Cosmetic Facts and Myths
The Myths and Facts
Behind Cosmetic Safety
MYTH #1
Cosmetics aren't safe.
FACT:
Cosmetics are among the safest of all consumer products. Their continued safety is ensured by ongoing industry voluntary programs, as well as by ample FDA authority to regulate. In California, the state has Prop 65 and California’s Sherman Food, Drug, and Cosmetic Law to provide Californians with one of the toughest regulatory systems in the world which further ensures that cosmetics are safe.
MYTH #2
FDA lacks authority to regulate cosmetic products and their ingredients.
FACT
This simply is not true. Existing law gives FDA abundant authority to ensure that cosmetics are safe. Among other things, FDA can:
Ban or restrict ingredients for safety reasons
Mandate warning labels
Seize illegal products. Products that are “adulterated†or “misbrandedâ€
Enjoin the sale of illegal products
Publicize health issues
Most recently, on July 9, 2004, FDA announced sweeping new regulations for cosmetic products and ingredients to further protect American consumers from the potential effects of BSE or Mad Cow disease. In fact, there has never been one case worldwide that associates this disease with cosmetics, but this did not prevent FDA from taking action. This is just one example of the FDA’s clear and extensive authority.
MYTH #3
Cosmetic products can be marketed without any testing.
FACT
The law prohibits marketing any product that is unsafe, and manufacturers must fully substantiate the safety of their cosmetic products. If they don’t, the products must display the following warning on its front label: “WARNING– The safety of this product has not been determined.â€
MYTH #4
Lack of government oversight leads to companies routinely marketing products with ingredients that are poorly studied, not studied at all, or worse, known to pose potentially serious health risks.
FACT
Any company marketing such a product would be violating federal and state law and subject to prosecution and criminal penalties. The company and its brands would also be ruined by the publicity associated with such a thing. Cosmetic companies are committed to providing safe products and work very hard to earn the trust of their consumers. They would not do anything to jeopardize that.
MYTH #5
Federal law allows the cosmetic industry to put unlimited amounts of chemicals into personal care products with no required testing.
FACT
An FDA regulation requires each ingredient used in a cosmetic and each finished cosmetic product to be substantiated for safety before it is marketed or to carry a conspicuous warning on its front label stating: “WARNING – The safety of this product has not been determined.†The FDA and the California Department of Health Services, which enforce the Federal Food, Drug and Cosmetic Act and California's Sherman Food, Drug, and Cosmetic Law, respectively, have abundant legal authority to take action against any cosmetic – even one displaying a warning – that they believe may be hazardous.
MYTH #6
Testing has found that cosmetic and personal care products often contain substances known or suspected of causing cancer and reproductive toxicity.
FACT
No credible research has ever shown that any cosmetic or personal care products cause cancer or reproductive toxicity. We don’t use ingredients that would be harmful for use in cosmetics or personal care products. Ingredients and products must be substantiated for safety before they are marketed.
MYTH #7
More than 10,000 chemical ingredients are used in personal care products.
FACT
This erroneous statement is apparently based on data from the Environmental Working Group's (EWG's) flawed report, “Skin Deep,†which was published in June 2004. Careful review of the "Skin Deep" report shows that many of the "ingredients" it lists are not ingredients at all, but rather name fragments, duplicates and misspellings, which were somehow overlooked by the EWG investigators. Once these errors are corrected, there are actually fewer than half that number of individual ingredients listed in the report.
MYTH #8
The Environmental Working Group (EWG) found one-third of all personal care products contain ingredients classified as possible human carcinogens. The EWG found that one out of every 100 products on the market contains ingredients listed by government authorities as known, or probable, human carcinogens.
FACT
Chemicals that have been found to be human carcinogens are not used in cosmetics. Any statement that relies on the Environmental Working Group's report should be automatically suspect. The report is filled with mistakes and unfounded conclusions. For example, two of the ingredients (coal tar and selenium sulfide) that the EWG identifies as probable carcinogens aren't cosmetic ingredients. They are over-the-counter drug active ingredients that have been specifically evaluated for both safety and effectiveness by the FDA and its outside expert scientific and medical advisors for their drug use and found to be safe.
MYTH #9
The European Union has a superior regulatory and scientific system that should be adopted by California.
FACT
The regulation of cosmetics in the European Union is in many ways similar to that in the United States, including California. For example, in both the US and the EU the responsibility for providing a safe product rests with the manufacturer; there is no pre-market clearance for cosmetic products; and only a few ingredient types (colors, sunscreen active ingredients, preservatives) require prior government approval. There are also some regulatory differences. For example, the United States Food and Drug Administration subjects sunscreens, skin protectants, anticaries toothpastes, antiperspirants, and anti-dandruff shampoos to particular testing requirements, ingredient limitations, and labeling mandates that are not required for those products in the EU. Additionally, synthetic organic colorants, which must be individually batch certified by the FDA before use in the US, are not subject to such scrutiny in the EU. On the other hand, a recent EU regulation prohibits the use of ingredients in cosmetics that are on a list of chemicals that have demonstrated carcinogenic or reproductive effects in animals, regardless of any actual risk. This rule was based on political expediency rather than scientific fact, and it will result in the banning of useful and perfectly safe materials from cosmetics in the EU.
*All information obtained from www.ButterFlyResults.com
Behind Cosmetic Safety
MYTH #1
Cosmetics aren't safe.
FACT:
Cosmetics are among the safest of all consumer products. Their continued safety is ensured by ongoing industry voluntary programs, as well as by ample FDA authority to regulate. In California, the state has Prop 65 and California’s Sherman Food, Drug, and Cosmetic Law to provide Californians with one of the toughest regulatory systems in the world which further ensures that cosmetics are safe.
MYTH #2
FDA lacks authority to regulate cosmetic products and their ingredients.
FACT
This simply is not true. Existing law gives FDA abundant authority to ensure that cosmetics are safe. Among other things, FDA can:
Ban or restrict ingredients for safety reasons
Mandate warning labels
Seize illegal products. Products that are “adulterated†or “misbrandedâ€
Enjoin the sale of illegal products
Publicize health issues
Most recently, on July 9, 2004, FDA announced sweeping new regulations for cosmetic products and ingredients to further protect American consumers from the potential effects of BSE or Mad Cow disease. In fact, there has never been one case worldwide that associates this disease with cosmetics, but this did not prevent FDA from taking action. This is just one example of the FDA’s clear and extensive authority.
MYTH #3
Cosmetic products can be marketed without any testing.
FACT
The law prohibits marketing any product that is unsafe, and manufacturers must fully substantiate the safety of their cosmetic products. If they don’t, the products must display the following warning on its front label: “WARNING– The safety of this product has not been determined.â€
MYTH #4
Lack of government oversight leads to companies routinely marketing products with ingredients that are poorly studied, not studied at all, or worse, known to pose potentially serious health risks.
FACT
Any company marketing such a product would be violating federal and state law and subject to prosecution and criminal penalties. The company and its brands would also be ruined by the publicity associated with such a thing. Cosmetic companies are committed to providing safe products and work very hard to earn the trust of their consumers. They would not do anything to jeopardize that.
MYTH #5
Federal law allows the cosmetic industry to put unlimited amounts of chemicals into personal care products with no required testing.
FACT
An FDA regulation requires each ingredient used in a cosmetic and each finished cosmetic product to be substantiated for safety before it is marketed or to carry a conspicuous warning on its front label stating: “WARNING – The safety of this product has not been determined.†The FDA and the California Department of Health Services, which enforce the Federal Food, Drug and Cosmetic Act and California's Sherman Food, Drug, and Cosmetic Law, respectively, have abundant legal authority to take action against any cosmetic – even one displaying a warning – that they believe may be hazardous.
MYTH #6
Testing has found that cosmetic and personal care products often contain substances known or suspected of causing cancer and reproductive toxicity.
FACT
No credible research has ever shown that any cosmetic or personal care products cause cancer or reproductive toxicity. We don’t use ingredients that would be harmful for use in cosmetics or personal care products. Ingredients and products must be substantiated for safety before they are marketed.
MYTH #7
More than 10,000 chemical ingredients are used in personal care products.
FACT
This erroneous statement is apparently based on data from the Environmental Working Group's (EWG's) flawed report, “Skin Deep,†which was published in June 2004. Careful review of the "Skin Deep" report shows that many of the "ingredients" it lists are not ingredients at all, but rather name fragments, duplicates and misspellings, which were somehow overlooked by the EWG investigators. Once these errors are corrected, there are actually fewer than half that number of individual ingredients listed in the report.
MYTH #8
The Environmental Working Group (EWG) found one-third of all personal care products contain ingredients classified as possible human carcinogens. The EWG found that one out of every 100 products on the market contains ingredients listed by government authorities as known, or probable, human carcinogens.
FACT
Chemicals that have been found to be human carcinogens are not used in cosmetics. Any statement that relies on the Environmental Working Group's report should be automatically suspect. The report is filled with mistakes and unfounded conclusions. For example, two of the ingredients (coal tar and selenium sulfide) that the EWG identifies as probable carcinogens aren't cosmetic ingredients. They are over-the-counter drug active ingredients that have been specifically evaluated for both safety and effectiveness by the FDA and its outside expert scientific and medical advisors for their drug use and found to be safe.
MYTH #9
The European Union has a superior regulatory and scientific system that should be adopted by California.
FACT
The regulation of cosmetics in the European Union is in many ways similar to that in the United States, including California. For example, in both the US and the EU the responsibility for providing a safe product rests with the manufacturer; there is no pre-market clearance for cosmetic products; and only a few ingredient types (colors, sunscreen active ingredients, preservatives) require prior government approval. There are also some regulatory differences. For example, the United States Food and Drug Administration subjects sunscreens, skin protectants, anticaries toothpastes, antiperspirants, and anti-dandruff shampoos to particular testing requirements, ingredient limitations, and labeling mandates that are not required for those products in the EU. Additionally, synthetic organic colorants, which must be individually batch certified by the FDA before use in the US, are not subject to such scrutiny in the EU. On the other hand, a recent EU regulation prohibits the use of ingredients in cosmetics that are on a list of chemicals that have demonstrated carcinogenic or reproductive effects in animals, regardless of any actual risk. This rule was based on political expediency rather than scientific fact, and it will result in the banning of useful and perfectly safe materials from cosmetics in the EU.
*All information obtained from www.ButterFlyResults.com
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