US FDA's Centre for Food Safety and Applied Nutrition
CFSAN/Office of Cosmetics and Colours
March 20, 2006
FDA has received a number of inquiries on the safety of paraben's as used in cosmetics. The following information is intended to answer questions on this subject.
Paraben's are the most widely used preservatives in cosmetic products. Chemically, paraben's are esters of p-hydroxybenzoic acid. The most common paraben's 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 micro-organisms. The use of mixtures of paraben's allows the use of lower levels while increasing preservative activity.
Preservatives may be used in cosmetics to protect them against microbial growth, both to protect consumers and to maintain product integrity.
They are used in a wide variety of cosmetics, as well as foods and drugs. Cosmetics that may contain paraben's include makeup, moisturizers, hair care products, and shaving products, among others. Most major brands of deodorants and antiperspirants do not currently contain paraben's.
Cosmetics sold on a retail basis to consumers are required by law to declare ingredients on the label. This is important information for consumers who want to determine whether a product contains an ingredient they wish to avoid. Paraben's are usually easy to identify by name, such as methylparaben, propylparaben, butylparaben, or benzylparaben.
The Federal Food, Drug, and Cosmetic Act (FD&C Act) does not authorize FDA to approve cosmetic ingredients, with the exception of colour 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 labelled conditions of use, or under customary or usual conditions of use.
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 paraben's 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 paraben's 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 paraben's 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 paraben's in breast tumours. The study also discussed this information in the context of the weak oestrogen-like properties of paraben's and the influence of oestrogen on breast cancer. However, the study left several questions unanswered. For example, the study did not show that paraben's 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 paraben's can act similarly to oestrogen, they have been shown to have much less estrogenic activity than the body’s naturally occurring oestrogen. 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 oestrogen). Further, paraben's are used at very low levels in cosmetics. In a review of the estrogenic activity of paraben's, (Golden et al., in Critical Reviews in Toxicology, 2005) the author concluded that based on maximum daily exposure estimates, it was implausible that paraben's could increase the risk associates 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 paraben's. 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.
FDA/Centre for Food Safety & Applied Nutrition
Hypertext updated March 24, 2006