Parabens

PARABENS ARE NOT USED IN ANY PHARMANEX® PRODUCTS
PARABENS ARE USED IN SOME Nu Skin® Products

The Use and Safety of Parabens in Nu Skin® Products

What Are Parabens?
Parabens are a very common group of organically synthesized preservatives used in cosmetics as well as drugs and foods. As a group of multiple compounds, they include methylparaben, ethylparaben, propylparaben, isobutylparaben, and butylparaben. Like most preservatives, they are antimicrobial, meaning they prevent the growth and reproduction of bacteria, mold, and fungi. This attribute allows parabens to keep products safe for repeated consumption. All daily use, personal care products must contain some form of preservation.

Types of Parabens
Methylparaben - This paraben prevents fungi from invading cosmetics, drugs and food. Methylparaben is commonly found in skin and face products. It is easily absorbed through the skin or via the gastrointestinal tract, but is rapidly discharged without building up in the body. Toxicity studies demonstrate methylparaben is non-toxic when asorbed by orally and parenterally, and is not known to irritate skin. Methylparaben is also frequently used as a component of fragrances.

Propylparaben - Though propylparaben is found naturally in many plants and insects, for use in cosmetics, pharmaceuticals and food, it is synthetically produced. This is the type of paraben you will typically find in water-based products including creams, lotions, shampoos and bath products. Propylparaben is soluble at a level of one per cent in water and oil and water solutions.

Butylparaben - Butylparaben is used to extend the shelf life of cosmetics, and prevents the occurrences of mold, fungus and bacteria, though it is also used in several medications. It is oil-soluble and considered non-toxic and non-irritating when used at .05 of one percent, but could irritate the skin if greater than five per cent is used in formulation.

How Nu Skin Uses Parabens
Nu Skin uses parabens to maintain product freshness because of their proven safety record and low irritation profile—and at extremely low levels (usually between 0.1% to 0.8%). Nu Skin formulates its products within these guidelines for the beneficial qualities and safety that parabens provide.

FDA and CTFA Proclaim Parabens Safe for Cosmetic Use
The U.S. Food and Drug Administration (FDA) and the Cosmetic Toiletries and Fragrance Association (CTFA) have thoroughly researched the use of parabens in cosmetics. The FDA regulates product safety, and the CTFA provides specific ingredient safety through the Cosmetic Ingredient Review Board (CIR). The CIR is an independent panel of renowned physicians and scientists that reviews ingredients used in cosmetics since 1976. Both organizations continue to review research on parabens and, as recently as 2004, proclaimed them safe and effective for use in cosmetic formulations.

Nu Skin's Commitment to Safety
Nu Skin actively monitors scientific research on all our ingredients, including parabens, to ensure our distributors can offer safe and efficacious products. The majority of paraben research for the past 50 years supports the safety of parabens in consumer use. However, misinformation circulated about recent paraben studies has caused undue concern that parabens may have weak estrogenic effects. Putting these study results into perspective is important as we determine whether or not parabens are safe for use in cosmetics. There are many other common substances, such as soy, that have more substantial estrogenic properties, but because these substances have been used culturally for centuries without harmful effects they do not raise concern. Additionally, the recent paraben studies were conducted with exaggerated levels of test material ingested or injected into animals rather than applied topically. The conclusion that parabens at extremely low levels in a topical application would produce a similar outcome as an exaggerated use test is without direct evidence and unproven. Since cosmetic products have very low levels of parabens, it is unscientific to assume they could be absorbed through the skin in any significant amount to create adverse effects. In fact, to date there are no scientific studies that show a causal link between topical products that contain paraben and detrimental effects. The CTFA asserted in a statement on April 17, 2003:

Suggestions that parabens have an estrogenic potential or affect the male reproductive system are not relevant to the cosmetic use of these ingredients. The level of parabens used in cosmetics is extremely low. (CTFA Response Statement, April 17, 2003; RSPT 03-12) Nu Skin is committed to protecting product integrity and providing the best results for its customers. The long history of paraben use in cosmetics, backed by the continued, careful research of the cosmetic industry, FDA, and other qualified sources, reassures our pledge of "all of the good, none of the bad."

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CFSAN/Office of Cosmetics and Colors
March 20, 2006

Parabens

FDA has received a number of inquiries on the safety of parabens as used in cosmetics. The following information is intended to answer questions on this subject.
What are parabens?

Parabens are the most widely used preservatives in cosmetic products. Chemically, parabens are esters of p-hydroxybenzoic acid. The most common parabens 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 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.

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. Parabens are usually easy to identify by name, such as methylparaben, propylparaben, butylparaben, or benzylparaben.

Does FDA regulate the use of preservatives in cosmetics?

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."

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.

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