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| This article originally appeared
in the May 1992 FDA Consumer. The version below is from a reprint of the original article and contains revisions made in February 1995. More information about cosmetics is available from FDA's Center for Food Safety and Applied Nutrition.
Cosmetic Ingredients:
Understanding the Pufferyby Judith E. FoulkeThe 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. (See "Cosmetic Safety: More Complex Than at First Blush" in the November 1991 FDA Consumer.) 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. Baffling Names 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: Liposomes are microscopic sacs, or spheres, manufactured from a variety of fatty substances, including phospholipids. While phospholipids are natural components of cell membranes, the material actually used in cosmetics may be obtained either from natural or synthetic sources. When properly mixed with water, phospholipids form liposome spheres, which can "trap" any substance that will dissolve in water or oil. Manufacturers say that liposomes act like a delivery system. They claim that, when present in a cream or lotion, liposomes can more easily penetrate the surface skin to underlying layers, "melt," and deposit other ingredients of the product. Nayad is a trade name for yeast extract. The manufacturer's literature describes Nayad as a "new system that takes yeast cells and refines them hundreds of times.... What results is a highly concentrated, odor-free, unusually potent yeast extract ...." The same literature reports that "no one really knows how Nayad is working in the skin; all we know for certain is the way it makes the skin look and feel. Test subjects report a noticeable smoothing of lines and wrinkles." FDA has no data to either substantiate or refute these claims. Vitamins are added to cosmetics by manufacturers because foods containing vitamins A, D, E, K, and some of the B complex group are necessary in diets to maintain healthy skin and hair. Using these vitamins in cosmetics that are applied to the skin surface implies that skin will be nourished by them. 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, Ltd., 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. Aloe vera is a plant from the lily family whose anti-irritant properties have been recognized since before the days of Cleopatra. It is listed as an ingredient in many skin lotions, but it would take much more aloe vera than most products contain for the anti-irritant properties to work. 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. What About Biological Ingredients?A number of biological products in cosmetics have raised consumer concern: Human placenta is the nourishing lining of the womb (uterus), which is expelled after birth. When placental materials were first used as cosmetic ingredients in the 1940s, manufacturers promoted the products as providing beneficial hormonal effects such as stimulating tissue growth and removing wrinkles. (Although newborn infants emerge from the womb with wrinkled skin!) The hormone content and the tissue-growth and wrinkle-removing claims classified the placenta-containing products as drugs, and FDA declared them to be ineffective and therefore misbranded. FDA's challenge caused placenta suppliers to change marketing strategies by claiming that hormones in their placenta ingredients had been extracted and were no longer in the product. They then offered placental raw materials without medical claims--only as a source of protein. Can you get a disease from placental cosmetic ingredients? Bailey says no. Placenta used in cosmetics is washed and processed many times to destroy any harmful bacteria or viruses. Besides that, says Bailey, the cosmetic matrix (components that bind the ingredients in products) is made from a wide variety of substances, such as alcohol and preservatives, that would present a hostile environment to any viruses or bacteria the placenta might have carried. Amniotic liquid (from cow or ox) is the fluid that surrounds the developing fetus and protects it from physical injury. It is promoted for benefits similar to those of human placenta and has limited use in moisturizers, hair lotions, scalp treatments, and shampoos. Collagen (from young cows) is the protein substance found in connective tissue. (Connective tissue binds together and supports organs and other body structures.) A great deal of research has been done on the different types and uses for collagen. In cosmetics, collagen has a moisturizing effect. It is not water soluble, but it holds water. FDA says there is no convincing evidence that collagen can penetrate the skin and have an effect below the surface. Cerebrosides (from animals or plants) are a type of glycolipid (a chemically combined form of fatty substance and carbohydrate) produced naturally in basal epidermal cells--the deepest layer of skin. After cerebrosides are formed, they are secreted to the outside of the cells and serve as a protective coating. As new cells form in lower layers of skin, the older skin cells move closer to surface layers and start to dry out. During this process, the cerebrosides are chemically changed and form ceramides, part of a network of membranes between cells. Skin moisture and suppleness comes from this network. 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. Industry Self-Regulation"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.Publication No. (FDA) 95-5013 |
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