Parabens in Skin Care Products
There are a number of myths circulating on the internet regarding the pros and cons of various skin care ingredients.
It is important to know the reality about such claims and misguided beliefs. One such false statement is about the use of preservatives
such as Parabens in skin care products. Preservatives are absolutely necessary in skin care products, as without preservation no skin care
products would have any shelf life. Products "claiming" to be "preservative free" always have some ingredient, most often hidden, that acts
in reducing bacterial growth and preserving the shelf life of the product.
Parabens are small well proven organic molecules that are very effective in preventing bacterial growth in most skin care products.
These have therefore been used as preservatives in cosmetic products for many years. They are shown to be safe by all good scientific studies.
Recently because of questions raised by consumers regarding this safety, the FDA has revisited the question and concluded that the safety if
these molecules is valid, and use of parabens is very appropriate. The following excerpt is from the latest FDA monograph on parabens and
addresses the safety issue:
Are there health risks associated with the use of parabens in cosmetics?
The Cosmetic Ingredient Review (CIR) reviewed the safety of methylparaben, propylparaben, and butylparaben in 1984 and
concluded they were safe for use in cosmetic products at levels up to 25%. Typically parabens are used at levels ranging from 0.01 to 0.3%.
On November 14, 2003, the CIR began the process to reopen the safety assessments of methylparaben, ethylparaben, propylparaben,
and butylparaben in order to offer interested parties an opportunity to submit new data for consideration. In September 2005,
the CIR decided to re-open the safety assessment for
parabens to request exposure estimates and a risk assessment for cosmetic uses.
In December 2005, after considering the margins of safety for exposure to women and infants,
the Panel determined that there was no need to change its original conclusion that parabens are safe as
used in cosmetics. (The CIR is an industry-sponsored organization that reviews cosmetic ingredient
safety and publishes its results in open, peer-reviewed literature. FDA participates in the CIR in a non-voting capacity.)
A study published in 2004 (Darbre, in the Journal of Applied Toxicology) detected parabens in breast tumors.
The study also discussed this information in the context of the weak estrogen-like properties of parabens and the influence
of estrogen on breast cancer. However, the study left several questions unanswered. For example, the study did not show that
parabens cause cancer, or that they are harmful in any way, and the study did not look at possible paraben levels in normal tissue.
FDA is aware that estrogenic activity in the body is associated with certain forms of breast cancer. Although parabens can act
similarly to estrogen, they have been shown to have much less estrogenic activity than the body’s naturally occurring estrogen.
For example, a 1998 study (Routledge et al., in Toxicology and Applied Pharmacology) found that the most potent paraben tested
in the study, butylparaben, showed from 10,000- to 100,000-fold less activity than naturally occurring estradiol (a form of estrogen).
Further, parabens are used at very low levels in cosmetics. In a review of the estrogenic activity of parabens, (Golden
et al., in Critical Reviews in Toxicology, 2005) the author concluded that based on maximum daily exposure estimates, it was
implausible that parabens could increase the risk associated with exposure to estrogenic chemicals.
FDA believes that at the present time 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.
Further details can be found on the FDA website at: http://www.cfsan.fda.gov/~dms/cos-para.html