The Safety of Parabens - A Scientific Analysis of the Data

Parabens are the most widely used preservatives in cosmetic products. Parabens are esters of p-hydroxybenzoic acid, they are found naturally in blueberries, blackberries and raspberries. The parabens found in our products include methylparaben and propylparaben. We use a combination of parabens and diazolidinyl urea in our products to provide preservation against a broad range of microorganisms. By using a combination of parabens, we can use lower levels while increasing preservative activity.

Why Do We Need Preservatives in Cosmetics?

Preservatives are substances that kill bacteria and fungi (or at the very minimum make it very difficult for "living things" to survive), and have no effect on the shelf life of the oils. Bacteria, fungi, yeast and other potentially dangerous microorganisms typically avoid waterless compounds (such as Calypso's Oils, Body Perfumes and Squalanes) and also substances with a relatively high pH (such as soap), but thrive in humid environments. For this reason, soaps and oil-based skin care applications do not need preservatives - but unlike these, creams, lotions and any other compound where water is present require adding a preservative if the shelf life and integrity of the product needs to be extended further than 2 or 3 weeks.

Among the synthetic preservatives available for handmade skin care products, paraben-based preservatives have a long history of safe use and extensive testing and studies showing that paraben-based preservatives are by far less dangerous, both for the skin, and for the environment, than most other types of preservatives.

Why Do We Use Parabens and Not Another “Natural Preservative?

As “natural” cosmetics companies have spread fears about the presence of “unnatural” parabens in cosmetics, many of our customers have asked us to replace our parabens with a “natural” alternative. For the peace of mind of our customers, we have given serious consideration to alternative preservatives. However the safety of our products is our first concern and there still does not exist an alternative to parabens with the same proven safety record, efficacy and scientific testing.

It is important to understand that the efficacy of preservatives relies, by definition, on their ability to kill live cells; in other words, their toxicity is an unavoidable component of their reason of being. A number of natural extracts, plants and essential oils contain substances that have the power to effectively kill bacteria, yeast and fungi; however, in many cases these substances are or can be toxic for humans, too. A typical example are citrus or grapefruit seed extracts: although these have natural anti microbial properties, some of their constituents are thought to be responsible for life-threatening hormonal imbalances. Also, citrus seed extracts are not approved for cosmetic use in Europe and in Japan, and are therefore not an option in those countries.

In the last year, a new preservative based on grapefruit seed extract has taken off in the cosmetics market. There has been lots of hype around this preservative, sold by the same “natural” cosmetic companies that spread misleading information about parabens. While we at Skin Biology would welcome new alternative ingredients that would calm customers worries, it would be unethical for us to use a lower standard for these new ingredients. Thus far, there is no scientific or clinical safety data on this preservative, and the concerns about grapefruit seed extract are real ones. It takes years to discover all the contraindications for a new chemical and it would be truly dangerous to include it in our products when so little is known.

The Safety of Parabens

Parabens have a long history of use in cosmetic products and their safety is well-documented and continually evaluated. Parabens have been specifically recognized as safe for use in food by the U.S. Food and Drug Administration (FDA). According to the FDA, parabens are the most widely used cosmetic preservatives in the United States. FDA believes that at the present time there is no reason for consumers to be concerned about the use of cosmetics containing parabens.

The Cosmetic Ingredient Review (CIR) reviewed the safety of methylparaben, propylparaben, and butylparaben and concluded they were safe for use in cosmetic products at levels up to 25%. We use parabens at levels from 0.01 to 0.1%.

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.)

What are the Connections Between Parabens and Cancer?

There is NO proven link between between parabens and cancer.

The controversy began in 2004 when a study – which has been criticized as flawed by many researchers including the American Cancer Society- 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.

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 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, the author concluded that based on maximum daily exposure estimates, it was implausible that parabens could increase the risk associates with exposure to estrogenic chemicals.

A recent review of the available data concluded "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" and that "that worst-case daily exposure to parabens would present substantially less risk relative to exposure to naturally occurring endocrine active chemicals (EACs) in the diet such as the phytoestrogen daidzein." In addition, the American Cancer Society has concluded that there is no good scientific evidence to support a claim that use of paraben containing cosmetics increase an individual's risk of developing breast cancer.

Although some parabens have shown estrogenic effect in screening tests, they are many thousands of times less potent than the natural estrogens in the body, and even less potent than the estrogenic compounds in foods such as apples, carrots, beans, dairy foods, garlic, papaya, potatoes, rice, soybeans, wheat, and yams that are eaten everyday.

More Cancer Scares...

A recent study found that a single piece of sashimi drenched in soy and wasabi produces more oestrogenic activity inside the body than a lifetime's use of parabens. The Japanese happily continue to enjoy their sashimi and have continued to produce offspring, whereas the personal care industry immediately jumped the bandwagon of commercial success and decided to ban these products because a scientist with a not-so-hidden objective to sell his or her alternative to parabens decided to tell the press-at-large that they were feminized by the outrageous exposure to these parabens.

From The Journal of the National Cancer Institute

Can Rumors Cause Cancer?
Jemarion Jones

You can’t believe everything you read. Nowhere is this more true than with information on the Internet. For example, a number of wild rumors associated with various types of cancer have made the rounds on the Internet.

One rumor claimed that common antiperspirants, used mostly by women, cause breast cancer. Circulated via e-mail, the rumor has been around for months, possibly years. It claims that antiperspirants are the leading cause of breast cancer and that antiperspirants prevent the body from purging toxins that can then deposit in the lymph nodes, where they can produce cancer-causing mutations.

Most experts in breast cancer research say there is nothing to this rumor. There are no epidemiologic studies to support the idea that antiperspirant use is a risk factor. Additionally, the lymphatic system does clear some toxins, but the liver and kidneys play a more crucial role in purging substances from the body. More substances leave the body through urination than through perspiration.

"There’s no proof to my knowledge that antiperspirants cause breast cancer," said Jeff Abrams, M.D., of the National Cancer Institute’s Cancer Therapy Evaluation Program, adding that "these rumors . . . have the potential to do harm."

The "harm" is that the rumor alarmed enough people that several medical and health information organizations issued rebuttals to the e-mail’s claims. NCI, when asked, states that it is not aware of any research that supports a link between antiperspirant use and breast cancer. The U.S. Food and Drug Administration does not have evidence to support the claims. Additionally, the American Cancer Society, the Canadian Cancer Society, and the Susan G. Komen Breast Cancer Foundation have all posted statements denying any link between traditional breast cancer risk factors and the use of antiperspirants.

Holding for an Answer

Another health concern showing up in e-mail inboxes is a warning that cellular phones cause brain cancer. According to a recent Gallup poll, almost half of all Americans own a cellular phone, and there is a growing concern that all that talking could pose a serious health risk.

Unlike the antiperspirant rumor, which major health establishments actively debunk, the jury is still out on whether talking on a cellular phone can be hazardous to health. As a result of conflicting reports and overall lack of information, the FDA announced in June that it would collaborate with the Cellular Telecommunications Industry Association to research mobile phone safety. At issue is whether radio frequency (RF) emissions from mobile phones have an adverse effect on human beings. According to the FDA and the World Health Organization, there is no evidence to date that proves mobile phone usage poses a health risk; however, there is not enough information currently available to totally rule out the possibility.

"Results from the first large studies are in the process of coming out," said Peter Inskip, Sc.D., of NCI’s Division of Cancer Epidemiology and Genetics. "By the end of this year or early next year, we should have more information relevant to these concerns." He pointed out that cellular phones have not been widely available for a long period of time, making it too early to assess the long-term risks of cellular phone use.

On Aug. 1, CTIA began requiring mobile phone manufacturers to disclose how much radiation from their cellular equipment could enter a user’s brain under laboratory conditions. The Federal Communications Commission already requires phones to meet safety standards.

Soy Foods

The health benefits of soy have recently gotten a lot of notice. However, e-mail campaigns have warned that overconsumption of soy can lead to an increased risk of breast cancer. Scientists, however, are quick to dismiss these claims.

"There is no data to suggest that soy increases the risk of breast cancer," said Worta McCaskill-Stevens, M.D., of NCI’s Division of Cancer Prevention, who is also the program director for the Study of Tamoxifen and Raloxifene. "A high level of soy food products, which contain isoflavones [plant chemicals], is thought to reduce the risk of breast cancer. Studies have shown high levels of isoflavones among Asian women [in Asia] in which the breast cancer rates are among the lowest in the world."

Ovarian Cancer and CA-125

Another Internet rumor comes in the form of a personal testimonal from a woman who claims she was not properly diagnosed with ovarian cancer until she received the CA-125 (tumor marker) blood test. After describing the experience, the e-mail goes on to urge women to insist on the test as a part of their annual physical exam. According to the experts, this is yet another case of misinformation transmitted via the Internet.

"CA-125 is neither sufficiently sensitive or specific to be a good screen for ovarian cancer," said Edward Trimble, M.D., head of the surgery section in NCI’s Cancer Therapy Evaluation Program. "Among premenopausal women, conditions such as endometriosis, uterine fibroids, and menstruation can cause CA-125 elevations." According to Trimble, the CA-125 test was approved by the FDA only for monitoring the response to chemotherapy in women with advanced or recurrent ovarian cancer; it was not approved for diagnosis.

Does Everything Cause Cancer?

Shampoo, underwire bras, and NutraSweet have all been identified by e-mail as contributors to cancer. Health experts and health organizations are quick to deny any truth to these rumors.

"Part of the problem is that some rumors hold just enough logic to sound convincing to anyone who is not an expert," said Steverna Fields, who heads NCI’s Public Inquiries Office. "It’s understandable that the average lay person may not know the difference."

"There continues to be voids in the fund of knowledge about cancer," added McCaskill-Stevens, "such that a little bit of erroneous information can further alienate women who are in the greatest need of facts about cancer."