Many mineral cosmetics companies are starting a scare — a scare about parabens and allergies caused by these helpful cosmetic ingredients.  But is this scare influenced by anything warranted?

Realistically, parabens have less allergic reactions and less skin irritations than common ingredients in many mineral cosmetics (such as bismuth oxychloride).  Even over a prolonged period of use, there haven’t been any reactions out of the ordinary, and under 3% of users ever see any at all.

I like parabens, personally.  They keep our make up from separating and getting nasty before we have the opportunity to use it all.  They’re pretty easy to find on an ingredient label, seeing as there’s always just a couple syllables prior to paraben in the name of that particular preservative.

Parabens are used in cosmetics to prevent microbial growth (like mold, ew).  Many hair care, skin care, cosmetics, moisturizers, and shaving creams (and more) contain parabens.

Cosmetics sold on a retail basis are required by the FDA to show the ingredients listed on the outside of the container where it is available to read by the consumers.

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 ingredient they choose, except for a few ingredients that are prohibited by regulation. However, it is against the law to market a cosmetic in interstate commerce if it is adulterated. Under the FD&C Act, a cosmetic is adulterated 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. For more on this subject, see FDA Authority Over Cosmetics and Key Legal Concepts: “Interstate Commerce,” “Adulterated,” and “Misbranded.” (6)

In other words, for that section in bold right up there, unless a material is proven cancerous or that it affects the health of the consumer when the product is used in the way it’s supposed to be, that it is safe for use.  It does ban proven carcinogenic materials.

In 1984 the CIR (Cosmetic Ingredient Review) reviewed the safety of propylparaben, methylparaben, and butylparaben (the most popular parabens around!), and conducted that they were safe for use in cosmetic products up to levels of 25%!  That means a lot of your product could be a paraben without causing you any harm, yet, no cosmetic company puts that much paraben in a product (it’s not necessary).  Typically, you’ll see about 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.” (6 again)

If a product or ingredient has not been shown to be safe, it is legally supposed to have this warning on the label:

“Warning: The safety of this product has not been determined.”