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From: TSS ()
Subject: The beauty products from the skin of executed Chinese prisoners AND CJD
Date: September 13, 2005 at 8:10 am PST

Special report

--------------------------------------------------------------------------------
The beauty products from the skin of executed Chinese prisoners

· Cosmetics firm targets UK market ·
Lack of regulation puts users at risk

Ian Cobain and Adam Luck
Tuesday September 13, 2005
The Guardian


A Chinese cosmetics company is using skin harvested from the corpses of executed convicts to develop beauty products for sale in Europe, an investigation by the Guardian has discovered.
Agents for the firm have told would-be customers it is developing collagen for lip and wrinkle treatments from skin taken from prisoners after they have been shot. The agents say some of the company's products have been exported to the UK, and that the use of skin from condemned convicts is "traditional" and nothing to "make such a big fuss about".


With European regulations to control cosmetic treatments such as collagen not expected for several years, doctors and politicians say the discovery highlights the dangers faced by the increasing number of Britons seeking to improve their looks. Apart from the ethical concerns, there is also the potential risk of infection.
MPs on the Commons select health committee are to examine the regulatory system and may launch an investigation and question ministers about the need for immediate new controls. "I am sure that the committee will want to look at this," said Kevin Barron, its Labour chairman. "This is something everyone in society will be very concerned about."

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
Last updated: 26 April 2005
Adopted on 26 January 2005 (Question N° EFSA-Q-2004-085)

Opinion
http://www.efsa.eu.int/science/biohaz/biohaz_opinions/849/opinion_safety_collagen2.pdf
Summary
http://www.efsa.eu.int/science/biohaz/biohaz_opinions/849/summary_safety_collagen2.pdf
Summary

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.


The company concerned, hereafter named ‘the company’ uses a different process (hydrolysis), whose resulting hydrolysed collagen apparently cannot be extruded due to its low molecular weight. The company’s process complies with the rest of the production process specified in Part V(1) of the Decision 2003/721/EC. Consequently the EC has asked the European Food Safety Authority (EFSA) to evaluate, from biological risk perspectives, the data presented.


The company collects poultry and pig bone at registered premises of the meat industry which are supervised by veterinary authorities. The bones comply with the demands of Decision 2003/721/EC, and are declared fit for human consumption. The manufacturing process contains several steps of which is known that they can remove or inactivate Transmissible Spongiform Encephalopathy (TSE) infectivity. The TSE inactivation by the entire process is conservatively estimated 5 logs.


Considering the information provided by the company it is concluded that the production process proposed by the industry ensures equivalent or higher health safety of collagen intended for human consumption compared to the safety achieved by applying the standards of Part V(1) of Decision 2003/721/EC.

================================================

Cosmetic Ingredients:
Understanding the Puffery
by Judith E. Foulke

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,


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

http://www.fda.gov/fdac/reprints/puffery.html

Coverage of Bovine-Derived Ingredients for Bovine Spongiform Encephalopathy (BSE)
By letter dated May 9, 1996 (ATTACHMENT C), FDA recommended that firms that manufacture or import cosmetic products and their ingredients containing specific bovine tissues, including extracts or substances derived from such tissues, take whatever steps necessary to assure themselves that such ingredients do not come from cattle born, raised, or slaughtered in countries where bovine spongiform encephalopathy (BSE) exists. BSE is a fatal transmissible spongiform encephalopathy similar to Creutzfeldt-Jakob disease in humans.

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


USF Ointment® STANDARD PROCESS INC.
Ingredients: Lard, lanolin, linseed oil, soybean lecithin, beeswax, bovine orchic glandular extract, and fragrance.

http://www.standardprocess.com/sp_catalog_product_detail.asp



CATRIX® 5 Rejuvenation Cream

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
Soothes itchiness
Reduces erythema
Controls oozing and crusting
Limits tautness
Faster healing with increased comfort - that’s the Catrix 10 Ointment advantage.

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:
Massage gently a small amount with fingertips into face at night and moming. Excellent as a make-up base.

Placenta Wrinkle Moisture Cream is suggested for all types of skin for women and men.

Ingredients:
Deionized water, stearic acid, safflower oil, Cetyl alcohol, glyceryl stearate PEG-100 stearate, propytene glcol, triethanolamine, almond oil, rose hips oil, placenta extract, tocopheryl acetate (vitamin E acetate). Retinyl palmitate (vitamin A palmitate). Hydrolyzed protin, Panthenol, lecithin (and) superoxide dismutase, bht, methylparaben. Tetrasodium EDT, imidazolidinyl urea, fragrance.

http://store.yahoo.com/vitasprings/placenta-wrinkle-cream-skin-oil-.html

July 14, 2004


An Evaluation of the Risk of Variant Creutzfeldt-Jakob Disease from Exposure to Cattle-Derived Protein Used in Cosmetics
Introduction
The discovery of a cow with bovine spongiform encephalopathy (BSE) in Washington State in December 2003 triggered action to put in place additional safeguards against BSE. Even though the cow was born in Canada, the fact that the cow was discovered in the U.S. and had been sent to slaughter and rendering before it was identified as positive indicates a vulnerability in the U.S. BSE protective net.

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
Hazard Identification
In April 1996, British scientists reported a previously undetected new variant of Creutzfeldt-Jakob disease (vCJD) in young patients, with symptoms somewhat different from sporadic CJD (Refs. 1 and 2). All cases of vCJD had histopathologic evidence of spongiform changes in the brain, but also showed formation of "florid" plaques (a core of amyloid protein with surrounding halos of vacuoles) not typically seen in other forms of CJD (Ref. 3). Clinically, vCJD usually begins with a psychiatric presentation, such as depression, anxiety, nightmares or hallucinations. These symptoms are followed by memory impairment, then dementia in the late stages. The clinical course may last up to two years before death occurs (Ref. 4). Because scientific evidence suggests that the presence and infectivity of abnormal prion proteins in vCJD share characteristics with abnormal prion proteins found in cattle with BSE, scientists have concluded that exposure to the BSE agent is the most plausible explanation for the occurrence of vCJD (Refs. 5 - 8). Monkeys (genetically the closest animal model to humans) inoculated with samples of brain from BSE-infected cattle have been found to develop a TSE that is histopathologically similar to vCJD (Ref. 9), as have mice inoculated or fed with BSE-infected tissue (Ref. 10). In addition, studies have shown that abnormal prion proteins from vCJD patients are molecularly similar to abnormal prion proteins from BSE-infected cattle and different from abnormal prion proteins from patients with CJD and other spongiform encephalopathies (Ref. 4).

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
BSE in the United States
On December 23, 2003, USDA diagnosed a positive case of BSE in an adult Holstein cow in the State of Washington.

Use of Cattle Protein in Cosmetics
Cosmetics may be made from a variety of cattle-derived ingredients. These ingredients include albumin, brain extract, brain lipid, cholesterol, fibronectin, sphingolipids, collagen, keratin, and tallow and tallow derivatives. However, tallow derivatives, particularly fatty acids and glycerin, are the predominant bovine ingredient used by the cosmetic industry and contain very little protein, and are therefore unlikely vehicles for the transmission of prions. Cattle-derived ingredients serve many functions and may be used as skin conditioning agents, emollients, binders, and hair and nail conditioning agents.

Absorption of Prions from Cosmetics
There are several routes through which cosmetics contaminated with the agent that causes BSE could transmit disease to humans. Transmission of the BSE agent to humans through intact skin is believed to be unlikely; however, cosmetics may be ingested or applied to cut or abraded skin or to conjunctival tissues that can provide direct routes for infection.

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
Prions with a particular abnormal tertiary structure are apparently able to generate a similar misconformation in normal proteins, which can in turn cause further misconformations. This allows propagation of the disease and is also important for understanding the relationship between dose, response, and the incubation required for the disease to develop. Once the prions have entered the brain, the prion concentration grows with a relationship that has been described as exponential (Ref. 14).

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
This is not a quantitative risk assessment. However, it does sketch out the logical structure that a quantitative model could use if one were constructed. Some conclusions can be drawn without a quantitative analysis. Since there is considerable uncertainty associated with the premises outlined in the present analysis, it follows that there will also be considerable uncertainty associated with the risk estimate. In the exposure assessment, there are considerable uncertainties associated with the origin of protein used in making cosmetics, the effect of processing on prion concentration, and the transmission rates for dermal and ocular exposure. Particularly large uncertainties associated with the dose response assessment include the magnitude of the species barrier and the length of the incubation period.

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
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.

References
Will, R.G., J.W. Ironside, M. Zeidler, S.N. Cousens, K. Estibeiro, A. Alperovitch, S. Poser, M. Pocchiari, A. Hofman, and P.G. Smith. 1996. A new variant of Creutzfeldt-Jakob disease in the UK. Lancet 347: 921-25.

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
Independent of Migratory Langerhans Cells

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.

------------------------------------------------------------------------
* Corresponding author. Mailing address: Institute for Animal Health, Neuropathogenesis Unit, Ogston Bldg., West Mains Rd., Edinburgh EH9 3JF, United Kingdom. Phone: 44(0)131-667-5204. Fax: 44(0)131-668-3872. E-mail: neil.mabbott@bbsrc.ac.uk .

------------------------------------------------------------------------
Journal of Virology, February 2005, p. 1888-1897, Vol. 79, No. 3
0022-538X/05/$08.00+0 DOI: 10.1128/JVI.79.3.1888-1897.2005
Copyright © 2005 , American Society for Microbiology . All Rights Reserved.

http://jvi.asm.org/cgi/content/abst...journalcode=jvi


hmmm, cosmetics ingredients and CJD via animal TSEs ????

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
had the Heidenhain Variant of CJD WHICH is in the brain directly behind the eyes,
causing you to go blind first? she rubbed the stuff on her face and arms for as long as
i can remember, every night...

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.


References

http://www.cfsan.fda.gov/%7Ecomm/bse-ra.html

continued...






January 15th, 2005, 01:56 PM #2
Terry
Registered User


Join Date: Oct 2002
Location: Bacliff, Texas
Posts: 485
-------- Original Message --------
Subject:
Docket No. 2004N-0081 and or RIN number RIN-0910-AF47 Use of Materials Derived
From Cattle in Human Food and Cosmetics [comment submission]
Date: Tue, 13 Jul 2004 16:08:38 -0500
From: "Terry S. Singeltary Sr."
To: fdadockets@oc.fda.gov
CC: burt.pritchett@fda.gov, Agriculture@mail.house.gov

COMMENT SUBMISSION
[Docket No. 2004N-O081]
RIN-0910--AF47
Use of Materials Derived From Cattle in Human Food and Cosmetics
http://www.fda.gov/OHRMS/DOCKETS/98...081-nir0001.pdf

Greetings FDA,

I would kindly like to comment on the potential for TSE transmission from
cosmetics to humans and why I think that ALL animal by-products should be
excluded from cosmetics. IF we look at the TSE 'KURU'. Kuru is a
transmissible spongiform encephalopathy that was identified in Papua New
Guinea in the late 1950s. Several thousand cases of the disease occurred
during a period of several decades. Epidemiologic investigations
implicated ritual endocannibalistic funeral feasts as the likely route
through which the infectious agent was spread. The incubation period in
females was estimated to be shorter than that in males. The shortest
incubation periods were estimated in adult women, who may have been
exposed to the largest doses of infectious material.
MY question is, was the woman exposed to larger doses, are was it the
route of the
agent that may have been the factor of shorter incubation in woman, or both?

What is Kuru?
Kuru is a rare and fatal brain disorder that occurred at epidemic levels
during the 1950s-60s among the Fore people in the highlands of New
Guinea. The disease was the result of the practice of ritualistic
cannibalism among the Fore, in which relatives prepared and consumed the
tissues (including brain) of deceased family members. Brain tissue from
individuals with kuru was highly infectious, and the disease was
transmitted either through eating or by contact with open sores or
wounds. Government discouragement of the practice of cannibalism led to
a continuing decline in the disease, which has now mostly disappeared.

snip...

PLEASE NOTE the later ''or by contact with open sores or wounds.''

> and the disease was transmitted either through eating or by contact
> with open sores or wounds.


http://www.ninds.nih.gov/health_and...orders/kuru.htm

> the Fore women would scoop the brains of their dead relatives out of
> their skulls by hand before cooking. They then wiped the residual
> liquid and cadaver tissue over their paint-daubed bodies, leaving it
> caked in their hair and on their bodies for weeks after a mortuary feast.


Jennifer Cooke: kuru deaths continue in 1999

Sydney Morning Herald, Saturday, August 28, 1999


TSE INFECTION does takes place when the skin surface has been broken by
scarification (Taylor et al, 1996).

The transmission of KURU into animals supported the belief that the
disease had
been transmitted through ceremonial cannibalistic rituals in New Guinea
with a
possible route of spread involving handling fresh tissue and inoculation
through
mucous membranes and wounds including skin abrasions (Gajdusek, 1977)

Masters, C.J., Gajdusek, D.C. and Gibbs, C.J., (1980). The spongiform
encephalopathies: the natural history of CJD and its relationship to
kuru and scrapie.


* Gajdusek D.C. (1996). Kuru: From the New Guinea field journals
1957-1962. Grand Street, 15:6-33


* Gajdusek D.C. (1973). Kuru in the New Guinea Highlands. In
Spillane JD (ed): Tropical Neurology. New York, Oxford University
Press.


* Gajdusek D.C., Gibbs C.J., and M. Alpers (1966). Experimental
transmission of a kuru-like syndrome to chimpanzees. Nature, 209:794.


* Lindenbaum S. (1979). Kuru Sorcery. Mountain View, Ca, Mayfield
Publishing Company.

SCCNFP/0724/03, final
THE SCIENTIFIC COMMITTEE ON COSMETIC PRODUCTS AND NON-FOOD PRODUCTS
INTENDED FOR CONSUMERS
OPINION
CONCERNING
USE OF SPECIFIED RISK MATERIAL IN COSMETICS
CLARIFICATION FOR TALLOW DERIVATIVES
adopted by the SCCNFP on 30 July 2003
by means of the written procedure
SCCNFP/0724/03, final
Opinion on the Use of specified risk material in cosmetics -
Clarification for tallow derivatives
__________________________________________________ ___________________________________________
2
1. Background

snip...FULL TEXT;

http://www.vegsource.com/talk/madco...ages/92820.html


Conclusion: Following
inoculation with scrapie by skin scarification, replication in the
spleen and subsequent neuroinvasion is critically dependent upon mature
FDCs.

Author Keywords: Transmissible spongiform encephalopathy; Scrapie; Skin;
Follicular dendritic cell; Prion protein; Spleen


Corresponding Author Contact Information
Corresponding

author. Tel.: +44 131 667 5204; fax: +44 131 668 3872.

http://www.sciencedirect.com/scienc...e239a820e6aea0b


http://www.prwatch.org/forum/showthread.php?t=5296



-------- Original Message --------
Subject: An Evaluation of the Risk of Variant Creutzfeldt-Jakob Disease from Exposure to Cattle-Derived Protein Used in Cosmetics
Date: Tue, 27 Jul 2004 11:53:23 -0500
From: "Terry S. Singeltary Sr."
Reply-To: Bovine Spongiform Encephalopathy
To: BSE-L@uni-karlsruhe.de


Greetings,


I submitted the following on July 13, 2004 to FDA.

Docket No. 2004N-0081 and or RIN number RIN-0910-AF47 Use of Materials
Derived From Cattle in Human Food and Cosmetics [TSS SUBMISSION]
- TSS 7/13/04 (0)

THE following was posted the next day by FDA;

July 14, 2004

horizontal rule


An Evaluation of the Risk of Variant Creutzfeldt-Jakob Disease from
Exposure to Cattle-Derived Protein Used in Cosmetics


Introduction

The discovery of a cow with bovine spongiform encephalopathy (BSE) in
Washington State in December 2003 triggered action to put in place
additional safeguards against BSE. Even though the cow was born in
Canada, the fact that the cow was discovered in the U.S. and had been
sent to slaughter and rendering before it was identified as positive
indicates a vulnerability in the U.S. BSE protective net.

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


Hazard Identification

In April 1996, British scientists reported a previously undetected new
variant of Creutzfeldt-Jakob disease (vCJD) in young patients, with
symptoms somewhat different from sporadic CJD (Refs. 1 and 2). All cases
of vCJD had histopathologic evidence of spongiform changes in the brain,
but also showed formation of "florid" plaques (a core of amyloid protein
with surrounding halos of vacuoles) not typically seen in other forms of
CJD (Ref. 3). Clinically, vCJD usually begins with a psychiatric
presentation, such as depression, anxiety, nightmares or hallucinations.
These symptoms are followed by memory impairment, then dementia in the
late stages. The clinical course may last up to two years before death
occurs (Ref. 4). Because scientific evidence suggests that the presence
and infectivity of abnormal prion proteins in vCJD share characteristics
with abnormal prion proteins found in cattle with BSE, scientists have
concluded that exposure to the BSE agent is the most plausible
explanation for the occurrence of vCJD (Refs. 5 - 8). Monkeys
(genetically the closest animal model to humans) inoculated with samples
of brain from BSE-infected cattle have been found to develop a TSE that
is histopathologically similar to vCJD (Ref. 9), as have mice inoculated
or fed with BSE-infected tissue (Ref. 10). In addition, studies have
shown that abnormal prion proteins from vCJD patients are molecularly
similar to abnormal prion proteins from BSE-infected cattle and
different from abnormal prion proteins from patients with CJD and other
spongiform encephalopathies (Ref. 4).

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

BSE in the United States
On December 23, 2003, USDA diagnosed a positive case of BSE in an adult
Holstein cow in the State of Washington.

Use of Cattle Protein in Cosmetics
Cosmetics may be made from a variety of cattle-derived ingredients.
These ingredients include albumin, brain extract, brain lipid,
cholesterol, fibronectin, sphingolipids, collagen, keratin, and tallow
and tallow derivatives. However, tallow derivatives, particularly fatty
acids and glycerin, are the predominant bovine ingredient used by the
cosmetic industry and contain very little protein, and are therefore
unlikely vehicles for the transmission of prions. Cattle-derived
ingredients serve many functions and may be used as skin conditioning
agents, emollients, binders, and hair and nail conditioning agents.

Absorption of Prions from Cosmetics
There are several routes through which cosmetics contaminated with the
agent that causes BSE could transmit disease to humans. Transmission of
the BSE agent to humans through intact skin is believed to be unlikely;
however, cosmetics may be ingested or applied to cut or abraded skin or
to conjunctival tissues that can provide direct routes for infection.

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

SNIP...

SEE FULL TEXT;


http://www.vegsource.com/talk/madcow/messages/92911.html

FULL TEXT;

http://www.prwatch.org/forum/showthread.php?t=4596



From: TSS (216-119-143-162.ipset23.wt.net)
Subject: LIP IMPLANT TISSUE LINK WITH MAD COW DISEASE
Date: January 29, 2005 at 1:07 pm PST


-------- Original Message --------
Subject: Lip implant tissue link with mad cow disease
Date: Fri, 28 Jan 2005 20:07:10 -0600
From: "Terry S. Singeltary Sr."
Reply-To: Bovine Spongiform Encephalopathy
To: BSE-L@LISTSERV.KALIV.UNI-KARLSRUHE.DE


##################### Bovine Spongiform Encephalopathy #####################


Britain


January 29, 2005

Lip implant tissue link with mad cow disease
By Sam Lister
One in six cosmetic surgery firms may be closed as fears for patients
health prompt a clampdown

FEARS that cosmetic implants used in lips and cheeks could trigger vCJD,
the human form of mad cow disease, have prompted the Government to
launch an investigation.

Sir Liam Donaldson, the Chief Medical Officer, said that experts were
examining the possibility that tissue implants such as collagen could
transmit blood-borne diseases such as variant Creutzfeldt-Jakob disease
if contaminated. Although no evidence of such transmission has been
discovered, the committee on microbiological safety of blood and tissues
believes there might be a risk.


Societys obsession with high cheekbones and luscious lips have prompted
thousands of Britons to resort to implants to enhance their features.

Mockingly termed the trout pout, a collagen lip injection is one of
the most common treatments, which costs as little as £300. Rumoured
recipients of collagen, a fibrous protein which bonds tissue in the
body, include celebrities such as Liz Hurley, Kylie Minogue and Leslie Ash.

The expert groups study of a range of aesthetic fillers, which are
often made from human or bovine tissue, had already found samples
containing material from dead bodies and birds, Sir Liam added.

The investigation is part of an overhaul of the cosmetic treatments
industry, designed to root out the growing number of cowboys offering
unregulated procedures such as Botox injections, implants and chemical
skin peels. Under new rules, rogue clinics will be shut and
practitioners prosecuted in an attempt to improve patient safety. As
many as a sixth of providers could be forced to close.

The move follows a surge in demand for cosmetic procedures, some of
which are avail-able at not only clinics but also at hairdressing and
beauty salons and even as gifts administered at peoples homes. Sir Liam
said some providers were illegally advertising Botox, which is a
prescription drug.

From next April, legal action will be taken against any providers who
are not registered with the Healthcare Commission, the health watchdog,
and fail to comply with its regulations. Of the 20,000 providers in
England, identified through medical lists, advertisements, phone
directories and the internet, just 100 are registered and subject to the
commissions annual inspection. It believes at least 15 per cent would
not meet necessary standards.

The Governments hard line is in response to reports published yesterday
by the commission and the experts group headed by Harry Cayton, the
national director for Patients and the Public. Both reports call for
tighter controls of a rapidly expanding industry.

Mr Cayton said the group had found a diverse range of sources of
implant tissue. Many fillers did not fall under any type of regulation
because they used human tissue products.

The Government said it would follow all the recommendations, revealed by
The Times this week, including: mandatory specialist training for
doctors and nurses, who must be registered with a professional body;
clearer definitions of the procedures and what they involve; and a
clampdown on cut-price deals. The commission is to carry out more spot
checks on clinics.

Cosmetic procedures are a rapidly growing area of private healthcare,
Sir Liam said. Some (people) are disappointed with the outcome but a
minority can suffer serious harm or disfigurement.We must ensure we
properly protect patients safety by improving the training, regulation
and information provided.

Simon Gillespie, head of operations at the commission, said that it had
found there was good compliance with current regulations among cosmetic
surgery providers, especially among larger operators. But we did find
and have concerns about the number of organisations that did not fall
under the scope or regulations(where) there could be some increases in
risk to patients, and patients did not realise that they were receiving
a medical procedure.

MOST POPULAR TREATMENTS

The number of cosmetic procedures rose by more than 50 per cent last
year, with women having 92 per cent of the 16,367 operations


TOP FIVE FOR WOMEN
Breast enlargement, 3,731
Breast reduction, 2,417
Eyelid surgery, 1,993
Face/neck lift, 1,511
Tummy tuck, 1,465

TOP FIVE FOR MEN
Nose reshaping, 362
Ear pinning, 295
Eyelid surgery, 280
Liposuction, 130
Face/neck lift, 93

Operations conducted by the British Association of Aesthetic Plastic
Surgeons

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
STARS $ MAD COW DISEASE ...

Date: June 10, 2001 at 8:24 am PST

Greetings ALL,

was reading a 'smut' magazine about the 'babes'
and came across this article about the different
movie stars 'fat lips' (collagen injections).
something in the article caught my eye. ONE
was Collagen and the other was HASK PLACENTA
No-Rinse Treatment. (if containing animal tissues,
and then running down into the eye's, seems
like a potential transmission route, if you
consider kuru and the fact transmission of
that TSE agent via topical applications {rubbing
of organs etc on skin, cuts etc...TSS}).

""Attention, Goldie Hawn: You might want to forget
about more collagen infections for that full-lipped
look. Collagen for the procedure usually comes
from cows -- as in "mad cow disease". So what's a
girl to do? Some docs are using an acid found in
roosters' combs instead of collagen. Others use
collagen from 'ELITE' herds that don't mix with
common bovines. And one scientist is awaiting
approval for a human collagen from the foreskin
of infant boys -- further proof that beauty is
only skin deep""-- 'The National Enquirer' 5/6/01

are these babes in far a 'rude' awakening. firstly,
these so called 'ELITE' herds they speak of, are
what they call, 'tissue donor herds', that are
suppose to be fed 'only' certain products that
_do not_ include ruminant feed of any sort.
AND from the exact question i asked at the
infamous '50 STATE EMERGENCY CONFERENCE CALL'
of Jan, 9, 2001, sadly we find, there is
absolutley, NO SUCH THING. It was all a joke.
The 'partial' ruminant to ruminant feed ban
of August 4, 1997, never was enforced, and most
knew nothing about it, and/or chose to ignore
it.

50 STATE BSE CONFERENCE CALL JAN. 9 2001
http://vegancowboy.org/TSS-part1of8.htm

U.S.A., G.B.R.
http://vegancowboy.org/TSS-part2of8.htm

T.S.S. Transcripts / Articles on BSE and CJD,
parts 1 though 8
http://vegancowboy.org/TSS-Shortcut-parts1to8.htm

The Safety of Gelatin?
http://www.vegsource.com/talk/lyman/messages/7295.html

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
abused by relaxing, tinting, bleaching and exposure
to the sun.

Price:
US$4.95
Package:
5 fl oz (150 ml)
Item No.:
P8225
**discontinued** - replaced by Perm-Aid®
No-Rinse Conditioning Treatment

Placenta, the most powerful natural protein for the hair instantly
restores life and
luster to day brittle hair.

Directions:

Shake well. Apply after shampooing. Use pump and spray until hair is
saturated.
Massage thoroughly. Do not rinse. Wait 3 minutes: proceed as usual with
setting or
styling.

Ingredients:

Water, SD Alcohol 40, Placental Protein, Cetrimonium Bromide, Lactic Acid,
Fragrance, Stearamide MEA, Polysorbate 80, Phenoxyethanol, Methylparaben,
Butylparaben, Propylparaben, Stearyl Imidazoline, Cetearyl Alcohol,
Dimethicone,
FD&C Yellow #5.


http://www.folica.com/shampoos/haskplacenta.htm

Hask Perm-Aid® Revitalizing Treatment


Special care for permed hair, also for chemically
damaged and extremely abused hair.

Price:
US$3.95
Package:
2.5 oz (70.94 grams)
Item No.:
P8216
Availability:
**discontinued**
recommend Perm-Aid No Rinse Conditioning
Treatment

This product had been discontinued by the manufacturer, we recommend
Perm-Aid® No Rinse Conditioning Treatment, which is more potent!


http://www.folica.com/shampoos/haskpermaid_revtre.htm

Part No : 1227
Description : Hask Placenta Treat.Vial 24/unit

This product is in stock, and will ships in one to two business day.
If the order is received before 1:00 pm Pacific Time, usually ships on
same business day.

http://www.beautycentury.com/mall/stockIS.asp?sku=1227

HASK PLACENTA products are leaders in the Deep Conditioner segment of
Hair Care.
Henna-n-Placenta Pacs are #13 in Unit Sales of ALL conditioners and #1
of all DEEP conditioners in
the Drug Class*. Hask Placenta Instant Hair Repair, with No-Rinse
treatment, is a top-10 unit seller*.
National Media Support drives the brand and Hasks strong professional
heritage has consumer
recognition.

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

***
(Third paragraph: The wording of this paragraph
will raise NEW concerns which cannot be
scientifically answered. We would ask that
the third paragraph be OMITTED.)

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
administered by injection that are trying to
_evade_ the Medicines Act by calling themselves
cosmetics. If _any_ of those involve bovine
ingredients, they need to _comply_ with the
CSM guidelines)...

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
Cosmetics Industry in February 1990 (ref.)

It is possible that some ruminant-derived
materials are being incorporated into
cosmetics or beauty treatments which are
then marketed as 'natural
products.

The particular materials that should not
under _ANY_ circumstances be used in the
manufacturer of cosmetics or beauty treatments
are:

1. bovine (cattle)-derived offals, or proteins
derived from these offals. These offals are:
brain, spinal cord, spleen, thymus, tonsils,
intestines of Bovine offal (prohibition)
regulations

2. ovine (sheep)-derived offals and ovine placenta.

In view of the current uncertainty about the
incidence of infection with spongiform
encephalopathy agents it is probably advisable
that these recommendations apply to the above
ruminant-derived materials of ANY COUNTRY OF ORIGIN...

31 October 1991

91/10.31/9.1

It also emerged from the 16- volume
report of Lord Phillips, released on
Thursday, that people who bought anti-aging
cream may have exposed themselves to BSE
unwittingly.

The report describes their use as a potential
pathway to infection because some creams may have
included cattle brain placenta.

http://www.sesahs.nsw.gov.au/albionstcentre/infection_control/newsletter6.htm

A CONSIDERATION OF THE POSSIBLE HAZARD OF GELATIN TO MAN IN RELATION TO
THE TRANSMISSION OF BSE

http://www.bseinquiry.gov.uk/files/sc/seac13/tab07.pdf

TSS

CONTACT LENS CARE PRODUCTS $ MAD COW DISEASE ???
TSS 6/10/01 (1)
http://www.vegsource.com/talk/madcow/messages/9462.html

Re: re-FAT LIPS AND BABES AND MAD COW DISEASE !!! (THAT AINT THE HALF OF
IT) TSS 6/12/01 (0)

http://www.vegsource.com/talk/madcow/messages/9477.html

TSS


######### https://listserv.kaliv.uni-karlsruhe.de/warc/bse-l.html ##########

http://www.vegsource.com/talk/madcow/messages/93969.html


Re: re-FAT LIPS AND BABES AND MAD COW DISEASE !!! (THAT AINT THE HALF OF IT) TSS 6/12/01 (0)
http://www.vegsource.com/talk/madcow/messages/9477.html

TSS



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