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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.
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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.
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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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