French recall beef-based cosmetics
Pharmaceuticals substances derived from cattle
U.S. Beef Drug List
Japanese Ban
April 3: FDA Cracks Down on Beef Products
FDA position on cosmetics and dietary supplements

European cosmetics makers recall cosmetics products made with beef

PARIS -- European cosmetics makers, including French, will recall products made with beef tissues as part of a broader effort to prevent the spread of "mad cow" disease to humans, European consumer affairs commissioner Emma Bonino told Journal du Dimanche.

She revealed the decision of the producers ahead of tomorrow's extraordinary meeting of European Agriculture ministers in Luxembourg, following last week's EU ban on exports of all beef products from the U.K. The ban stems from the discovery that there may be a link between bovine spongiform encephalopathy, or BSE, known also as "mad cow" disease, and Creutzfeldt-Jakob disease in humans who ate beef from infected cattle.

European cosmetics makers have agreed to pull products made with beef tissues from shelves, and companies will use alternative ingredients in the future, French daily Le Journal du Dimanche reported Bonino as having said Friday. Until that happens, some consumers prefer not to take any chances. "We had one client earlier who was asking all sorts of questions about what went into Estee Lauder creams," said Martine Drauart, a cosmetics vendor at Bon Marche department store in Paris.

Cosmetics makers use a variety of beef by-products in the composition of products, including fat as an emulsifier in skin creams. The animal parts most likely to carry disease, Bonino reportedly told consumer protection representatives at a Brussels meeting Friday, are brain tissues, eyes and tissues from the central nervous system.

"I imagine it'll take a few days to see whether this really changes peoples' behavior," Drauart said. If the consumer reaction to the "mad cow" scare in edible beef products is a gauge, cosmetics makers could be in for a tough campaign to prevent a collapse of sales.

Since the first report of a link between BSE and the brain-wasting disease in humans, beef sales in French stores have fallen as much as fifty percent. Stores are using measures such as labeling beef products "made in France" to reassure consumers, but this has done little to win back customers.

Outside France stores are being hurt too. "In Italy, our Continent stores have seen a similar drop in beef sales, as well as in virtually all the countries where we have a presence," said Corinne Henry, director of marketing for Promodes SA, France's second-largest supermarket and mall chain operator, recently.


Pharmaceuticals substances derived from cattle

Neue Z¸rcher Zeitung 7.7.95/8.8.95 The article followed a report from the Central Veterinary Laboratory, Weybridge, England, with a section on the use in pharmaceuticals of substances derived from cattle. According to Jean-Christophe MÈroz of the IKS, which licenses pharmaceuticals, some 170 products on the market in 1992 contained bovine products.

Of these, 40 had been withdrawn voluntarily, 15 had been reformulated to replace bovine material for a different animal source such as porcine material, 20 had been prohibited by the IKS because of an unfavourable cost/benefit analysis, and the remainder were still in production because of their irreplaceable medical value and very low risk, of which bovine insulin was an example.



U.S. Cosmetics Industry -- Not to Worry

NEW YORK -- From cosmetics, candy and gelatins to drugs for diabetes, hay fever and arthritis, there are beef parts in dozens of products Americans use every day. Worries about the safety of British beef spread beyond just steaks and chops Wednesday when the European Community ordered Britain to stop exporting all beef-derived products including ice cream, candy, cosmetics and drugs.

U.S. scientists noted, however, that very few of these products use pieces of the steer's brain and spinal cord, the only parts of the steer's body where mad cow disease, or bovine spongiform encepthalopathy, has been found. The most widely used beef product is collagen, the spongy substance derived from beef skin or bones. Collagen is often an ingredient in ice cream, custards, cheeses, candies, sausage casings and cosmetics.

Even if it were found to be a carrier, the vast majority of the collagen in U.S. products comes from domestic beef because it is so plentiful, said Bob Rust, professor emeritus in meat science at Iowa State University.

The FDA, prior to approval of any drug with beef products, requires the manufacturer to certify that the beef only come from countries free of the disease, he said. [Wrong - manucturers have refused to do this, saying they take their supplier 's word for this-- webmaster]

The variety of drugs derived from cattle parts is diverse and includes:

(c) Copyright 1996 Nando.net ... Bloomberg Business News

Japanese Pharmaceutical makers ordered to shun British beef

TOKYO, April 10 (Kyodo) _ The Health and Welfare Ministry on Wednesday advised pharmaceutical makers across the country not to use British beef and beef products in the manufacturing of medicine and cosmetics to prevent the spread of ''mad cow'' disease in Japan. The ministry also called on wholesalers and retailers to halt imports of medicine and cosmetics containing substances from British cows.

Cattle in several European countries have been infected with a protein that can cause mad cow disease or BSE, a form of brain degeneration resulting in death, but the outbreak has been particularly severe in Britain. Recent research indicates that humans who eat infected meat could develop Creutzfeldt-Jakob Disease (CJD), the human equivalent of the cattle disease. At least 10 CJD patients in Britain are believed to have contracted the disease from eating beef.

The health ministry guidance comes on the heels of an import ban on British beef and beef products for food consumption, imposed by the Agriculture Forestry and Fisheries Ministry late last month.

The ministry also called on drug makers who use cattle substances for their products to quickly declare which parts of the animals they process and their raw materials' country of origin.

[04-10-96 at 13:27 EDT, 1996, Kyodo News International]


FDA Crack-Down on Beef Products April 3, 1996

WASHINGTON _The Food and Drug Administration is planning to close a regulatory loophole that allows dietary supplements and cosmetics to contain ingredients from cattle with "mad cow disease."

The proposed action comes after evidence surfaced that the disease, bovine spongiform encephalopathy, might be linked to Creautzfeldt-Jacob disease, a rare, fatal brain disease in humans.

Many supplements and cosmetics, ranging from "energy boosters" to "anti-aging creams" contain beef proteins or hormonal extracts from bovine organs and glands.... FDA officials have grown increasingly concerned ... that a contaminated cosmetic could infect a person through a cut in the skin or contact with the eyes, providing easy access to the brain.

Herds in at least five European countries are known to harbor the cow disease. with little or no documentation to indicate the country of origin for bovine ingredients, consumers cannot be certain that the products are free of the disease agent, experts said.

Representatives of the food supplement and cosmetics industry said keeping track of indivdual sources for every lot of product sold would be unnecessarily burdensome. Instead they rely on promises from supppliers that ingredients come from countries without the cow disease.

Copyright 1996 The Washington Post


To Manufacturers and Importers of Dietary Supplements and Importers of Cosmetics:
August 17, 1994 FDA Attachment B The Food and Drug Administration (FDA) is recommending that firms that manufacture or import dietary supplements and cosmetics containing specific bovine tissues (see Appendix A) ensure that such tissues do not come from cattle born, raised, or slaughtered in countries where bovine spongiform encephalopathy (BSE) exists (BSE-countries). Extracts of these tissues and ingredients derived from these tissues are also of concern. The recommended actions are precautionary measures to reduce potential risk of human exposure to, or transmission of, the agent which causes BSE in cattle.

At this time, FDA is not extending the recommendation in this letter to dairy products or gelatin, because available evidence does not suggest transmission via these foods. Furthermore, meat (i.e., skeletal muscle) is not covered by this letter. For guidance on importation of meat and other products regulated by the United States Department of Agriculture (USDA), refer to Title 9 of the Code of Federal Regulations.

The Agency is providing the following information to explain why it believes that BSE may potentially be a concern with certain dietary supplements and cosmetic products. BSE has been identified in more than 100,000 cattle in the United Kingdom and, to a much lesser extent, in several other countries. BSE has not been diagnosed in the United States. This neurological disease is a transmissible spongiform encephalopathy (TSE) and is similar to other TSEs such as scrapie in sheep and Creutzfeldt-Jakob Disease (CJD) in humans. The spongiform encephalopathies are uniformly fatal and no rapid diagnostic test for infection in living animals or humans is presently available. Current scientific information indicates that the causative agent is extremely resistant to inactivation by normal disinfection or sterilization procedures. A range of research projects into the exact nature of both the BSE agent and other TSE agents, host range, patterns of pathogenicity, and development of rapid ante mortem diagnostic tests is ongoing.

Since 1991, USDA has prohibited the importation into the U.S. of certain tissues and organs from ruminants from countries where BSE exists (BSE-countries; see 9 CFR 94.18). USDA's regulations are intended to protect livestock in the United States from contracting TSEs and address known or strongly suspected modes of transmission. For the up-to-date listing of BSE-countries please contact USDA, Animal and Plant Health Inspection Service (APHIS) at (301) 436-7830.

The USDA regulations permit, under certain conditions, the importation of some cosmetic ingredients (i.e., collagen, collagen products, amniotic liquids or extracts, placental liquids or extracts, serum albumin, and serocolostrum) derived from ruminants from BSE-countries; see 9 CFR 95.4.

The USDA regulations do not apply to imports of:

While documented transmission of the causative agents of BSE or scrapie to humans has not been reported to date, the FDA wrote to manufacturers of dietary supplements in November 1992, alerting them to the developing concern about TSEs in animals and CJD in man. That letter recommended that manufacturers voluntarily investigate the geographic source(s) of any bovine or ovine material used in their products (generally neural or glandular tissue or tissue extracts). The Agency also suggested that each manufacturer develop a plan "to assure, with a high degree of certainty," that such materials are not from BSE-countries, as identified by USDA's APHIS, or from scrapie-infected sheep flocks, either foreign or domestic.

FDA now considers further protective steps to be reasonable and is restating and expanding its recommendation to manufacturers and importers of dietary supplements and their ingredients, to develop plans for ensuring, with a high degree of certainty, that specific bovine-derived materials (see Appendix A) from BSE-countries are not being used. The Agency is also recommending that manufacturers and importers of cosmetic products and their ingredients develop the same type of plans. FDA is not, at this time, recommending restrictions on the use of ovine-derived materials in the manufacture of dietary supplement and cosmetic products and ingredients, as the epidemiological evidence now appears convincing that scrapie is not related to TSEs in humans.

FDA believes it is prudent to expand its recommendation to cosmetics and cosmetic ingredients because extracts of listed tissues, e.g. sphingolipids isolated from brain tissue and extracts of bovine placenta, are used in cosmetics. Additionally, FDA is unaware of data demonstrating that processing techniques used in the manufacture of cosmetics will inactivate TSE agents. Further, little is known about the potential human risk of transmission from topical application of cosmetics containing TSE agents to intact, broken or abraded skin.

To assist manufacturers and importers whose products are within the scope of this recommendation in developing their plans, the following guidance is provided: