Thursday, July 28, 2011
I have found recently that some companies and organizations are coming out saying the support the Safe Cosmetics Act of 2011 but yet still find many faults in the bill. They are apparently assuming that these faults will somehow be ‘worked out’ before or if it passes. My opinion continues to be that this bill is completely unacceptable and unworkable, so I wanted to go through each section of the bill to point out these flaws.
The Campaign for Safe Cosmetics, part of the Environmental Working Group, a non-governmental organization and lobbying group has been working for several years to pass a bill putting huge restrictions on cosmetics. Two years ago they introduced a bill in Colorado which I had the pleasure of testifying against. The sponsor of the Colorado bill, Rep. Diane Primavera decided that is was her personal care products that caused her breast cancer. Despite the fact that there is no medical evidence linking personal care products to breast cancer (or any cancer) she sponsored a bill to regulate these products because in her mind they cause breast cancer. I remind you of this just so you understand (or don’t) the thinking of the people behind these bills.
So lets look at the first section of the Safe cosmetics Act (HR2359), 611, about Definitions.
Anyone who determines the final formulation of a cosmetic is considered a manufacturer, fair enough. The tricky part comes with the definition of ingredient. This includes not just the ingredients you use to make the cosmetic itself (which is how ingredient is defined now) but those that are there because they are incorporated into the cosmetic as an ingredient of another cosmetic ingredient. By this I am assuming they mean solvents that some active ingredients come in. For instance, if you have an extract that is in glycerin or propylene glycol then the name of that solvent must also be listed. No problem with me here.
Processing aids are also ingredients, even if they do not appear in the final product. I’m not sure what they are getting at here but I wish they would clarify this part. One situation that comes to mind is in making soap. Soapmaking involves a chemical reaction between fats and lye (sodium hydroxide) so even though no sodium hydroxide is found in the finished soap it would still have to be on the label. This would indeed frighten many consumers.
Additional situations would be anything used in the actual synthesis of an ingredient. Pulling from my biochemistry background I know that proteins are hydrolyzed using strong acids such as Hydrochloric acid and then neutralized with Sodium Hydroxide. Alternatively pancreatic protease might be used. Amino acids such as glutamate are released during this process. So instead of ‘Hydrolyzed Wheat Protein’ on a label it might read, “wheat protein, pancreatic protease, hydrochloric acid, sodium hydroxide, peptides, alanine, arginine, asparagine, aspartic acid, cystein, glutamic acid, glutamine, glycine, histidine, isoleucine, leucine, lysine, methionine, phenylalanine, proline, serine, threonine, tryptophan, tyrosine, valine”. The last 20 being the amino acids that might be released as the protein is hydrolyzed. Does that labeling make your cosmetics safer?
Substances that are present by reason of having been added to a cosmetic during processing for their technical or functional effect are ingredients. Again, I wish they would clarify.
The components of a fragrance, flavor or preservative must be listed as ingredients. This may sound ok, but there are many proprietary secrets in fragrance that should be fair to remain proprietary. To list known allergens is one thing, but to list all the components of a fragrance is not helpful.
Any individual component of a petroleum-derived, animal-derived, or other ingredient that the Secretary deems an ingredient for purposes of this chapter must also be listed as ingredients. Again, this is like the previous bill where each component of an oil would need to be listed making ingredient lists unreadable. I don’t use animal oils in my products but I do use beeswax which according to Wikipedia is: palmitate, palmitoleate, hydroxypalmitate, oleate esters of long chain aliphatic alcohols, triacontanyl palmitate, cerotic acid and more. And of course this does not include any contaminants that might be in the beeswax. Keep in mind that you will need to test your beeswax for any contaminants that might be there because the next section deals with contaminants.
The term ‘ingredient’ also includes contaminants that are present above technically feasible detection levels which means 1 part per billion (or one microgram per liter)! And not only contaminants that might be in your ingredients such as lead, microbes, arsenic, and a variety of contaminants from soil and water, but also contaminants from a container that may appear over the shelf life of the product! So do we also have to do testing a year after manufacturing?
The bill defines a microbusiness as one that sells less than 2 million dollars per year. This includes most people I know but there are issues with this later.
The definition of Reasonable Certainty of No Harm – means that no harm will be caused to anyone! It includes not only the general population but vulnerable populations, low dose exposure, additive effects over time and cumulative exposure from all sources – including environmental! Now we certainly all formulate so that the general population will not be harmed but we cannot guarantee no harm to any vulnerable population. There are people with immune deficiencies, allergies, sensitivities etc.
The language here is just too broad. What does the Campaign for Safe Cosmetics Really want?? I know that they have been concerned about lead in lipstick and the dangers associated with 1, 4, dioxane as a byproduct of ethoxylation. Since lead is a naturally occurring contaminant of red pigments used in lipstick how about requiring lead testing of mined red pigments? And then letting EPA determine an allowable safe level for lead. If the amount of lead tested for is higher than that, I don’t want it listed on the label, I want it not used! Just ban lead at a given level in red pigments don’t make everybody pay the testing prices for ingredients that are not likely to contain lead! Lets have manufacturers of ethoxylated (peggylated) ingredients test for 1, 4, dioxane. I believe these manufacturing procedures are such that there is little to no contamination now, but it might be a good thing to be sure of. Let the EPA determine a safe level and if manufacturers find a level higher than that in these ingredients, forget about putting it on the label, get rid of it! I don’t want it. But everybody should not have to test for 1, 4, dioxane when that contaminant is not going to be there. Every grower of herbs should not have to test their herb extracts for whatever list of contaminants the Campaign for Safe Cosmetics (or I mean the ‘Secretary’) deems important.
I also wonder if the supporters of this bill such as Badger Balm think that by backing the bill they become exempt from listing ingredients in this way or testing for parts per billion of contaminants in their products. How much would this cost and how much would it increase the price of a tube of lip balm. I’m sure Badger Balm sells more lip balms than I do, so while my lip balm price might have to increase by $200 a tube, there’s may only have to increase by $50 a tube. But still, are Badger Balm customers willing to pay that price to insure that their lip balm does not contain 1 ppb of lead or arsenic even though there is more than that in the food they eat?
Here are other blogs that address these issues:
Here is where you can sign a petition against SCA http://www.thepetitionsite.com/1/no-2-sca-2011/
Thursday, July 21, 2011
I had a great weekend at the Lavender Association of Western Colorado's first annual Lavender Festival in Palisade Colorado, about a 4.5 hour drive for us over the mountains of Colorado. Speakers at this conference included Sarah Bader, a well known lavender grower at Stonegate Farm in Oregon; Barbara Lucks, an aromatherapist; Dr. Curtis Swift, from CSU Extension Service and myself, talking on Herbal Extracts and Distillates. All the talks were well attended and all were enthusiastic about lavender; and I for one learned alot! Katherine Kimbrough, president of the LAWC along with Dr. Swift have gone a long way in promoting lavender as a crop in Western Colorado and many growers have gravitated to it. Lavender loves the hot, dry conditions and even the high elevation of Colorado. On Sunday we visited some farms and saw some of the research going on such as looking at growing lavender under partial shade between rows of grapes or fruit trees; two other big crops in Western Colorado.
There were many vendors at the festival selling lots of lavender but also skin care, stone bird baths and more. We were selling our Colorado Aromatics brand of skin care too which did quite well. I came away with a few things including a lavender festival T-shirt, poster and lavender cookbook.
It was fun being in Western Colorado again; we lived there in 1997-98 and tried unsuccessfully to grow lavender. We enjoyed one of our favorites hikes in the National Monument to Devil's Kitchen over the weekend as well. I'm looking forward to next years Festival but also have thoughts of starting a Front Range Lavender Association since there are also many growers on my side of the mountain!
Monday, July 4, 2011
After spending a good several hours reading the new Safe Cosmetics Act of 2011 I see that the changes in this bill compared to 2010 are minimal. Here is my initial take on the bill which may or may not change depending on if some points get clarified or others appear as I reread it.
Again this bill includes in the definition of an ingredient any contaminants that are present at levels above technically feasible detection limits. As we all know, detection limits now are quite minute so any type of contaminant would be included here. This includes contaminants from the container as well. But what contaminants are they referring to here and why don’t they specify?
Ingredient safety can fall under just two categories: ‘Safe Without Limits’ and ‘Prohibited and Restricted’ This is misleading to both the consumer and the manufacturer since there is no such thing as a substance that is safe without limits. Even water can be lethal under certain conditions. It mentions ‘considerations’ in determining toxicity such as “is found to be present in the body through biomonitoring”. Does this mean that something is toxic if found in the body? I’m not sure I understand this. Many things are found in the body through biomonitoring including water. A second consideration is an ingredient that is suspected immunological toxicant. Is this another way of saying “allergen”? If so, does this mean that a substance that causes allergies will be prohibited? Anything can be an allergen and some common allergens are shea butter, almond butter, soy oil, milk, etc. Many herbs are also allergens. All in all, the bill has very poor definitions of toxicity and leaves most of it up to the FDA to determine in one year’s time! Wow, where is the FDA going to find those resources?
Labels must list ingredients in decreasing order of concentration. This is already required by the FDA so is redundant here. Contaminants however must also be listed. Knowing that water alone can contain any number of contaminants this immediately causes problems. Is testing of all our ingredients for contamination required?? Besides water, vegetable oils will contain contaminants, herbs grown in the backyard could contain contaminants. However, it does allow the FDA to determine such possible contaminants within one year’s time as well as determine requirements for testing and detection limits. If it is determined that cosmetic manufacturers are required to test for various contaminants this would add considerably to the cost of cosmetics. I am glad to see that ingredient lists are required on websites that sell cosmetics.
Some of the most dangerous contaminants of cosmetics are fungus and bacteria that can grow on nutrients in the product. Unfortunately, no specific mention of this is made. This is one area where consumers have suffered because of improperly made and improperly preserved products – in fact, this is the only area of documented harm to consumers from cosmetics.
Again, toxic is defined as a 1 in a million risk for adverse health effects. Toxic effects include allergic reactions and I challenge anyone to find any ingredient natural or synthetic that does not cause an allergic reaction in one in a million people.
Many things are not clear for instance “the safety standard results in exposure to the amount or concentration of an ingredient or cosmetic that is shown to produce no adverse health effects, incorporating a margin of safety of at least 1,000 and considering the impact of cumulative exposure from all sources (including environmental sources).” Does anyone know what this means and if so can you tell me? Does it mean 1000th of the determined toxic dose? If so, who determines this dose?
The bill goes on to require that the FDA issue guidance prescribing Good Manufacturing Practices. This is something that again, the FDA already has issued and so is redundant.
The bill requires manufacturers of cosmetics and ingredients to submit information including toxicological properties of each such ingredient or cosmetic. I’m not sure if this means the manufacturer who is buying ingredients is required to submit data to the FDA on those ingredients or not. Since the source of this data would probably be from the ingredient manufacturer this seems redundant. When this ingredient is purchased at the grocery store such as some small manufacturers do with vegetable oils, where is the toxicological data and contaminant data and how is this reported as an ingredient source? When the ingredient is an herb from the small manufacturer’s back yard where will this toxicological information come from or will this no longer be possible? I am still very concerned about the future of using natural ingredients in cosmetics with this bill. There are many herbs, oils, and natural extracts that have quite a data gap in toxicological studies.
I find it interesting that the ‘authoritative source’ of toxicology information includes the (A) Environmental Protection Agency,
(B) the International Agency for Research on Cancer,
(C) the National Toxicology Program,
(E) any other authoritative international, Federal, and State Entity, as determined by the Secretary.
I’m not sure what E means but I know there are pseudo science activists groups who may pose as an authority so that they can determine law. I would rather be sure toxicity was determined by peer reviewed scientific literature.
Some of the considerations in the bill for toxicity are also quite vague, for instance; if it is found in the body through biomonitoring. Does this imply that if something is found in the body it is toxic? I use water in my cosmetic formulas and I know it is found in the body. Another consideration is known or suspected immunological toxicant. Is an immunological toxicant the same thing as an allergen? Anyone can be allergic to anything but some of the more common allergens are shea butter, almond oil, soy oil, wheat and herbs. Will these ingredients be prohibited?
There is no definition of an ingredient manufacture. Many small companies use ingredients from their backyard; herbs and other botanicals. Are these companies required to have these ingredients tested to find what contaminants might be present and in what levels?
The thing that concerns me the most here though is that microbusinesses (those with sales less than $2 million) are not required to register with the FDA. Although I am glad to see that the bill waives a costly registration fee for these small companies (of which I am one) I don’t understand the lack of even registering with the FDA. Registration allows a link with the FDA so that companies can get timely information regarding ingredients and toxicity but just as important is that it allows consumers a way to report adverse effects that may occur due to cosmetic usage. By not registering, these microbusinesses are out of the communications link with the FDA. FDA will have no knowledge of the microbusiness’s existence, their activities, the products they manufacture or the functions and toxicities of those cosmetics. In the initial bill of 2010 small businesses rallied hard to be exempt from paying high registration and testing fees. However, we did not rally against registration.
If small companies are exempt from registering and having communication with the FDA are they exempt from submitting information on toxicological properties of ingredients and cosmetic product; exempt from “cease distribution” orders due to misbranding; exempt from use that causes serious adverse health effects; exempt from using contaminants and testing for these contaminants, exempt from good manufacturing practices issued by the FDA, etc? Having that link to the FDA could be valuable for a small business to learn the laws and requirements necessary especially when it comes to testing. This concerns me because many small cosmetics business owners just starting out do not have the knowledge base to draw from to know how to make safe cosmetics and have the potential to put something out there that is less than safe. And consumers should have a way to report possible adverse effects. It was the costs involved in the first version of this bill that had small business owners concerned, not having to register and be held accountable for their actions.
Should small businesses be just as responsible for their actions? Registration is important to keep open communication with the FDA.
Overall it is still a case of an activist group who knows nothing about the cosmetics business trying to make laws about things they do not understand. The bottom line still is that this bill will not make cosmetics safer.