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.
Thank you for sharing this information, Cindy. I admit that I haven't read through the current bill, so I was curious to see what had changed from last year. Very interesting!
I read the full text and agree with your assessment. It is a poorly written bill that makes the FDA and the Secretary responsible for accumulating huge volumes of information in a tiny period of time from unknown or possibly untrustworthy sources.
The bill does allow microbusinesses to not be registered, and you're correct in your further assumptions that these businesses will not need to follow the law at all.
I think there are some serious problems with the reporting of health issues section of the bill too, which might conflict with HIPA regulations since it demands the name of the person(s) afflicted by the offending substance.
As the bill is written I don't think there is a single ingredient the cosmetics industry could "safely" use by its guidelines.
I found your post when I Binged for Safe Cosmetics Act of 2010. Thank you for your astute evaluation. Most informative!
I only wish your blog page had something about you and the name of your business. Or is it Sagescript Institute and Colorado Aromatics? I also live in Boulder and have a small organic skin care company. – Pam
Amy and Bud, thanks for reading. I'm hoping that once the legislators have these problems pointed out to them that the bill will be dropped.
yes, my business name is Sagescript Institute. I do cosmetic microbiology, formulations and product development consulting. I grow herbs on my farm and make botanical extracts for sale as well. My own product line is called Colorado Aromatics and I sometimes do the Boulder Market – I'll be there this Sat, come by and introduce yourself.