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The European cosmetic known as ceruse was used faithfully - and fatally, because it was mainly white lead - by wealthy women from the second century until well into the 19th century to make their faces look fashionably pale. Nothing on the market today approaches ceruse's deadliness. But many consumers wonder about the eye makeup, lipsticks, foundations, and nail products that are on the shelves. Are there any risks in using these cosmetics? Are long lashes, even skin tone, and brightly colored nails worth any risk at all? Serious injury from makeup is a "pretty rare event," says John E. Bailey, Ph.D., director of FDA's Office of Colors and Cosmetics. "We don't see it happen that often." Even one of the most serious problems, eye infections from a scratch on the eyeball with a contaminated mascara wand, has become rare. January 1989 was the last time an infection of this type was reported to FDA. In 1994, FDA headquarters received approximately 200 reports of adverse reactions to cosmetics. Skin-care products and makeup accounted for about 65. Of those, at least 22 concerned products containing the chemical alpha hydroxy acid (AHA), used in so-called "skin peelers." Most of the 65 reports were either allergic reactions or skin irritations. The other complaints were about hair products, soaps, toothpastes, and mouthwashes. Although industry probably received about 50 reports for every one made to FDA, says Bailey, the problems reported to the companies are along the same lines - allergies and skin irritation. The agency can't do much about isolated allergic reactions or irritation problems. It's up to the individual to avoid the product that caused the reaction and any other products that contain the offending ingredient. But that doesn't mean reporting the problem isn't important. "We look for clusters," says Bailey. "If we see we're getting a number of complaints for the same product, then that is cause for concern." Unlike reports of allergic or irritation reactions, even one report of an acute injury, usually caused by a contaminated product, results in quick action by the agency. "We'll inspect the establishment, talk to the consumer, talk to the doctor, collect samples, and analyze them to determine the extent of contamination," says Bailey.
Contaminated makeup is the result of either inadequate preservatives or product misuse. But contamination doesn't necessarily translate into serious injury for the user. "Cosmetics are not expected to be totally free of microorganisms when first used or to remain free during consumer use," according to a 1989 FDA report on contamination of makeup counter samples in department stores. The report was based on a survey which found that over 5 percent of samples collected were seriously contaminated with such things as molds, other fungi, and pathogenic organisms. Every time you open a bottle of foundation or case of eye shadow, microorganisms in the air have an opportunity to rush in. But adequately preserved products can kill off enough of the little bugs to keep the product safe. Occasionally, however, a product will be seriously contaminated. According to FDA data, most cases of contamination are due to manufacturers using poorly designed, ineffective preservative systems and not testing the stability of the preservatives during the product's customary shelf life and under normal use conditions.
Consumers must take an active role in keeping product contamination and potential infection to a minimum once they take a product home, says Gerald McEwen, Ph.D., vice president for science for one of the cosmetic industry's trade associations, The Cosmetic, Toiletry and Fragrance Association. You need [to follow] good personal hygiene clean hands, clean face," he says. "And common sense." One of the riskiest things a woman can do is put on mascara while she's driving, says McEwen. "You hit a bump and you scratch your eyeball," he explains. "Once you've scratched your eyeball, you have all kinds of possibilities of contamination. We're not talking about disease germs here. We're talking about normal bacteria that are all over the air. Those get into that kind of a cut, and without proper medical attention you can go blind."
There's something else that is definitely taboo when using makeup - sharing. "Never share, not even with your best friend," says Irene Malbin, CTFA' s vice president of public relations. Sharing cosmetics means sharing germs, and the risk, though small, isn't worth it, says Malbin. Shared-use cosmetics - the testers commonly found at department store cosmetic counters - are even more likely to become contaminated than the same products in an individual's home, according to the 1989 FDA report. FDA followed its 1989 report on makeup testers with a survey of corresp onding unopened retail packages. The survey found only negligible contamination, and the agency concluded that the preservatives couldn't handle the challenge of constant use. "At home, the preservatives have time - usually a whole day - to kill the bacteria that is inevitably introduced after each use," says Bailey. "But in a store, there may be only minutes between each use. The preservatives can't handle it." If you really want to test a cosmetic before you buy, "you should insist - must insist - on a new, unused applicator," says CTFA's Malbin. She says that some companies use cotton swabs for that purpose.
According to a study of cosmetic reactions conducted by the North American Contact Dermatitis Group, preservatives are the second most common cause of allergic and irritant reactions to cosmetics. Fragrances are number one. Although the study is more than 10 years old, the results can still be considered valid today, says Harold R. Minus, M.D., an associate professor of dermatology at Howard University Hospital. People who have had allergic reactions to cosmetics may try hypoallergenic or allergy-tested products. These are, however, only a partial solution for some and no solution at all for others. "Hypoallergenic can mean almost anything to anybody," says Bailey. "Hypo" means "less than," and hypoallergenic means only that the manufacturer feels that the product is less likely than others to cause an allergic reaction. Although some manufacturers do clinical testing, others may simply omit perfumes or other common problem-causing ingredients. But there are no regulatory standards on what constitutes hypoallergenic. Likewise, label claims that a product is "dermatologist-tested," "sensitivity tested," "allergy tested," or "nonirritating" carry no guarantee that it won't cause reactions. "FDA tried to publish regulations [in 1975] defining hypoallergenic to mean a lower potential for causing an allergic reaction," says Bailey. "In addition, we were going to require that companies submit information to FDA establishing that in fact their products were hypoallergenic." However, two cosmetic manufacturers, Almay and Clinique, challenged the proposed regulations in court, claiming that consumers already understood that hypoallergenic products were no panacea against allergic reactions. In July 1975, the U.S. District Court for the District of Columbia upheld FDA's regulations, but the two companies appealed. On Dec. 21, 1977, the U.S. Court of Appeals for the District of Columbia reversed the district court's ruling.
Like hypoallergenic, "natural" can mean anything to anybody. "There are no standards for what natural means," says Bailey. "They could wave a tube [of plant extract] over the bottle and declare it natural. Who's to say what they're actually using?" Revlon, Inc., uses natural plant extracts in its New Age Naturals cosmetics line, says Dan Moriarity, Revlon's director of public relations. "But the base formulas are the same as our conventional products," he says. In addition, because these products contain fragrances, they don't fit Revlon's definition of hypoallergenic, he explains. Anyone who has ever had poison ivy knows that "natural" and "hypoallergenic" are not necessarily interchangeable terms. For example, some manufacturers of cosmetics marketed as natural products use naturally occurring vitamins E and C as preservatives. But, according to Alexander Fischer, M.D., author of Contact Dermatitis, "Topical vitamin E is a potent sensitizer which can produce both delayed allergic contact dermatitis and immediate allergic hives." In addition, natural doesn't mean pure or clean or perfect either. According to the cosmetic trade journal Drug and Cosmetic Industry, "all plants [including those used in cosmetics] can be heavily contaminated with bacteria, and pesticides and chemical fertilizers are widely used to improve crop yields."
Whether driven by altruism, liability, or the bottom line, most companies see the need for safety testing. But safety testing can rarely be mentioned without bringing up the controversy surrounding the use of animals for those tests. Many companies have begun to label their products with statements indicating that no animals have been used in testing. "As far as we know," says Neil Wilcox, D.V.M., director of FDA's Office of Animal Care and Use, "what these companies do is use, for the most part, old reliable ingredients that have been proven safe [based on past animal data and a history of safe use] and then test the final product on people." "There's kind of a fine point here," says CTFA's McEwen. "These companies that say they don't test on animals are skirting the issue. Practically every ingredient that's used in cosmetics was at some point tested on animals. Probably a statement like `no new animal testing' would be more accurate."
Unlike drugs, FDA does not require pre-market approval for cosmetics. However, if a safety problem with a cosmetic product arises after it's been marketed, FDA can take action to obtain the manufacturer's safety data on the product. Because there is not yet enough information on alternatives to animal testing to validate their use in ensuring human safety, FDA, at this point, would only accept animal safety data. The most widely used, and possibly most controversial, animal test, the Draize Eye Irritancy Test, involves putting drops of the substance in question into the eye of an albino rabbit. Investigators then note if any redness, swelling, cloudiness of the iris, or corneal opacity occurs. In addition, the ability of the eye to repair any damage is noted. "Draize may be impossible to replace with a single alternative test," says Sidney Green, Ph.D., a toxicologist with FDA's Center for Food Safety and Applied Nutrition. He explains that because the Draize test measures three different areas of the eye, replacing Draize will probably take a combination of alternative tests, "but we've not seen that combination yet." Wilcox explains that for FDA to approve other methods, those methods will have to produce test results that can be reproduced in other labs. In addition, databases will have to correlate historical animal test results with newer lab results. "Database development and cooperation [between industry and FDA] is pivotal to the validation process," says Wilcox. The cosmetics industry has taken one step towards database development—the Cosmetic Ingredient Review. The basic purpose of the review is to gather information from the scientific literature and from company files on the safety of cosmetic ingredients and make that information publicly available. FDA's division of toxicological review and evaluation is currently evaluating two alternatives for the Draize eye test. One is Eytex, manufactured by Ropak Corp., Irvine, Calif., a chemical assay that produces opacity similar to that of an animal cornea upon exposure to irritants. The other is vertebrate cell cultures from humans and mice. But until alternatives have been scientifically verified, the option for animal testing must be available for new ingredients and new products, says Wilcox. "No one wants to think of animals being used for anything other than kindness and human companionship," he says. "But it's important that we continue to recognize the risk to human health if unreliable tests are used."
Dori Stehlin is a staff writer for FDA Consumer.
Draize test - an animal test used to determine the effects of different substances on the eyes
fragrance - any natural or synthetic substance or substances used solely to impart an odor to a cosmetic product
*fragrance-free - products so labeled may still contain small amounts of fragrances to mask the fatty odor of soap or other unpleasant odors
*hypoallergenic - cosmetics that are less likely to cause allergic reactions
in vitro - from the Latin meaning "in glass," in vitro tests do not involve the use of living vertebrate animals
lanolin - a natural extract of sheep wool used as a moisturizer, which is a common cause of allergic reactions but is rarely used in pure form
*natural - ingredients extracted directly from plants or animal products as opposed to being produced synthetically
*non-comedogenic - products so labeled do not contain common pore-clogging ingredients that could lead to acne
parabens (methyl-, propyl-, and butyl-) - the most widely used preservatives in the United States, commonly used in shampoos, foundations, facial masks, hair-grooming aids, nail creams, and permanent wave products
propylene glycol - the most common moisture-carrying vehicle in cosmetics other than water.
(*here are no official, government definitions for these terms.)
Besides never putting on makeup while driving, consumers should follow other precautions to protect themselves and the quality of their cosmetics:
"We don't have a hard and fast rule on [when to throw cosmetics out]," says McEwen. McEwen says makeup can be kept indefinitely as long as it looks and smells all right and the consistency doesn't change. "It would be difficult to have any kind of bacterial growth and not have it be noticeable," he explains.
However, Janice Teal, a microbiologist who heads the product and package safety division of Avon Products, Inc., disagrees. "Even after the preservatives have stopped working, you may not be able to see or smell anything different," she says. She agrees with McEwen that there is no absolute date for discarding various products, but says Avon recommends that consumers throw mascara away after three months. They can keep other makeup products a few months longer. "Mascara is our biggest concern because of the wand," she says. "Normally, the eye is a good barrier to bacteria, but one slip and that wand can scratch the cornea and introduce all kinds of bacteria."
The Federal Food, Drug, and Cosmetic Act defines cosmetics as "articles other than soap which are applied to the human body for cleansing, beautifying, promoting attractiveness, or altering the appearance."
FDA has classified cosmetics into 13 categories:
It is against the law to distribute cosmetics that contain poisonous or harmful substances that might injure users under normal conditions. Manufacturing or holding cosmetics under insanitary conditions, using non-permitted colors, or including any filthy, putrid or decomposed substance is also illegal. Except for color additives and a few prohibited ingredients, a cosmetic manufacturer may use any ingredient or raw material and market the final product without government approval. The prohibited ingredients are:
Manufacturers must test color additives for safety and gain FDA approval for their intended use. Cosmetic firms may voluntarily register their manufacturing plants with FDA, file cosmetic formulas, and report adverse reactions. Cosmetics sold to consumers must bear labels that list ingredients in descending order of predominance. Trade secrets (as defined by FDA) and the ingredients of flavors and fragrances do not have to be specifically listed.
Source: FDA Consumer U.S. Food and Drug Administration
The lotion contained bovine albumin and the label claimed it would give a "face lift without surgery." The Food and Drug Administration said the claims caused the product to be a misbranded drug. In 1968, the court said no. "If lifting and firming products are deemed intended to affect the structure of the body, girdles and brassieres must be devices within the meaning of the law." In 1969 an appellate court overturned this decision, but the issues persist today. "Most cosmetics contain ingredients that are promoted with exaggerated claims of beauty or long-lasting effects to create an image," says John E. Bailey, Ph.D., director of FDA's division of color and cosmetics. "Image is what the cosmetic industry sells through its products, and it's up to the consumer to believe it or not," Bailey says. In the past, cosmetic manufacturers have depended upon mysterious "gimmick" additives, such as turtle oil to promote skin rejuvenation or tighten chin muscles, shark oil, queen bee royal jelly, chick embryo extract, horse blood serum, and pigskin extracts. Promotion of these "gimmick" additives, combined with today's more sophisticated cosmetic ingredients, is what Bailey and the cosmetic industry call "puffery." The argument is sometimes made that while Congress intended to safeguard the health and economic interests of consumers with the Federal Food, Drug, and Cosmetic Act, it also meant to protect a manufacturer's right to market a product free of excessive government regulation. And, in an industry that sells personal image, especially images of beauty and sex appeal, not allowing the puffery claims would certainly hurt the marketing, says Bailey. But there's hope for credibility in claims for cosmetic ingredients. Some of the more responsible cosmetic firms are rethinking their claims that push believability to its outside edge. Linda Allen Schoen of Neutrogena says that today's more knowledgeable consumer wants "facts versus puffery - products based on skin care realities, promises banked on achievable benefits." Besides, says Schoen, limited recession dollars tend to be spent on products consumers can trust. Still, with the exception of colors and certain prohibited ingredients, a cosmetic manufacturer may use essentially any raw material in a product and market it without prior FDA approval. The prohibited ingredients are biothionol, hexachlorophene, mercury compounds (except as preservatives in eye cosmetics), vinyl chloride and zirconium salts in aerosol products, halogenated salicylanilides, chloroform, and methylene chloride. Federal regulations require ingredients to be listed on product labels in descending order by quantity, but often the list is not user-friendly. Because cosmetic ingredients are often complex chemical substances, the list may be incomprehensible to the product's average user. However, if the same name is used by all manufacturers, consumers can compare different products and make reasonable value judgments. Although cosmetic claims, even those considered "puffery," are allowed without scientific substantiation, if a cosmetic makes a medical claim, such as removing dandruff, the product is regulated as an over-the-counter drug for which scientific studies demonstrating safety and effectiveness must be submitted to FDA.
Because of the unusual and sometimes bewildering nature of some ingredients in cosmetics, consumers often ask FDA for explanations. "My night cream contains liposomes - what is that?" "Why is placenta used in cosmetics - is it human placenta, and could I get a disease from it?" "What are cerebrosides and ceremides?" FDA cosmetic scientists can explain the nature of an ingredient when it is identified by its chemical name. But when an ingredient is listed by its trade name, FDA usually must consult the manufacturer's trade literature or the International Cosmetic Ingredient Dictionary, published by the Cosmetic, Toiletry, and Fragrance Association, Inc., the industry's major trade association. The dictionary, now in its fourth edition, provides a uniform system for assigning ingredient names. FDA currently recognizes the second edition as a primary reference.
Here is what FDA knows about some currently marketed ingredients:
But Stanley R. Milstein, Ph.D., associate director for FDA's cosmetics division, says the notion that skin can be nourished by a vitamin applied to its surface has not been proven clinically. For that reason, says Milstein, a vitamin added to a cosmetic product must be listed in the ingredient label by its chemical name so that it doesn't convey a misleading message. However, FDA does not prohibit listing vitamins by their common names on the principal display panel of a cosmetic as long as the consumer is not misled and no therapeutic claims are made. Some leaders in the cosmetic industry, such as Neutrogena's Schoen, agree with the FDA position on vitamins in skin care products. Others, such as Chris Vaughn of Sun Pharmaceuticals, L., cite clinical studies done by Hoffmann-La Roche and others that show that vitamins can penetrate layers of skin and have beneficial effects. This, however, would make it a drug use, and manufacturers who use vitamins in their products don't usually make claims that would cause their products to be classified as drugs. Vaughn says that getting a drug classification is time-consuming and expensive, and in his opinion not justifiable because the informed consumer understands the beneficial properties of vitamins. Although the debate about the value of vitamins in skin care products continues, it is generally accepted that a sufficient quantity of vitamin E (shown on ingredient lists as tocopherol), an antioxidant, preserves the fatty components in cosmetic creams and lotions to prevent off-color and off-odors.
Milstein explains that aloe vera, as a cosmetic ingredient, is expensive because it requires delicate processing and handling. A product that contains the 5 to 10 percent aloe vera necessary for the anti-irritant properties to be effective would send the price out of range for many consumers.
A number of biological products in cosmetics have raised consumer concern:
The raw material for cerebrosides in cosmetics comes from cattle, oxen or swine brain cells or other nervous system tissues. Alternatively, the raw material may be isolated from plant sources. Industry cosmetic scientists claim that the use of cerebrosides in skin products results in a smoother skin surface and better moisture retention, effects that translate into marketing claims such as luminosity and ever-improving hydration. FDA has not evaluated the studies on which these claims are based.
"The cosmetic industry is sensitive to the image of an uncontrolled market where anything goes," says Bailey. "They counter this image with well-established self-regulation programs. Part of the incentive for such industry policy is to avoid increased regulatory authority." The most well-known of industry-sponsored self-regulation is the Cosmetic Ingredient Review, sponsored by the Cosmetic Toiletry and Fragrance Association. The CIR is accomplished by a panel of scientific and medical experts who evaluate cosmetic ingredients for safety and publish detailed reviews of available safety data. "A finding of safety by the CIR provides a degree of confidence that the ingredient can safely be used in cosmetics," Bailey says. "In the absence of the CIR program, there would be no systematic examination of the safety of individual cosmetic ingredients." FDA has no statutory authority to require that the data be submitted to the agency. FDA encourages industry cooperation through its cosmetic voluntary reporting program. Cosmetic firms registered in the program voluntarily report manufacturing and formulation information, along with product experience data, to FDA. Adverse reactions such as skin irritations are also reported. Using this information, FDA can determine a baseline reaction rate for specific product categories such as hair coloring or eye makeup preparations. The agency gives participating companies this baseline information so they can compare their own adverse reaction rates to the FDA-established baseline.
"Registration in this voluntary program does not mean that FDA approves or endorses a firm, raw material, or product," says Mary Waleski, chief of the cosmetic registration program. "But it does provide for an interaction between the industry and government for exchange of information." FDA would like to see wider industry participation. "Based on the number of companies we think are eligible to participate, only about 35 percent do," Waleski says. There are also other problems. "Sometimes the information a firm submits is incomplete," Waleski says. "And if a firm does not update its submissions with additions or deletions, the information in the registration files could accumulate as inaccurate information." FDA continues to explore ways to make the program more useful for both industry and government, says Bailey. "We compare product information available to the agency with registered data, and now we're considering periodic field surveys of products on the shelves. Such a review would include comparison of label ingredient declarations with information reported to FDA." The quest for sustained youth and beauty that sells cosmetics is age-old, though ingredients used to achieve that image may change. Shakespeare noted the same concern that keeps the cosmetic industry going when he said,
Time doth transfix the flourish set on youth And delves the parallels in beauty's brow.But he gave voice to another standard when he wrote,
To me, fair friend, you never can be old, For as you were when first your eye I eyed, Such seems your beauty still.
Judith Foulke is a staff writer for FDA Consumer.
Source: FDA Consumer U.S. Food and Drug Administration
By law, FDA does not have the authority to approve cosmetic products or ingredients, except for color additives. However, regulations prohibit or restrict the use of several ingredients because of safety concerns.
In addition, cosmetic and fragrance trade associations have recommended avoiding or limiting the use of some substances. Contaminants raise additional concerns. The following is an introduction to special safety and regulatory issues related to cosmetic ingredients.
It is the responsibility of the manufacturer and distributor to assure the safety of each ingredient and finished product. Without substantiation of safety, Title 21 of the Code of Federal Regulations (21 CFR), Part 740.10 requires that the product carry the following warning on the label:
"Warning: The safety of this product has not been determined."
Ingredients prohibited or restricted by regulation
Regulations specifically prohibit or restrict the use of the following ingredients in cosmetics. For complete details, refer to the relevant regulations (21 CFR, Parts 250.250 and 700.11 through 700.23):
In the early 1970s, FDA received a number of complaints of personal injury associated with the use of fingernail extenders containing methyl methacrylate monomer. Among these injuries were reports of fingernail damage and deformity, as well as contact dermatitis. On the basis of its investigations of the injuries and discussions with medical experts in the field of dermatology, FDA concluded that liquid methyl methacrylate was a poisonous and deleterious substance that should not be used in fingernail preparations. The agency chose to remove products containing 100 percent liquid methyl methacrylate monomer through court proceedings, which resulted in a preliminary injunction against one firm as well as several seizure actions and voluntary recalls. Although there is no specific regulation prohibiting the use of liquid methyl methacrylate monomer in cosmetic products, FDA continues to believe that this substance, when used in cosmetic fingernail preparations, is a poisonous and deleterious substance.
Color additives are strictly regulated. In order to protect consumers from harmful contaminants, many cannot be used unless the color comes from a batch certified by FDA and that batch is provided with its own individual certification lot number. Their uncertified counterparts are not allowed and addition of the color to a product will make the entire product adulterated. While colors exempt from certification are not subject to such testing, manufacturers must assure that each color additive complies with the identity, specifications, labeling requirements, use, and restrictions of color additive regulations. With the exception of coal-tar hair dyes, all color additives - whether or not they are subject to certification - must be approved by FDA for their intended use. Check FDA's color listings to determine whether a color additive is approved for your intended use and whether it is subject to certification requirements.
In addition to the ingredients that are controlled by regulation or were the subject of a court ruling, cosmetic and fragrance trade associations have recommended eliminating or limiting maximum levels of certain ingredients associated with health risks. For example, the Cosmetic Ingredient Review (CIR) Expert Panel, an independent panel of scientific experts, regularly assesses the safety of numerous cosmetic ingredients and publishes its findings. (The CIR was established by the Cosmetic, Toiletry, and Fragrance Association.) According to its 1999 Annual Report, CIR has found the following ingredients unsafe:
CIR also has recommended limits for the use of a number of other ingredients. You can contact CIR at:
Cosmetic Ingredient Review
1101 17th St. N. W. Suite 310
Washington D. C. 20036-4702
phone: 202-331-0651 fax: 202-331-0088
Web site: www.cir-safety.org
Similarly, the International Fragrance Association (IFRA) establishes usage guidelines for fragrance materials. IFRA's Code of Practice currently recommends against the use of more than 30 substances as fragrance materials and advises limiting the use of many more. Among the many that IFRA recommends avoiding are:
The IFRA member organization in the United States is:
Fragrance Materials Association (FMA)
1620 I St., NW, Suite 925
Washington, DC 20006
Phone: (202) 293-5800
Fax: (202) 463-8998
The risk of introducing contaminants into a product is always a concern in cosmetic manufacture, whether they are introduced through contaminated raw ingredients or form during the manufacturing process. Nitrosamines and dioxane are among those contaminants that may form during the manufacturing process and raise safety issues. Research also has raised safety questions about diethanolamine (DEA) and related ingredients that may contain residual levels of this substance.
• Nitrosamines. Many nitrosamines have been determined to cause cancer in laboratory animals. They also have been shown to penetrate the skin.
FDA expressed its concern about the contamination of cosmetics with nitrosamines in a notice published in the Federal Register of April 10, 1979 (44 FR 21365). It stated that cosmetics containing nitrosamines may be considered adulterated and subject to enforcement action.
Cosmetics containing as ingredients amines or amino derivatives, particularly diethanolamine, or ingredients that are derived from diethanolamine or possibly contain diethanolamine as a contaminant, may form nitrosamines if they also contain an ingredient that acts as a nitrosating agent, such as 2-bromo-2-nitropropane-1,3-diol (Bronopol), 5-bromo-5-nitro-1,3-dioxane (Bronidox L) or tris(hydroxymethyl)nitromethane (Tris Nitro), or if they are contaminated with a nitrosating agent, e.g., sodium nitrite. Amines and their derivatives are mostly present in creams, cream lotions, hair shampoos, and cream hair conditioners. Nitrosamines are avoidable by proper formulation: by not using amines or amino derivatives in combination with a nitrosating agent and by testing the product under use conditions to make sure that nitrosamines do not form under customary conditions of use.
Although cosmetic manufacturers are not required to register with FDA, companies are encouraged to register their establishments and list their products and ingredients through the agency's Voluntary Cosmetic Registration Program (VCRP). If a cosmetic manufacturer files a product formulation with the VCRP, FDA can advise the manufacturer if he or she is inadvertently using a non-permitted color additive or other prohibited or restricted ingredients. In this way, manufacturers can correct their formulations before attempting to import or distribute them, thus avoiding the risk of detention or recall due to ingredient-related violations. Products containing prohibited ingredients are not accepted into the registration program. The information received by FDA from the VCRP is evaluated and entered into a computer database. If it is determined that a cosmetic ingredient presently being used is harmful and should be removed from product use, FDA can notify the product's manufacturer or distributor by using a mailing list generated from the VCRP database. If your products are not in the registration database, you won't be on the notification mailing list.
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 became 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 4-MMPD 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.
It's never a good sign when the hairdresser panics. That's what happened to Barbara Cabrera-Avila, 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 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. 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.'"
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.
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 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."
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.
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."
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 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.
Michelle Meadows is a staff writer for FDA Consumer.
Source: FDA Consumer