The Debate Over Paraben Use in Cosmetics
The FDA defines parabens as "the most widely used preservatives in cosmetic products. The most common parabens used in cosmetic products are methylparaben, propylparaben, and butylparaben. Typically, more than one paraben is used in a product, and they are often used in combination with other types of preservatives to provide preservation against a broad range of microorganisms." It should be noted, however that the FDA does not have authorization to approve cosmetic ingredients, with the exception of color additives so cosmetic manufacturers may use any ingredient they choose, except for a few ingredients that are prohibited by regulation. The exception to this rule is if the cosmetic ingredient is adulterated. Under the Food Drug and Cosmetic Act, adulterated is defined as "if, among other reasons, it bears or contains any poisonous or deleterious substance which may render it injurious under the labeled conditions of use, or under customary or usual conditions of use."
In 1984, the Cosmetic Ingredient Review (an industry-sponsored organization that reviews cosmetic ingredient safety and publishes its results in open, peer-reviewed literature. The FDA participates in the CIR in a non-voting capacity) reviewed the safety of methylparaben, propylparaben, and butylparaben and concluded they were safe for use in cosmetic products at levels up to 25%. Usually, parabens are used at a fraction of that level. In 2005, after a great deal of reexamination, the CIR determined that there was no reason to change its original conclusion on the safety of parabens as a preservative.
However, in 2004, an article in The Journal of Applied toxicology revealed a study which found parabens in breast tumors. According to the FDA, the study did not determine that parabens caused cancer, just that parabens act like estrogen, mimicking your body's own hormones which can have endocrine-disrupting effects when introduced into the bloodstream and the FDA currently has declared that, "there is no reason for consumers to be concerned about the use of cosmetics containing parabens. However, the agency will continue to evaluate new data in this area. If FDA determines that a health hazard exists, the agency will advise the industry and the public, and will consider its legal options under the authority of the FD&C Act in protecting the health and welfare of consumers."
According to Dr. Elizabeth Smith, "It is a known medical fact that estrogen stimulates breast cancer" and that "anything absorbed through the skin may be as high as 10 times the concentration of an oral dose" similar to the absorption of hormones in a birth control patch.
Additional debate occurs when parabens are found in organic skin care products. The National Organic Program prohibits chemical preservatives in products that are labeled "organic". Most organic formulations have lengthy but limited shelf lives as a result of abstaining from adding chemical (read paraben) preservatives as compared to cosmetics which add preservatives.
While a few cosmetic companies will argue that the level of a harmful chemical in any one product is not enough to harm you, based on studies of chemical exposure in adults, most cosmetic products are used on a daily basis and need to be monitored for the exact amount absorbed into the system. Regardless of FDA findings, many cosmetic companies currently have decided to discontinue the use of parabens as a preventative measure. The debate on the safety of the use of parabens continues, but it is evident that more information is necessary to determine the safety of paraben use in cosmetics. The common sense approach to chemical use says "an ounce of prevention is worth a pound of cure."
Related Tags: estrogen, breast cancer, fda, parabens, cosmetic preservatives, cosmedic ingredient review
Kimberly Kolodzizejski Vice President of Media Relations and Customer Service for Chella Professional Skin Care
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