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Special report -------------------------------------------------------------------------------- · Cosmetics firm targets UK market · Ian Cobain and Adam Luck Plastic surgeons are also concerned about the delay in introducing regulations to control the cosmetic treatments industry. Norman Waterhouse, a former president of the British Association of Aesthetic Plastic Surgeons, said: "I am surprised that we are taking the lead from the European commission, because this is bound to delay action on this important area which is increasingly a matter for concern. It seems like a bit of a cop out to me." It is unclear whether any of the "aesthetic fillers" such as collagen available in the UK or on the internet are supplied by the company, which cannot be identified for legal reasons. It is also unclear whether collagen made from prisoners' skin is in the research stage or is in production. However, the Guardian has learned that the company has exported collagen products to the UK in the past. An agent told customers it had also exported to the US and European countries, and that it was trying to develop fillers using tissue from aborted foetuses. Traditional When formally approached by the Guardian, the agent denied the company was using skin harvested from executed prisoners. However, he had already admitted it was doing precisely this during a number of conversations with a researcher posing as a Hong Kong businessman. The Press Complaints Commission's code of practice permits subterfuge if there is no other means of investigating a matter of public interest. The agent told the researcher: "A lot of the research is still carried out in the traditional manner using skin from the executed prisoner and aborted foetus." This material, he said, was being bought from "bio tech" companies based in the northern province of Heilongjiang, and was being developed elsewhere in China. He suggested that the use of skin and other tissues harvested from executed prisoners was not uncommon. "In China it is considered very normal and I was very shocked that western countries can make such a big fuss about this," he said. Speaking from his office in northern China, he added: "The government has put some pressure on all the medical facilities to keep this type of work in low profile." The agent said his company exported to the west via Hong Kong."We are still in the early days of selling these products, and clients from abroad are quite surprised that China can manufacture the same human collagen for less than 5% of what it costs in the west." Skin from prisoners used to be even less expensive, he said. "Nowadays there is a certain fee that has to be paid to the court." The agent's admission comes after an inquiry into the cosmetic surgery industry in Britain, commissioned by the Department of Health, pointed to the need for new regulations controlling collagen treatments. Sir Liam Donaldson, the chief medical officer, has highlighted the inquiry's concerns about the use of cadavers for cosmetic treatments. "Cosmetic procedures are a rapidly growing area of private health care," he said. "We must ensure we properly protect patients' safety by improving the training and regulation." The DoH has agreed to the inquiry's recommendations, but is waiting for the European commission to draw up proposals for laws governing cosmetic products. It could be several years before this legislation takes force. Meanwhile, cosmetic treatments, including those with with aesthetic fillers, are growing rapidly in popularity, with around 150,000 injections or implants administered each year in the UK. Lip enhancement treatments are one of the most popular, costing an average of £170. Some fillers are made from cattle or pig tissue, and others from humans. The DoH believes that there may be a risk of transmission of blood-borne viruses and even vCJD from collagen containing human tissue. Although there is as yet no evidence that this has happened, the inquiry found that some collagen injections had triggered inflammatory reactions causing permanent discomfort, scarring and disfigurement. In their report, the inquiry team said that if there was a risk, "action should be taken to protect patient safety through regulation". While new regulations are to be drawn up, the department is currently powerless to regulate most human-tissue fillers intended for injection or implant, as they occupy a legal grey area. Most products are not governed by regulations controlling medical products, as they are not classified as medicines. They also escape cosmetics regulations, which only apply to substances used on the surface of the skin and not those injected beneath it. The Healthcare Commission is planning new regulations for cosmetic surgery clinics next year, but these will not control the substances used by plastic surgeons. Hand transplants A number of plastic surgeons have told the Guardian that they have been hearing rumours about the use of tissue harvested from executed prisoners for several years. Peter Butler, a consultant plastic surgeon and government adviser, said there had been rumours that Chinese surgeons had performed hand transplants using hands from executed prisoners. One transplant centre was believed to be adjacent to an execution ground. "I can see the utility of it, as they have access and no ethical objection," he said. "The main concern would be infective risk." Andrew Lee of the University of Pittsburgh School of Medicine, who has visited China to examine transplant techniques, said he had heard similar rumours. Manufacturers of aesthetic fillers said they had seen Chinese collagen products on sale at trade fairs, but had not seen any labelled Chinese-made in the UK. Dan Cohen, whose US-based company, Inamed, produces collagen products, said: "We have come across Chinese products in the market place. But most products from China are being sold 'off-label' or are being imported illegally." In China, authorities deny that prisoners' body parts are harvested without their consent. However, there is some evidence to suggest it may be happening. In June 2001, Wang Guoqi, a Chinese former military physician, told US congressmen he had worked at execution grounds helping surgeons to harvest the organs of more than 100 executed prisoners, without prior consent. The surgeons used converted vans parked near the execution grounds to begin dissecting the bodies, he told the house international relations committee's human rights panel. Skin was said to be highly valued for the treatment of burn victims, and Dr Wang said that in 1995 he skinned a shot convict's body while the man's heart was still beating. Dr Wang, who was seeking asylum in the US, also alleged that corneas and other body tissue were removed for transplant, and said his hospital, the Tianjin paramilitary police general brigade hospital, sold body parts for profit. Human rights activists in China have repeatedly claimed that organs have been harvested from the corpses of executed prisoners and sold to surgeons offering transplants to fee-paying foreigners. Dr Wang's allegations infuriated the Chinese authorities, and in a rare move officials publicly denounced him as a liar. The government said organs were transplanted from executed prisoners only if they and their family gave consent. Although the exact number of people facing the death penalty in China is an official secret, Amnesty International believes around 3,400 were executed last year, with a further 6,000 on death row. What is it? Collagen is a major structural protein found in abundance in skin, bones, tendons and other connective tissue. Matted sheets of collagen give skin its toughness and by winding into molecular "cables", it adds strength to tendons. What is it used for? Collagen injections are used in cosmetic surgery to plump up lips and flatten out wrinkles. After botox, collagen injections are the second-most popular cosmetic operations in Britain. Collagen does not have a permanent effect and several injections are often needed. What else is it good for? Collagen was being put to good use as far back as the stone age. Neolithic cave dwellers around the Dead Sea are believed to have used it as a primitive form of glue some 8,000 years ago. More recently, researchers have developed a form that can be poured or injected into wounds to seal them. Where does it come from? A number of sources. Some companies extract it from cow skin and treat it to minimise the risk of allergic reactions or infection. Others collect it from human donors or extract cells from the patient before growing the necessary amount in a laboratory. Is it safe? Collagen can cause allergic reactions if it has not been treated correctly, and there is a theoretical risk of disease being passed on. A small amount of collagen is often injected into the skin a few weeks before treatment to test for possible allergic reactions. Earlier this year, Sir Liam Donaldson warned that collagen injections could spread conditions such as hepatitis and variant CJD, the human form of mad cow disease. http://www.guardian.co.uk/uk_news/story/0,,1568467,00.html Opinion of the BIOHAZ Panel on the safety of collagen and a processing method for the production of collagen Opinion Chapter 4, Section B, Part V(1) of the Annex II of the Council Directive 92/118/EEC, amended by the Decision 2003/721/EC, specifies that collagen must be produced using a process that ensures that the raw material is subjected to a treatment involving washing, pH adjustment using acid or alkali followed by one or more rinses, filtration and extrusion; or by an equivalent process approved by the European Commission (EC) after consultation of the appropriate Scientific Committee. ================================================ Cosmetic Ingredients: 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. (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, But he gave voice to another standard when he wrote, Judith Foulke is a staff writer for FDA Consumer. Publication No. (FDA) 95-5013 http://www.fda.gov/fdac/reprints/puffery.html Coverage of Bovine-Derived Ingredients for Bovine Spongiform Encephalopathy (BSE) BSE continues to be prevalent in Great Britain (including Northern Ireland and the Falklands), Belgium, Luxenbourg, the Netherlands, France, Switzerland, Republic of Ireland, Oman, and Portugal. This list of BSE countries is subject to change. Refer to I.A. #17-04 for the most up-to-date list. Manufacturers and importers of cosmetic products and their ingredients should have planned, systematic Procedures in place to provide assurances to themselves and to consumers that bovine-derived tissues do not come from cattle in countries where BSE occurs. NOTE: The list of tissues contained in the Agency's 5/9/96 letter has been expanded (ATTACHMENT B) to include additional bovine tissue or tissue-derived ingredients with a suspected risk of infectivity. The tissues and tissue derived-ingredients marked with asterisks are considered to present the highest risk of infectivity (hereinafter referred to as high-risk tissues). http://www.cfsan.fda.gov/~comm/cp29002.html http://www.standardprocess.com/sp_catalog_product_detail.asp Active Ingredients (SPF 15 Cream only): Ethylhexyl-P- Methoxycinnamate 7.5%, Oxybenzone 5%, Titanium Dioxide 2% Ingredients: Water, Isopropyl Palmitate, Catrix® Cartilage, C12-15 Alkyl Benzoate, Cetyl Alcohol, Hydrogenated Vegetable Oil, Aloe Barbadensis Gel, PEG-100 Stearate, Algae Extract, Tocopheryl Acetate, Matricaria (Chamomilla Recutita) Extract, Apple (Pyrus Malus) Extract, Kola (Cola Accuminata) Extract, Bisabolol, Polysorbate 60, Phospholipids, Steareth-2, Butylene Glycol, Xanthan Gum, Magnesium Aluminum Silicate, Orange (Citrus Aurantium Dulcis) Oil, Triethanolamine, Dimethicone, Disodium EDTA, Phenoxyethanol, Methylparaben, Ethylparaben, Propylparaben, Butylparaben, Potassium Sorbate Catrix® is a bovine-derived complex mucopolysaccharide product. CATRIX® 10 Ointment CATRIX® 10 Ointment Catrix 10 Ointment is a professional strength topical application containing 10% Catrix powder in a petrolatum base. Catrix 10 Ointment is a clinically-tested and specially-formulated post-procedure application designed to help relieve discomfort and restore skin to its natural healthy condition following laser resurfacing, chemical peels and dermabrasions. Catrix 10 Ointment provides important benefits for patients who undergo these therapies. 1. Expedites the development of epithelial cells, helping the patient to heal faster. 2. Relieves the discomfort experienced post-procedure: Reduces redness For surgical incisions and other wounds Catrix 10 is equally effective. It applies easily with no patient discomfort, and provides a moist environment important to proper healing. This non-irritating formula is also an effective therapy for diaper rash, skin problems resulting from incontinence, abrasions, burns and psoriasis. Directions: Liberally apply a layer immediately following the dermatological procedure and whenever treated area feels or looks dry (every 2-5 hrs.). In the unlikely event of crust formation, gently soak off using water and a soft cloth; then reapply Catrix 10 Ointment. Important: keep skin moist with Catrix 10 Ointment at all times for increased comfort and speed in healing. For other uses, apply frequently as directed by a skin care professional. Ingredients: Petrolatum, Catrix® Cartilage, Isopropyl Palmitate, Beeswax, Parafin, Benzyl Alcohol Catrix® is a bovine-derived complex mucopolysaccharide product. http://www.catrix.com/products/catrix10.html Placenta Wrinkle Cream is a rich moisture cream containing essential vitamins, minerals and sheep placenta that helps to nourish the skin, accelerates tissue regeneration and improves absorption of moisture. Australian sheep placenta is known to be one of the best. Placenta Cream (skin oil) has been fortified with collagen and liposomes to nourish your skin as a day and night cream. We suggest to use Placenta Cream daily if you wish to have a younger looking skin. Liposomes is one of the newest discoveries in skin care and used in the most sophisticated creans today. Suggested use: Placenta Wrinkle Moisture Cream is suggested for all types of skin for women and men. Ingredients: http://store.yahoo.com/vitasprings/placenta-wrinkle-cream-skin-oil-.html July 14, 2004 While BSE is usually identified with either food safety or animal health, cosmetics, because of the ways they are used, provide another route for BSE infectivity to enter the human system. Cosmetics may contain a wide range of cattle-derived ingredients, many of which may carry the BSE agent. FDA prepared this assessment of the risks to public health if cattle-derived ingredients are used in cosmetics. This qualitative risk assessment follows the generally accepted framework for risk assessments endorsed by the Codex Alimentarious Commission, the U.S. National Academy of Sciences, and other authoritative bodies. The framework divides risk assessment into four components: (1) hazard identification, (2) exposure assessment, (3) hazard characterization (or dose-response assessment), and (4) risk characterization. The risk assessment uses scientific evidence to the extent that it exists. The agency has determined that this qualitative risk assessment is appropriate to the circumstances. Risk Assessment Prions are predominantly found in the central nervous system, portions of the intestine, and tonsils of cattle with BSE. Cosmetic ingredients can be derived from some of these tissues. Although large prion doses are known to have a shorter incubation period before the disease develops, even low doses may cause vCJD if infectious prions survive digestion and the host survives long enough to complete a longer incubation period. Although most scientists believe that vCJD in humans is caused by consumption of cattle-derived food products contaminated with the agent that causes BSE (Refs. 11-14), exposure from cosmetics derived from cattle protein is another potential route of exposure. Exposure Assessment Use of Cattle Protein in Cosmetics Absorption of Prions from Cosmetics It is well-documented that central nervous system tissue, including the optic nerve, carries infectivity in animals with TSEs and humans with vCJD, and serves as an efficient route of transmission. In mice, intraocular injection of scrapie caused infection along the optic nerve, which eventually spread into non-neural tissue via the lymphatic system (Ref. 15). In addition to intraocular injection, infectivity has been transmitted to animals via the conjunctiva of the eye (mucosal tissue). Scott et al. (Ref. 16) found that scrapie was induced in 42 percent of rodents by dropping a high concentration of infectivity onto the conjunctiva. Klitzman et al. (Ref. 17) suggested that kuru, a human TSE disease found only among the Fore people of New Guinea, might have been transmitted by rubbing infected human brain into eyes or cut skin, while handling and consuming infected brain during funeral rituals. Cut or abraded skin also has been proposed as a route for contracting TSE diseases. The transmission of kuru through cut skin has been suggested and was mentioned previously. Taylor et al. (Ref. 18) and Ingrosso et al. (Ref. 19) demonstrated increased transmission of scrapie via oral mucosal tissue. In one study, 100 percent of mice with experimentally damaged oral mucosal tissue developed scrapie through ingestion of infected material, while only 71 percent of mice with intact mucosa developed the disease (Ref. 18). In addition, Pammer et al. (Ref. 20) and Sugaya et al. (Ref. 21) noted that epithelial cells, dendritic cells, and keratinocytes (the primary cell types found in the epidermis) have been found to contain infectious prion protein, indicating that these cells are potential targets for peripheral infection with a TSE disease. Use of BSE-contaminated cosmetics could provide a means of human infection via several routes discussed above. Many cosmetics are typically applied in the area of the eye (mascara, eye brow pencil, eyeliner, eye lotion, and eye makeup remover) and almost any cosmetic, including shampoo, can get into the eye via eye rubbing or incorrect application. Any cosmetic product, but particularly shaving creams and gels and lotions, may be applied to cut or abraded skin. Cosmetics that are ingested, such as lipstick, dentifrices, mouthwash, and breath fresheners, would have an oral route of infection, and the ingested fraction would have the same risk as prion-contaminated meat and other food products derived form cattle. Furthermore, the presence of cattle derived ingredients is not generally obvious to the consumer, since the source of the ingredient (i.e. cattle derived) does not need to be placed on the label. Hazard Characterization In cattle, there is a minimal incubation period of six months to a year required for the development of the disease, regardless of the size of the initial dose, although incubation periods of 4 or more years appear to be more common (Refs. 11 and 12). The lag period may reflect the fact that transmission from food to brain may be preceded by symptomless amplification of infectious prions in the intestine and lymphoreticular tissues. While cattle at this stage would be clinically normal and may have negative BSE test results, various tissues could be infectious (Refs. 11 and 12). Despite widespread exposure in the U.K. to BSE-contaminated meat products, only a very small percentage of the exposed population has been diagnosed with vCJD to date. However, ongoing experiments indicate that the infectious dose for cattle is very low. One gram of affected bovine brain homogenate is sufficient to cause BSE in more than 50 percent of calves exposed by mouth. Five years after oral consumption of lower doses of brain material, 2 of 15 calves fed 0.1 gram had onset of BSE, and 1 of 15 fed 0.01 gram had developed the disease. This experiment is ongoing (Ref. 22). There is thought to be a 10- to 10,000-fold increase in the amount of infectious material needed to cause illness in humans as compared with cattle, because of the species barrier (Ref. 23). Risk Characterization With exception of the uncertainty associated with estimates of the dermal and ocular transmission rates, most of the uncertainties associated with a risk assessment of BSE prions in cosmetics are also associated with the risk from food consumption. For example, the number of BSE-affected cattle and the variability in human susceptibility will impact the risk of both food- and cosmetic-associated vCJD. Some of these uncertainties may concomitantly affect both sides of a cost-benefit analysis. In particular, if there is not substantial use of cattle-derived protein in making cosmetics, then there will be little exposure, and also little economic consequence from regulating use. Conversely, high use would require substantial substitution and alternative means of animal-by-product disposal. Conclusions The risk of BSE from cosmetics may be reduced through the control of exposure. Aside from the derivation processes used on tallow, the effectiveness of cosmetic manufacturing processes for inactivating BSE prions is unknown. The surest way to prevent transmission of BSE-prion through cosmetics is to avoid the use of high-risk cattle-derived protein in the manufacture of cosmetics. References Chazot, G., E. Broussolle, C.I. Lapras, T. Blattler, A. Aguzzi, and N. Kopp. 1996. New variant of Creutzfeldt-Jakob disease in a 26-year-old French man. Lancet 347: 1181. Prusiner, S.B. 2001. Shattuck Lecture--Neurodegenerative diseases and prions. N Engl J Med 344 (20): 1516-1526. Collinge, J. 2001. Prion diseases of humans and animals: Their causes and molecular basis. Annu. Rev. Neurosci. 24: 519-50. Almond, J. and J. Pattison. 1997. Human BSE. Nature 389: 437-38. Scott, M.R., R. Will, J. Ironside, H-O.B Nguyen, P. Tremblay, S.J. DeArmond, and S.B. Prusiner. 1999. Compelling transgenetic evidence for transmission of bovine spongiform encephalopathy prions to humans. Proc. Natl. Acad. Sci. 96 (26): 15137-142. Hill, A.F., M. Desbruslais, S. Joiner, K.C.L. Sidle, I. Gowland, J. Collinge L.J. Doey, and P. Lantos. 1997. The same prion strain causes vCJD and BSE. Nature 389: 448-450. Collinge, J. 1999. Variant Creutzfeldt-Jakob disease. Lancet 354: 317-323. Lasmezas, C.I., J-G. Fournier, V. Nouvel, H. Boe, D. Marce, F. Lamoury, N. Kopp, J-J. Hauw, J. Ironside, M. Bruce, D. Dormont and J-P. Deslys. 2001. Adaptation of the bovine spongiform encephalopathy agent to primates and comparison with Creutzfeldt-Jakob disease: Implications for human health. Proc. Natl. Acad. Sci. 98 (7): 4142-4147. Bruce, M.E., R.G. Will, J. W. Ironside, I. McConnell, D. Drummond, A. Suttie, L. McCardle, A. Chree, J. Hope, C. Birkett, S. Cousens, H. Fraser, and C.J. Bostock. 1997. Transmissions to mice indicate that 'new variant' CJD is caused by the BSE agent. Nature 389: 498-501. Brown, P. 1997. The risk of bovine spongiform encephalopathy ('mad cow disease') to human health. J. Am. Med. Assn. 278 (12): 1008-1011. Brown, P., R.G. Will, R. Bradley, D.M. Asher, and L. Detwiler. 2001. Bovine spongiform encephalopathy and variant Creutzfeldt-Jakob disease: Background, evolution, and current concerns. Emerging Infect. Dis. 7 (1): 6-16. Scientific Steering Committee, European Commission. 1999. Opinion of the Scientific Steering Committee on the Human Exposure Risk (HER) via food with respect to BSE. Accessed online at http://europa.eu.int/comm/food/fs/bse/scientific_advice08_en.html. Harvard Center for Risk Analysis, Harvard School of Public Health. 2003. Evaluation of the potential for bovine spongiform encephalopathy in the United States. Accessed online at http://www.hcra.harvard.edu/pdf/madcow.pdf. Fraser, J.R. 1996. Infectivity in extraneural tissues following intraocular scrapie infection. J. Gen. Virol. 77: 2663-68. Scott, J.R., J. D. Foster and H. Fraser. 1993. Conjunctival instillation of scrapie in mice can produce disease. Vet Microbiol 34 (4): 305-309. Klitzman R.L., M.P. Alpers, and D.C. Gajdusek. 1984. The natural incubation period of kuru and the episodes of transmission in three clusters of patients. Neuroepidemiology 3 (1): 3-20. Taylor, D.M., I. McConnell, and H. Fraser. 1996. Scrapie infection can be established readily through skin scarification in immunocompetent but not immunodeficient mice. J. Gen. Virol. 77: 1595-99. Ingrosso, L., F. Pisani, and M. Pocchiari. 1999. Transmission of the 263K scrapie strain by the dental route. J. Gen. Virol. 80: 3043-47. Pammer, J., W. Weninger, and E. Tschachler. 1998. Human keratinocytes express cellular prion-related protein in vitro and during inflammatory skin diseases. Am. J. Pathol. 153: 1353-58. Sugaya, M., K. Nakamura, T. Watanabe, A. Asahina, N. Yasaka, Y. Koyama, M. Kusubata, Y. Ushiki, K. Kimura, A. Morooka, S. Irie, T. Yokoyama, K. Inoue, S. Itohara, and K. Tamaki. 2002. Expression of cellular prion-related protein by murine Langerhans cells and keratinocytes. J. Dermato. Sci. 28: 126-134. Vossen, P., J. Kreysa, and M. Goll. 2003. Overview of the BSE risk assessment of the European Commission's Scientific Steering Committee (SSC) and it TSE/BSE ad hoc group. Accessed online at http://europa.eu.int/comm/food/fs/sc/ssc/out364_en.pdf. Scientific Steering Committee, European Commission. 2000. Oral exposure of humans to the BSE agent: Infective dose and species barrier. Accessed online at http://europa.eu.int/comm/food/fs/sc/ssc/out79_en.pdf. http://www.cfsan.fda.gov/~comm/bse-ra.html Journal of Virology, February 2005, p. 1888-1897, Vol. 79, No. 3 Neuroinvasion by Scrapie following Inoculation via the Skin Is Joanne Mohan, Moira E. Bruce, and Neil A. Mabbott* Neuropathogenesis Unit, Institute for Animal Health, Edinburgh, Scotland, United Kingdom Received 18 June 2004/ Accepted 7 September 2004 Many natural transmissible spongiform encephalopathy (TSE) infections are likely to be acquired peripherally, and studies in mice show that skin scarification is an effective means of scrapie transmission. After peripheral exposure, TSE agents usually accumulate in lymphoid tissues before spreading to the brain. The mechanisms of TSE transport to lymphoid tissues are not known. Langerhans cells (LCs) reside in the epidermis and migrate to the draining lymph node after encountering antigen. To investigate the potential role of LCs in scrapie transportation from the skin, we utilized mouse models in which their migration was blocked either due to CD40 ligand deficiency (CD40L/ mice) or after caspase-1 inhibition. We show that the early accumulation of scrapie infectivity in the draining lymph node and subsequent neuroinvasion was not impaired in mice with blocked LC migration. Thus, LCs are not involved in TSE transport from the skin. After intracerebral inoculation with scrapie, wild-type mice and CD40L/ mice develop clinical disease with similar incubation periods. However, after inoculation via skin scarification CD40L/ mice develop disease significantly earlier than do wild-type mice. The shorter incubation period in CD40L/ mice is unexpected and suggests that a CD40L-dependent mechanism is involved in impeding scrapie pathogenesis. In vitro studies demonstrated that LCs have the potential to acquire and degrade protease-resistant prion protein, which is thought to be a component of the infectious agent. Taken together, these data suggest that LCs are not involved in scrapie transport to draining lymphoid tissues but might have the potential to degrade scrapie in the skin. ------------------------------------------------------------------------ ------------------------------------------------------------------------ http://jvi.asm.org/cgi/content/abst...journalcode=jvi RUB A DUB DUB, A TSE IN THAT TUB OF CREAM OR EYE LINER ??? kuru infection via open wounds etc. , accumulation ??? just thinking out loud here... what does the fda say, everything is ok, but what about before July 14, 2004 ??? WHAT about all that cream and eye make-up my mother used for decades and she Conclusions A form of spongiform encephalopathy that occurs in humans (vCJD) is thought to result from the same protein (a prion) that causes BSE in cattle. Although the primary source of exposure is likely to be due to the ingestion of beef and other food derived from cattle, other routes of exposure may also be important. Although small doses require longer incubation periods for clinical signs to develop, small doses of infectious prions can potentially cause disease. Cosmetics that contain protein derived from bovine sources are a potential source of exposure. It has been demonstrated experimentally that TSEs may result from ocular absorption of protein, and systemic absorption of protein may also occur when cosmetics are applied to lacerated or abraded skin. As a result, it may be concluded that there is some risk of occurrence of vCJD from the use of cattle-derived protein in cosmetics. However, since there are large uncertainties associated with the quantitative estimates of many of the important variables, any quantitative estimate of the risk or rate at which the disease may be expected to occur would be correspondingly imprecise. The risk of BSE from cosmetics may be reduced through the control of exposure. Aside from the derivation processes used on tallow, the effectiveness of cosmetic manufacturing processes for inactivating BSE prions is unknown. The surest way to prevent transmission of BSE-prion through cosmetics is to avoid the use of high-risk cattle-derived protein in the manufacture of cosmetics. http://www.cfsan.fda.gov/%7Ecomm/bse-ra.html continued... January 15th, 2005, 01:56 PM #2 COMMENT SUBMISSION Greetings FDA, I would kindly like to comment on the potential for TSE transmission from What is Kuru? snip... PLEASE NOTE the later ''or by contact with open sores or wounds.'' > and the disease was transmitted either through eating or by contact > the Fore women would scoop the brains of their dead relatives out of Sydney Morning Herald, Saturday, August 28, 1999 The transmission of KURU into animals supported the belief that the Masters, C.J., Gajdusek, D.C. and Gibbs, C.J., (1980). The spongiform SCCNFP/0724/03, final snip...FULL TEXT; http://www.vegsource.com/talk/madco...ages/92820.html Author Keywords: Transmissible spongiform encephalopathy; Scrapie; Skin; author. Tel.: +44 131 667 5204; fax: +44 131 668 3872. http://www.sciencedirect.com/scienc...e239a820e6aea0b Docket No. 2004N-0081 and or RIN number RIN-0910-AF47 Use of Materials THE following was posted the next day by FDA; July 14, 2004 horizontal rule The discovery of a cow with bovine spongiform encephalopathy (BSE) in While BSE is usually identified with either food safety or animal This qualitative risk assessment follows the generally accepted In April 1996, British scientists reported a previously undetected new Prions are predominantly found in the central nervous system, portions BSE in the United States Use of Cattle Protein in Cosmetics Absorption of Prions from Cosmetics It is well-documented that central nervous system tissue, including the Cut or abraded skin also has been proposed as a route for contracting Use of BSE-contaminated cosmetics could provide a means of human SNIP... SEE FULL TEXT; FULL TEXT; http://www.prwatch.org/forum/showthread.php?t=4596 Lip implant tissue link with mad cow disease FEARS that cosmetic implants used in lips and cheeks could trigger vCJD, Sir Liam Donaldson, the Chief Medical Officer, said that experts were Mockingly termed the trout pout , a collagen lip injection is one of The expert groups study of a range of aesthetic fillers, which are The investigation is part of an overhaul of the cosmetic treatments The move follows a surge in demand for cosmetic procedures, some of From next April, legal action will be taken against any providers who The Governments hard line is in response to reports published yesterday Mr Cayton said the group had found a diverse range of sources of The Government said it would follow all the recommendations, revealed by Cosmetic procedures are a rapidly growing area of private healthcare, Simon Gillespie, head of operations at the commission, said that it had MOST POPULAR TREATMENTS The number of cosmetic procedures rose by more than 50 per cent last TOP FIVE FOR MEN Operations conducted by the British Association of Aesthetic Plastic http://www.timesonline.co.uk/article/0,,2-1461514,00.html http://www.timesonline.co.uk/article/0,,2-1461514_2,00.html Subject: FAT LIPS/SHINY HAIR/Creams (Cosmetics) PRETTY WOMEN $ MOVIE Date: June 10, 2001 at 8:24 am PST Greetings ALL, was reading a 'smut' magazine about the 'babes' ""Attention, Goldie Hawn: You might want to forget are these babes in far a 'rude' awakening. firstly, 50 STATE BSE CONFERENCE CALL JAN. 9 2001 U.S.A., G.B.R. T.S.S. Transcripts / Articles on BSE and CJD, The Safety of Gelatin? The Crumbling TSE Walls of the U.S.A.; http://www.vegsource.com/talk/lyman/messages/9163.html http://www.vegsource.com/talk/lyman/messages/9241.html http://www.vegsource.com/talk/lyman/messages/9214.html http://www.vegsource.com/talk/lyman/messages/9347.html http://www.vegsource.com/talk/lyman/messages/9294.html Hask Placenta® No-Rinse Hair Repair Treatment Nature's protein treatment. Excellent for hair that is Price: Placenta, the most powerful natural protein for the hair instantly Directions: Shake well. Apply after shampooing. Use pump and spray until hair is Ingredients: Water, SD Alcohol 40, Placental Protein, Cetrimonium Bromide, Lactic Acid, Hask Perm-Aid® Revitalizing Treatment Price: This product had been discontinued by the manufacturer, we recommend Part No : 1227 This product is in stock, and will ships in one to two business day. http://www.beautycentury.com/mall/stockIS.asp?sku=1227 HASK PLACENTA products are leaders in the Deep Conditioner segment of http://www.ecrm-epps.com/Expose/V4_7/Table_Profiles/Alleghany.html Use of Bovine offal in Cosmetics; http://www.bseinquiry.gov.uk/files/yb/1990/02/01004001.pdf http://www.bseinquiry.gov.uk/files/yb/1990/02/01007001.pdf http://www.bseinquiry.gov.uk/files/yb/1990/01/26018001.pdf http://www.bseinquiry.gov.uk/files/yb/1990/01/29001001.pdf http://www.bseinquiry.gov.uk/files/yb/1990/01/29015001.pdf http://www.bseinquiry.gov.uk/files/yb/1990/01/31014001.pdf *** http://www.bseinquiry.gov.uk/files/yb/1991/06/00005001.pdf http://www.bseinquiry.gov.uk/files/yb/1991/07/25003001.pdf (there may still be some strange products http://www.bseinquiry.gov.uk/files/yb/1991/06/26003001.pdf http://www.bseinquiry.gov.uk/files/yb/1991/06/30001001.pdf http://www.bseinquiry.gov.uk/files/yb/1991/10/15002001.pdf http://www.bseinquiry.gov.uk/files/yb/1991/10/31009001.pdf BSE110/1 0180 RUMINANT-DERIVED MATERIAL IN COSMETICS The Department of Health wishes to reinforce the advice given to the It is possible that some ruminant-derived The particular materials that should not 1. bovine (cattle)-derived offals, or proteins 2. ovine (sheep)-derived offals and ovine placenta. In view of the current uncertainty about the 31 October 1991 91/10.31/9.1 It also emerged from the 16- volume The report describes their use as a potential http://www.sesahs.nsw.gov.au/albionstcentre/infection_control/newsletter6.htm A CONSIDERATION OF THE POSSIBLE HAZARD OF GELATIN TO MAN IN RELATION TO http://www.bseinquiry.gov.uk/files/sc/seac13/tab07.pdf TSS CONTACT LENS CARE PRODUCTS $ MAD COW DISEASE ??? Re: re-FAT LIPS AND BABES AND MAD COW DISEASE !!! (THAT AINT THE HALF OF http://www.vegsource.com/talk/madcow/messages/9477.html TSS http://www.vegsource.com/talk/madcow/messages/93969.html TSS
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