Vegetarian Capsules

Gelatin Capsules & BSE/TSE, FDA (2)

Welcome to Vegetarian capsules - Many of us knowingly or unknowingly consume non-veg shiny shells derived from cows, pigs and other animals. Enjoy this lead starting from gelcaps, to FDA status and guidelines, the potential risk of CJD and finally vote for vegcaps by using them.

BSE Or Bovine Spongiform Encephalopathy/ TSE Or Transmissible Spongiform Encephalopathies And Gelatin Capsules:

CJD or Creutzfeldt-Jakob Disease belongs to a family of human and animal diseases known as the transmissible spongiform encephalopathies (TSEs). Spongiform refers to the characteristic appearance of infected brains, which become filled with holes until they resemble sponges under a microscope. CJD is the most common of the known human TSEs.

Other human TSEs include kuru, fatal familial insomnia (FFI), and Gerstmann-Straussler-Scheinker disease (GSS). Kuru was identified in people of an isolated tribe in Papua New Guinea and has now almost disappeared. FFI and GSS are extremely rare hereditary diseases, found in just a few families around the world. Other TSEs are found in specific kinds of animals. These include bovine spongiform encephalopathy (BSE), which is found in cows and is often referred to as “mad cow” disease; scrapie, which affects sheep and goats; mink encephalopathy; and feline encephalopathy. Similar diseases have occurred in elk, deer, and exotic zoo animals

Creutzfeldt-Jakob disease (CJD) is a rare, degenerative, invariably fatal brain disorder. It affects about one person in every one million people per year worldwide; in the United States there are about 200 cases per year. CJD usually appears in later life and runs a rapid course. Typically, onset of symptoms occurs about age 60, and about 90 percent of patients die within 1 year.

In the early stages of disease, patients may have failing memory, behavioral changes, lack of coordination and visual disturbances. As the illness progresses, mental deterioration becomes pronounced and involuntary movements, blindness, weakness of extremities, and coma may occur.

As gelatin is derived from animals - cow and pigs - there had been great concern over about its susceptibility to pass the infection to men. There had been some research and studies that show some faint possibility of its being transmitted. So we have vegetarian capsules coming to horizon. Finally more in-depth studies are needed about gelcaps. And the vegetarian capsules are 100% safe.

Who Could BE At Risk Of CJD?

If you eat beef from countries with a relatively high incidence of BSE — such as the United Kingdom, Portugal, France, Spain and Germany — you increase your chances of contracting vCJD. The risk is highest if you eat meat products that are more likely to contain prions, such as hamburgers, hot dogs, sausages and deli meats. Even so, in the UK the current risk of acquiring vCJD from beef and beef products appears to be very low — about one case per 10 billion servings. The risk from beef in other high-incidence countries is also small.

On the other hand, it's difficult to assess the true risk of contracting vCJD from infected beef because so much about the disease is still unknown, including the exact length of its incubation period and the ultimate effectiveness of public health control measures. People believed to be at greatest risk are those who ate British beef between 1980 and 1996, before measures to prevent the spread of mad cow disease were implemented. The risk in other countries where BSE is endemic remains unclear.

You also may be at risk if you received a blood transfusion or used bovine-derived insulin after 1980 in a country with a high incidence of mad cow disease, such as Great Britain, Portugal, Spain, France and Germany. Why not avoid the gelcaps and begin to use the vegetarian capsules. Yes Vegetarian capsules are fully safe.

FDA And CJD And The Advent Of Vegetaroan Capsules:

FDA is well concerned and active about the sourcing and processing of gelatin to reduce the potential risk posed by Bovine Spongiform Encephalopathy for FDA regulated products for human use.

APPENDIX B
SUMMARY OF TSE ADVISORY COMMITTEE MEETING

On April 23-24, 1997, FDA held a public meeting of the Transmissible Spongiform Encephalopathies Advisory Committee to help FDA assess the safety of imported and domestic gelatin and gelatin by-products in FDA-regulated products with regard to the risk posed by bovine spongiform encephalopathy (BSE). Following presentations on gelatin sourcing and processing, risk assessment, process validation, and BSE's infectivity, panel members were asked the following:

1. Which, if any, specific gelatin-processing procedure is preferred or essential to assure optimal inactivation of any contaminating TSE agent?

The committee agreed with the FDA that the alkali treatment step in gelatin production was a key step in the inactivation of BSE infectious agent. It stated that steps such as heat, alkaline treatment, and filtration could be effective in reducing the level of contaminating TSE agents; however, scientific evidence is insufficient at this time to demonstrate that these treatments would effectively remove the BSE infectious agent if present in the source material.

2. What criteria should be considered in designing gelatin process validation studies and analyzing the results of such studies?

The committee agreed with FDA that there is a need for well-designed process validation protocols to verify that a specific manufacturing process would inactivate BSE's infectious agent. It recommended that FDA use the help of outside experts to review industry submissions. The committee also offered to provide input. The committee stated the need for assurance that manufacturers would follow the specified manufacturing processes.

3. If gelatin and gelatin by-products are no longer to be exempted from FDA BSE restrictions, what level of restriction is sufficient to reduce risk appropriately?

The committee expressed some concern over the current list of USDA-designated BSE countries because ineffective BSE surveillance by some countries may fail to detect BSE cases. It indicated the need for developing criteria for BSE designation/classification. USDA is addressing the issue of effective surveillance and revising its current list. However, it may be some time before this is completed. The committee stated that sourcing for gelatin should be as safe as possible and that countries which had no reported cases, but had an established BSE risk, or lacked an appropriate surveillance system would be of concern.

The committee stated that criteria for gelatin should be established relative to the risk posed by the use of that gelatin . The risk would differ for oral consumption, parenteral, and cosmetic uses. Other factors, such as processing and the type of material processed (bovine/porcine, bones/hides), should be considered in this risk assessment.

4. Does current scientific evidence justify continuing to exempt gelatin from restrictions recommended by FDA for other bovine-derived materials from BSE countries (i.e., that these materials NOT come from BSE countries)?

Ten members said NO or a qualified no; three said YES or a qualified yes; one abstained.

More of the guidelines of FDA could be reached by following the link that would open in new window. These are to support our visitor friends to get the most relevant guidelines and the current status.

Follow this link to know the potential risk and guidelines of gelatin that is used in cosmetics.

Finally we know that FDA is cautious about this issue. So this is the best time for vegetarian capsules. Vegetarian capsules are natural and safe to use. Vegetarian capsules eliminate the risk of all such TSE's. Definitely use vegetarian capsules for their benefits and supporting the vegetarianism.



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Vegetarian Capsules - Gelcaps VS Vegcaps(1st) - Know the importance of gelatin and about the gelcaps.

Vegetarian capsules - Gelcaps VS Vegcaps(2nd) - Know why gelcaps come under the scrutiny of FDA and about the potential danger of TSE/BSE/CJD.

Vegetarian Capsules - Gelcaps VS Vegcaps(3rd) - The adorable Vegcap  is here.

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