(These extracts from Senator Edward Kennedy's speeches can be found in full in the book by Dr Samuel Epstein,
Unreasonable Risk)
In 1988, our colleague, then-Congressman Wyden held landmark hearings looking at the safety of cosmetics. The industry gave his subcommittee a list of 2,983 chemicals used in cosmetics. The National Institute of Occupational Safety and Health at NIH analyzed those 2,983 chemicals and found that 884 cosmetic ingredients had been reported to the Government as toxic substances. We've known for ten years that a third of cosmetic chemicals are toxic but we've done nothing to strengthen Federal consumer protections-- instead, we'd rather weaken State consumer protections.
Pre-emption of cosmetic regulation is outrageous and shows a callous disregard for the health of American women, especially those who are pregnant. It shows a callous disregard for the likelihood of birth defects in newborn children. Cosmetics are broadly used--far more broadly than most prescription drugs, medical devices, or biologic products. In fact, cosmetics include: baby powder, bubble bath, toothpaste, deodorants, shaving creams, hair tonics, hairsprays, colognes, suntan lotions, mouthwashes, douches, baby shampoo, hand lotion, hair dyes, deodorants, moisturizing cream, as well as many other products
Whether the issue is hair spray, or shampoo, or lipstick, or baby powder, suntan lotion, soap and toothpaste, Americans assume that the products they use are safe.
But this confidence is too often unjustified--because Federal oversight of this $20 billion industry today is extremely limited. The basic Federal law regulating cosmetics has not been updated since 1938. The FDA has less than 30 employees overseeing this huge industry--and only two employees dealing with the critical issues of packaging, labelling, and consumer warnings. 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 injuries. 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 manufacturers' records. It cannot require recall of a product.
In the Federal Food Drug and Cosmetic Act there are 126 pages devoted to the regulation of drugs and devices. 55 pages are devoted to foods regulation. A full 8 pages of the Act is dedicated to definitions. But less than 2 pages are devoted to cosmetic regulation.
In 1938, there was no requirement that industry show safety of drugs, medical devices, food additives, or cosmetics before they were marketed. Today, the public demands higher standards of protection, and they have been established for drugs, for medical devices, and for food additives--but not for cosmetics.
A study by the respected, nonpartisan General Accounting Office reported that more than 125 ingredients available for use in cosmetics are suspected of causing cancer. Twenty cosmetic ingredients may cause adverse effects on 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."
The cosmetics industry wants the public to believe that no effective regulation is necessary at either the state or federal level. They are masters of the slick ad and expensive public relations campaign. But all the glamorous pictures in the world cannot obscure the basic facts: this is an industry that is under-regulated and too often hazardous. A mother of a beautiful six year old girl in Oakland, California found this out when she used a hair product on her child that resulted in second degree burns on her ears and neck. A 59-year old California women almost died from an allergic reaction to hair dye. A 47 year old woman had her cornea destroyed by a mascara wand. In another tragic case, a woman's hair caught fire as the result of an inflammable hair treatment gel. She lost her hair and was severely scarred.
In fact, for every one million cosmetic products purchased, there are more than 200 visits to the doctor to treat cosmetic-caused illnesses. A 1987 study for the Consumer Product Safety Commission found that in one year alone, cosmetic products resulted in 47,000 emergency room visits. Another study found that between 1985 and 1987, more than 151,000 cosmetic-related injuries occurred.
Let me read a dishonor roll of just a few of the complaints made to the FDA in the last few months.
- Eye problems such as rash, redness, swelling, and inflammation from Alberto Culver's "European Instant Hot Oil Treatment for Color Treated and Permed Hair."
- Clairol's Helene Curtis "Nice and Easy Natural Lite" causing problems such as pain and tissue damage.
- Proctor & Gamble "Cover Girl Make Up Master Sponge Puffs" causing such problems as rash, redness, swelling, sores.
- Maybelline "Great Lash Mascara" : pain and rash.
- Proctor and Gamble "Pantene" shampoo: neck tissue damage
- Personal Care Products "Personal Care Anti-Wrinkle Cream": eye infection
- Neutrogena Corporation "Neutragena Glow Sunless Tanning Spray," hand pain and tissue damage.
The list goes on and on.
These severe reactions are only the tip of the iceberg. As the GAO study 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."
These potential dangers come into startling focus when we review the risks associated with just four widely-used products--risks unknown to the average consumer. Alpha-hydroxy acid used in face creams can be a potent contributor to skin cancer. Feminine hygiene products can cause pelvic inflammatory disease leading to infertility in young women. Talc used in baby powder and other products is a carcinogen. And mascara can cause blindness.
Alpha-hydroxy acid is one of the hottest selling cosmetic products on the market. This product is sold to erase fine lines and tighten the skin but has devastating health effects that are unknown to most consumers.The agency has received 100 reports of adverse effects with alpha-hydroxy acid products, ranging from mild irritation and stinging to blistering and burns. More importantly, these products make users more sensitive to ultraviolet radiation from sunlight -- which can cause skin cancer.
Many woman would be surprised to find that an overwhelmingly majority of feminine hygiene products are regulated as cosmetics. These products have been shown to cause upper reproductive tract infections, pelvic inflammatory disease, ectopic pregnancies, and infertility with the most profound effect in young woman. But the FDA has done little to protect or warn women against these dangers. And this legislation will prohibit states from taking action as well.
Talc is used in baby powder and other products. In 1992, the National Toxicology Program published a study of the effects of talc inhalation in animals and an epidemiology study on Exposure to Talc and Ovarian Cancer Risk. The researchers reported an elevated risk of ovarian cancer associated with talc use. Workers at Columbia University have reported the detection of talc particles in the ovaries of patients undergoing surgery. The Cancer Prevention Coalition has submitted a citizen's petition to FDA expressing their concern about the possible health risks posed by talc and requested the agency establish regulations to require carcinogen warning labels on cosmetics containing talc as an ingredient.
FDA is reviewing the information and may respond sometime in the future. If a State wanted to warn its consumers about this potential carcinogen, they would be prohibited under S. 830.
The FDA has received numerous reports of corneal ulceration associated with mascara products, some of which caused partial blindness of the infected eye. In addition, many other reports of conjunctivitis caused by contaminated mascara were received. In response, FDA published a notice asking the industry to provide information covering microbial testing methods and standards of performance suitable to assure that cosmetics do not become contaminated with microorganisms during manufacture as well as use. However, FDA's request for information resulted in little response from industry--and FDA has no power to require industry to provide the needed information.
Beauty parlor employees are particularly vulnerable to asthma and other diseases that result from exposure to chemicals in the products they use. In fact, their exposure to the chemicals in cosmetic products results in asthma rates twice as high as a comparison group.
Some states are already taking an active role in protecting consumers. Many more may do so in the future--but not if this bill becomes law. Minnesota has passed a hazardous product labelling bill, requiring a warning on all products that are ignitable, corrosive, reactive, or toxic. You would think that all consumers should be entitled to that kind of information about products they put on their faces, spray on their hair, or wash their bodies with. But the cosmetics industry disagrees.
California requires notification if products contain carcinogens, or reproductive toxins that can cause birth defects. You would think every consumer should be entitled to that information. But the cosmetic industry disagrees.
Let's continue our world tour: Canada requires that manufacturers submit data showing that a product is safe under normal use conditions. Sweden is initiating product registration for cosmetics and Denmark is considering a similar law. Malaysia requires mandatory registration of cosmetics. The list goes on and on, but the point is clear. Not only has our Federal regulation of cosmetics lagged far behind other countries, but this greedy industry now proposes to use its political muscle to ban state regulation as well.
This is unacceptable to the President, to the National Women's Health Network, to the National Governor's Association, the National Council of State Legislators, the Association of State and Territorial Health Officers, the Environmental Defense Fund, and to a broad coalition of consumer and health groups as well. When similar attempts to preempt state action were proposed a decade ago, they were even opposed by the Reagan Administration. The only group that supports it is the cosmetics industry--an industry with a consistent record of placing profits ahead of public health. And the Senate should have the courage to stand up to this corporate greed.
