Dear FDA, Can we please take another look at Parabens?

History:  Back around ten years ago there was a rising concern about the safety of antiperspirants. Many of articles and studies were done and raised enough questions that scientists were calling for more research. Below are but a few of the studies done up until 2005.

  1. Darbre PD. Underarm cosmetics and breast cancer. Journal of Applied Toxicology 2003; 23(2):89–95. [PubMed Abstract]
  2. Darbre PD. Aluminium, antiperspirants and breast cancer. Journal of Inorganic Biochemistry 2005; 99(9):1912–1919. [PubMed Abstract] advise: “Further studies are now needed to identify the molecular basis of this action, the longer term effects of aluminium exposure and whether aluminium can cause aberrations to other signalling pathways in breast cells.”
  3. Harvey PW, Everett DJ. Significance of the detection of esters of p-hydroxybenzoic acid (parabens) in human breast tumours. Journal of Applied Toxicology 2004; 24(1):1–4. [PubMed Abstract]
  4. Darbre PD, Aljarrah A, Miller WR, et al. Concentrations of parabens in human breast tumours. Journal of Applied Toxicology 2004; 24(1):5–13. [PubMed Abstract]   “These studies demonstrate that parabens can be found intact in the human breast and this should open the way technically for more detailed information to be obtained on body burdens of parabens and in particular whether body burdens are different in cancer from those in normal tissues.” Copyright 2004 John Wiley & Sons, Ltd.
  5. According to a Safety assessment of esters of p-hydroxybenzoic acid (parabens) by the US National Library of Medicine National Institutes of Health at, “In light of the recent controversy over the estrogenic potential of parabens, conduct of a reproductive toxicity study may be warranted.” 5/2005


In March 2006 the FDA published their findings:[1]

NOTE:  The Federal Food, Drug, and Cosmetic Act (FD&C Act) DOES NOT authorize FDA to approve cosmetic ingredients, with the exception of color additives that are not coal-tar hair dyes. In general, cosmetic manufacturers may use any ingredients they choose, except for a few ingredients that are prohibited by regulation. 

What are parabens?  Parabens are the most widely used preservatives in cosmetic products. Chemically, parabens are esters of para-hydroxybenzoic acid. The most commonplace bactericidal/fungicidal additives to cosmetics are methylparaben, propylparaben, and butylparaben (cheapest and most used). 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. The use of mixtures of parabens allows the use of lower levels while increasing preservative activity.

Why are preservatives used in cosmetics?  Preservatives may be used in cosmetics to protect them against microbial growth, both to protect consumers and to maintain product integrity.

What kinds of products contain parabens?  They are used in a wide variety of cosmetics, as well as foods and drugs. Cosmetics that may contain parabens include makeup, moisturizers, hair care products, and shaving products, among others. Most major brands of deodorants and antiperspirants do not currently contain parabens.

FDA Conclusion:  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. March 24, 2006; Updated October 31, 2007

According to a Safety assessment of esters of p-hydroxybenzoic acid (parabens) by the US National Library of Medicine National Institutes of Health at, “In light of the recent controversy over the estrogenic potential of parabens, conduct of a reproductive toxicity study may be warranted.”



Everyone feel safe!  Parabens were last evaluated safe in 2007. The problem with the FDA’s conclusion is it seems to discount or throw out any leading studies of the time and chooses to draw their conclusion from a single source.

Please read: A Review of the Endocrine Activity of Parabens and Implications for Potential Risks to Human Health.[2]

This study seems to be based on an almost pre-drawn conclusion when it states in the opening, ”parabeans (and their salts) are widely used as preservatives in cosmetics, toiletries, and pharmaceuticals due to their relatively low toxicity profile and a long history of safe use”.  They do state, “While exposure to sufficient doses of exogenous estrogen can increase the risk of certain adverse effects”. The conclusion the FDA reaches from the report is, “it is biologically implausible that parabens could increase the risk of any estrogen-mediated endpoint, including effects on the male reproductive tract or breast cancer”. This may be a bit presumptive.

The study’s conclusion: is that there is no risk of cancer because the endocrine-active chemicals (EACs) did not have the same amount of activity as estrogen. That is all.  There has been a lot of research that has come out in the past seven years on the behavior of cancer cells which this study did not and could not have taken into consideration.

It may be time we took another and better look at Parabens. Let us see how much EACs are being absorbed by the breast tissue and the effects it has on the lymphatic system.  It just seems like anything that is absorbed into the body and mimics human hormones should be given a closer look. Also, this time let’s make sure the study accounts for actual amount of parabeans a person is being exposed to on a daily basis and over the course of a lifetime.

No one cares if the old study was a cover up or just had flawed judgment.  People only want to be able to be given honest, current and accurate data about the products they use.  Most of us do not have the means to conduct independent studies, that is why we rely on our Government to police these industries.  □

  1.  U.S. Food and Drug Administration /10903 New Hampshire Avenue /Silver Spring, MD 20993 /Ph. 1-888-INFO-FDA (1-888-463-6332)
  2.  A Review of the Endocrine Activity of Parabens and Implications for Potential Risks to Human Health  2005, Vol. 35, No. 5 , Pages 435-458  Robert GoldenJay Gandy and Guenter Vollmer  ToxLogic LC, Potomac Maryland, USA.  Department of Environmental and Occupational Health, University of Arkansas Medical Sciences, Little Rock, Arkansas, USA. Institute for Zoology, Dresden University, Dresden Germany. ToxLogic LC 9808 Clagett Farm Dr., Potomac, MD, 20854, USA. Read More: carries 100s of Paraben & Phthate Free Cosmetics carries 100s of Paraben Free Cosmetics

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