Senator Kennedy’s Remarks on the Cosmetics Industry
STATEMENT OF SENATOR EDWARD M. KENNEDY
FDA REFORM AND COSMETIC PREEMPTION
Mr. President, the most egregious and unjustified provision in this bill would cripple consumer protections by effectively pre-empting state regulation of over-the-counter drugs and cosmetics.
I want to note for the record that these provisions were not included in the Chairman's original mark. They were not the subject of significant hearings. They have no place in a bill whose primary purpose is to reauthorize the Prescription Drug User Fee Act.
If the Congress was in earnest about addressing over-the-counter drug and cosmetic regulation, it would have undertaken a serious and detailed inquiry into the regulatory structure and authorities which assure that consumers are adequately protected before remotely contemplating the possibility of preempting active and essential state protections.
Pre-emption of cosmetic regulation is especially outrageous and shows a callous disregard for the health of American women and, in many cases, of the children they may be carrying in their wombs.
Cosmetics are broadly used by Americans-- far more broadly than most prescription drugs, medical devices, or biologic products.
Whether the product in question is hair spray, shampoo, lipstick, or baby powder, or suntan lotion, and soap or toothpaste, every American routinely assumes that the product is safe.
But this confidence is too often unjustified--because Federal oversight of the $20 billion cosmetics industry is so limited. The basic Federal law regulating cosmetics has not been updated since 1938. The FDA has less than 30 employees overseeing this huge industry.
The FDA has no authority to require manufacturers to register their plants and products.
It cannot require manufacturers to file data on the ingredients in their products.
It cannot compel manufacturers to file reports on cosmetic-related industries.
It cannot require that products be tested for safety or that the results of safety testing be made available to the agency.
It does not have the right of access to manufacturersą records. It cannot even require recall of a product.
A study by the General Accounting Office reported that more than 125 ingredients used in cosmetics are suspected of causing cancer.
Twenty cosmetic ingredients may cause adverse effects of the nervous system, including headaches, drowsiness, and convulsions.
Twenty cosmetic ingredients are suspected of causing birth defects.
The GAO concluded that "cosmetics are being marketed in the United States which may pose a serious hazard to the public." GAO also found that additional Federal authority is necessary to adequately protect the public.
Mr. President, the cosmetics industry wants the public to believe that no effective regulation is necessary of desirable. They are masters of the slick ad and expensive public relations campaign. But all the glamorous pictures in the world cannot obscure the facts: this is an industry that is under-regulated and its products are too often hazardous.
. . . Beauty parlor employees are particularly vulnerable to asthma and other chronic diseases that result from exposure to chemicals in the products they use. Yet today, FDA cannot require labeling on products used in beauty parlors. In fact, for every one million cosmetic products purchased, there are more than 200 visits to the doctor to treat cosmetic-caused illnesses.
But these severe reactions may be only the tip of the iceberg. Long-term illnesses ranging from cancer to birth defects may not be linked to their underlying cosmetic-related causes. As the GAO points out, "Available estimates of cosmetic-related injuries do not accurately reflect the extent to which consumers are exposed to toxic cosmetic products and ingredients.
Because symptoms of chronic toxic effects may not occur until months or years after exposure, injury estimates generally account for only acute toxic effects."
In light of the limited Federal authority to protect the public against these hazards and even more limited Federal resources devoted to these problems, you would think that the Congress would want to encourage states to fill the regulatory vacuum.
But, instead, this bill entirely bars states from regulating packaging and labeling and places severe limits on their ability to establish other forms of regulation. In fact, the language is so extreme that states are barred from establishing "any requirement relating to public information or any other form of public communication relating to the safety and effectiveness of a drug or cosmetic."
What does this mean for consumers? No warning labels. No information that a product contains carcinogens or can cause severe allergic reactions. No "keep out of reach of children" labels. No notification that a product has been recalled because it is dangerous or adulterated.
The cosmetic industry seems to believe that, for purchasers of their products, ignorance should be bliss.
Friends, let's replace these debilitating products with HEALTH GIVING PRODUCTS. Go right now to YOUR HEALTH AND WELLNESS CENTER
HAVE YOU FALLEN FOR THESE COMMON MYTHS?
MYTH #1: ALBUMIN
MYTH: The chief ingredient in artificial face lifts. It is being touted as a wrinkle treatment.
FACT: The last time a serious case concerning consumer claims came up was in the 1960's. Both of these products were temporary wrinkle removers. The formulas contained a bovine serum albumin, which, when dried, formed a film over wrinkles, thus making wrinkles less obvious (Brumberg).
MYTH #2: BENTONITE
MYTH: This is a naturally occurring mineral used in facial masks. It differs from true clay, kaolin, in that when it is mixed with liquid it forms a gel. It can have sharp edges that scratch the skin. Most bentonites can be drying to the skin (Hampton)
FACT: Bentonite is used in formulations and masks. It forms films that are gas impermeable, effectively trapping toxins and CO2 in the skin that need to vent and escape, suffocating the skin by shutting out the vitally needed oxygen.
MYTH #3: BIOTIN (Vitamin H)
MYTH: An exotic ingredient promoted as being necessary and beneficial for skin and hair care.
FACT: A deficiency of this vitamin has been associated with greasy scalps and baldness in rats and other experimental animals. Fur-bearing animals, however, have a very different hair growth from human beings. Biotin deficiency in man is extremely rare. Biotin is considered a worthless additive in cosmetic products (Chase). The molecular size of Biotin is too large to penetrate the skin.
MYTH #4: COLLAGEN
MYTH: Some companies imply that collagen can support the skin's own collagen network. Others claim it can be absorbed to moisturize skin.
FACT: The Collagen in creams and lotions acts like any protein ingredient in that it merely provides a coating on the skin's surface (Chase). The Collagen molecule cannot penetrate your skin because it is much too large to be absorbed by the epidermis (Brumberg)....Collagen, elastin, or other proteins, and amino acids cannot get into the skin through topical application. The
molecules of these substances are simply too large to penetrate your skin (Novick). Cosmetics manufacturers have heralded it as a new wonder ingredient, but according to medical experts, it cannot affect the skin's own collagen when applied topically (Winter).
MYTH #5: ELASTIN (Not cross-linked Elastin)
MYTH: Another ingredient promoted as being beneficial for skin and hair care.
FACT: Elastin is included in some skin care products, but nowhere near as much as collagen. It too cannot be absorbed by the epidermis (Brumberg). In a cosmetic product, they cannot restore tone to skin. When used in such products as moisturizers, they act like all other commercial proteins by forming a film that holds moisture (Chase).
MYTH #6: GLYCERIN
MYTH: Promoted as being a beneficial humectant.
FACT: This is a clear, syrupy liquid made by chemically combining water and fat. The water splits the fat into smaller components glycerol and fatty acids. It improves the spreading qualities of creams and lotions and prevents them from losing water through evaporation.
Glycerin, however, has a tendency to draw water out of the skin and so can make dry skin dryer (Chase). A solvent, humectant, and emollient in many cosmetics, it absorbs moisture from the air and therefore helps keep moisture in creams and other products, even if the consumer leaves the cap off the container (Winter). SEE HUMECTANTS.
Unless the humidity of the air is over 65%, Glycerin will pull the moisture out of the skin, drying you from the inside out.
MYTH #7: HUMECTANTS
MYTH: Ingredients that draw moisture to and aid in moisturizing skin.
FACT: Most moisturizers contain humectants that act as water attractors, they actually pull moisture out of your skin (Valmy). The problem with humectants, including propylene glycol and glycerin is that although they are most effective when you are in areas with high humidity, if you are going to be in an extremely low humidity atmosphere, such as in an airplane or even a dry room, they can actually take moisture from your skin.
Here's why: Humectants are on the search for moisture that can be absorbed from the environment. If the environment is so drying that there is no moisture to be had, they will get it from the next best source - your skin. When this happens, the ingredient, which is supposed to help your skin retain moisture, instead does the opposite (Brumberg). A substance used to preserve the moisture content of materials, especially in hand creams and lotions (Winter).
SEE GLYCERIN, PROPYLENE GLYCOL. These are natural or synthetic compounds that are used to prevent water loss and drying of the skin. They also form a smooth feel to cosmetic lotions. Some are safe, some aren't.
MYTH #8: HYPOALLERGENIC
MYTH: A product to which you are not allergic.
FACT: Hypoallergenic means "less than" and the word hypoallergenic tells the consumer that
the manufacturer believes the product has fewer allergens than other products. There are no federal regulations defining allergens, nor are there any guidelines. So "hypoallergenic" has little meaning (Brumberg).
MYTH #9: KAOLIN
MYTH: A very fine natural clay originally from Mt. Kaolin in China, hence the name.
FACT:Quite drying and may be dehydrating to the skin. It also may be contaminated with impurities (Hampton). It is used in formulations and masks, forms films that are gas impermeable. It effectively traps toxins and CO2 in the skin that need to vent and escape, then suffocates the skin by shutting out the vitally needed oxygen.
MYTH #10: LANOLIN
MYTH: A beneficial moisturizer.
FACT: Advertisers have found that the words "contains Lanolin" help to sell a product and have promoted it as being able to "penetrate the skin better than other oils," although there is little scientific proof of this. Lanolin has been found to be a common skin sensitizer causing allergic contact skin rashes (Winter). Lanolin usually contains pesticides used on sheep and wool.
MYTH #11: LAURAMIDE DEA
Lauramide DEA is a partly natural, partly synthetic chemical used to build lather and thicken various cosmetic products, is also used in dishwashing detergents for its grease-cutting ability. It can be drying to the hair, cause skin and scalp itching, and allergic reactions (Hampton).
MYTH #12: LIPOSOMES
MYTH: Nanosphenes or Micellization - Ultimate anti-aging agent.
Liposomes are one of the newest entries in the "fountain of youth" arena. According to one recent theory, cellular aging involves the edification of skin cell membranes. Liposomes, which are tiny bags of fat and thymus gland extract suspended in a gel, are supposed to merge with your aging skin cells, revive them, and add moisture to them.
Current scientific understanding does not support the rigidification theory. The cell membranes of young and old persons are alike. As a result, it is likely that liposome-containing moisturizers represent nothing more than another expensive allure (Novick).
MYTH #13: MINERAL OIL
MYTH: A beneficial moisturizer.
FACT: Mineral oil is an oil manufactured from crude oil. It is a mixture of liquid hydrocarbons separated from petroleum. Dr. T. G. Randolph, an allergist, has found that this and many other cosmetic chemicals cause petrochemical hypersensitivity.
The allergic reactions can become quite serious in time, leading to arthritis, migraine, hyperkinesis, epilepsy, and diabetes. Taken internally, Mineral Oil binds the fat soluble Vitamins A, D and E and carries them unabsorbed out of the body.
Although little mineral oil is able to penetrate the skin, this tendency is so dangerous that Adelle Davis in Let's Eat Right to Keep Fit says that she "personally would be afraid to use this oil even in baby oils, cold creams, and other cosmetics"
(New York: Harcourt, Brace, Jovanovich, 1970, p. 46).
The fact that Mineral Oil does not penetrate the skin well makes it inappropriate for use in an absorption base in a skin cream of any kind. In fact, mineral oil-containing cosmetics can produce symptoms similar to dry skin by inhibitng the natural moisturizing factor of your skin.
Petrolatum, Paraffin or Paraffin oil and Propylene Glycol are other common cosmetic forms of Mineral Oil. Toxic. Avoid them (Hampton). Has tendency to dissolve the skin's own natural oil and thereby increase dehydration. Mineral oils have been found to be probably the single greatest cause of breakouts in women who use a new product (Chase). Serious carcinogens are commonly found in Mineral Oil.
MYTH #14: NATURAL COSMETICS
MYTH: No artificial ingredients. Pure or from nature.
FACT:There is no legal definition for "natural" which is why you see it everywhere. A chemist's definition of organic simply requires that the molecule contain carbon (Hampton). In cosmetic terminology, the term "natural" usually means anything the manufacturer wishes. There are no legal boundaries for the term.
There are no guidelines surrounding what can or cannot be inside a "natural" product. Most cosmetics called "natural" still contain preservatives, coloring agents, and all the other things you can think of that sound very unnatural (Begoun).
MYTH #15: pH
The term pH stands for the power of the hydrogen atom. Skin and hair do not have a pH. A scale from 0 to 14 is used to measure acidity and alkalinity of solutions, and pH 7.0 is neutral. Acidity increases as the pH number decreases, and alkalinity increases as the pH number increases.
Usually the pH of a cosmetic will not change the natural pH of the hair or skin because the hair and skin contain keratin, fatty acids, and other substances that adjust the pH levels with which they come into contact.
As long as a pH is not unusually high or low there is no problem - pH wise - with a cosmetic. Naturally the high pH of cold wave solutions and hair straighteners can damage the hair and skin, but even this is rare providing a proper conditioner or moisturizer is used after such pH alterations. There is no such thing as a "pH balanced" product because a product's pH will drift during shelf life and alter when applied to the hair and skin.
A product's pH is not a danger to the body, but the synthetic chemicals used n cosmetics often to alter the pH to please the ones who fall for the "pH balanced" story are (Hampton).
MYTH #16: PLACENTAL EXTRACT
MYTH: Promoted for rejuvenating and nourishing aging skin.
FACT: Placental Extracts are another big hype. In moisturizers, these ingredients allegedly supplement the vitamin and hormone content. The manufacturers of these products take advantage of the belief that since the placenta nourishes the developing embryo, an extract of it can nourish and rejuvenate aging skin.
Placental Extracts can do no such thing (Novick). The value of a cosmetic depends on its active ingredients and with cosmetics containing "placental extract" it is impossible to tell what you are getting (Chase). Temporary means temporary, but it's still nice every now and then, to be able to get a smoother look.
Some ingredients include sodium silicate, bovine serum albumin, and human placental protein (Bromberg). Worst yet many may come from aborted fetuses or might not be properly sanitized.
MYTH #17: SODIUM CHLORIDE (Salt - NaCl)
Sodium cloride is used to increase the viscosity in some cosmetics. It can cause eye and skin irritation if used in too high concentrations (Hampton). Its usually used to make a cheap, watery
consistency product look thick and rich instead.
MYTH #18: SODIUM LAURETH SULFATE (SLES)
Chemical name: Sodium Lauryl "ether" Sulfate An ether chain is added to SLS, and is called a premium agent in cleansers and shampoos. In reality it is very inexpensive, but thickens when salt is added in the formula and produces high levels of foam to give the concentrated illusion it is thick, rich, and expensive. Used as a wetting agent in the textile industry, SLES is irritating to scalp and may cause hair loss (Wright). SEE SODIUM LAURYL SULFATE.
MYTH #19: SODIUM LAURYL SULFATE (SLS)
No one making any claims about this one - and for good reason
We examined an anionic detergent, Sodium Lauryl Sulfate, which is commonly found in soaps and shampoos, that showed penetration into the eyes, as well as systemic tissues (brain, heart, liver, etc.).
SLS also showed long-term retention in tissues. Because SLS and related substances are widely used in many populations on a daily basis in soaps and shampoos, there is an immediate concern relating to the penetration of these chemicals into the eyes and other tissues.
This is especially important in infants, where considerable growth is occurring, because a much greater uptake occurs by tissues of younger eyes, and SLS changes the amounts of some proteins in cells from eye tissues.
Tissues of young eyes may be more susceptible to alternation by SLS (Green). SLS forms nitrates, a possible carcinogen, when used in shampoos and cleansers containing nitrogen-based ingredients. These nitrates can enter the blood stream in large numbers from shampooing, bubble baths, bath, and shower gels and facial cleansers.
These snthetic substances are used in shampoos for their detergent and foam-building abilities. They can cause eye irritations, skin rashes, hair loss, scalp scurf similar to dandruff, and allergic reactions. They are frequently disguised in pseudo-natural cosmetics with the parenthetic explanation "comes from coconut."
Let's save the coconut from defamation of character and NOT use products with sodium lauryl sulfate, etc.! (Hampton) Dr. David H. Fine, the chemist who uncovered NDELA contamination in cosmetics, estimates that a person would be applying 50 to 100 micrograms of nitrosamine to the skin each time he or she used a nitrosamine-contaminated cosmetic.
By comparison, a person consuming sodium nitrite-preserved bacon is exposed to less than 1 microgram of nitrosamine (Hampton).
MYTH #20: TYROSINE
MYTH: An amino acid that can help you attain a deep, dark tan.
FACT: Some tanning accelerator lotions do contain Tyrosine. You can be sure they'll advertise it if they do an amino acid that's essential to melanization (darkening) of the skin. Melanization is an internal process and spreading lotion on the skin's surface does nothing to fuel it.
Similar logic would have us trying to rub food through our pores to satisfy hunger (Matarasso). Manufacturers claims for the efficacy of tan accelerators remain unproven; a recent, independent study of these products failed to demonstrate any augmentation of tanning.
Indeed, it is doubtful that sufficient amounts of tyrosine can penetrate to the level of the skin where it could enhance melanin production (Novick).
MYTH #21: AHA's (Alpha Hydroxy Acids, i.e.: Glycolic, Lactic and Others)
MYTH: Exfoliates the skin to remove wrinkles and expose young skin.
FACT: Removing the outer layer of the skin exposes the young skin to the harsh aging and damaging environmental agents. Use of AHA's could make you age much faster. You could look better today but may not be such a pretty sight in 10 years. Your outer layer of skin is your first and most important line of defense. Everything should be done to make it healthy and keep it NOT LOSE IT.
The FDA reported their deep concern about exfoliating the stratum corneum, and the aging and health risks associated with this potentially dangerous procedure. (May 1994)
Friends, let's replace these debilitating products with HEALTH GIVING PRODUCTS.
Go right now to YOUR HEALTH AND WELLNESS CENTER
Begoin, Paula - Blue Eyeshadow Should Still Be Legal, Beginning Press, 1988
Brumberg, Elaine - Take Care of Your Skin, Harper & Row Publishers, Inc.1989
Chase, Deborah - The New Medically-Based No-Nonsense Beauty Book, Henry Holt and Co., 1989
Friend, Tim - "USA Today," 4-10-90
Green, Dr. Keith - Detergent Penetration Into Young and Adult Eyes Department of Opthamology, Medical College of GA, Augusta, GA
Hampton, Aubrey - Dictionary of Cosmetic Ingredients Organica Press
Metarasso, Dr. Seth L. - "Faking It" - Muscle & Fitness, November, 1990
Novick, Dr. Nelson Lee - Super Skin, Clarkston, N. Potter, Inc., Publishers, 1988
Valmy, Christine & Vons Ulrich, Elise - "Mid-Air Skin Care" - Entrepreneurial Woman, July/August 1990
Winter, Ruth - A Consumer's Dictionary of Cosmetic Ingredients, Crown Publishers, Inc. 1989P
Wright, Camille S. - Shampoo Report, Images International, Inc., 1989
This is a list of multi-source references and documents, such as Material Safety Data Sheets, that document the harmful ingredient presence:
Different industries' MSDS Sheets on SLS and Propylene Glycol *
Article on SLS and aphthous ulcers (Univ of Oso, Norway) *
Article on Dermatological Barrier (VA Medical Center; Univ of CA School of Medicine) *
Article "Final Report on Safety Assessment of SLS" (Journal of American College of Toxicology) *
Article on Molecular Basis of Skin Irritation (Unilever Research Lab, England) *
Newspaper article "City Hairstylist Sheds Light on Beauty Dangers" (Richmond Times) *
Article on SLS induced cutaneous irritation (Univ of CA Medical School) *
Article on Skin irritability to SLS... (Clinical & Experimental Dermatology) *
Newspaper article on Shampoo Linked to Decline in Sperm Quality (The Calgary Sun) *
Article on Cutaneous Reaction to Propylene Glycol (The Energy Times) *
Article "Doctors Worry: Is Your Baby Safe?" (New Health & Longevity) *
Article "Good News for Kids who Hate Baths' (Wall Street Journal) *
Article on detergent penetration in eyes...(Research to Prevent Blindness Science Writers Seminar) *
Report on propylene glycol (Chemical Business) *
Article on Cosmetics Overview (Zia Great Face quarterly newsletter) *
Report on AHAs (Cosmetics & Toiletries Magazine) *
Special report on Collagens & contact dermatitis from propylene glycol (Chemical Week) *
Newspaper article "Beauty Creams only Skin Deep" (Denver Post) *
TV investigative report on harmful ingredients in cosmetics (Channel 4 News) *
Newspaper article on Cosmetics Proposal Draws Fire - Sen T.Kennedy (Boston Globe) *
Newspaper article on Chromosome Damage (New York Times HEALTH) *
Article on Stearic Acid inhibiting T-Cell Response (Thorne Research Dist. LTD) *
Article on environmental estrogens aging effects (AP News in Deseret News) *
Article on Dioxins in Shampoos, skin creams... (Science News) *
Article on Fluoride Causes Cancer (Spotlight reprint) *
Articles on Cancer link to Mouthwashes (Wall St. Jounal, Nat'l Cancer Institute, NY Univ College of Dentistry, NIH) *
Articles on adverse effects of fingernail cosmetics (NY Univ Graduate School)
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