if they have to wear a gas mask during the processing to get there. There are dangerous and toxic ingredients in cosmetics. Absolutely. And people are going to fight to keep them. That is not what the people opposed to the SCA 2011 are all about -- not at all. They ARE about not lumping in ingredients that have a history of safe use in cosmetics with "the rest". They are about not expecting a product like soap, or a simple lip balm or skin lotion to be tested on animals to prove they do not cause cancer...when there is not event the slightest suggestion that these products could be linked to cancer or any diseases.
The reason I mention the CFSC is because their media campaigns and the things they tell the public are in many cases, the sole reason people support this bill. They never in any place that I have seen, asked the public to "read" the bill. They did however, ask the public to contact their representatives and tell them to support this bill. They demand consumers read the ingredients on the products they buy -- but really hope the public does not "read the ingredients" in this bill...but instead support it based on it's publicized "intent" alone.
This bill is the equivalent of shutting down every grocery store and testing every product for bacteria, based on one brand of alfafa sprouts having life threatening bacteria. It's too broad, to unfocused, to unrealistic and not based on scientific facts or the reality of the fact that most ingredients in cosmetics are safe, and most have been tested.
What we need is a clarification of the laws that are already there -- that it is illegal to sell a cosmetic UNLESS the safety has been established; that if the safety has NOT been established the product needs to display a WARNING on the label; that the ingredients need to be listed in INCI language. Because if other companies are making and selling products in spite of being unable to get safety information from the ingredient supplier, as you have said; and they do not have a warning on their label; then they are breaking the law.
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"But there are still unregulated ingredients on the market that have known safety concerns. "
Most ingredients are unregulated...only colorants are regulated. So the focus should be on those with known safety concerns. Example; parabens. There are many companies reformulating to remove parabens because of consumer concern. But lets say this bill passed. There would be no effect on parabens. Because in spite of "concerns", these ingredients have sufficient safety data that they will be unaffected by this bill. So what ingredients with known safety concerns will be effected by this bill? No one seems to be able to answer that.
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***I agree with much of what you are saying here. The new law that you are suggesting is very much in line with the proposed SCA 2011. This would require cosmetic companies to pay fees on a sliding scale and those fees would go towards funding a committee that would assess the safety of cosmetic ingredients."
It's similar but very different, all this committee will do it evaluate the data the cosmetic companies submit to them. I don't understand how this will do a single thing about making cosmetics safer. The fact that my kitchen cabinets are in alphabetical order* does not make me a good cook. (* analogy)
My proposal is for the fees to go toward a non-profit organization charged with TESTING "the ingredients on the market that have known safety concerns.
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"***The bill does specify that ingredients should be evaluated on the basis of risk. That means that ingredients with a safe history of use would be put at the bottom of the “to do” list."
I'd recommend re-reading that section - that is not how I read it at all. ALL ingredients are submitted to the Secretary - THEN the ingredients are catagorized. I don't see any place in the bill that excludes any ingredients prior to going through this process.
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***There are ingredients on the market for which there is sufficient science to prove that they are hazardous and they have not been banned because the cosmetic regulations have not been updated to reflect current data. This bill would require ingredients to be reassessed based on all current available data and these ingredients harmful ingredients would be restricted or banned."
"There are ingredients on the market for which there is sufficient science to prove that they are hazardous and they have not been banned because the cosmetic regulations have not been updated to reflect current data." - what are some examples? Are there 3 ingredients, 300 or 3,000?
The problem those opposed have is that this bill requires "This bill would require (ALL COSMETIC) ingredients to be reassessed based on all current available data" instead of "This bill would require SUSPECTED HAZARDOUS COSMETIC ingredients to be reassessed based on all current available data"
Certainly this bill must have a "hit list" - a goal - some ingredients they hope will be banned or restricted? Or are they just shooting wildly and hoping to hit a target?
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"I believe that this country deserves to have solid cosmetic regulations that are reflective of current scientific knowledge and safety standards." Me too, and everyone I know who is opposed does as well.
"I also believe that there is enough concern in this country that something will get passed within the next few years." I don't, because the FDA isn't doing it's job now and so adding more requirements isn't going to make that situation any better. So I don't thing the general public expects the FDA to be protecting them "from" cosmetics - I think they hope the FDA is concentrating on protecting the countries food safety and trying to get the drugs that have more side effects than benefits off the shelves. I think cosmetic safety is not on very many people's radar. And for those people who are concerned, they educate themselves and shop accordingly. Because as consumers, we already have quite a bit of information available to us in order to be informed consumers.
Thanks again for your reply - we do all have the same goals just different paths to get there! Sue
Susan, do you honestly
Susan, do you honestly believe - seriously?? - that naturally occurring (or my personal favorite - "derived from nature" which is simply a crock of dodo) materials are somehow automatically safe? Or even automatically safer?
"Susan, do you honestly
"Susan, do you honestly believe - seriously?? - that naturally occurring (or my personal favorite - "derived from nature" which is simply a crock of dodo) materials are somehow automatically safe? Or even automatically safer?"
No...I certainly don't. I hope you didn't hurt yourself jumping to such a ridiculous conclusion!
I never said or implied any such thing!
The passage of the Safe
The passage of the Safe Cosmetics Act would be a huge victory for consumers, many of whom falsely believe they are using safe cosmetics and personal care products--because they assume that only safe products would be allowed on shelves. Transparency and full disclosure will protect consumers and help those businesses already taking care in making products with ingredients that are non-toxic and safe for use.
Protect the public + the
Protect the public + the planet! As a holistic health and eco expert, I can't tell you how many people I work with have never considered how toxic mainstream cosmetics can be for their health or the health of countless species and water sources. For example, my clients are blown away when they learn that it's illegal to throw away typical nail polish (it's supposed to be dropped off at a local Household Hazardous Waste Collection Site). Even people with cancer are almost never educated on this important topic by Western or alternative doctors. We need the Safe Cosmetics Act and we need it now! Thanks Rebecca Hamilton for a great article (and great all-natural products too).
All Americans deserve access
All Americans deserve access to safe products. Legislation to prevent manufacturers from using harmful ingredients in our personal care products is the only way to protect ALL Americans from the dangers these ingredients pose. As it is now, it is a luxury to be able to buy safer products, which typically cost more than mainstream products. Perhaps passage of this bill will not only raise awareness in consumers but also encourage manufacturers to make it an opportunity to enhance their business by providing safe products at reasonable prices, a win-win for everyone!
What a helpful perspective,
What a helpful perspective, thanks Rebecca! And thanks to the Congressional leaders who worked so hard to introduce this legislation! I'm hopeful that this issue can be viewed and responded to as the non partisan issue it is, because it's really about women and men wanting to protect their families and customers, and wanting to have more control over the products they bring into their homes, put on their bodies and market to others seeking the same. We have enough evidence to see that many businesses are not interested in proper self-regulation, and its time to support the businesses who want to do the right thing and grow at the same time.
Hi there! Thanks so much for
Hi there! Thanks so much for your article!! I've been trying to find the text of the new bill, but according to OpenCongress, it is not yet available, because it hasn't been released by the Government Printing Office. Can you share the site where you were able to read it? I'm interested in reading how different it is compared to HR5786 (the 2010 Safe Cosmetics Act). Thanks so much! :)
I know there were so many
I know there were so many concerns this legislation would hurt small cosmetics companies. It's great to see that this concern will hopefully be eliminated with the revised Safe Cosmetics Act of 2011. There's no reason this bill should not get passed, when it is so long overdue. When carcinogens are making their way into products, the problem is easily apparent. There's no reason the industry should continue with their unsafe, dishonest, and unethical practices. Hopefully, if this meaningful legislation is passed, we will get a chance to see the industry clean up its act!