Dangerous Cosmetic and Skin Care Ingredients

Dangerous Cosmetic and Skin Care Ingredients Sodium Laurel Sulfate

DANGEROUS BEAUTY: Scientists Warn of Harmful Ingredients In Our Shampoos and Cosmetics, by David Lowell Kern New health concerns are being raised over some common ingredients in hair shampoos, skin creams, toothpastes, and other personal care items. Researchers in the U. S., Germany, Switzerland, Japan, found these ingredients may be linked to premature baldness, cataracts, environmental cancers, contact dermatitis, and possible eye damage in young children. SLS and Eye Damage in Young Children The greatest concern of many scientists is sodium lauryl sulfate (SLS), a detergent found in about 90 percent of commercial shampoos. Also known as sodium dodecyl, sodium laureth sulfate (SLFS) this chemical has been shown to damage protein formation in eye tissue in young animals, raising serious concerns about the possibility of ocular tissue malformation, blindness in infants and young children. In animal studies, SLS penetration and uptake is much greater in neonatal and young animal eye tissue, compared to adult animals, showing "penetration into the eye, as well as systemic tissues (brain, heart, liver, etc.)" SLS also showed long-term retention in tissues, up to 5 days after a single drop.1 Researcher Keith Green, Ph.D., D. Sc., of the Medical College of Georgia, also reports that SLS extends the healing of corneal tissue by a factor of 5, from 2 days (normal) to more than 10 days. He also has concerns about cataract formation from SLS. Writing for Research to Prevent Blindness, Inc., Dr. Green states in part: There is an immediate concern relating to the penetration of these chemicals into the eye and other tissues. This is especially important in infants...exposure to SLS results in accumulation in eye tissues, a process that could retard healing and possibly have long-term effects. Dr. Green concludes that exposure to SLS sulfate causes improper eye development in children and that since SLS is absorbed systemically through the skin, it doesn't have to enter the eye directly. Our own research found that SLS is present as a main ingredient in most commercial shampoos for adults or children. SLS Toxicity and Cancer Another serious health concern with SLS is its tendency to react with other ingredients to form NDELA, a nitrosamine and potent carcinogen. According to a 1978 FDA report, shampooing the hair with a product contaminated with this nitrosamine can lead to its absorption into the body at levels much higher than eating nitrate- contaminated foods. (Researchers estimate the nitrate absorption from one shampoo is equal to eating a pound of bacon.) The FDA has recently warned shampoo manufacturers of unacceptable levels of dioxin formation in products containing SLFS (dioxins are also dangerous carcinogenic compounds). Only laboratory testing can determine if a shampoo is contaminated with these powerful carcinogenic compounds.

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Damage To Your Skin Researchers have known for years that SLS is a skin irritant. SLS is used as a laboratory standard for irritating skin and inducing contact dermatitis.2,3,4 SLS is useful to lab testing because of its ability to penetrate and impair the skin barrier. 5 SLS damages the skin barrier functions,6 enhances allergic response to other toxins and allergens,7 damages and alters skin cells, 8 causes substantial roughness to the skin, 9 results in severe modification of skin recombinant structure.10 SLS is listed as toxic to skin in many studies.11,12,13 In patients with seborrhea and eczema, SLS increases irritant reactions and susceptibility.14 SLS is indicated in migration of Langerhans cells to regional lymph sites in contact dermatitis, explaining lymph node inflammation in some cases. (A systemic response is clearly indicated.) Research also found that fair skin is more susceptible to SLS irritations, as is skin with existing eczema even where the eczema is not local to the SLS contact.15 SLS and Premature Hair Loss SLS is implicated in premature hair loss in men and women, and may be one reason for wide-spread incidence of thinning hair. Because SLS is such a caustic cleanser, it actually corrodes the hair follicle and impairs its ability to grow hair. SLES (sodium lauryl ether sulfate) causes dramatic decline in the hair growth cycle, and prolongs the hair loss phase (normally 3 months) by a factor of eight. Simply removing this ingredient, and its corrosive and irritating effects, begins to restore the natural, healthy function of the follicle. SLS is also implicated in scalp irritation, eczema, dandruff, and other scalp conditions. Many shampoos designed to alleviate dandruff, itching, and other scalp disorders may actually be causing the toxicity of SLS-containing formulas to the skin and scalp. Avoiding contact with this cytotoxic (cell- killing) chemical is all that many people require to completely alleviate scalp disorders. Natural Brands Offer No Protection Ingredient reviews of shampoos sold in health food stores under natural brands and labels have turned up many formulas containing SLS. The cost, reputation, or market position of a shampoo apparently has little to do with its contents. Some of the most reputable and exclusive brands contain SLS. Don't be fooled by high prices or marketing hype. You must check the ingredients on each product if you want to avoid the harmful effects of SLS. What You Should Do * Check your shampoos, toothpaste, liquid soaps, body gels, and other skin products for sodium lauryl sulfate. We recommend that you avoid any further skin contact with products containing this ingredient. * If you have children, make sure they are not using shampoos and toothpastes containing sodium lauryl sulfate. Children under 6 are especially vulnerable to improper eye development. Also check sunblock products. (We found one that contains SLS and aluminum, a potentially dangerous combination for brain cell deterioration.) * Replace products containing SLS with safe alternatives (formulas without SLS). * Check all your cosmetic products for propylene glycol, and get them off your skin. If you have infants, check your baby wipes and baby lotions, and find alternative products that are safe for children (some baby wipes are available with aloe instead 2

of propylene glycol). From: www.pronature.com Alkylphenol Ethoxylates

Found to reduce sperm count

Benzene/Benzoic Acid/Benzyl Benzoate

Considered a carcinogen, is an endocrine disruptor, and is suspected to cause birth defects

Coal Tar

Known human carcinogen. Prohibited for us in cosmetics in the European Union. May contian harmful impurities or breakdown products. Found in dandruff shampoos, anti-itch creams and hair dyes.

Methyl, Propyl, Butyl and Ethyl Paraben

Used as inhibitors of microbial growth and to extend shelf life of products. Have caused many allergic reactions and skin rashes. Studies have shown that they are weakly estrogenic and can be absorbed by the body through the skin. Widely used even though they are known to be toxic.

Dibutyl Phthalate

Prohibited for us in cosmetics in the European Union. Possoble human reproductive or developmental toxin. Endocrine disruptor. Found in some nail polish, perfume and hair spray.

Diethanolamine (DEA), Triethanolamine (TEA)

Often used in cosmetics as emulsifiers and/or foaming agents. They can cause allergic reactions, eye irritation and dryness of hair and skin. DEA and TEA are "amines" (ammonia compounds) and can form cancer-causing nitrosamines when they come in contact with nitrates. Toxic if absorbed into the body over a long period of time. This chemical interferes with the body's ability to absorb choline which is needed for proper fetal brain development.

Diazolidinyl Urea, Imidazolidinyl Urea

These are widely used preservatives. The American Academy of Dermatology has found them to be a primary cause of contact dermatitis. Two trade names for these chemicals are Germall II and Germall 115. Neither of the Germall chemicals contains a good antifungal agent, and they must be combined with other preservatives. Both these chemicals release formaldehyde, which can be toxic.

Formaldehyde

This is an extreme irritant to the mucous membranes with often destructive effects. It is also considered to be a neurotoxin and carcinogen.

Fragrances

The label of "Fragrances" can mask a multitude of toxic, synthetic chemicals, many of which suppress the immune system, are endocrine disruptors, and cause cancer. When looking for scented products, make sure it's scented by essential oils -- which are expensive; therefore, companies usually list what essential oils are contained in the product without reverting to the generic term "Fragrances".

Isopropanol/Isopropyl Alcohol

This is a skin irritant that causes flushing, pulse rate fluctuations, dizziness, headaches, and nausea.

Lead Acetate

Known human reproductive and developmental toxin. Prohibited for use in cosmetics in the European Union. Found in some hair dyes and cleanser.

Mercury

Possible human carcinogen. Possoble human reproductive or developmental toxin. Found in some eye drops and ointment.

Methylisothiazoline, or MIT This can cause skin and eye irritation and is known to cause neurological damage. Parabens (Isobutylparaben, Butylparaben, Methylparaben, Propylparaben) Petrolatum

Increases a person's risk of breast cancer. These class of chemicals are also endocrine disruptors and have been linked to fertility problems. Also known as petroleum jelly, this mineral oil derivative is used for its emollient properties in cosmetics. It has no nutrient value for the skin and can interfere with the 3

body's own natural moisturizing mechanism, leading to dryness and chapping. It often creates the very conditions it claims to alleviate. Manufacturers use petrolatum because it is unbelievably cheap. Petroleum Distillates

Possible human carcinogen. May contain harmful impurities or breakdown products. Prohibited for use in cosmetics in the European Union. Found in some mascara, perfume, foundation, lipstick and lip balm.

Phthalates

This has been linked to damage of the organs -- kidneys, lungs, and liver -- as well as the reproductive system.

Propylene Glycol

Ideally this is a vegetable glycerin mixed with grain alcohol, both of which are natural. Usually it is a synthetic petrochemical mix used as a humectant. It has been known to cause allergic reactions, hives and eczema. When you see PEG (polyethylene glycol) or PPG (polypropylene glycol) on labels, beware?these are related synthetics. Although exposure to high levels of Propylene Glycol is known to cause serious and potentially irreversible health conditions, the chemical industry tell us that "small" quantities or low level exposure of Propylene Glycol is "safe" to use on the skin and in food. According to the safety data sheets of industrial chemical manufacturers, chemicals such as Ethylene Glycol and Propylene Glycol will cause serious health conditions, including liver and heart damage and damage to the central nervous system if sufficient is absorbed by the body.

PVP/VA Copolymer

A petroleum-derived chemical used in hairsprays, styling aids and other cosmetics. It can be considered toxic, since inhaled particles can damage the lungs of sensitive persons.

Sodium Lauryl/Laureth Sulfate

A cheap, harsh detergent used in shampoos for its cleansing and foam-building properties. Often derived from petroleum, it is frequently disguised in pseudo-natural cosmetics with the phrase "comes from coconuts." It causes eye irritation, scalp scurf similar to dandruff, skin rashes and other allergic reactions.

Stearalkonium Chloride

A quaternary ammonium compound used in hair conditioners and creams. Developed by the fabric industry as a fabric softener, it is a lot cheaper and easier to use in hair conditioning formulas than proteins or herbals, which are beneficial to the hair. Causes allergic reactions. Toxic.

Synthetic Colors

Used to make cosmetics "pretty," synthetic colors, along with synthetic hair dyes, should be avoided at all costs. They will be labeled as FD&C or D&C, followed by a color and a number. Example: FD&C Red No. 6 / D&C Green No. 6. Many synthetic colors can be carcinogenic. If a cosmetic contains them, don't use it.

Synthetic Fragrances

The synthetic fragrances used in cosmetics can have as many as 200 ingredients. There is no way to know what the chemicals are, since on the label it will simply read "fragrance." Some problems caused by these chemicals include headaches, dizziness, rash, hyperpigmentation, violent coughing, vomiting, skin irritation?the list goes on. Advice: Don't buy a cosmetic that has the word "fragrance" on the ingredients label.

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Alpha Hydroxy Acids • • • • • • •

Why are AHAs used in some cosmetics? How do AHAs work? What about products that contain AHAs and are marketed with therapeutic claims? Has FDA received reports of adverse events related to AHAs? Has FDA conducted research on the safety of AHAs? How can AHAs be used safely? How can I know if a product contains AHAs?

The following information is intended to answer questions about alpha hydroxy acids, also known as AHAs, which are often used as ingredients in cosmetic and drug products applied to the skin. Why are AHAs used in some cosmetics? Products containing AHAs are marketed for a variety of purposes, such as smoothing fine lines and surface wrinkles, improving skin texture and tone, unblocking and cleansing pores, and improving skin condition in general. Sometimes AHAs are used in cosmetics for other purposes, such as to adjust the pH (the degree of acidity or alkalinity). How do AHAs work? AHA-containing products cause exfoliation, or shedding of the surface skin. The extent of exfoliation depends on the type and concentration of the AHA, its pH, and other ingredients in the product. What about products that contain AHAs and are marketed with therapeutic claims? Some products containing AHAs have been marketed for uses such as treating acne, removing scars, and lightening discolorations. Among these are some products marketed as "skin peelers," which may contain relatively high concentrations of AHAs or other acids and are designed to remove the outer layer of the skin. Products that are intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease, or to affect the structure or any function of the body are drugs under the law (Federal Food, Drug, and Cosmetic Act, Sec. 201(g)). For example, products intended for use as acne treatments or skin lighteners are considered drugs. For more on this subject, see Is It a Cosmetic, a Drug, or Both? (or Is It Soap?) and the Warning Letter issued to Global Esthetics (available in PDF (230KB)). Has FDA received reports of adverse events related to AHAs? FDA received a total of 114 adverse dermatologic experience reports for AHA-containing skin care products between 1992 and February 2004, with the maximum number in 1994. The reported adverse experiences included burning (45), dermatitis or rash (35), swelling (29), pigmentary changes (15), blisters or welts (14), skin peeling (13), itching (12), irritation or tenderness (8), chemical burns (6), and increased sunburn (3). The frequency of such reports for skin exfoliating products that contain AHAs has been considerably lower in subsequent years. The more serious adverse reactions appear to occur most often with products that cause the greatest degree of exfoliation, such as "skin peelers." Has FDA conducted research on the safety of AHAs? 5

Yes. These studies (1) compared the effect of AHAs, topically applied in a cream, on the sensitivity of human skin to ultraviolet (UV) radiation with the effect of the same cream containing no AHAs, (2) measured how fast the skin returns to normal after use of the AHA-containing cream is discontinued, and (3) investigated whether AHAs enhance UV-induced damage to DNA in the skin (Kays Kaidbey, Betsy Sutherland, Paula Bennett, Wayne G. Wamer, Curtis Barton, Donna Dennis, and Andrija Kornhauser, Topical glycolic acid enhances photodamage by ultraviolet light, Photodermatology, Photoimmunology and Photomedicine, vol. 19 (2003), issue 1, pages 21-27). These studies confirmed previous industry studies indicating that applying AHAs to the skin results in increased UV sensitivity. After four weeks of AHA application, volunteers' sensitivity to skin reddening produced by UV increased by 18 percent. Similarly, the volunteers' sensitivity to UVinduced cellular damage doubled, on average, with considerable differences among individuals. However, the studies also indicated that this increase in sensitivity is reversible and does not last long after discontinuing use of the AHA cream. One week after the treatments were halted, researchers found no significant differences in UV sensitivity among the various skin sites. The studies did not identify exactly how AHAs bring about the increased UV sensitivity, although the effects did not appear to involve dramatic increases in UV-induced damage to DNA in the skin. Previous FDA studies have indicated that a cosmetic-type cream base caused an AHA to penetrate more deeply into the skin when compared to an AHA solution without the usual cosmetic ingredients. However, further studies will be needed to learn how much, if at all, those cosmetictype ingredients influence the AHA-related effects on UV sensitivity. FDA also has collaborated with the National Toxicology Program (NTP) to assess the safety of the long-term use of AHAs. This study determined that glycolic acid did not affect photocarcinogenesis (the development of cancer cells associated with exposure to light) in mice, and that salicyclic acid had a photoprotective effect (protected against the effects of light) in mice. The complete results of this study are available in the NTP Technical Report on the Photocarcinogenesis Study of Glycolic Acid and Salicylic Acid (CAS NOS. 79-14-1 and 69-72-7) in SKH-1 Mice (available in PDF(1.9MB)). FDA continues to review available data on AHAs to address the potential for this increased skin sensitivity to the sun. How can AHAs be used safely? It is important to follow directions carefully and heed any warning statements on the label when using any cosmetic product. If you are using AHAs, it is advisable to use sun protection. In January 2005, FDA issued Guidance for Industry: Labeling of Cosmetics Containing Alpha Hydroxy Acids as Ingredients. The purpose of this guidance is to educate consumers about the potential for increased skin sensitivity to the sun from the topical use of cosmetics containing AHAs and to educate manufacturers to help ensure that their labeling for these products is not false or misleading. FDA recommends that the labeling of a cosmetic product that contains an AHA as an ingredient and that is topically applied to the skin or mucous membrane, such as the lips, bear a statement that conveys the following information: Sunburn Alert: This product contains an alpha hydroxy acid (AHA) that may increase your skin's sensitivity to the sun and particularly the possibility of sunburn. Use a sunscreen, wear protective clothing, and limit sun exposure while using this product and for a week afterwards. Based on industry-sponsored studies, the Cosmetic Ingredient Review (CIR) Expert Panel — the industry's self-regulatory body for reviewing the safety of cosmetic ingredients — concluded that products containing the AHAs glycolic and lactic acid are safe for use by consumers if: • The AHA concentration is 10 percent or less. • The final product has a pH of 3.5 or greater. • The final product is formulated in such a way that it protects the skin from increased sun sensitivity or its package directions tell consumers to use daily protection from the sun. 6

How can I know if a cosmetic product contains AHAs? Under the authority of the Fair Packaging and Labeling Act (FPLA), FDA requires an ingredient declaration on cosmetic products sold at the retail level to consumers. However, because the FPLA does not apply to products used exclusively by professionals — for example, in salons — the requirement for an ingredient declaration does not apply to these products. The most common AHAs in cosmetic products are glycolic acid and lactic acid. Among others are citric acid, hydroxycaprylic acid, and hydroxycapric acid. Beta Hydroxy Acids in Cosmetics Throughout the last decade, alpha hydroxy acids (AHAs) have increasingly appeared as ingredients in cosmetics intended to reduce the signs of aging in the skin. More recently, beta hydroxy acids (BHAs), or a combination of AHAs and BHAs, have appeared as ingredients in these skin care products. While both AHAs and BHAs act as exfoliants, it has been claimed that BHAs are effective in reducing the appearance of fine lines and wrinkles, and improving overall skin texture, without the occasional irritation associated with the use of AHAs. BHA ingredients may be listed as • salicylic acid (or related substances, such as salicylate, sodium salicylate, and willow extract) * • beta hydroxybutanoic acid • tropic acid • trethocanic acid Currently, the BHA most commonly used in cosmetics is salicylic acid. On rare occasions, citric acid is also cited as a BHA in cosmetic formulations. More commonly, citric acid is referred to as an AHA. The safety of salicylic acid used as a cosmetic ingredient has been evaluated by both the cosmetic industry and FDA. At a meeting in February 2000, the Cosmetic Ingredient Review (CIR) Expert Panel, the cosmetic industry's independent body for reviewing the safety of cosmetic ingredients, reached the tentative conclusion that the use of salicylic acid related substances in cosmetics is "safe as used when formulated to avoid irritation and when formulated to avoid increased sun sensitivity." CIR added that "when sun sensitivity would be expected, directions for use [should] include the daily use of sun protection." In other words, according to CIR Director Alan Andersen, products containing salicylic acid should either contain a sunscreen or bear directions advising consumers to use other sun protection. In order to comply with the CIR recommendations, cosmetic manufacturers should test their products to determine whether or not they cause an increase in sensitivity to the harmful ultraviolet radiation in sunlight. The long-term safety of salicylic acid in cosmetics also is being evaluated in studies initiated by FDA and sponsored by the National Toxicology Program. These government-sponsored studies are examining the long-term effects of both glycolic acid (an AHA) and salicylic acid on the skin's response to ultraviolet (UV) light. These studies have determined that applying glycolic acid to the skin can make people more susceptible to the damaging effects of the sun, including sunburn. Until these safety assessments are completed, FDA advises that similar precautions be taken for the use of cosmetics containing AHAs and BHAs. These precautions are: • Test any product that contains a BHA on a small area of skin before applying it to a large area. If you use cosmetics with BHAs and experience skin irritation or prolonged stinging, stop using the product and consult your physician. • Follow the use instructions on the label. Do not exceed the recommended applications. 7

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Avoid using BHA-containing products on infants and children. Use sun protection if you use a BHA product.

Consumers should report any adverse reactions, such as irritation or sun sensitivity, associated with the use of BHAs to their local FDA office, listed in the Blue Pages of the phone book, or to FDA's Office of Consumer Affairs at 1-800-532-4440.+ If you have purchased a product whose outer packaging has become separated from the product and you are unsure whether it contains BHAs, call the manufacturer, whose phone number may be listed on the inner packaging. *

From a chemist's perspective, salicylic acid is not a true BHA. However, cosmetic companies often refer to it as a BHA and, consequently, many consumers think of it as one. See also: Information About Suntan Products, Sunscreens, and Tanning

Color Additives and Cosmetics More information on - Color Additives - Color Additives and Cosmetics Color additives are subject to a strict system of approval under U.S. law [FD&C Act, sec. 721; 21 U.S.C. 379e]. Except in the case of coal-tar hair dyes, failure to meet U.S. color additive requirements causes a cosmetic to be adulterated [FD&C Act, sec. 601(e); 21 U.S. Code 361(e)]. Color additive violations are a common reason for detaining imported cosmetic products offered for entry into this country. Some Basic Requirements If your product (except coal-tar hair dyes) contains a color additive, by law [FD&C Act, Sec. 721; 21 U.S.C. 379e; 21 CFR Parts 70 and 80] you must adhere to requirements for: • Approval. All color additives used in cosmetics (or any other FDA-regulated product) must be approved by FDA. There must be a regulation specifically addressing a substance's use as a color additive, specifications, and restrictions. • Certification. In addition to approval, a number of color additives must be batch certified by FDA if they are to be used in cosmetics (or any other FDA-regulated product) marketed in the U.S. • Identity and specifications. All color additives must meet the requirements for identity and specifications stated in the Code of Federal Regulations (CFR). • Use and restrictions. Color additives may be used only for the intended uses stated in the regulations that pertain to them. The regulations also specify other restrictions for certain colors, such as the maximum permissible concentration in the finished product. How are color additives categorized? The FD&C Act Section 721(c) [21 U.S. C. 379e(c)] and color additive regulations [21 CFR Parts 70 and 80] separate approved color additives into two main categories: those subject to certification (sometimes called "certifiable") and those exempt from certification. In addition, the regulations refer to other classifications, such as straight colors and lakes. 8

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Colors subject to certification. These color additives are derived primarily from petroleum and are sometimes known as "coal-tar dyes" or "synthetic-organic" colors. (NOTE: Coal-tar colors are materials consisting of one or more substances that either are made from coal-tar or can be derived from intermediates of the same identity as coal-tar intermediates. They may also include diluents or substrata. (See Federal Register, May 9, 1939, page 1922.) Today, most are made from petroleum.) o Except in the case of coal-tar hair dyes, these colors must not be used unless FDA has certified that the batch in question has passed analysis of its composition and purity in FDA's own labs. If the batch is not FDA-certified, don't use it. o These certified colors generally have three-part names. The names include a prefix FD&C, D&C, or External D&C; a color; and a number. An example is "FD&C Yellow No. 5." Certified colors also may be identified in cosmetic ingredient declarations by color and number alone, without a prefix (such as "Yellow 5"). Colors exempt from certification. These color additives are obtained primarily from mineral, plant, or animal sources. They are not subject to batch certification requirements. However, they still are considered artificial colors, and when used in cosmetics or other FDA-regulated products, they must comply with the identity, specifications, uses, restrictions, and labeling requirements stated in the regulations [21 CFR 73]. Straight color. "Straight color" refers to any color additive listed in 21 CFR 73, 74, and 81 [21 CFR 70.3(j)]. Lake. A lake is a straight color extended on a substratum by adsorption, coprecipitation, or chemical combination that does not include any combination of ingredients made by a simple mixing process [21 CFR 70.3(l)]. Because lakes are not soluble in water, they often are used when it is important to keep a color from "bleeding," as in lipstick. In some cases, special restrictions apply to their use. As with any color additive, it is important to check the Summary of Color Additives and the regulations themselves [21 CFR 82, Subparts B and C] to be sure you are using lakes only for their approved uses.

How can I guard against color additive violations? Several precautions can help you avoid color additive violations that will cause your cosmetic to be adulterated: • Do not confuse certified colors with their uncertified counterparts. For example, FD&C Yellow No. 5 is the certified form of tartrazine, and is approved for use in cosmetics generally. But tartrazine, which has not undergone FDA analysis and received FDA certification, must not be substituted for or identified in an ingredient declaration as FD&C Yellow No. 5. • Do not confuse certified colors with colors identified only by a Colour Index (CI) number, or by the E number sometimes used in European color identification. You must not use a color subject to certification unless FDA has certified the batch in question [FD&C Act, sec. 721(a)(1)(A). A CI or E number does not indicate FDA certification. • When purchasing color additives subject to certification, check the label. If the lot is certified, the color's label must state the legal name for the color (such as "FD&C Yellow No. 5"), or, if it is a mixture, the name of each ingredient; the FDA lot certification number; and the color's uses and restrictions as stated in the CFR [21 CFR 70.25). • Check the Summary of Color Additives on FDA's Web site. Although this table is not a substitute for the regulations, it is an easy-to-use reference that introduces you to FDAapproved color additives and directs you to the regulations addressing specific color additives. • Become familiar with the regulations themselves. The color additive regulations are in 21 CFR Parts 70 through 82. Specific color additives are addressed in Parts 73, 74, and 82. 9

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The color additive regulations are posted on FDA's Web site at http://www.cfsan.fda.gov/~dms/col-cfr.html. To purchase printed copies of the CFR by credit card, call the Government Printing Office at (202) 512-1800, Monday through Friday, from 8:00 a.m. to 4:00 p.m., Eastern Standard Time. To pay by check, write to the Superintendent of Documents, Attn: New Orders, P.O. Box 371954, Pittsburgh, PA 152507954. Contact the Government Printing Office directly for current costs. Confirm the status of color additives before use. There may be changes in color additive approvals and changes in the uses and restrictions that apply to a color additive. Such changes may affect colors subject to certification as well as colors exempt from certification. To stay current with the regulations, you can check the latest edition of the CFR and FDA Dockets. You also may contact FDA at [email protected]. When purchasing colors subject to certification, confirm that the manufacturer has requested certification. For example, you can choose a manufacturer from FDA's list of companies that have requested color certification within the past two years. This list is posted on FDA's Web site at http://www.cfsan.fda.gov/~dms/col-comp.html and is available as Document #710 by mail or fax through the Center for Food Safety and Applied Nutrition Outreach and Information Center's toll-free phone number, 1-888-SAFEFOOD. If the company that appears on the color additive label is not on this list, you may contact FDA at [email protected] to determine whether the company has in fact requested certification of its color additives.

Must I match colors with intended use? Yes. No matter whether a particular color is subject to certification or exempt from certification, U.S. law prohibits its use in cosmetics (or any other FDA-regulated product) unless it is approved specifically for the intended use [FD&C Act, sec. 721(a)(1)(A); 21 U.S.C. 379e(a)(1)(A)]. The regulations also restrict intended use as follows: • Eye-area use: You may not use a color additive in the area of the eye unless the regulation for that additive specifically permits such use [21 CFR 70.5(a)]. The "area of the eye" includes "the area enclosed within the circumference of the supra-orbital ridge and the infraorbital ridge, including the eyebrow, the skin below the eyebrow, the eyelids and the eyelashes, and conjunctival sac of the eye, the eyeball, and the soft areolar tissue that lies within the perimeter of the infra-orbital ridge" [21 CFR 70.3(s)]. Although there are color additives approved for use in products such as mascara and eyebrow pencils, none is approved for dyeing the eyebrows or eyelashes. • Externally applied cosmetics: This term does not apply to the lips or any body surface covered by mucous membrane. For instance, if a color additive is approved for use in externally applied cosmetics, you may not use it in products such as lipsticks unless the regulation specifically permits this use [21 CFR 70.3 (v)]. • Injection: No color additive may be used in injections unless its listing in the regulations specifically provides for such use. This includes injection into the skin for tattooing or permanent makeup. The fact that a color additive is listed for any other use does not mean that it may be used for injections [21 CFR 70.5(b)]. There are no color additives listed in the regulations as approved for injections. What about special effects and novelty use? No matter how exotic or novel the color additive or its intended use, it is subject to the same regulations as the more everyday colors and products. The following items are a sampling of some out-of-the-ordinary color additives. This list is not exhaustive. Rather, it is intended to show how the regulations apply to such colors: 10

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Color-changing pigments: Colors that change in response to such factors as change in pH or exposure to oxygen or temperature are subject to the same regulations as all other color additives. Composite pigments: Color additives used in combination to achieve variable effects, such as those found in pearlescent products, are subject to the same regulations as all other color additives. Some color additives, when used in combination, may form new pigments, which may not be approved for the intended use. An example is a "holographic" glitter, consisting of aluminum an approved color additive bonded to an etched plastic film. Fluorescent colors: Only the following fluorescent colors are approved for use in cosmetics, and there are limits on their intended uses: D&C Orange No. 5, No. 10, and No. 11; and D&C Red No. 21, No. 22, No. 27, and No. 28 [21 CFR 74.2254, 74.2260, 74.2261, 74.2321, 74.2322, 74.2327, and 74.2328]. Glow-in-the-dark colors: Luminescent zinc sulfide is the only approved glow-in-the-dark color additive [21 CFR 73.2995]. Halloween makeup: These products are considered cosmetics [FD&C Act, sec. 201(i); 21 U.S.C. 321(i)] and are therefore subject to the same regulations as other cosmetics, including the same restrictions on color additives. Liquid crystal colors: These additives, which produce color motifs in a product through diffraction, are unapproved color additives. Their use in cosmetics is therefore illegal [FD&C Act, sec. 601(e); 21 U.S.C. 361(e)]. Tattoo pigments: As noted above, no color additives are approved for injection into the skin, as in tattoos and permanent makeup. Theatrical makeup: Like Halloween makeup, these products are considered cosmetics [FD&C Act, sec. 201(i); 21 U.S.C. 321(i)] and are therefore subject to the same regulations as other cosmetics, including the same restrictions on color additives.

Diethanolamine and Cosmetic Products The National Toxicology Program (NTP) completed a study in 1998 that found an association between the topical application of diethanolamine (DEA) and certain DEA-related ingredients and cancer in laboratory animals. For the DEA-related ingredients, the NTP study suggests that the carcinogenic response is linked to possible residual levels of DEA. The NTP study did not establish a link between DEA and the risk of cancer in humans. DEA and DEA-related ingredients function as emulsifiers or foaming agents in cosmetics, or to adjust a product's pH (acidity). Based on information filed with FDA's Voluntary Cosmetic Registration Program, it appears that DEA and DEA-related ingredients are used much less frequently in cosmetic products than they were when the NTP completed its study. Generally speaking, except for most color additives and those ingredients that are prohibited or restricted by regulation from use in cosmetics, a manufacturer may use any ingredient in the formulation of a cosmetic product provided that the ingredient and the finished cosmetic are safe, the product is properly labled, and the use of the specific substance does nototherwise cause the cosmetic to be adulterated or misbranded under the laws that FDA enforces. FDA believes that at the present time there is no reason for consumers to be alarmed based on the use of these substances in cosmetics. However, consumers wishing to avoid cosmetics containing DEA or DEA-related ingredients may do so by reviewing the ingredient statement that is required to appear on the outer container label of cosmetics offered for retail sale to consumers. The following are some of the most commonly used ingredients that may contain DEA: • Cocamide DEA • Cocamide MEA 11

• • • • • • • • •

DEA-Cetyl Phosphate DEA Oleth-3 Phosphate Lauramide DEA Linoleamide MEA Myristamide DEA Oleamide DEA Stearamide MEA TEA-Lauryl Sulfate Triethanolamine

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 Food, Drug and Cosmetic Act in protecting the health and welfare of consumers.

1,4-Dioxane What is 1,4-dioxane? Is 1,4-dioxane in cosmetic products harmful? What is FDA doing to assure that cosmetics do not contain unsafe levels of 1,4-dioxane? FDA has received questions on the subject of 1,4-dioxane, a contaminant that may occur in trace amounts in certain cosmetics. The following information has been compiled from responses to those questions, from the published scientific literature, and other public sources. What is 1,4-dioxane? The compound 1,4-dioxane is a contaminant that may be present in extremely small amounts in some cosmetics. It forms as a byproduct during the manufacturing process of certain cosmetic ingredients. These ingredients include certain detergents, foaming agents, emulsifiers and solvents identifiable by the prefix, word, or syllables "PEG," "Polyethylene," "Polyethylene glycol," "Polyoxyethylene," "-eth-," or "-oxynol-." However, 1,4-dioxane itself is not used as a cosmetic ingredient. Is 1,4-dioxane in cosmetic products harmful? The levels at which a chemical compound would be considered harmful in a cosmetic depend on the conditions of use (FD&C Act, section 601(a)). The 1,4-dioxane levels we have seen in our monitoring of cosmetics do not present a hazard to consumers. Concerns initially were raised in the 1970s, when studies at the National Cancer Institute found an association between1,4-dioxane and cancer in animals when 1,4-dioxane was administered in high levels in the animal feed. However, the levels in cosmetic products are far lower than those found to be harmful in feeding studies and, for the most part, the types of products in which it is found are only in contact with the skin for a short time. As a precaution, FDA followed up with skin absorption studies, which showed that 1,4-dioxane can penetrate animal and human skin when applied in certain preparations, such as lotions. However, further research by FDA determined that 1,4-dioxane evaporates readily, further diminishing the already small amount available for skin absorption, even in products that remain on the skin for hours. (Robert L. Bronaugh, "Percutaneous Absorption of Cosmetic Ingredients," in Principles of Cosmetics for the Dermatologist, Philip Frost, M.D., and Steven Horwitz, M.D., Eds. St. Louis: The C.V. Mosby Company, 1982) 12

What is FDA doing to assure that cosmetics do not contain unsafe levels of 1,4-dioxane? FDA has been monitoring this issue since the late 1970s. We periodically monitor the levels of 1,4dioxane in cosmetic products, and have observed that the changes made in the manufacturing process have resulted in a significant decline in the levels of this contaminant. (Roderick E. Black, Fred J. Hurley and Donald C. Havery, "Occurrence of 1,4-Dioxane in Cosmetic Raw Materials and Finished Cosmetic Products," Journal of AOAC International, 84 (3), 2001, pp. 666-667) FDA has not established or recommended a specific limit on the level of 1,4-dioxane in cosmetics. We have provided guidance to manufacturers alerting them to the health concerns and how to minimize 1,4-dioxane by means of a process called "vacuum stripping" at the end of the polymerization process. This information has been posted on our website in the Cosmetic Handbook for Industry: Cosmetic Product-Related Regulatory Requirements and Health Hazard Issues. We also provide FDA inspectors with information on this procedure in our Guide to Inspections of Cosmetic Product Manufacturers so that when they conduct inspections they will know what to look for and what questions to ask. If FDA were to determine that a health hazard exists, it would advise the industry and the public, and would consider its legal options for protecting the health and welfare of consumers. For more on the subject of cosmetic safety and the law, see FDA Authority Over Cosmetics, Key Legal Concepts: "Interstate Commerce," "Adulterated," and "Misbranded", and the cosmetics provisions of the Federal Food, Drug, and Cosmetic Act.

Eye Cosmetic Safety (This document in Arabic (August 1, 2001)) Eye cosmetics are intended to make eyes more attractive, or in some cases to cleanse the eye area. One thing they shouldn't do is cause harm. Most are safe when used properly. However, there are some things to be careful about when using these products, such as the risk of infection, the risk of injury from the applicator, and the use of unapproved color additives. The following information provides an introduction to some safety concerns and legal issues related to eye cosmetics. Keep it clean! Eye cosmetics are usually safe when you buy them, but misusing them can allow dangerous bacteria or fungi to grow in them. Then, when applied to the eye area, a cosmetic can cause an infection. In rare cases, women have been temporarily or permanently blinded by an infection from an eye cosmetic. See the Safety Checklist below for tips on keeping your eye cosmetics clean and protecting against infections. Occasionally, contamination can be a problem for some eye cosmetics even when they are new. FDA has an Import Alert in effect for cosmetics -- including eye cosmetics -- contaminated with harmful microorganisms. Don't share! Don't swap! Don't share or swap eye cosmetics -- not even with your best friend. Another person's germs may be hazardous to you. The risk of contamination may be even greater with "testers" at retail stores, where a number of people are using the same sample product. If you feel you must sample cosmetics at a store, make sure they are applied with single-use applicators, such as clean cotton swabs. 13

Hold still! It may seem like efficient use of your time to apply makeup in the car or on the bus, but resist that temptation, even if you're not in the driver's seat. If you hit a bump, come to a sudden stop, or are hit by another vehicle, you risk injuring your eye (scratching your cornea, for example) with a mascara wand or other applicator. Even a slight scratch can result in a serious infection. What's in it? As with any cosmetic product sold on a retail basis to consumers, eye cosmetics are required to have an ingredient declaration on the label, according to regulations implemented under the Fair Packaging and Labeling Act, or FPLA -- an important consumer protection law. If you wish to avoid certain ingredients or compare the ingredients in different brands, you can check the ingredient declaration. If a cosmetic sold on a retail basis to consumers does not have an ingredient declaration, it is considered misbranded and is illegal in interstate commerce. Very small packages in tightly compartmented display racks may have copies of the ingredient declaration available on tear-off sheets accompanying the display. If neither the package nor the display rack provides the ingredient declaration, you aren't getting the information you're entitled to. Don't hesitate to ask the store manager or the manufacturer why not. What's that shade you're wearing? In the United States, the use of color additives is strictly regulated. A number of color additives approved for cosmetic use in general are not approved for use in the area of the eye. An import alert for cosmetics containing illegal colors lists several eye cosmetics. Keep away from kohl -- and keep kohl away from kids! One color additive of particular concern is kohl. Also known as al-kahl, kajal, or surma, kohl is used in some parts of the world to enhance the appearance of the eyes, but is unapproved for cosmetic use in the United States. Kohl consists of salts of heavy metals, such as antimony and lead. It may be tempting to think that because kohl has been used traditionally as an eye cosmetic in some parts of the world, it must be safe. However, there have been reports linking the use of kohl to lead poisoning in children.* An FDA Import Alert cites three main reasons for detaining imports of kohl: 1. For containing an unsafe color additive, which makes the product adulterated. 2. For labeling that describes the product falsely as "FDA Approved." 3. For lack of an ingredient declaration. Some eye cosmetics may be labeled with the word "kohl" only to indicate the shade, not because they contain true kohl. If the product is properly labeled, you can check to see whether the color additives declared on the label are in FDA's list of color additives approved for use in cosmetics, then make sure they are listed as approved for use in the area of the eye. Dying to dye your eyelashes? Permanent eyelash and eyebrow tints and dyes have been known to cause serious eye injuries, including blindness. There are no color additives approved by FDA for permanent dyeing or tinting of eyelashes and eyebrows. FDA has an Import Alert in effect for eyelash and eyebrow dyes containing coal tar colors. 14

Thinking of false eyelashes or extensions? FDA considers false eyelashes, eyelash extensions, and their adhesives to be cosmetic products, and as such they must adhere to the safety and labeling requirements for cosmetics. False eyelashes and eyelash extensions require adhesives to hold them in place. Remember that the eyelids are delicate, and an allergic reaction, irritation, or other injury in the eye area can be particularly troublesome. Check the ingredients before using these adhesives. Bad Reaction? If you have a bad reaction to eye cosmetics, first contact your healthcare provider. FDA also encourages consumers to report any adverse reactions to cosmetics either to their nearest FDA district office or to FDA's Center for Food Safety and Applied Nutrition (CFSAN) Adverse Event Reporting System (CAERS). Here's how: • To contact your nearest FDA district office, you can find their phone numbers on FDA's Web site. These phone numbers also are included in the U.S. Government listings in the Blue Pages of the phone book under United States Government/Health and Human Services. • To contact FDA's Center for Food Safety and Applied Nutrition (CFSAN) Adverse Event Reporting System (CAERS), call (301) 436-2405 or email [email protected]. Safety Checklist If you use eye cosmetics, FDA urges you to follow these safety tips: • If any eye cosmetic causes irritation, stop using it immediately. If irritation persists, see a doctor. • Avoid using eye cosmetics if you have an eye infection or the skin around the eye is inflamed. Wait until the area is healed. Discard any eye cosmetics you were using when you got the infection. • Be aware that there are bacteria on your hands that, if placed in the eye, could cause infections. Wash your hands before applying eye cosmetics. • Make sure that any instrument you place in the eye area is clean. • Don't share your cosmetics. Another person's bacteria may be hazardous to you. • Don't allow cosmetics to become covered with dust or contaminated with dirt or soil. Keep containers clean. • Don't use old containers of eye cosmetics. Manufacturers usually recommend discarding mascara two to four months after purchase. • Discard dried-up mascara. Don't add saliva or water to moisten it. The bacteria from your mouth may grow in the mascara and cause infection. Adding water may introduce bacteria and will dilute the preservative that is intended to protect against microbial growth. • Don't store cosmetics at temperatures above 85 degrees F. Cosmetics held for long periods in hot cars, for example, are more susceptible to deterioration of the preservative. • When applying or removing eye cosmetics, be careful not to scratch the eyeball or other sensitive area. Never apply or remove eye cosmetics in a moving vehicle. • Don't use any cosmetics near your eyes unless they are intended specifically for that use. For instance, don't use a lip liner as an eye liner. You may be exposing your eyes to contamination from your mouth, or to color additives that are not approved for use in the area of the eye. • Avoid color additives that are not approved for use in the area of the eye, such as "permanent" eyelash tints and kohl. Be especially careful to keep kohl away from children, since reports have linked it to lead poisoning 15

Kohl, Kajal, Al-Kahl, or Surma: By Any Name, Beware of Lead Poisoning Many people are aware of some of the most common and best known sources of lead poisoning, such as lead paint and fumes from leaded gasoline. But many may be unaware of the risk of lead poisoning, in both adults and children, from an easily avoidable source: the traditional eye cosmetic known variously as kohl, kajal, al-kahl, or surma. The following information is intended to answer questions people may ask about kohl and its dangers: What is kohl made of? Samples tested often contain significant amounts of lead. Lead sometimes accounts for more than half the weight of a sample of kohl, usually in the form of lead sulfide. Kohl may also contain a variety of other materials, such as aluminum, antimony, carbon, iron, and zinc compounds, as well as camphor and menthol.1, 2, 6, 7, 8, 9, 10, 11 What are the effects of lead poisoning? The risks associated with exposure to lead are especially serious for children, who are particularly susceptible to absorbing lead from the environment. Among the effects associated with high levels of exposure are anemia, kidney problems, and neurological damage that may include seizures, coma and death. Even at relatively low levels, chronic exposure to lead may lead to learning and behavior problems (see Dangers of Lead Still Linger," FDA Consumer, January-February 1998). Is kohl directly linked to increased levels of lead in children? Yes. FDA has learned of recent instances of kohl-related lead poisoning in children in the U.S. A number of studies have shown that children exposed to kohl have increased levels of lead in their blood.3, 4, 9, 11 This exposure puts them at increased risk for the serious consequences of lead poisoning. How are children exposed to kohl? In some cultures, it is common for parents to apply kohl to the eyes of infants and children. Infants of mothers who use kohl sometimes have elevated levels of lead in their blood. 9, 11 Also, some people traditionally paint a newborn's umbilical stump with kohl, supposedly for medicinal reasons. 3, 4

Unlike some sources of exposure to lead, this one is easily avoidable by not using kohl on your children or yourself, and keeping it out of your home. If someone in my family has been exposed to kohl, what should I do? Stop all use of kohl immediately and be especially careful to protect children from further exposure. Place unused kohl in a sealable container or plastic bag and contact your local sanitation or waste department regarding appropriate methods for disposal. Thoroughly wash hands and any other body parts that may have come in contact with kohl. Wash exposed household surfaces with soap and hot water. Ask a health care provider to test children as well as pregnant or nursing women for lead poisoning if they have used kohl. Is kohl legal in the U.S.? No. Kohl is a color additive as that term is defined in the Federal Food, Drug and Cosmetic Act (FD&C Act), and there is no regulation permitting its use in a cosmetic or in any other FDAregulated product. Color additives (other than coal-tar hair dyes) that are not permitted by regulation are considered unsafe under the law. (For more information on color additives and the law, see the FD&C Act, sections 201(t) and 721 as well as FDA's Color Additives Web site. 16

FDA has an Import Alert in effect for cosmetics containing kohl, not only because it is an unsafe color additive, but also because of labeling violations. For example, some samples have been labeled with the false statement, "FDA Approved." Such products are subject to detention and refusal of admission at U.S. ports of entry. NOTE: Some manufacturers may label eye cosmetics with the term "kohl" simply to indicate the shade, not because the product actually contains kohl. If the product is properly labeled, consumers can check the ingredient declaration to determine whether it contains only color additives that are approved for cosmetic use in the area of the eye. If no color additives are declared, it would be wise to stay on the safe side and assume that the product is, in fact, kohl. Where does kohl come from? Popular in much of the world since ancient times, particularly in parts of Africa, the Middle East, Iran, Pakistan, and India, kohl now sometimes appears in Europe and North America, especially in some Middle Eastern and Asian specialty markets. Despite its illegal status in the U.S., it may be imported surreptitiously, for example, in personal luggage. It also has been advertised for mail order on some Web sites. Where can I learn more about lead poisoning? The following are some useful resources: FDA: •

"Dangers of Lead Still Linger," FDA Consumer, January-February 1998

Centers for Disease Control and Prevention: • Lead Poisoning Prevention Program Environmental Protection Agency: • Traditional remedies reported to contain lead Use Eye Cosmetics Safely Printer-friendly PDF (342 KB) The Food and Drug Administration (FDA)regulates all cosmetics marketed in the United States, including mascara, eye shadows, eye liner, concealers, and eyebrow pencils. Safety experts within the Office of Cosmetics and Colors in FDA's Center for Food Safety and Applied Nutrition (CFSAN) offer consumers the following advice: Keep everything clean. Dangerous bacteria or fungi can grow in some cosmetic products, as well as their containers. Cleanliness can help prevent eye infections. Always wash your hands before applying eye cosmetics, and be sure that any instrument you place near your eyes is clean. Be especially careful not to contaminate cosmetics by introducing microorganisms. For example, don't lay an eyelash wand on a countertop where it can pick up bacteria. Keep containers clean, since these may also be a source of contamination. Don't moisten cosmetic products. Don't add saliva or water to moisten eye cosmetics. Doing so can introduce bacteria. Problems can arise if you overpower a product's preservative capability. Don't share or swap. People can be harmed by others' germs when they share eye makeup. Keep this in mind when you come across "testers" at retail stores. If you do sample cosmetics at a store, be sure to use single-use applicators, such as clean cotton swabs. Don't apply or remove eye makeup in a moving vehicle. Any bump or sudden stop can cause injury to your eye with a mascara wand or other applicator. 17

Check ingredients, including color additives. As with any cosmetic product sold to consumers, eye cosmetics are required to have an ingredient declaration on the label. If they don't, they are considered misbranded and illegal. In the United States, the use of color additives is strictly regulated. Some color additives approved for cosmetic use in general are not approved for areas near the eyes. If the product is properly labeled, you can check to see whether the color additives declared on the label are in FDA's List of Color Additives Approved for Use in Cosmetics. (Under "For More Information" below, see "Color Additives Approved for Use in Cosmetics" and "FDA's Import Alert for Cosmetics Containing Illegal Colors.") Use only cosmetics intended for the eyes on the eyes. Don't use a lip liner as an eye liner, for example. You may expose eyes either to contamination from your mouth or to color additives that are not approved for use near the eyes. Say "no" to kohl! Also known as al-kahl, kajal, or surma, kohl is used in some parts of the world for enhancing the appearance of the eyes. But kohl is unapproved for cosmetic use in the United States. Kohl contains salts of heavy metals such as antimony and lead. Reports have linked the use of kohl to lead poisoning in children. Some eye cosmetics may be labeled with the word "kohl" only to indicate the shade, not because they contain true kohl. A product's "ingredient statement" should not list kohl—this is not an FDA-approved color additive. Check the ingredient statement to make sure that kohl is not present. Don't dye eyelashes and eyebrows. No color additives are approved by FDA for permanent dyeing or tinting of eyelashes and eyebrows. Permanent eyelash and eyebrow tints and dyes have been known to cause serious eye injuries. Use care with false eyelashes or extensions. False eyelashes and extensions, as well as their adhesives, must meet the safety and labeling requirements for cosmetics. Since the eyelids are delicate, an allergic reaction, irritation, or injury in the eye area can occur. Check the ingredients to make sure you are not allergic to the adhesives. Don't use eye cosmetics that cause irritation. Stop using a product immediately if irritation occurs. See a doctor if irritation persists. Avoid using eye cosmetics if you have an eye infection. Discard any eye cosmetics you were using when you got the infection. Also, don't use eye cosmetics if the skin around the eye is inflamed. Don't use old eye cosmetics. Manufacturers usually recommend discarding mascara two to four months after purchase. Discard dried-up mascara. Don't store cosmetics at temperatures above 85° F. Preservatives that keep bacteria or fungi from growing can lose their effectiveness, for example, in cosmetics kept for long periods in hot cars

Hair Removal The following is excerpted from FDA Consumer, March-April 2007: Warnings for Makers of Compounded Pain Products: Removing Hair Safely The FDA's Center for Devices and Radiological Health regulates electrolysis equipment and lasers. Chemical depilatories, waxes, and shaving creams and gels fall under the jurisdiction of the FDA's Office of Cosmetics and Colors in the Center for Food Safety and Applied Nutrition. The practice of professional hair removal is generally regulated by state and local authorities. Here are some tips related to common methods of hair removal. 18

Laser Hair Removal In this method, a laser destroys hair follicles with heat. Lasers are prescription devices that should be used only under the direction of a licensed practitioner. If a topical anesthetic product is recommended before a laser hair removal procedure to minimize pain, the FDA recommends that consumers discuss the circumstances under which the cream should be used with a medical professional, and whether the use is appropriate. Those who decide to use a skin-numbing product should follow the directions of a health care provider and consider using a product that contains the lowest amount of anesthetic drugs possible. The FDA's Center for Drug Evaluation and Research has received reports of serious and life-threatening side effects after use of large amounts of skinnumbing products for laser hair removal. Side effects of laser hair removal can include blistering, discoloration after treatment, swelling, redness, and scarring. Sunlight should be avoided during healing after the procedure. Epilators: Needle, Electrolysis, and Tweezer Needle epilators introduce a fine wire close to the hair shaft, under the skin, and into the hair follicle. An electric current travels down the wire and destroys the hair root at the bottom of the follicle, and the loosened hair is removed with tweezers. Medical electrolysis devices destroy hair growth with a shortwave radio frequency after a thin probe is placed in the hair follicle. Risks from these methods include infection from an unsterile needle and scarring from improper technique. Electrolysis is considered a permanent hair removal method, since it destroys the hair follicle. It requires a series of appointments over a period of time. Tweezer epilators also use electric current to remove hair. The tweezers grasp the hair close to the skin, and energy is applied at the tip of the tweezer. There is no body of significant information establishing the effectiveness of the tweezer epilator to permanently remove hair. Depilatories Available in gel, cream, lotion, aerosol, and roll-on forms, depilatories are highly alkaline (or, in some cases, acidic) formulations that affect the protein structure of the hair, causing it to dissolve into a jellylike mass that the user can easily wipe from the skin. Consumers should carefully follow instructions and heed all warnings on the product label. For example, manufacturers typically recommend conducting a preliminary skin test for allergic reaction and irritation. Depilatories should not be used for eyebrows or around eyes or on inflamed or broken skin. The FDA's Office of Cosmetics and Colors has received reports of burns, blisters, stinging, itchy rashes, and skin peeling associated with depilatories and other types of cosmetic hair removers. Waxing, Sugaring, and Threading Unlike chemical depilatories that remove hair at the skin's surface, these methods pluck hairs out of the follicle, below the surface. With waxing, a layer of melted wax is applied to the skin and allowed to harden. (Cold waxes, which are soft at room temperature, allow the user to skip the steps of melting and hardening.) It is then pulled off quickly in the opposite direction of the hair growth, taking the uprooted hair with it. Labeling of waxes may caution that these products should not be used by people with diabetes and circulatory problems. Waxes should not be used over varicose veins, moles, or warts. Waxes also shouldn't be used on eyelashes, the nose, ears, or on nipples, genital areas, or on irritated, chapped, or sunburned skin. As with chemical depilatories, it can be a good idea to do a preliminary test on a small area for allergic reaction or irritation. Sugaring is similar to waxing. A heated sugar mixture is spread on the skin, sometimes covered with a strip of fabric, and then lifted off to remove hair. Threading is an ancient technique in which a loop of thread is rotated across the skin to pluck the hair. All of these techniques may cause skin irritation and infection.

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Shaving Shaving hair only when it's wet, and shaving in the direction in which the hairs lie, can help lessen skin irritation and cuts. It's important to use a clean razor with a sharp blade. Contrary to popular belief, shaving does not change the texture, color, or growth rate of hair. Razors and electric shavers are under the jurisdiction of the Consumer Product Safety Commission.

Hair Dye Products Hair dye products may be divided into three categories, i.e., permanent, semi-permanent and temporary hair colors. Permanent hair colors are the most popular hair dye products. They may be further divided into oxidation hair dyes and progressive hair dyes. Oxidation hair dye products consist of (1) a solution of dye intermediates, e.g., p-phenylenediamine, which form hair dyes on chemical reaction, and preformed dyes, e.g., 2-nitro-p-phenylenediamine, which already are dyes and are added to achieve the intended shades, in an aqueous, ammoniacal vehicle containing soap, detergents and conditioning agents; and, (2) a solution of hydrogen peroxide, usually 6%, in water or a cream lotion. The ammoniacal dye solution and the hydrogen peroxide solution, often called the developer, are mixed shortly before application to the hair. The applied mixture causes the hair to swell and the dye intermediates (and preformed dyes) penetrate the hair shaft to some extent before they have fully reacted with each other and the hydrogen peroxide and formed the hair dye. Progressive hair dye products contain lead acetate as the active ingredient. Lead acetate is approved as a color additive for coloring hair on the scalp at concentrations not exceeding 0.6% w/v, calculated as metallic lead (21 CFR 73.2396). Bismuth citrate, the other approved color additive (21 CFR 73.2110), is used to a much lesser extent. Progressive hair dyes change the color of hair gradually from light straw color to almost black by reacting with the sulfur of hair keratin as well as oxidizing on the hair surface. Semi-permanent and temporary hair coloring products are solutions (on rare occasions dry powders) of various coal-tar, i.e. synthetic organic, dyes which deposit and adhere to the hair shaft to a greater or lesser extent. Temporary hair colors must be reapplied after each shampooing. The vehicle may consist of water, organic solvents, gums, surfactants and conditioning agents. The coal-tar dyes are either listed and certified colors additives or dyes for which approval has not been sought. The dyes may not be non-permitted metallic salts or vegetable substances. A hair dye product containing a non-approved coal-tar color (but not a non-approved metallic or vegetable dye) which is known to cause adverse reactions under conditions of use cannot be considered adulterated if the label bears the caution statement provided in section 601(a) of the FD&C Act and offers adequate directions for preliminary patch testing by consumers for skin sensitivity. The caution statement reads as follows: Caution - This product contains ingredients which may cause skin irritation on certain individuals and a preliminary test according to accompanying directions should first be made. This product must not be used for dyeing the eyelashes or eyebrows; to do may cause blindness. If the label of a coal-tar color-containing hair dye product does not bear the caution statement of section 601(a) and the patch testing directions, it may be subject to regulatory action if it is determined to be harmful under customary conditions of use. Several coal-tar hair dye ingredients have been found to cause cancer in laboratory animals. In the case of 4-methoxy-m-phenylenediamine (4-MMPD, 2,4-diaminoanisole) which had also been demonstrated in human and animal studies to penetrate the skin, the agency considered the risk associated with its use in hair dyes a "material fact" which should be made known to consumers. The regulation requiring a label warning on hair dye products containing 4-MMPD published in 20

October 1979 was to become effective April 16, 1980. The regulation required that hair dyes containing 4-MMPD bear the following warning: Warning - Contains an ingredient that can penetrate your skin and has been determined to cause cancer in laboratory animals. Some hair dyes manufacturers held that the potential risk was too small to be considered "material" and challenged the validity of the regulation in court. The agency decided to reconsider its earlier position, entered into a consent agreement with hair dye manufacturers, and stayed the effectiveness of the regulation until completion of an assessment of the carcinogenic risk of 4MMPD in accordance with scientifically accepted procedures. In addition to 4-MMPD, the following other hair dye ingredients have been reported to cause cancer in at least one animal species in lifetime feeding studies: 4-chloro-m-phenylenediamine, 2,4-toluenediamine, 2-nitro-p-phenylenediamine and 4-amino-2-nitrophenol. They were also found to penetrate human and animal skin.

Heading Off Hair-Care Disasters: Use Caution With Relaxers and Dyes By Michelle Meadows It's never a good sign when the hairdresser panics. That's what happened to Barbara CabreraAvila, 38, when she returned to the salon about six weeks after having her hair straightened a couple of years ago. The cause for alarm: several bald spots in the back of her head. The Adelphi, Md., resident began having her curls straightened at the age of six so her hair would be easier to comb and style. She says over-processed hair likely played a role in her hair loss, and stress could have been a factor. What's certain is that three dermatologists advised her to take a break from hair straighteners, also known as relaxers. Barbara says giving up the straight hair she had grown comfortable with wasn't easy. After all, people's personal preferences about how they want to look tie into self-esteem--a fact that makes for good sales in the hair business. In addition to paying for trims and cuts to achieve a certain look, consumers spend millions of dollars each year to get hair that's different from what nature intended--whether it's to tame tight curls, give flat hair a boost, or get rid of the gray. According to the Food and Drug Administration's Office of Cosmetics and Colors, hair straighteners and hair dyes are among its top consumer complaint areas. Complaints range from hair breakage to symptoms warranting an emergency room visit. Reporting such complaints is voluntary, and the reported problem is often due to incorrect use of a product rather than the product itself. FDA encourages consumers to understand the risks that come with using hair chemicals, and to take a proactive approach in ensuring their proper use. The agency doesn't have authority under the Federal Food, Drug, and Cosmetic Act to require premarket approval for cosmetics, but it can take action when safety issues surface. When the Product Is the Problem When consumers notify FDA of problems with cosmetics, the agency evaluates evidence on a case-by-case basis and determines if follow-up is needed, says Allen Halper, an FDA consumer safety officer. FDA looks for patterns of complaints or unusual or severe reactions. The agency may conduct an investigation, and if the evidence supports regulatory action, FDA may request removal of a cosmetic from the market. Take the example of two popular hair relaxer products by World Rio Corp.--the Rio Naturalizer System (Neutral Formula) and the Rio Naturalizer System with Color Enhancer (Black/Licorice). After receiving complaints about these products in November and December of 1994, FDA warned the public against using them. Consumers complained of hair loss, scalp irritation, and discolored hair. 21

In December 1994, the World Rio Corp., Inc. of Los Angeles, Calif., announced that it stopped sales and shipments of the product. But reports indicated that the company continued to take orders, and the California Department of Health also stepped in to stop sales. In January of 1995, the U.S. Attorney's Office in Los Angeles filed a seizure action against these products on behalf of FDA. By then, the agency had received more than 3,000 complaints about the Rio products. Although most relaxers are alkaline, this product was formulated to be acidic. In the resulting consent decree of condemnation and permanent injunction, FDA alleged that the products were potentially harmful or injurious when used as intended, that they were more acidic than declared in the labeling, and that the labeling described the products as "chemical free" when "allegedly they contained ingredients commonly understood to be 'chemicals.'" Safer Straightening FDA has received complaints about scalp irritation and hair breakage related to both lye and "no lye" relaxers. Some consumers falsely assume that compared to lye relaxers, "no lye" relaxers take all the worry out of straightening. "People may think because it says 'no lye' that it's not caustic," says FDA biologist Lark Lambert. But both types of relaxers contain ingredients that work by breaking chemical bonds of the hair, and both can burn the scalp if used incorrectly. Lye relaxers contain sodium hydroxide as the active ingredient. With "no lye" relaxers, calcium hydroxide and guanidine carbonate are mixed to produce guanidine hydroxide. Research has shown that this combination in "no lye" relaxers results in less scalp irritation than lye relaxers, but the same safety rules apply for both. They should be used properly, left on no longer than the prescribed time, carefully washed out with neutralizing shampoo, and followed up with regular conditioning. For those who opt to straighten their own hair, it's wise to enlist help simply because not being able to see and reach the top and back of the head makes proper application of the chemical and thorough rinsing more of a challenge. Some stylists recommend applying a layer of petroleum jelly on the scalp before applying a relaxer because it creates a protective barrier between the chemical and the skin. Scratching, brushing, and combing can make the scalp more susceptible to chemical damage and should be avoided right before using a relaxer. Parents should be especially cautious when applying chemicals to children's hair and should keep relaxers out of children's reach. There have been reports of small children ingesting straightening chemicals and suffering injuries that include burns to the face, tongue, and esophagus. How often to relax hair is a personal decision. According to Pearl Freier, an instructor at the International Academy of Hair Design in South Daytona, Fla., relaxing at intervals of six to eight weeks is common, and the frequency depends on the rate of a person's hair growth. Leslie F. Safer, MD, a dermatologist in Albany, Ga., who has treated women with scalp irritation from relaxers, says straightening every six weeks is too frequent, in his opinion. Relaxers can cause hair breakage in the long term, he says, and blow drying and curling can do more damage. Consumers should be aware that applying more than one type of chemical treatment, such as coloring hair one week and then relaxing it the next, can increase the risk of hair damage. "The only color we recommend for relaxed hair is semi-permanent because it has no ammonia and less peroxide," compared with permanent color, Freier says. Hair Dye Reactions As with hair relaxers, some consumers have reported hair loss, burning, redness, and irritation from hair dyes. Allergic reactions to dyes include itching, swelling of the face, and even difficulty breathing. Coal tar hair dye ingredients are known to cause allergic reactions in some people, FDA's Lambert says. Synthetic organic chemicals, including hair dyes and other color additives, were originally manufactured from coal tar, but today manufacturers primarily use materials derived from 22

petroleum. The use of the term "coal tar" continues because historically that language has been incorporated into the law and regulations. The law does not require that coal tar hair dyes be approved by FDA, as is required for other uses of color additives. In addition, the law does not allow FDA to take action against coal tar hair dyes that are shown to be harmful, if the product is labeled with the prescribed caution statement indicating that the product may cause irritation in certain individuals, that a patch test for skin sensitivity should be done, and that the product must not be used for dyeing the eyelashes or eyebrows. The patch test involves putting a dab of hair dye behind the ear or inside the elbow, leaving it there for two days, and looking for itching, burning, redness, or other reactions. "The problem is that people can become sensitized--that is, develop an allergy--to these ingredients," Lambert says. "They may do the patch test once, and then use the product for 10 years" before having an allergic reaction. "But you're supposed to do the patch test every time," he says, even in salons. And what about ending up with something other than the exact shade of strawberry blonde on the shelf? "Don't think the color on the box is the color you'll get," says Freier, the cosmetology instructor. "There are so many variables, like what chemicals are already in your hair and what your natural color is, that go into how your hair will turn out." When using all hair chemicals, it's critical to keep them away from children to prevent ingestion and other accidents, and to follow product directions carefully. It sounds basic, but some people don't do it, says FDA's Halper. "If it says leave on hair for five minutes, seven minutes doesn't make it better," he says. "In fact, it could do damage." Michelle Meadows is a staff writer for FDA Consumer. FDA encourages voluntary reporting of adverse reactions to hair products to: FDA, Center for Food Safety and Applied Nutrition, Office of Cosmetics and Colors, 200 C St. S.W., Washington, DC 20204, 202-205-4706. * Look Out For Your Eyes Whether applying hair chemicals at home or in a hair salon, consumers and beauticians should be careful to keep them away from the eyes. FDA has received reports of injuries from hair relaxers and hair dye accidentally getting into eyes. And while it may be tempting to match a new hair color to eyebrows and eyelashes, consumers should resist the urge. The use of permanent eyelash and eyebrow tinting and dyeing has been known to cause serious eye injuries and even blindness. There are no color additives approved by FDA for dyeing or tinting eyelashes and eyebrows. The law does not require that coal tar hair dyes be approved by FDA, as is required for other uses of color additives. In addition, the law does not allow FDA to take action against coal tar hair dyes that are shown to be harmful, if the product is labeled with the following caution statement: "Caution-This product contains ingredients which may cause skin irritation on certain individuals and a preliminary test according to accompanying directions should first be made. This product must not be used for dyeing the eyelashes or eyebrows; to do so may cause blindness." --M.M. Hair Color and Cancer Over the years, some studies have indicated a possible link between hair dye use and cancer, while others have not. In February 1994, FDA and the American Cancer Society released an epidemiologic study involving 573,000 women. Researchers found that women who had ever used permanent hair dyes showed decreased risk of all fatal cancers combined and also of urinary system cancers. The study also revealed that women who had ever used permanent hair dyes 23

showed no increased risk of any type of hematopoietic cancer (cancer of the body's blood-forming systems). This research, published in the Journal of the National Cancer Institute, did suggest that prolonged use (20 years or more of constant use) of black hair dye may slightly increase the occurrence of non-Hodgkin's lymphoma and multiple myeloma, but these cases represented a small fraction of hair dye users. This study followed previous NCI studies that raised concern about the use of hair dyes and higher rates of non-Hodgkin's lymphoma. In another study, published in the October 5, 1994, issue of the Journal of the National Cancer Institute, researchers from Brigham and Women's Hospital in Boston followed 99,000 women and found no greater risk of cancers of the blood or lymph systems among women who had ever used permanent hair dyes. Then in 1998, scientists at the University of California at San Francisco questioned 2,544 people about their use of hair-color products. After integrating the results of this study with those of animal and other epidemiologic studies, they concluded that there was little convincing evidence linking non-Hodgkin's lymphoma with normal use of hair-color products in humans. The study was published in the December 1998 issue of the American Journal of Public Health. FDA continues to follow research in this field. --M.M.

Ingredients Prohibited and Restricted by FDA Regulations With the important exception of color additives that are not coal-tar hair dyes, cosmetic ingredients are not subject to FDA premarket approval authority. However, regulations prohibit the use of some substances and restrict the use of others because of safety concerns or environmental factors. Violating the restrictions on the use of these substances may cause FDA to pursue regulatory action. What ingredients are prohibited by regulation? Regulations specifically prohibit or restrict the use of the following ingredients in cosmetics. For complete details, refer to the regulations (21 CFR, Parts 250.250 and 700.11 through 700.35). • Bithionol. The use of bithionol is prohibited because it may cause photo-contact sensitization (21 CFR 700.11). • Chlorofluorocarbon propellants. The use of chlorofluorocarbon propellants (fully halogenated chlorofluoroalkanes) in cosmetic aerosol products intended for domestic consumption is prohibited (21 CFR 700.23). • Chloroform. The use of chloroform in cosmetic products is prohibited because of its animal carcinogenicity and likely hazard to human health. The regulation makes an exception for residual amounts from its use as a processing solvent during manufacture, or as a byproduct from the synthesis of an ingredient (21 CFR 700.18). • Halogenated salicylanilides (di-, tri-, metabromsalan and tetrachlorosalicylanilide). These are prohibited in cosmetic products because they may cause photocontact sensitization (21 CFR 700.15). • Methylene chloride. The use of this substance in cosmetic products is prohibited because of its animal carcinogenicity and likely hazard to human health (21 CFR 700.19). 24

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Vinyl chloride. The use of vinyl chloride is prohibited as an ingredient of aerosol products, because of its carcinogenicity [21 CFR 700.14]. Zirconium-containing complexes. The use of zirconium-containing complexes in aerosol cosmetic products is prohibited because of their toxic effect on lungs, including the formation of granulomas [21 CFR 700.16]. Prohibited cattle materials. To protect against bovine spongiform encephalopathy (BSE), also known as "mad cow disease," cosmetics may not be manufactured from, processed with, or otherwise contain, prohibited cattle materials. These materials include specified risk materials*, material from nonambulatory cattle, material from cattle not inspected and passed, or mechanically separated beef. Prohibited cattle materials do not include tallow that contains no more than 0.15 percent insoluble impurities, tallow derivatives, and hides and hide-derived products, and milk and milk products.** [21 CFR 700.27, as amended].

What cosmetic ingredients are restricted by regulation? Some ingredients may be used in cosmetics, but only under the restrictions stated in the regulations: • Hexachlorophene. Because of its toxic effect and ability to penetrate human skin, hexachlorophene (HCP) may be used only when an alternative preservative has not been shown to be as effective. The HCP concentration of the cosmetic may not exceed 0.1 percent. HCP may not be used in cosmetics that in normal use may be applied to mucous membranes, such as the lips [21 CFR 250.250]. • Mercury compounds. Mercury compounds are readily absorbed through the skin on topical application and tend to accumulate in the body. They may cause allergic reactions, skin irritation, or neurotoxic manifestations. The use of mercury compounds as cosmetic ingredients is limited to eye area cosmetics at concentrations not exceeding 65 parts per million (0.0065 percent) of mercury calculated as the metal (about 100 ppm or 0.01 percent phenylmercuric acetate or nitrate) and is permitted only if no other effective and safe preservative is available for use. All other cosmetics containing mercury are adulterated and subject to regulatory action unless it occurs in a trace amount of less than 1 part per million (0.0001 percent) calculated as the metal and its presence is unavoidable under conditions of good manufacturing practice [21 CFR 700.13]. • Sunscreens in cosmetics. Use of the term "sunscreen" or similar sun protection terminology in a product's labeling generally causes the product to be subject to regulation as a drug. However, sunscreen ingredients may also be used in some products for nontherapeutic, nonphysiologic uses (for example, as a color additive or to protect the color of the product). To avoid consumer misunderstanding, if a cosmetic product contains a sunscreen ingredient and uses the term "sunscreen" or similar sun protection terminology anywhere in its labeling, the term must be qualified, in accordance with 21 CFR 700.35(b), by describing the benefit to the cosmetic product provided by the sunscreen ingredient (for example, "Contains a sunscreen to protect product color."). Otherwise, the product may be subject to regulation as a drug [21 CFR 700.35]. For further information on sunscreens, refer to Information About Suntan Products, Sunscreens, and Tanning. Are these the only ingredients that can cause a product to become violative? No. A product may become adulterated or misbranded in a number of ways. Among these are improperly used color additives or any ingredient, other than a coal-tar hair dye, that causes a cosmetic to be harmful under customary or usual conditions of use, or cause a cosmetic to become misbranded, as stated in the Federal Food, Drug, and Cosmetic Act, Sections 601 and 602. 25

Additionally, an ingredient having a history of use in or as a cosmetic may at any time have its safety brought into question by new information. For related information, see Key Legal Concepts: Interstate Commerce, Adulteration, and Misbranding and FDA Authority Over Cosmetics. * "Specified risk material" means the brain, skull, eyes, trigeminal ganglia, spinal cord, vertebral column (excluding the vertebrae of the tail, the transverse processes of the thoracic and lumbar vertebrae, and the wings of the sacrum), and dorsal root ganglia of cattle 30 months and older and the tonsils and distal ileum of the small intestine of all cattle. ** Tallow must be produced from tissues that are not prohibited cattle materials or must contain not more than 0.15 percent insoluble impurities as determined by the method entitled "Insoluble Impurities" (AOCS Official Method Ca 3a-46), American Oil Chemists' Society (AOCS), 5th Edition, 1997, incorporated by reference in accordance with 5 U.S.C. 552(a) and 1 CFR part 51, or another method equivalent in accuracy, precision, and sensitivity to AOCS Official Method Ca 3a-46. You may obtain copies of the method from AOCS, 2211 W. Bradley Ave. Champaign, IL 61821

Lipstick and Lead: Questions and Answers • • • • • •

What is FDA's legal authority over cosmetics? Has FDA been aware of concerns about lead in lipstick ? Has FDA published tolerance levels for lead in lipstick ? It's been reported that levels of lead in certain lipstick exceed those for candy. Is this a fair comparison? Is FDA following up on the latest reports? Does FDA intend to take enforcement action, given the latest report ?

The Food and Drug Administration (FDA) has received a number of inquiries regarding reports of levels of lead in lipstick. The following information is drawn from responses to those inquiries. What is FDA's legal authority over cosmetics? FDA regulates cosmetics under the authority of the Federal Food, Drug, and Cosmetic Act (FD&C Act). The Act does not subject cosmetics to pre-market approval by FDA, with the exception of most color additives. It does, however, require that cosmetics marketed in interstate commerce be safe when used as directed in the labeling or under customary conditions of use. The FD&C Act subjects all color additives (other than coal-tar hair dyes) used in FDA-regulated products, including those used in lipstick, to pre-market approval. The listing regulation for each approved color additive includes limits for trace levels of heavy metal contaminants, if appropriate. FDA can and does take action against firms and individuals who violate the law, as determined by public 26

health priorities and resources. To learn more on this subject, please refer to FDA Authority Over Cosmetics. Has FDA been aware of concerns about lead in lipstick? Reports about lead in lipstick are not new. In the 1990s, reports of analytical results from a commercial testing laboratory suggested that traces of lead in lipstick might be of concern. Subsequent evaluation by FDA of that laboratory's test results determined that an unvalidated and inappropriate testing method had been used. FDA's analyses did not detect levels of lead that would be considered harmful. The levels found did not exceed trace amounts that would be unavoidable even under conditions of good manufacturing practice, given background levels in the environment. Has FDA published tolerance levels for lead in lipstick? FDA has not published tolerance levels for contaminants, such as lead, in cosmetics. However, FDA does set specifications for impurities, such as lead, for color additives used in cosmetics. In addition, as noted above, cosmetics must by law be safe when used as directed in the labeling or under customary conditions of use. It's been reported that levels of lead in certain lipstick exceed those for candy. Is this a fair comparison? FDA has yet to confirm the latest reports. However, it is not valid to compare the FDArecommended level for lead in candy, a product intended for ingestion and which may be consumed on a regular basis, with lead levels in lipstick, a product intended for topical use and which is ingested in much smaller quantities than candy. Is FDA following up on the latest reports? Because allegations regarding lead in lipstick surface periodically, and because of the amount of time since FDA last surveyed lipsticks in the marketplace, FDA has decided to allocate the resources necessary to conduct independent testing of a selection of lipstick on the market. FDA has obtained commercial samples of the same lipstick brands cited in the recent report. FDA laboratories have been adapting a previously validated, state-of-the-art method to do the analyses. Does FDA intend to take enforcement action, given the latest report? As a science-based public health agency, FDA bases its actions upon authoritative scientific evidence and the agency's authority under the law. FDA takes seriously its commitment to develop and implement policies that will promote consumer safety and enhance public health. If FDA determines that a health hazard exists, the agency will advise the industry and the public, and will consider its options under the authority of the FD&C Act in protecting the health and welfare of consumers.

Using Nail Products How Nail Products Are Regulated Nail Product Ingredient Safety 27

Some Common Nail Product Ingredients Acetonitrile Formaldehyde Methacrylate Monomers Methacrylic Acid Reporting Adverse Nail Product Reactions There are many nail products on the market. It is important to know how to use them safely. As with any cosmetic product, follow the labeled directions carefully and pay careful attention to any warning statements. The following information will answer commonly asked questions about some nail products and ingredients. How Nail Products Are Regulated Nail products for both home and salon use are regulated by the Food and Drug Administration. Under the Federal Food, Drug, and Cosmetic Act (FD&C Act), these products are cosmetics [FD&C Act, section 201(i)]. By law, nail products sold in the United States must be free of poisonous or deleterious (harmful) substances that might injure users when used as labeled or under the usual or customary conditions of use (see Key Legal Concepts: Interstate Commerce, Adulteration and Misbranding). Many nail products contain potentially harmful ingredients, but are allowed on the market because they are safe when used as directed. For example, some nail ingredients are harmful only when ingested, which is not their intended use. The labels of all cosmetics, whether marketed to consumers or salons, must include a warning statement whenever necessary or appropriate to prevent a health hazard that may occur with use of the product (21 CFR 740.1). Cosmetics sold on a retail basis to consumers also must bear an ingredient declaration, with the names of the ingredients listed in descending order of predominance. The requirement for an ingredient declaration does not apply, for example, to products used at professional establishments or samples distributed free of charge. However, the requirement does apply if these products are also sold at retail, even if they are labeled "For professional use only" (see Cosmetic Labeling: An Overview). Under the law, cosmetic products and ingredients, including nail products, are not subject to FDA premarket approval authority, with the exception of most color additives. However, FDA may pursue enforcement action against violative products, or against firms or individuals who violate the law (See FDA Authority Over Cosmetics). While FDA regulates the nail products intended for use at home and in salons, the operation of nail salons and the licensing of their technicians are regulated by state and local authorities. Also, the Occupational Safety and Health Administration has addressed the safety of employees in nail salons. Nail Product Ingredient Safety Infections and allergic reactions can occur with some nail products. As mentioned previously, some ingredients in nail products may be harmful if ingested. Some can easily catch fire if exposed to the flame of the pilot light of a stove, a lit cigarette, or other heat source, such as the heating element of a curling iron. Nail products also can be dangerous if they get in the eyes. Consumers should read labels of nail products carefully and heed any warnings. Some Common Nail Product Ingredients

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Acetonitrile in Artificial Nail Removers Artificial nail removers consist primarily of acetonitrile. Child-resistant packaging is required for all household glue removers in liquid form containing more than 500 milligrams of acetonitrile in a single container [16 CFR 1700.14 (18)]. The Consumer Product Safety Commission (CPSC) enforces this requirement under authority of the Poison Prevention Packaging Act [15 U.S.C. 14711476]. However, the fact that a product is in "child-resistant" packaging does not mean that a child could not open it. Like any cosmetic product that may be hazardous if misused, it is important for these artificial nail removers to carry an appropriate warning on the label, along with directions for safe use. Formaldehyde in Nail Hardeners Nail hardeners that contain formaldehyde may cause an irritation or allergic reaction to those sensitized to this compound. There is also some evidence that certain individuals may become allergic to toluene sulfonamide–formaldehyde resin, a common ingredient in nail preparations. In 1984, the Cosmetic Ingredient Review (CIR) Expert Panel * reported that available toxicological data and other information were insufficient to conclude that cosmetics containing formaldehyde in excess of 0.2% are safe. However, the CIR was referring to cosmetic products applied to the skin, not nail products. The concentration of formaldehyde needed for nail hardening is higher than 0.2%, but formaldehyde is less likely to cause skin sensitization when shields are used to keep the hardener away from the skin. If you are allergic to formaldehyde, have previously experienced an allergic reaction to nail preparations or for any other reason wish to avoid this ingredient, be sure to read the product ingredient statement on the label to determine if formaldehyde and toluene sulfonamide-formaldehyde resin are present. Methacrylate Monomers in Artificial Nails ("Acrylics") Artificial nails are composed primarily of acrylic polymers and are made by reacting together acrylic monomers, such as ethyl methacrylate monomer, with acrylic polymers, such as polymethylmethacrylate. When the reaction is completed, traces of the monomer are likely to remain in the polymer. For example, traces of methacrylate monomers remain after artificail nails are formed. The polymers themselves are typically quite safe, but traces of the reactive monomers could result in an adverse reaction, such as redness, swelling, and pain in the nail bed, among people who have become sensitive (allergic) to methacrylates. Ethyl methacrylate monomer is commonly used today in acrylic nails, although methyl methacrylate monomer may still be found in some artificial nail products. In the early 1970s, FDA received a number of complaints of injury associated with the use of artificial nails containing methyl methacrylate monomer. Among these injuries were reports of fingernail damage and deformity, as well as contact dermatitis. Unlike methyl methacrylate monomer, methyl methacrylate polymers were not associated with these injuries. Based on its investigations of the injuries and discussions with medical experts in the field of dermatology, the agency chose to remove from the market products containing 100 percent methyl methacrylate monomer through court proceedings, which resulted in a preliminary injunction against one firm as well as several seizure actions and voluntary recalls. No regulation specifically prohibits the use of methyl methacrylate monomer in cosmetic products. The CIR Expert Panel determined in 2002 that ethyl methacrylate is safe as used when application is accompanied by directions to avoid skin contact because of its sensitizing potential (that is, the possibility that a person might develop an allergy to this material). Methacrylic Acid in Nail Primers Despite the similar names, methacrylic acid is different from methacrylate monomers. It also is used differently and raises different safety concerns. Methacrylic acid (MAA) has been used in nail primers to help acrylic nails adhere to the nail surfaces. In response to cases of poisoning and 29

injury, the CPSC issued a regulation [16 CFR 1700.14 (29)] requiring child-resistant packaging for household products containing MAA. A number of serious injuries have occurred to children who ingested such products or spilled them, receiving burns to their skin. Nail primers that contain MAA are most commonly distributed through wholesale suppliers to nail salons and retail beauty supply stores, and they usually are labeled "For Professional Use Only." However, some of these retail stores sell to both professionals and consumers. The CPSC regulation, established in accordance with the Poison Prevention Packaging Act, requires child- resistant packaging for liquid household products containing more than 5 percent MAA, weight to volume, in a single retail package. That means that it applies, for example, to a product containing more than 5 grams of MAA per 100 milliliters. MAA products applied by means of absorbent material in a dispenser, such as a pen-like marker, are exempt from this requirement if there is no free liquid in the device and if, under any reasonably foreseeable conditions of use, the methacrylic acid will emerge only through the tip of the device. For more information regarding the child-resistant packaging requirements for MAA, contact the Office of Compliance, CPSC, at (301) 504-0608. Toluene in Nail Polishes and Other Products Toluene is used as a solvent in a variety of nail products, such as nail polish, nail hardeners, and polish removers. Toluene was reviewed by the CIR Expert Panel in 1987, when the Panel determined that it was safe for cosmetic use in nail products when limited to concentrations no greater than 50 percent. The Panel re-evaluated the safety of toluene in 2005 and confirmed its original conclusion. Reporting Adverse Nail Product Reactions Consumers, nail technicians, and healthcare providers can report adverse reactions from nail products to the nearest FDA office, listed in the blue section of the telephone book. Or, contact FDA's Center for Food Safety and Applied Nutrition, Adverse Events Reporting System (CAERS) by phone at (301) 436-2405 or by e-mail at [email protected].

FDA Nanotechnology Task Force Report Outlines Scientific, Regulatory Challenges Fact Sheet Nanotechnology is changing the way that many FDA-regulated products will be made. To further its mission of promoting and protecting the public health, FDA will work to clarify what information will be needed in its efforts to oversee products that contain nanoscale materials –those created at sizes as small as 1/100,000th of a human hair. The Food and Drug Administration’s Nanotechnology Task Force report released in July 2007 addresses the science and regulatory needs to regulate drugs, medical devices and other products built on the nanoscale. • Nanotechnology may provide new drugs that are able to reach specific areas of the body more effectively and at safer doses. • “Nanomedicine” includes development of tiny sensors that detect disease markers in the body far earlier than existing diagnostic methods, and incredibly small pumps capable of delivering medications precisely to the cells and tissues that need them. • Other examples of nano-products in development include disease imaging tools and food packaging that further extends shelf life. FDA Commissioner, Dr. Andrew C. von Eschenbach says "Nanotechnology holds enormous potential for use in a vast array of products. Recognizing the emerging nature of this technology 30

and its potential for rapid development, this report fosters the continued development of innovative, safe and effective FDA-regulated products that use nanotechnology materials.” The Task Force reported that the potential use of nanoscale materials includes most product types regulated by FDA and that those materials present regulatory challenges similar to other emerging technologies. The Task Force recognizes, however, that product safety and effectiveness can change as size goes up or down within the nanoscale, adding additional complexity to the product review. The emerging and uncertain nature of nanotechnology and the potential for rapid development of FDA-regulated products using this particular technology make it all the more important that in regulating nanotechnology FDA follow its transparent, consistent, and predictable process. The report recommends: • Consideration of guidance that would clarify what information manufacturers should give FDA about products, and also when the use of nanoscale materials may change the regulatory status of particular products. • That manufacturers contact the FDA early in the product development process. In addition, the report recommends that the agency should assess data needs for regulated nanotechnology products, including biological effects and interactions of nano-particles. • That FDA develop in-house expertise and ensure the consideration of new information on nanotechnology as it becomes available. FDA also should evaluate current testing approaches to assess the safety, effectiveness, and quality of nanoscale materials. FDA and 22 other federal agencies are part of the National Nanotechnology Initiative, a federal research and development program established to coordinate the multi-agency efforts in nanoscale science, engineering, and technology. For more information: National Nanotechnology Initiative http://www.nano.gov/

Sunless Tanners and Bronzers A number of cosmetic products are marketed for consumers to achieve a tanned appearance without having to go out in the sun or use artificial sources of ultraviolet radiation. FDA has received questions about some of these products. The following information is provided in response to these questions. What are "sunless tanners"? Neither the laws nor the regulations enforced by FDA define the term "sunless tanner." It typically refers to products that provide a tanned appearance without exposure to the sun or other sources of ultraviolet radiation. One commonly used ingredient in these products is dihydroxyacetone (DHA), a color additive that darkens the skin by reacting with amino acids in the skin's surface. What are "bronzers"? Like the term "sunless tanner," "bronzer" is not defined in either the laws or the regulations enforced by FDA. It is often used to describe a variety of products intended to achieve a temporary tanned appearance. For example, among the products marketed as bronzers are tinted moisturizers and brush-on powders. These produce a temporary effect, similar to other types of makeup, and wash off over time. Some products are marketed with other ingredients in addition to DHA in order to provide a tanned appearance. 31

What does the law say about color additives, and DHA in particular? The Federal Food, Drug, and Cosmetic Act (FD&C Act), Section 721 authorizes the regulation of color additives (other than coal-tar hair dyes), including their uses and restrictions. These regulations are found in Title 21, Code of Federal Regulations (21 CFR), beginning at Part 70. If a color additive is not permitted by regulation or is used in a way that does not comply with the specific regulation(s) authorizing its use, it is considered unsafe under the law. Such misuse of color additives causes a cosmetic to be adulterated. DHA is listed in the regulations as a color additive for use in imparting color to the human body. However, its use in cosmetics--including sunless "tanning" products--is restricted to external application (21 CFR 73.2150). According to the CFR, "externally applied" cosmetics are those "applied only to external parts of the body and not to the lips or any body surface covered by mucous membrane" (21 CFR 70.3v). The industry has not provided safety data to FDA in order for the agency to consider approving it for use on these exposure routes, including "misting" from tanning booths. In addition, no color additive may be used in cosmetics intended for use in the area of the eye unless the color additive is permitted specifically for such use (21 CFR 70.5a) DHA is not permitted for use in the area of the eye. The CFR defines "area of the eye" as follows: "the area enclosed within the circumference of the supra-orbital ridge, including the eyebrow, the skin below the eyebrow, the eyelids and the eyelashes, and conjunctival sac of the eye, the eyeball, and the soft areolar tissue that lies within the perimeter of the infra-orbital ridge." (21 CFR 70.3s) As with the lips and other areas covered by mucous membrane, the industry has not provided safety data to FDA in order for the agency to consider approving it for use in the area of the eye. The regulations listing DHA as a color additive also require it to meet tight specifications, with strict limitations on impurities. For example, volatile matter must not exceed 0.5 percent when measured at 34.6 degrees centigrade for three hours at a pressure of not more than 30 mm. mercury. (Please note that the reference to "millimeters of mercury" is a measure of atmospheric pressure, not an indication that DHA contains mercury.) Certain minerals are restricted to miniscule amounts, measured in parts per million (21 CFR 73.1150 and 73.2150). What does this mean for DHA spray "tanning" booths? As noted above, the use of DHA in "tanning" booths as an all-over spray has not been approved by the FDA, since safety data to support this use has not been submitted to the Agency for review and evaluation, When using DHA-containing products as an all-over spray or mist in a commercial spray "tanning" booth, it may be difficult to avoid exposure in a manner for which DHA is not approved, including the area of the eyes, lips, or mucous membrane, or even internally. Consequently, FDA advises asking the following questions when considering commercial facilities where DHA is applied by spraying or misting: • Are consumers protected from exposure in the entire area of the eyes, in addition to the eyes themselves? • Are consumers protected from exposure on the lips and all parts of the body covered by mucous membrane? • Are consumers protected from internal exposure caused by inhaling or ingesting the product? If the answer to any of these questions is "no," the consumer is not protected from the unapproved use of this color additive. Consumers should request measures to protect their eyes and mucous membranes and prevent inhalation. 32

What about sunless tanning products sold in retail stores, such as creams and lotions? DHA is approved for external application to the human body, which is the way these products are intended to be used. Consumers can easily avoid inhaling them or applying them to the area of the eye or mucous membrane. Who is responsible for the safety of spray tanning booths? The FD&C Act does not authorize FDA to approve cosmetic products or ingredients, with the exception of color additives that are not coal-tar hair dyes. Firms and individuals who market cosmetics are responsible for assuring that the products they market are safe when used under labeled or customary conditions of use and properly labeled. FDA can take action against firms and individuals who violate the law. The practice of administering such products by professionals, such as in salons, is generally the responsibility of local and state health authorities. For more information about the regulation of cosmetic products and ingredients, see FDA Authority Over Cosmetics. Do sunless tanners and bronzers provide protection from the sun? Sunless tanners and bronzers may or may not provide protection from the sun. Only those sunless tanners that contain sunscreen ingredients and are labeled with sun protection factor ("SPF") numbers may provide protection. Consumers are advised to read the labeling carefully to determine whether or not these products provide protection from the sun. All suntanning preparations that do not contain sunscreen ingredients are required to carry the following warning statement on the label: "Warning--This product does not contain a sunscreen and does not protect against sunburn. Repeated exposure of unprotected skin while tanning may increase the risk of skin aging, skin cancer, and other harmful effects to the skin even if you do not burn." (21 CFR 740.19) Sunscreens are regulated as over-the-counter drugs unless they are used in the product for reasons other than protecting the consumer from the sun, such as protecting the product itself from fading. Cosmetic products that are marketed with sun-protection claims, such as makeup labeled with SPF numbers, are regulated as both drugs and cosmetics. (See "Is It a Cosmetic, a Drug, or Both (Or Is It Soap?") Has FDA received reports of adverse reactions associated with sunless tanners? FDA has received reports from consumers stating that they have experienced adverse events associated with sunless tanning, including rashes and, primarily in the case of spray tanning booths, coughing, dizziness, and fainting. It is uncertain what, if any, ingredient or combination of ingredients in the sunless tanning products might have caused these adverse events, whether an individual's allergic reaction might have played a part, or whether factors unrelated to the sunless tanning products may have been involved, such as pre-existing medical conditions. Under the authority of the Fair Packaging and Labeling Act (FPLA), FDA requires ingredient declarations on cosmetics sold on a retail basis to consumers. In this way, consumers can know what ingredients are contained in the products they purchase and avoid ingredients to which they may be sensitive. However, the FPLA does not apply to products used exclusively by professionals, such as those used in spray tanning booths. How can I report an adverse reaction to sunless tanners or other cosmetics?

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Consumers and healthcare providers can report adverse reactions from cosmetic products, including sunless tanners, to the nearest FDA office, listed in the blue section of the telephone book. Or, contact FDA's Center for Food Safety and Applied Nutrition, Adverse Events Reporting System (CAERS) by phone at (301) 436-2405 or by e-mail at [email protected]. Required Warning Statement for Tanning Products Without Sunscreen Effective May 22, 2000, all suntanning preparations that do not contain sunscreen ingredients are required to carry the following warning statement on the label: "Warning--This product does not contain a sunscreen and does not protect against sunburn. Repeated exposure of unprotected skin while tanning may increase the risk of skin aging, skin cancer, and other harmful effects to the skin even if you do not burn." (Title 21 of the Code of Federal Regulations, Section 740.19) FDA is requiring this warning statement so that consumers are fully informed that such products do not provide protection from the sun. The term "suntanning preparations" includes gels, creams, liquids, and other topical products that are intended to provide cosmetic effects on the skin while tanning through exposure to ultraviolet (UV) radiation (such as moisturizing or conditioning products) or to give the appearance of a tan by imparting color to the skin through the application of approved color additives, such as dihydroxyacetone, without the need for exposure to UV radiation. Because such products include those sold for use at the beach or for use in tanning salons, consumers are strongly encouraged to read carefully the labeling of all tanning products to determine whether or not they provide protection against the harmful effects of UV radiation. This required warning was published in the rulemaking for over-the-counter sunscreen drug products in the Federal Register May 21, 1999. For more information, see Tanning Products.

THIGH CREAMS Various products have been promoted in the skin care market as thigh and stomach slimmers. Some advertising claims also promise the reduction of "cellulite", waffly looking or orange-peel type skin caused by fatty deposits. Aminophylline, an approved prescription drug used in the treatment of asthma, is an ingredient used in many of these thigh cream products that marketers claim will dissolve the fat and smooth the skin. Since some individuals suffer from allergic reactions to ethylenediamine, a component of aminophylline, the FDA is concerned about the use of this ingredient in cosmetics. Consumers need to be aware of this potential for developing an allergic reaction and carefully read product labels and follow directions. Persons who suffer from asthma may wish to avoid these products so that they don't develop a sensitization (become allergic) to aminophylline. Drugs, unlike cosmetics, alter the structure or function of the body and are subject to an intensive review and approval process by FDA before their release to the public. Thigh creams may more appropriately be classified as drugs under the Food, Drug, and Cosmetic Act since removal or reduction of cellulite affects the "structure or function" of the body.

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