Kayla has done a fabulous job breaking down the Safe Cosmetics Act of 2011. We are starting at the end of the bill and working our way to the beginning. Here is the post that breaks down SEC 615 Cosmetic and Ingredient Safety Information.
KEY: All Plain Text is directly from H.R. 2359 as it is written and Green is my commentary.
‘‘SEC. 615. COSMETIC AND INGREDIENT SAFETY INFORMATION.
3 ‘‘(a) REQUIRED SUBMISSION OF ALL SAFETY INFORMATION.—
‘‘(1) IN GENERAL.—Manufacturers of cosmetics and ingredients shall submit to the Secretary (in an electronic format that the Secretary shall determine) all data and information that the manufacturer can access regarding the safety of the—
‘‘(A) ingredients listed on the cosmetic label under section 613 for a cosmetic; and
Companies are being required to submit all the safety data for every single ingredient and every single component of every ingredient in all of their cosmetics to the FDA. It won’t matter if someone already submitted it and it already exists in a public database. I wondered how many employees this would take my little company to manage, but the reality is how many new Federal employees will this required that the FDA hire on the backs of taxpayers? It is astronomical how many employees this would require to manage. We saw a similarly unmanageable requirement with the 1099 law that was hidden in Obama’s new social health care bill. This will literally create billions of documents per month for the FDA to manage. Someone is not thinking here.
‘‘(B) cosmetic itself.
This is a backhanded way to say that all cosmetics will be required to do pre-market testing just like over-the-counter (OTC) drugs. These two words are the single fasted method of putting all those small businesses out of business before they ever hit the $2-$10 in sales required for reporting and fees purposes. This isn’t a case of big businesses trying to put small businesses out of business. This is the case of government not understanding the industry that they are attempting to write legislation for. So just because you don’t have to register or pay a fee does not mean you do not have to test every single product you make or package for sale. So it does not matter if you buy a bulk base or make it…you are required to have it tested. The only way you get out of that is to go directly with Private Labeling and then the onus falls on the company that you got the product from. Of course, they will pass that cost on to you in fees, so there is not escaping the cost for everyone here.
‘‘(2) REQUIRED INFORMATION.—The required data and information under paragraph (1) shall include, for each ingredient in a cosmetic and for the cosmetic, the following:
‘‘(A) Functions and uses.
‘‘(B) Data and information on the physical, chemical, and toxicological properties of each such ingredient or cosmetic.
‘‘(C) Exposure and fate information.
‘‘(D) Results of all safety tests that the manufacturer can access or has conducted.
‘‘(E) Any other information used to substantiate the safety of such ingredient and cosmetic.
All this data already exists on cosmetic chemicals. All created cosmetic ingredients are carefully studied, researched and tested. When I consider a new surfactant I read over all the environmental, physical, chemical, toxicological, carcinogen, teratogen, mutagen and so many more results prior to making a decision to even bring the ingredient into the lab for research and development. This information does not exist for the majority of natural ingredients. So you would be required to do the testing on all your ingredients or convince the manufacturers of these ingredients to provide this data and since much of the worlds botanical ingredient supply comes from outside the USA there is no way to know for certain that the information they are supplying is accurate. So I can see the FDA or EPA requiring verification from a registered lab in the US which will fall on you before you can use any such ingredients in your products.
‘‘(A) INITIAL SUBMISSION.—A manufacturer shall submit the data and information required under paragraph (1)—
‘‘(i) in the case of an ingredient or cosmetic which is marketed for sale in interstate commerce on or before the date of the enactment of this subchapter, not later than 1 year after such date; and
‘‘(ii) in the case of an ingredient or cosmetic which is not marketed for sale on or before such date—
‘‘(I) not later than the end of the 14-month period beginning on the date of the enactment of this subchapter; or
‘‘(II) if the ingredient or cosmetic is first marketed for sale in interstate commerce after the end of the period described in subclause (I), not later than 60 days after the date on which such ingredient or cosmetic is first marketed for sale.
‘‘(B) UPDATES.— mt 6201 C:\DOCUMENTS AND
‘‘(i) IN GENERAL.—Subject to clause
(ii), a manufacturer shall update the data and information submitted under subparagraph (A) annually.
This is a significant positive change from the previous draft of the Safe Cosmetics Act in which they required that you update all this information every single time you changed ingredients or suppliers.
‘‘(ii) ADVERSE HEALTH EFFECTS.—In the case of information related to an adverse health effect that is suspected to be caused by an ingredient or a cosmetic, a manufacturer shall update the information not later than 60 days after receiving such information.
There are no set perimeters of what “information related to an adverse health effect that is suspected to be caused by an ingredient or a cosmetic” actually means. Does this information mean an internet rumor? Or does it mean an unscientific suspicion of an ingredient or cosmetic causing an adverse reaction? I know that actually sounds absurd to wonder if rumors and a lack of science could trigger such a thing, but straight from the horse mouth here is a recording of one of the founders of the Campaign for Safe Cosmetics under testimony.
Susan Roll, a founding member of the CFSC testified before the Colorado House Committee, “I’ll tell you I’m not a scientist. I’m actually a social worker so I’m reading what your reading and also trying to make some ‘um’ educated guesses about it, ‘um’ when we have chemicals that cause tumors in rats I think that it is okay to say we don’t want those chemicals in consumer products. Do we have that they are causing mammomary tumors in humans. No we just don’t have that yet. We are not that far with the science….I wish I could say more. I wish I knew more of the science. I wish we had more science…I would just say that I think we have enough of the science that we need to make some steps towards safety.”
She continued, “I wish I could say that there was an abundance of science linking this…we have some science…there is a little bit of science…we don’t have an abundance of science. I wish we had it.”
When asked if she had a list of what ingredients were actually added to a cosmetic versus what is naturally occuring she answered, “I don’t know.”
“We can’t wait for the science..if we wait for the “good” science we are going to be sick.” Susan Roll, Founding member of the Campaign for Safe Cosmetics.
Here is a key point. They say they can’t wait for the science because if we wait for it then we are going to be sick. Cosmetics have been in use for multiple generations, hundreds of years. Manufacturers have employed hundreds of thousands of employees, billions of men and women have washed their hair and used personal care products for hundreds of years and there is not a single documented scientific case of anyone getting sick from their cosmetics despite the special interests groups saying otherwise.
Skin sensitivities, reactions and allergies, sure. But no one has gotten sick, no one is going to get sick. If anything, cosmetics have helped from getting sick by providing cleansers and antibacterial products that have extended our lifespan, but the EWG and the CFSC want us to believe differently and they have convinced lawmakers that we need bigger government, more regulation, fees and obstacles to business in order to protect the American people from the bogie man.
‘‘(4) SUPPLIER INFORMATION.—
‘‘(A) USE OF SUPPLIER INFORMATION.—
In order to meet the requirements of paragraph
(1) with respect to an ingredient, a manufacturer may submit safety data and information provided by the supplier of the ingredient.
This is great until you start talking about a fair trade shea butter from a small village in Africa that can’t provide me with the safety data on shea butter. Or the Northwest farmer that sells their lavender essential oil or the certified organic farmer selling the herbs that they grow. Again, safety data is readily available on cosmetic chemicals – it is the natural botanicals that won’t have the adequate paper trail to use in cosmetics and oddly, they don’t need this kind of testing to provide there goods to the food market. A certified organic farmer selling organic sunflower can sell his product into the food chain but that same farmer could not sell his product into the cosmetic ingredient world. Does anyone see a problem here?
‘‘(B) SUPPLIER PROVISION OF INFORMATION.—If a manufacturer requests that a supplier of an ingredient provide to such manufacturer any of the data and information described under paragraph (2), such supplier shall provide such data and information to such manufacturer not later than 90 days after receiving such request.
‘‘(1) INITIAL PUBLICATION.—Not later than 1 year after the date of the enactment of this subchapter, the Secretary shall publish a comprehensive, publicly accessible database containing all nonconfidential information (as such term is used under section 623) submitted under subsection (a)(1).
Imagining, where exactly the FDA will be housing all those new employees to make this happen within the first year and how fees will exactly cover the cost of them and their shiny new building. Rest assured, the current barely $4 million dollar budget for the Cosmetic Division of the FDA will have to grow by at least 30 times to begin to manage this new “safer” way.
‘‘(2) UPDATES.—Not later than 90 days after the Secretary receives new or updated information under subsection (a)(3)(B), the Secretary shall update the database under paragraph
This will be one mighty busy Secretary working way faster than the speed of government which means, layers of management, higher costs and consumers will pay in the end with higher prices, less options when companies go out of business and longer unemployement lines as they fight for a job that once existed before the government got involved. I am convinced that the government things the people are too dumb to do the right thing by themselves.
(1) with such information.
‘‘(c) REVIEW AND EVALUATION OF INFORMATION.—
‘‘(1) IN GENERAL.—Based on the data and information submitted under subsection (a)(1), available from an authoritative source (as such term is defined in paragraph (3), including data described under section 627(b)), and such other information as the Secretary may have available, the Secretary shall review and evaluate the safety of cosmetics and ingredients of cosmetics that are marketed in interstate commerce.
What qualifications will this Secretary have? It will need to be someone more qualified than all the expert PhD Chemist, Biologist, Scientits and Doctors on the CIR Expert Panel today because their qualifications have never been enough for EWG, the Campaign for Safe Cosmetics and the sponsors of The Safe Cosmetics Act.
If you find a Secretary that is more qualified than this group let me know:
Wilma F. Bergfeld, M.D., F.A.C.P., Head of Clinical Research and Dermatopathology, The Cleveland Clinic Foundation
Donald V. Belsito, M.D., Clinical Professor, Medicine (Dermatology), University of Missouri
Ronald A. Hill, Ph.D., Associate Professor of Medicinal Chemistry, Department of Basic Pharmaceutical Sciences, College of Pharmacy, The University of Louisiana at Monroe
Curtis D. Klaassen, Ph.D., University Distinguished Professor and Chair, Department of Pharmacology, Toxicology, and Therapeutics, School of Medicine, University of Kansas Medical Center
Daniel C. Liebler, Ph.D., Director, Jim Ayers Institute for Precancer Detection and Diagnosis, Ingram Professor of Cancer Research, Professor of Biochemistry, Pharmacology and Biomedical Informatics, Vanderbilt University School of Medicine
James G. Marks, Jr., M.D., Professor of Dermatology, Chairman of the Department of Dermatology, Pennsylvania State University College of Medicine
Ronald C. Shank, Ph.D., Professor and Chair, Department of Community and Environmental Medicine, Director, Environmental Toxicology Program, University of California
Thomas J. Slaga, Ph.D., Department of Pharmacology, University of Texas Health Science Center
Paul W. Snyder, D.V.M., Ph.D., School of Veterinary Medicine, Department of Veterinary Patholobiology, Purdue University
I, personally, would rather an expert panel of qualified doctors and scientist to evaluate the safety of cosmetic ingredients than a government appointed Secretary or a politically biased trade organization like the EWG/CFSC. Call me crazy…and they will.
‘‘(2) CONSIDERATION OF NANOMATERIALS.—
The Secretary shall—
‘‘(A) monitor developments in the scientific understanding from any adverse health effects related to the use of nanotechnology in the formulation of cosmetic (including progress in the standardization of testing methods and specific size definitions for nanomaterials); and
‘‘(B) consider scale specific hazard properties of ingredients when reviewing and evaluating the safety of cosmetics and ingredients under paragraph (1).
Not my specialty so I’m going to leave this one up to someone who specializes in nanomaterials.
‘‘(3) AUTHORITATIVE SOURCE DEFINED.—For purposes of this paragraph, the term ‘authoritative source’ means—
‘‘(A) the Environmental Protection Agency;
‘‘(B) the International Agency for Research on Cancer;
‘‘(C) the National Toxicity Program through the National Institutes of Health;
‘‘(D) the California Environmental Protection Agency; and
‘‘(E) any other authoritative international, Federal, and State entity, as determined by the Secretary.
I’m not surprised that they didn’t list CIR Expert Panel that is the one and only authoritative source of reviewing the safety of cosmetics ingredients among others, but I am disappointed. They also didn’t list the American Cancer Society, The National Cancer Institute or the FDA as authoritative sources either. I noticed this because all three of those organizations came out with a statement that parabens do not cause cancer and that story does not fit with the agenda of the CFSC and EWG. I am proud of the sponsors of this bill for resisting the urge to add the CFSC or EWG as sources, but it is clear in their statements and press releases that they have been counseled by them and are regurgitating CFSC/EWG talking points.
The Environmental Protection Agency (EPA) is an interesting choice of authoritative sources for information on the safety of cosmetics. Let me give you a good example of one product that the EPA would take issue with in cosmetics. Green Eye Shadow would be an issue because the EPA has the main ingredient of it listed as “likely to be a carcinogenic to humans.” Of course the EPA was talking about Chromic acid in a mist, but it is on the list of likely carcinogenic to humans so it would likely be banned, despite the fact that the ingredient is completely safe in cosmetics. As a matter of fact, eye lid cancer is extremely rare and is more common in men (19.6 cases per every 100,000 men) than in women (13.3 cases per every 100,000 women) and is attributed to the sun and not green eye shadow. If chromic acid was indeed a cosmetic hazard that would give us cancer the cases of eye lid cancer in women would be much higher.
In California they believe that everything causes cancer so we can expect either everything to be banned or little signed to pop up all over our cosmetics all over the world like they do in California. I think the people of California stopped noticing the Prop 65 signs long long ago that say, “WARNING: This product contains chemicals known to the State of California to cause cancer and birth defects or other reproductive harm.” This is exactly what the sponsors of this bill, the EWG/CFSC and groups like them want to happen.