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LARGE CJD TSE PRION POTENTIAL CASE STUDY AMONG HUMANS WHO TAKE DEER ANTLER VELVET WILL BE ONGOING FOR YEARS IF NOT DECADES, but

Posted Nov 10 2013 1:53pm
LARGE CJD TSE PRION POTENTIAL CASE STUDY AMONG HUMANS WHO TAKE DEER ANTLER VELVET WILL BE ONGOING FOR YEARS IF NOT DECADES, but who's cares$

 

November 6, 2013
 
 
Increased Usage By Pro Athletes Drives Deer Antler Supplement Popularity Among Amateur Athletes
 
Increased media coverage has driven interest in deer antler velvet, previously used only by professional athletes, in amateur athletes and fitness enthusiasts as well. WEBWIRE – Wednesday, November 06, 2013 Performance enhancing scandals among professional athletes are not a new phenomenon. Sports fans can hardly tune their TV to their favorite sports coverage without seeing another well-known athlete caught up in accusations of performance enhancing drugs, blood doping, or some other substance usage that gives them a perceived physical edge over the competition.
 
Most people presume that professional athletes, being richly compensated for their physical feats, are the people most likely to use (and have access to) any substance that would enhance athletic performance. In most cases that would be true, but an unusual exception to that rule is deer antler velvet. Because of its popular usage as a performance enhancing alternative to steroids among professional athletes, several governing bodies (most notably the NFL and PGA), have banned its usage. At one time Major League Baseball also banned it, but then later reversed course. The NCAA currently allows it, as does professional hockey. While some organizations technically “ban” its usage by their players, no test exists for a natural substance like antler velvet, so any ban would be largely unenforceable. Professional athletes know this, so their usage continues.
 
Deer antler velvet’s alleged effects on performance stem from it being a potent natural source of IGF-1, or Insulin-like Growth Factor. Found naturally in the body, IGF-1 is a chemical “cousin” to the body’s own human growth hormone. It spikes during periods of high anabolic activity, and is a key part of the body’s ability to regenerate after exhaustive physical activity, such as lifting weights or sports. The IGF-1 in deer antler velvet (along with other micro-nutrients and minerals found in the velvet) is primarily responsible for the rapid growth of new antler racks in the horns of male deer each year. This same form is easily absorbed by the human body, and these nutrients can be utilized by muscle tissue to rebuild, grow, and repair itself according to one Deer antler velvet spokesperson, Gabe Uris.
 
“The effects of deer antler velvet are well-documented both in clinical studies out of New Zealand, and in anecdotal evidence from pro-caliber athletes who swear by it” says Mr. Uris, a long-time proponent of deer antler velvet supplementation. “Most of our athletes see an effect literally within an hour of their first dose, 60 minutes after taking it they feel better recovered after strenuous workouts, and the science performed by researchers in New Zealand backs that.” While some researchers discount the effects of deer antler velvet, or doubt its ability to provide more than a negligible amount of IGF-1 to muscle tissue in a spray dosage, there is no indication that any negative side effects have occurred from its usage by either pro or amateur athletes.
 
For many amateurs, the attractiveness of no side effects, usage by professional athletes at the pinnacle of their sports, and the relative low cost (a 6-month cycle of one of the most popular products, AntlerX, retails online for less than forty dollars a bottle) of antler velvet usage may prove to alluring to resist. Until science finds the holy grail of inexpensive and safe “performance enhancers” to promote muscle gain and athletic performance, products like deer antler velvet spray will have a place in the sports world.
 
For more information about deer antler velvet sprays visit
 
 
 
 
 
May 2, 2013
 
Professional Athletes in Some Sports Now Allowed to Use Deer Antler Velvet Sprays
 
 
 
just a reminder for folks taking these type nutritional supplements...
 
 
 
Volume 15, Number 5—May 2009
 
Research
 
Chronic Wasting Disease Prions in Elk Antler Velvet
 
Abstract Chronic wasting disease (CWD) is a contagious, fatal prion disease of deer and elk that continues to emerge in new locations. To explore the means by which prions are transmitted with high efficiency among cervids, we examined prion infectivity in the apical skin layer covering the growing antler (antler velvet) by using CWD-susceptible transgenic mice and protein misfolding cyclic amplification. Our finding of prions in antler velvet of CWD-affected elk suggests that this tissue may play a role in disease transmission among cervids. Humans who consume antler velvet as a nutritional supplement are at risk for exposure to prions. The fact that CWD prion incubation times in transgenic mice expressing elk prion protein are consistently more rapid raises the possibility that residue 226, the sole primary structural difference between deer and elk prion protein, may be a major determinant of CWD pathogenesis.
 
SNIP...
 
The appearance of variant Creutzfeldt-Jakob disease in humans exposed to bovine spongiform encephalopathy (BSE) (19,20) and the demonstration of CWD prions in muscle (3) placed the human species barrier to CWD prions at the forefront of public health concerns. Our studies indicate that antler velvet represents an additional source for human exposure to CWD prions. Widely used in traditional Asian medicine to treat a variety of ailments including impotence, arthritis, and high blood pressure, antler velvet can be readily purchased in caplet form and its usage has increased worldwide.
 
 
Volume 15, Number 5—May 2009
 
Research
 
Chronic Wasting Disease Prions in Elk Antler Velvet
 
 
 
 
 
 
 
PO-031: Aerosol transmission of chronic wasting disease to white-tailed deer
 
Nathaniel Denkers,1 Jeanette Hayes-Klug,1 Kelly Anderson,1 Sally Dahmes,2 David Osborn,3 Karl Miller,3 Robert Warren,3 Candace Mathiason,1 Edward Hoover1 1Colorado State University; Fort Collins, CO USA; 2WASCO Inc.; Monroe, GA USA; 3Warnell School of Forestry and Natural Resources, University of Georgia; Athens, GA USA
 
Purpose. A signature feature of chronic wasting disease (CWD) is its efficient lateral transmission in nature, almost surely by mucosal exposure. Our previous studies employing Tg(cerPrP) mice determined that CWD can be transmitted to a susceptible host by aerosol exposure, a route with relatively little investigation. The present study was designed to determine whether CWD is transmissible by aerosol to a native cervid host, white-tailed deer.
 
Materials and Methods. Nine white-tailed deer were exposed to two (2) aerosol doses of a 5% w/v CWD+ (n = 6) or CWD- (n = 3) brain homogenate, delivered via the nasal passages using a customized aerosol apparatus. At 3-month intervals post inoculation (mpi), tonsil and recto-anal mucosa-associated lymphoid tissue (RAMALT) biopsies were collected and assayed for CWD infection by protein misfolding cyclic amplification (PMCA), western blotting (WB), and immunohistochemistry (IHC).
 
Results. At 3 mpi and 6 mpi, tonsil and RAMALT biopsies were collected from 5 of the 6 CWD + aerosol-exposed deer. Three of the 5 (60%) tested positive for CWD by PMCA but not IHC or western blot analysis at 3 mpi. By 6 mpi, 5 of 5 (100%) were tonsil and/or RAMALT biopsy positive by at least two of the three assays. Biopsies were collected from all CWD+ aerosol-exposed deer at 9 mpi, with 6 of 6 (100%) tonsil and/ or RAMALT positive by western blot or IHC. At 10 mpi 3 of the 6 prion-exposed deer have developed early clinical signs of CWD infection (hyperphagia, polydypsia, wide leg stance and head/neck dorsi-flexion). All sham-inoculated deer are showing no clinical signs and have remained CWD negative as assessed by all three assays. Interestingly, the prion dose delivered to the deer by aerosol-exposure is estimated to be 20-fold lower than the historical oral dose that has resulted in detectable CWD infection at 6 or 12 mpi.
 
Conclusions. This study documents the first aerosol transmission of CWD in deer. These results further infer that aerosolized prions facilitate CWD transmission with greater efficiency than does oral exposure to a larger prion dose. Thus exposure via the respiratory mucosa may be significant in the facile spread of CWD in deer and perhaps in prion transmission overall.
 
 
 
PO-073: Multiple routes of prion transepithelial transport in the nasal cavity following inhalation
 
Anthony Kincaid, Shawn Feilmann, Melissa Clouse, Albert Lorenzo, Jason Bartz Creighton University; Omaha, NE USA
 
Introduction. Inhalation of either prion-infected brain homogenate or aerosolized prions has been shown to cause disease, and in the case of inhalation of infected brain homogenate, the nasal route of infection has been shown to be 10–100 times more efficient than the oral route. The cell types involved in the in vivo transport of prions across the nasal cavity epithelium have not been determined. M cells in the follicular associated epithelium have been shown to mediate transcellular transport of prions in vitro and in the gut of experimentally infected mice. We tested the hypothesis that M-cell mediated transport was responsible for prion entry across nasal cavity epithelium following inhalation.
 
Materials and Methods. Hamsters were inoculated extranasally with 50 or 100ul of infected (n = 31) or mock-infected (n = 13) brain homogenate. Control animals were inoculated with buffer (n = 4) or were untreated (n = 5). Following survival periods ranging from 15 to 180 min, animals were perfused, skulls were decalcified and nasal cavities were embedded in paraffin. Tissue sections were cut and processed immunohistochemically for glial fibrillary acidic protein to identify brain homogenate, or for the disease-associated form of the prion protein. Tissue sections not further than 112 um apart through the entire extent of the nasal cavity were analyzed using light microscopy; photomicrographs were obtained wherever inoculum was observed on the surface of, within, or deep to the nasal mucosa for each animal.
 
Results. Infected or uninfected brain homogenate was identified within the nasal cavities of animals at all time points and was seen crossing the nasal cavity epithelium within minutes of inoculation; the transepithelial transport of brain homogenate continued for up to 3 h after inoculation. Infected or uninfected brain homogenate was seen adhering to, or located within, M cells at all time points. However, larger volumes of infected or uninfected brain homogenate were identified crossing between cells of the olfactory and respiratory epithelia in multiple locations. In addition, infected or uninfected brain homogenate was identified within the lumen of lymphatic vessels in the lamina propria beneath the nasal mucosa at all time points.
 
Conclusion. Transepithelial transport of prions across nasal cavity mucosa begins within minutes of inhalation and can continue for up to 3 h. While M cells appear to transport prions across the follicular associated epithelium, larger amounts of prions are transported between the cells of the respiratory and olfactory epithelia, where they immediately enter the lymphatic vessels in the lamina propria. Thus, inhaled prions can be spread via lymph draining the nasal cavity and have access to somatic and autonomic nerves in the lamina propria of the nasal cavity. The increased efficiency of the nasal cavity route of infection compared with the oral route may be due to the rapid and prolonged transport of prions between cells of the respiratory and olfactory epithelia.
 
 
 
Aerosols Transmit Prions to Immunocompetent and Immunodeficient Mice
 
Johannes Haybaeck1.¤a, Mathias Heikenwalder1.¤b, Britta Klevenz2., Petra Schwarz1, Ilan Margalith1, Claire Bridel1, Kirsten Mertz1,3, Elizabeta Zirdum2, Benjamin Petsch2, Thomas J. Fuchs4, Lothar Stitz2*, Adriano Aguzzi1*
 
1 Department of Pathology, Institute of Neuropathology, University Hospital Zurich, Zurich, Switzerland, 2 Institute of Immunology, Friedrich-Loeffler-Institut, Tu¨ bingen, Germany, 3 Department of Pathology, Clinical Pathology, University Hospital Zurich, Zurich, Switzerland, 4 Department of Computer Science, Machine Learning Laboratory, ETH Zurich, Zurich, Switzerland
 
Abstract
 
Prions, the agents causing transmissible spongiform encephalopathies, colonize the brain of hosts after oral, parenteral, intralingual, or even transdermal uptake. However, prions are not generally considered to be airborne. Here we report that inbred and crossbred wild-type mice, as well as tga20 transgenic mice overexpressing PrPC, efficiently develop scrapie upon exposure to aerosolized prions. NSE-PrP transgenic mice, which express PrPC selectively in neurons, were also susceptible to airborne prions. Aerogenic infection occurred also in mice lacking B- and T-lymphocytes, NK-cells, follicular dendritic cells or complement components. Brains of diseased mice contained PrPSc and transmitted scrapie when inoculated into further mice. We conclude that aerogenic exposure to prions is very efficacious and can lead to direct invasion of neural pathways without an obligatory replicative phase in lymphoid organs. This previously unappreciated risk for airborne prion transmission may warrant re-thinking on prion biosafety guidelines in research and diagnostic laboratories.
 
Citation: Haybaeck J, Heikenwalder M, Klevenz B, Schwarz P, Margalith I, et al. (2011) Aerosols Transmit Prions to Immunocompetent and Immunodeficient Mice. PLoS Pathog 7(1): e1001257. doi:10.1371/journal.ppat.1001257
 
Editor: David Westaway, University of Alberta,
 
 
 
 
Thursday, May 31, 2012
 
CHRONIC WASTING DISEASE CWD PRION2012 Aerosol, Inhalation transmission, Scrapie, cats, species barrier, burial, and more
 
 
 
Monday, September 17, 2012
 
Rapid Transepithelial Transport of Prions Following Inhalation
 
 
 
Prion2013
 
Chronic Wasting Disease CWD risk factors, humans, domestic cats, blood, and mother to offspring transmission
 
HD.13: CWD infection in the spleen of humanized transgenic mice
 
Liuting Qing and Qingzhong Kong
 
Case Western Reserve University; Cleveland, OH USA
 
Chronic wasting disease (CWD) is a widespread prion disease in free-ranging and captive cervid species in North America, and there is evidence suggesting the existence of multiple CWD strains. The susceptibility of human CNS and peripheral organs to the various CWD prion strains remains largely unclear. Current literature suggests that the classical CWD strain is unlikely to infect human brain, but the potential for peripheral infection by CWD in humans is unknown. We detected protease-resistant PrpSc in the spleens of a few humanized transgenic mice that were intracerebrally inoculated with natural CWD isolates, but PrpSc was not detected in the brains of any of the CWD-inoculated mice. Our ongoing bioassays in humanized Tg mice indicate that intracerebral challenge with such PrpSc-positive humanized mouse spleen already led to prion disease in most animals. These results indicate that the CWD prion may have the potential to infect human peripheral lymphoid tissues.
 
 
=====
 
 
HD.12: Comparative study of the distribution of the prion protein in the squirrel monkey (Saimiri sciureus) following experimental challenge with variant and sporadic CJD
 
Diane L. Ritchie,1 Paul Brown,2 Susan Gibson,3 Thomas R. Kreil,4 Christian Abee3 and James W. Ironside1
 
1National CJD Surveillance Unit; Edinburgh, UK; 2Bethesda; Bethesda, MD USA; 3Deparment of Comparative Medicine; University of South Alabama; Mobile, AL USA; 4Baxter Bioscience; Vienna, Austria
 
Introduction, Reports suggest that the number of tissues and organs showing the presence of the abnormal prion protein (PrPTSE) in variant CJD (vCJD) patients may be greater than previously thought. A limited peripheral involvement in some cases of sporadic CJD (sCJD) has also been reported. This accumulation of PrPTSE outside the brain has raised concerns about the possible iatrogenic transmission risk of vCJD. The squirrel monkey (Saimiri sciureus) has been shown to be highly susceptible to experimental challenge with human prion disease. Neuropathological and biochemical analyses of CNS tissue have shown that sCJD and vCJD can be distinguished in the squirrel monkey and that many of the strain characteristics that define these agents are conserved after transmission. Following on from these initial studies, immunohistochemistry and western blot analysis were performed on a wide range of peripheral tissues including, lymphoreticular tissues and peripheral neural tissue to establish the full-body distribution of PrPTSE in this primate animal model.
 
Materials and Methods. Brain homogenates from sCJD or vCJD patients were inoculated into the frontal cortex of squirrel monkeys. Animals were kept under constant clinical surveillance. At post-mortem, formalin fixed CNS tissue and a wide range of peripheral tissues were taken for immunohistochemical analysis together with frozen tissues taken for the biochemical detection of PrPTSE.
 
Results. Immunohistochemical analysis showed no evidence of PrPTSE deposition in peripheral tissues in either variant or sporadic CJD-infected animals. However, western blot assays detected PrPTSE in the spleen of a proportion of the vCJD- infected animals. The PrPTSE isotype resembled that detected in CNS tissue from the vCJD- infected animals and from human vCJD cases. ***In addition, western blot analysis detected PrPTSE in the spleen of a single animal following challenge with sporadic CJD. The PrPTSE type in this animal resembled that found in CNS tissue from the same animal, with a PrPTSE type similar to that found in human sCJD type 1 cases.
 
Conclusion. This study confirms the accumulation of PrPTSE in the CNS and spleen of a proportion of squirrel monkeys infected intra-cerebrally with human vCJD. Furthermore, this study extends the evidence that there may be a peripheral involvement in some cases of sCJD. PrPTSE typing confirms the conservation of PrPTSE type on transmission to the squirrel monkey and suggests that there are no tissue-specific adaptations in the biochemical phenotype of the agent strain following primate-to-primate transmission.
 
 
=====
 
 
Oral.15: Molecular barriers to zoonotic prion transmission: Comparison of the ability of sheep, cattle and deer prion disease isolates to convert normal human prion protein to its pathological isoform in a cell-free system
 
Marcelo A.Barria,1 Aru Balachandran,2 Masanori Morita,3 Tetsuyuki Kitamoto,4 Rona Barron,5 Jean Manson,5 Richard Kniqht,1 James W. lronside1 and Mark W. Head1
 
1National CJD Research and Surveillance Unit; Centre for Clinical Brain Sciences; School of Clinical Sciences; The University of Edinburgh; Edinburgh, UK; 2National and OIE Reference Laboratory for Scrapie and CWD; Canadian Food Inspection Agency; Ottawa Laboratory; Fallowfield. ON Canada; 3Infectious Pathogen Research Section; Central Research Laboratory; Japan Blood Products Organization; Kobe, Japan; 4Department of Neurological Science; Tohoku University Graduate School of Medicine; Sendai. Japan; 5Neurobiology Division; The Roslin Institute and R(D)SVS; University of Edinburgh; Easter Bush; Midlothian; Edinburgh, UK
 
Background. Bovine spongiform encephalopathy (BSE) is a known zoonotic prion disease, resulting in variant Creurzfeldt- Jakob disease (vCJD) in humans. In contrast, classical scrapie in sheep is thought to offer little or no danger to human health. However, a widening range of prion diseases have been recognized in cattle, sheep and deer. The risks posed by individual animal prion diseases to human health cannot be determined a priori and are difficult to assess empirically. The fundamemal event in prion disease pathogenesis is thought to be the seeded conversion of normal prion protein (PrPC) to its pathological isoform (PrPSc). Here we report the use of a rapid molecular conversion assay to test whether brain specimens from different animal prion diseases are capable of seeding the conversion of human PrPC ro PrPSc.
 
Material and Methods. Classical BSE (C-type BSE), H-type BSE, L-type BSE, classical scrapie, atypical scrapie, chronic wasting disease and vCJD brain homogenates were tested for their ability to seed conversion of human PrPC to PrPSc in protein misfolding cyclic amplification (PMCA) reactions. Newly formed human PrPSc was detected by protease digestion and western blotting using the antibody 3F4.
 
Results. C-type BSE and vCJD were found to efficiently convert PrPC to PrPSc. Scrapie failed to convert human PrPC to PrPSc. Of the other animal prion diseases tested only chronic wasting disease appeared to have the capability ro convert human PrPC to PrPSc. The results were consistent whether the human PrPC came from human brain, humanised transgenic mouse brain or from cultured human cells and the effect was more pronounced for PrPC with methionine at codon 129 compared with that with valine.
 
Conclusion. Our results show that none of the tested animal prion disease isolates are as efficient as C-type BSE and vCJD in converting human prion protein in this in vitro assay. However, they also show that there is no absolute barrier ro conversion of human prion protein in the case of chronic wasting disease.
 
 
=====
 
 
Invited.16: Studies of chronic wasting disease transmission in cervid and non-cervid species
 
Edward A, Hoover,1 Candace K. Mathiason,1 Davin M. Henderson,1 Nicholas J. Haley,1 Davis M. Seelig,1 Nathaniel D. Denkers,1 Amy V. Nalls,1 Mark D. Zabe,1 Glenn C. Telling,1 Fernando Goni2 and Thomas Wisniewski,2
 
1Prion Research Center; Colorado State University; Fort Collins, CO USA; 2New York University School of Medicine; New York, NY USA
 
How and why some misfolded proteins become horizontally transmitted agents and occasionally cross species barriers are issues fundamental to understanding prion disease. Chronic wasting disease (CWD) of cervids is perhaps a prototype of horizontal prion transmission, encompassing efficient mucosal uptake, lymphoid amplification, neuroinvasion, peripheralization, and dissemination via mucosal excretion. Efficient mucosal transmission of CWD in deer has been demonstrated by oral, nasal, aerosol, and indirect contact exposure. In addition, other studies (Mathiason CK, et al.) reported at the symposium support a significant role for pre- and/or postnatal transmission of CWD from doe to offspring. Accumulating, yet still incomplete, evidence also suggests that the period of relatively covert CWD infection may be longer than originally thought. Given the above, minimally invasive sensitive assays based on body fluids from live animals would aid substantially in understanding the biology of CWD. We have been applying seeded realtirne quaking-induced amplification of recombinant PrP substrates (i.e., RT-QuIC methodology) to: (1) investigate antemortem CWD detection, and (2) model PrP-based species barriers and trans-species adaptation-topics we previously explored using sPMCA and in vivo bioassays. At this symposium, we report sensitive and specific detection CWD prions in saliva, urine, blood (Mathiason lab), and rectal and pharyngeal lymph node samples (Haley NJ, et al.) from pre-symptomatic and symptomatic experimentally and naturally exposed deer. Other ongoing studies are employing RT-QuIC methodology to model amplification barriers among CWD, FSE, BSE, and CJD prions using cervine, feline, bovine, human, and promiscuous rPrP substrates and the above species prion seeds, cellular co-factors, and transgenic mice. Finally, in collaboration with the Wisniewski laboratory, we are conducting of experimental CWD vaccination studies in deer employing oral administration of an attenuated Salmonella vector expressing cervid PrP epitopes.
 
 
=====
 
 
AD.06: Detecting prions in the brain and blood of TSE-infected deer and hamsters
 
Alan Elder,1 Davin Henderson,1 Anca Selariu,1 Amy Nalls,1 Byron Caughey,2 Richard Bessen,1 Jason Bartz3 and Candace Mathiason1
 
1Colorado State University; Fort Collins, CO USA; 2NIH Rocky Mountain Laboratories; Hamilton, MT USA; 3Creighton University; Omaha, NE USA
 
While large quantities of protease resistant prion protein (PrPres) can be demonstrated by western blot or IHC in lymphoid biopsies or post-mortem brain tissues harvested from prion-infected animals, these conventional assays are less reliable as means to detect the small quantities of prions thought to be present in bodily fluids or associated with early and asymptomatic phases of TSE disease. The Real Time-Quaking Induced Conversion (RT-QuIC) assay is capable of detecting prions at concentrations below the level of sensitivity of conventional assays and provides a real-time fluorescent readout negating the use of proteases. We have made modifications to the RT-QuIC assay to utilize it for the detection of PrPres in brain and blood harvested from various species infected with prions. In this study, we analyzed CWD-infected deer and CWD/TME-infected hamster whole blood to determine the effect of:
 
(1) various anticoagulants,
 
(2) freezing and
 
(3) NaPTA precipitation.
 
Brain tissue and blood collected from naive deer and hamsters served as negative controls.
 
We were able to demonstrate amplifiable prions in
 
(1) brain and blood samples harvested from CWD/TME-infected animals,
 
(2) heparinized blood,
 
(3) frozen vs. fresh blood and
 
(4) NaPTA treated samples.
 
The RT-QuIC assay is able to detect PrPres in various species of animals and shows promise as an antemortem diagnostic tool for blood-borne TSEs.
 
 
=====
 
 
Oral.08: Mother to offspring transmission of chronic wasting disease in Reeve's Muntjac deer
 
Amy Nalls,1 Erin McNulty,1 Jenny Powers,2 Davis Seelig,1 Clare Hoover,1 Nicholas Haley,1 Jeanette Hayes-Klug,1 Kelly Anderson,1 Paula Stewart,3 Wilfred Goldmann,3 Edward A. Hoover1 and Candace K. Mathiason1
 
1Colorado State University; Fort Collins, CO USA; 2National Park Service; Fort Collins, CO USA; 3The Roslin Institute and Royal School of Veterinary Studies; Edinburgh, UK
 
To investigate the role mother to offspring transmission plays in chronic wasting disease (CWD), we have developed a cervid model employing the Reeve's muntjac deer (Muntiacus reevesi). Eight muntjac doe were orally inoculated with CWD and tested PrPCWD lymphoid positive by 4 mo post infection. Fourteen fawns were born to these eight CWD-infected doe-3 were born viable, 6 were born non-viable and 5 were harvested as fetuses from early or end-stage CWD-infected doe. All three viable fawns have demonstrated CWD IHC lymphoid biopsy positivity between 43 d post birth and 11 mo post birth. Two of these three CWD positive viable offspring have developed clinical signs consistent with TSE disease (28-33 mo post birth). Moreover, CWD prions have been detected by sPMCA in 11 of 16 tissues harvested from 6 full-term non-viable fawns and in 7 of 11 fetal tissues harvested in utero from the second and third trimester fetuses. Additional tissues and pregnancy related fluids from doe and offspring are being analyzed for CWD prions. In summary, using the muntjac deer model we have demonstrated CWD clinical disease in offspring born to CWD-infected doe, and in utero transmission of CWD from mother to offspring. These studies provide basis to further investigate the mechanisms of maternal transfer of prions.
 
 
=====
 
 
AD.63: Susceptibility of domestic cats to chronic wasting disease
 
Amy V.Nalls,1 Candace Mathiason,1 Davis Seelig,2 Susan Kraft,1 Kevin Carnes,1 Kelly Anderson,1 Jeanette Hayes-Klug1 and Edward A. Hoover1
 
1Colorado State University; Fort Collins, CO USA; 2University of Minnesota; Saint Paul, MN USA
 
Domestic and nondomestic cats have been shown to be susceptible to feline spongiform encephalopathy (FSE), almost certainly caused by consumption of bovine spongiform encephalopathy (BSE)-contaminated meat. Because domestic and free-ranging nondomestic felids scavenge cervid carcasses, including those in areas affected by chronic wasting disease (CWD), we evaluated the susceptibility of the domestic cat (Felis catus) to CWD infection experimentally. Cohorts of 5 cats each were inoculated either intracerebrally (IC) or orally (PO) with CWD-infected deer brain. At 40 and 42 mo post-inoculation, two IC-inoculated cats developed signs consistent with prion disease, including a stilted gait, weight loss, anorexia, polydipsia, patterned motor behaviors, head and tail tremors, and ataxia, and progressed to terminal disease within 5 mo. Brains from these two cats were pooled and inoculated into cohorts of cats by IC, PO, and intraperitoneal and subcutaneous (IP/SC) routes. Upon subpassage, feline-adapted CWD (FelCWD) was transmitted to all IC-inoculated cats with a decreased incubation period of 23 to 27 mo. FelCWD was detected in the brains of all the symptomatic cats by western blotting and immunohistochemistry and abnormalities were seen in magnetic resonance imaging, including multifocal T2 fluid attenuated inversion recovery (FLAIR) signal hyper-intensities, ventricular size increases, prominent sulci, and white matter tract cavitation. Currently, 3 of 4 IP/SQ and 2 of 4 PO inoculared cats have developed abnormal behavior patterns consistent with the early stage of feline CWD. These results demonstrate that CWD can be transmitted and adapted to the domestic cat, thus raising the issue of potential cervid-to- feline transmission in nature.
 
 
 
 
 
Sunday, July 21, 2013
 
*** As Chronic Wasting Disease CWD rises in deer herd, what about risk for humans?
 
 
 
*** PRION2013 ***
 
 
Sunday, August 25, 2013
 
Prion2013 Chronic Wasting Disease CWD risk factors, ***humans, domestic cats, blood, and mother to offspring transmission
 
 
 
Prion2013
 
Friday, August 09, 2013
 
***CWD TSE prion, plants, vegetables, and the potential for environmental contamination
 
 
 
Uptake of Prions into Plants
 
 
 
Wednesday, September 04, 2013
 
*** cwd - cervid captive livestock escapes, loose and on the run in the wild...
 
 
 
Thursday, August 08, 2013
 
*** Characterization of the first case of naturally occurring chronic wasting disease in a captive red deer (Cervus elaphus) in North America
 
 
 
*** The potential impact of prion diseases on human health was greatly magnified by the recognition that interspecies transfer of BSE to humans by beef ingestion resulted in vCJD. While changes in animal feed constituents and slaughter practices appear to have curtailed vCJD, there is concern that CWD of free-ranging deer and elk in the U.S. might also cross the species barrier. Thus, consuming venison could be a source of human prion disease. Whether BSE and CWD represent interspecies scrapie transfer or are newly arisen prion diseases is unknown. Therefore, the possibility of transmission of prion disease through other food animals cannot be ruled out. There is evidence that vCJD can be transmitted through blood transfusion. There is likely a pool of unknown size of asymptomatic individuals infected with vCJD, and there may be asymptomatic individuals infected with the CWD equivalent. These circumstances represent a potential threat to blood, blood products, and plasma supplies.
 
 
 
Envt.07:
 
Pathological Prion Protein (PrPTSE) in Skeletal Muscles of Farmed and Free Ranging White-Tailed Deer Infected with Chronic Wasting Disease
 
Martin L. Daus,1,† Johanna Breyer,2 Katjs Wagenfuehr,1 Wiebke Wemheuer,2 Achim Thomzig,1 Walter Schulz-Schaeffer2 and Michael Beekes1 1Robert Koch Institut; P24 TSE; Berlin, Germany; 2Department of Neuropathology, Prion and Dementia Research Unit, University Medical Center Göttingen; Göttingen, Germany †Presenting author; Email: dausm@rki.de
 
Chronic wasting disease (CWD) is a contagious, rapidly spreading transmissible spongiform encephalopathy (TSE) occurring in cervids in North America. Despite efficient horizontal transmission of CWD among cervids natural transmission of the disease to other species has not yet been observed. Here, we report a direct biochemical demonstration of pathological prion protein PrPTSE and of PrPTSE-associated seeding activity in skeletal muscles of CWD-infected cervids. The presence of PrPTSE was detected by Western- and postfixed frozen tissue blotting, while the seeding activity of PrPTSE was revealed by protein misfolding cyclic amplification (PMCA). The concentration of PrPTSE in skeletal muscles of CWD-infected WTD was estimated to be approximately 2000- to 10000-fold lower than in brain tissue. Tissue-blot-analyses revealed that PrPTSE was located in muscle- associated nerve fascicles but not, in detectable amounts, in myocytes. The presence and seeding activity of PrPTSE in skeletal muscle from CWD-infected cervids suggests prevention of such tissue in the human diet as a precautionary measure for food safety, pending on further clarification of whether CWD may be transmissible to humans.
 
 
 
Monday, August 26, 2013
 
***The Presence of Disease-Associated Prion Protein in Skeletal Muscle of Cattle Infected with Classical Bovine Spongiform Encephalopathy
 
 
 
Wednesday, September 25, 2013
 
Presence of subclinical infection in gene-targeted human prion protein transgenic mice exposed to atypical BSE
 
 
 
Nutritional Supplements, animal organ tissues, and CJD ? vCJD in the USA * BSE in U.S.15 November 1999
 
My neighbors Mom also died from CJD. She had been taking a nutritional supplement which contained the following; vacuum dried bovine BRAIN, bone meal, bovine EYE, veal bone, bovine liver powder, bovine adrenal, vacuum dried bovine kidney, and vacuum dried porcine stomach. As I said, this woman taking these nutritional supplements, died from CJD. The particular batch of pills that was located, in which she was taking, was tested. From what I have heard, they came up negative, for the prion protein. But, in the same breath, they said their testing, may not have been strong enough to pick up the infectivity. Plus, she had been taking these type pills for years, so, could it have come from another batch?
 
 
 
 
 
 
 
IPLEX NUTRITIONAL SUPPLEMENTS STILL HAVE BOVINE BY-PRODUCTS
 
see recall, but _not_ for prion disease. ....
 
Enforcement Report - Week of July 25, 2012
 
Product Detail Product Description SP Standard Process, Cataplex ACP (Product #0700 and 0750) , Dietary supplement, 90 & 360 Tablets, Proprietary Blend: Dried buckwheat ( leaf) juice, buckwheat (seed), carrot (root), calcium lactate, nutritional yeast, bovine adrenal, bovine kidney, alfalfa flour, dried alfalfa, (whole plant) juice, magnesium citrate, mushroom, bovine bone, Echinacea (root, deflated wheat, (germ), oat flour, soybean lecithin, yeast bone, calcium acid, phosphate, mixed tocopherols, (soy), rice (bran), and carrot oil., Other ingredients: Honey ascorbic acid, calcium stearate, arabic, gum, starch, sucrose, vitamin A palmate., UPC 8 12122 01003 0 18. Recall Number F-1764-2012 Classification Class I Code Info Lot 114, Lot 114, Best Used By dates of 05/13.
 
Product Distributed Qty 29,044 Reason For Recall Standard Process, Inc. is voluntarily recalling 3 dietary supplements due to potential Salmonella contamination.
 
Event Detail Event Id 62477 Product Type Food/Cosmetics Status Ongoing Recalling Firm Standard Process, Inc. City Palmyra State WI Country US Voluntary / Mandated Voluntary: Firm Initiated Recall Initiation Date 2012-06-27 Initial Firm Notification of Consignee or Public Letter Distribution Pattern AL, AZ, AR, CA,CO, CT, DE, DC, FL,GA, IL, IN, IA, KS, KY, LA, ME, MD, MA, MI, MN, MS, MO, NE, NV, NY, NH,NM, NY, NC, OH, OK, PA, RI,SC, TN,TX,VT, VA, WA, WV, WI.
 
Enforcement Report - Week of July 25, 2012
 
Product Detail Product Description SP Standard Process, Cataplex C, Dietary Supplement, (Product # 1650 and 1655) , 90 & 360 Tablets, Proprietary Blend: Veal bone PMG extract, bovine adrenal, dried buckwheat (leaf) juice, buckwheat (seed), nutritional yeast, dried alfalfa( whole plant) juice, alfalfa flour, mushroom , magnesium citrate, bovine bone, deflated wheat (germ), calcium acid phosphate, Echinacea(root), carrot (root), veal bone, soybean lecithin, mixed tocopherols (soy , and rice (bran)., Other Ingredients calcium lactate, honey, aerola (berry), camu camu (berry), manloc (root), calcium stearate, and arabic gum, UPC 8 12122 01029 0 16. Recall Number F-1765-2012 Classification Class I Code Info Lot 114, Lot 114, Best Used By dates of 05/13.
 
Product Distributed Qty 23,874 bottles Reason For Recall Standard Process, Inc. is voluntarily recalling 3 dietary supplements due to potential Salmonella contamination.
 
Event Detail
 
Event Id 62477 Product Type Food/Cosmetics Status Ongoing Recalling Firm Standard Process, Inc. City Palmyra State WI Country US Voluntary / Mandated Voluntary: Firm Initiated Recall Initiation Date 2012-06-27 Initial Firm Notification of Consignee or Public Letter Distribution Pattern AL, AZ, AR, CA,CO, CT, DE, DC, FL,GA, IL, IN, IA, KS, KY, LA, ME, MD, MA, MI, MN, MS, MO, NE, NV, NY, NH,NM, NY, NC, OH, OK, PA, RI,SC, TN,TX,VT, VA, WA, WV, WI.
 
 
 
 
 
 
 
 
Tuesday, March 5, 2013
 
Use of Materials Derived From Cattle in Human Food and Cosmetics; Reopening of the Comment Period FDA-2004-N-0188-0051 (TSS SUBMISSION)
 
FDA believes current regulation protects the public from BSE but reopens comment period due to new studies
 
 
 
 
----- Original Message -----
 
From: Terry S. Singeltary Sr.
 
To: LISTSERV@VM.CFSAN.FDA.GOV
 
Cc: FDA-DSFL@vm.cfsan.fda.gov ; Amy.Odegaard@fda.hhs.gov ; Kathleen.Smith1@fda.hhs.gov ; Diane.Schmit@fda.hhs.gov
 
Sent: Saturday, September 16, 2006 12:46 PM
 
Subject: NUTRITIONAL SUPPLEMENTS and USA MAD COW STRAINS TYPICAL AND ATYPICAL AND CJD
 
Greetings FDA list serve,
 
WHEN is the fda going to get tough on these nutritional supplements that still contain potential TSE agent that could cause CJD. after years and years of complaining about bovine brain in the standard process IPLEX supplements, they finally sometime recently changed this from bovine brain to porcine brain, but what about all the human guinea pigs that did take these supplements IPLEX, when it did contain bovine brain? i suppose they are just walking 'case studies' for a long incubating disease i.e. USA strain of human bovine TSE, dare i say BSE or BASE? BUT, if we look at the total ingredient list just for IPLEX, it is still a potential supplement for mad cow disease i.e. CJD of whatever phenotypes that exist in the USA and all of North America.
 
right, we dont have mad cow disease in the USA and all CJD in USA is spontaneous, and mission accomplished in Iraq.
 
FACT is sCJD in the USA has tripled in the past few years or so, and we now have unknown strains in the USA;
 
snip...
 
you must NOT continue to ignore this! please..........
 
IPLEX R
 
Proprietary Blend: 967 MG Arrowroot flour, inositol, calcium lactate, porcine eye PMG™ extract, phosphoric acid, dried buckwheat (leaf) juice, buckwheat (seed), veal bone PMG™ extract, carrot (root), bovine liver, magnesium citrate, porcine stomach, choline bitartrate, nutritional yeast, bovine adrenal, defatted wheat (germ), alfalfa flour, bovine kidney, dried alfalfa juice, allantoin, mushroom, manganese glycerophosphate, bovine adrenal Cytosol™ extract, porcine brain, bovine bone, dl-methionine, oat flour, soybean lecithin, veal bone, mixed tocopherols (soy), carrot oil, and peanut (bran).
 
 
 
 
HERE IS OLD INGREDIENT LIST FOR IPLEX ;
 
 
IPLEX (neighbors mom died from CJD while taking these pills for years)
 
bovine eye PMG extract, veal bone PMG, bovine liver, porcine stomach, bovine adrenal, bovine kidney, bovine adrenal Cytosol extract, BOVINE BRAIN, bovine bone, veal bone meal
 
IF you go to Standard Process FAQ page, the very first question and answer is a lie ;
 
Where do the bovine organs used in the supplements come from?
 
We purchase animal tissues and glands only from facilities inspected by the U.S. Food and Drug Administration, U.S. Department of Agriculture, and state departments of agriculture. The USDA will not allow the import of bovine materials from BSE infected countries.
 
 
 
IT seems Standard Process uses the excuse of USDA stamp of approval, and we all know that this stamp of approval is nothing more than a stamp of lies and deciet, proven time and time again by the OIG ;
 
MORE LIES HERE ;
 
When Standard Process received the FDA's November 1992 letter to dietary supplement manufacturers regarding BSE and imports, the company promptly instituted further procedures to assure that its USDA inspected suppliers were aware of and adhering to the FDA's advice not to use bovine materials from BSE affected countries. Standard Process was inspected by the FDA with respect to this issue and the FDA was satisfied that the company had proper procedures in place.
 
 
 
TRY telling this to my old neighbors mother, whom died after taking IPLEX for years of CJD on 12-14-96 CONFIRMED. oddly enough exactly one year later, to the day, my mother died from the Heidenhain Variant of CJD, also CONFIRMED. There have been other instances where victims of CJD were taking supplements that could carry the 100% lethal agent of TSE in the USA, that died from CJD. coincidence or source? until this agent can be destroyed by standard process, until this TSE agent can be detected in standard process and other supplement products, the following rule should be repealed, and a ban on all tissues and organs from any species that has been documented to have a TSE should be implemented immediately. ...
 
 
 
FOR IMMEDIATE RELEASE Media Inquiries: Michael Herndon P05-58 301-827-6242 September 6, 2005 Consumer Inquiries: 888-INFO-FDA
 
FDA Amends Interim Final Rule "Use of Materials Derived from Cattle in Human Food and Cosmetics"
 
The U.S. Food and Drug Administration today published several amendments to the July 2004 interim final rule, "Use of Materials Derived from Cattle in Human Food and Cosmetics," that will allow the use of certain cattle-derived material in human foods and cosmetics.
 
The rule prohibits the use of cattle-derived materials that can carry the infectious agent for bovine spongiform encephalopathy (BSE), or mad cow disease, in human foods, dietary supplements, and in cosmetics. Based on the scientific information provided during the interim final rule's comment period, which demonstrates that a part of the cow's digestive tract called the distal ileum can be consistently and effectively removed from the other sections of the small intestine, it is no longer necessary to designate the entire small intestine as a prohibited cattle material.
 
As a result, FDA is amending the rule to allow use of the small intestine in human food and cosmetics, provided that the distal ileum has been removed. The U.S. Department of Agriculture is publishing today a similar amendment to its interim final rule on BSE.
 
The amendments also clarify that milk and milk products, hides and hide-derived products, and tallow derivatives are not prohibited for use in human food and cosmetics.
 
Finally, FDA has reconsidered the recommended method for determining insoluble impurities in a type of solid fat known as tallow, in response to information submitted to the agency, to cite a method that is less costly to use and requires less specialized equipment.
 
FDA issued the interim final rule to minimize human exposure to materials that studies have demonstrated are highly likely to contain the BSE agent in cattle with the disease. The amended interim final rule provides the same level of protection against the agent that causes BSE as the original provisions.
 
The amendments to the interim final rule are effective on October 7, 2005 and comments are being are accepted on the amendments through November 7, 2005.
 
###
 
 
 
 
 
2003 - 2004 Product Catalog
 
Standard Process Inc.
 
NATURAL COCOA STANDARDBAR (mad cow candy bar) (i will just list animal organs) bovine adrenal, bovine liver, bovine spleen, ovine spleen, bovine kidney...
 
NATURAL PEANUT BUTTER STANDARDBAR
 
bovine adrenal, bovine liver, bovine spleen, ovine spleen, bovine kidney...
 
USF (MAD COW) OINTMENT (RUB A DUB DUB, KURU ETC) ;
 
bovine orhic glandular extract
 
UTROPHIN PMG
 
bovine uterus PMG
 
VASCULIN
 
bovine heart PMG extract, veal bone PMG extract, bovine liever, porcine duodenum, bovine adrenal Cytosol extract, bovine spleen, ovine spleen
 
IPLEX (neighbors mom died from CJD while taking these pills for years)
 
bovine eye PMG extract, veal bone PMG, bovine liver, porcine stomach, bovine adrenal, bovine kidney, bovine adrenal Cytosol extract, BOVINE BRAIN, bovine bone, veal bone meal
 
MYO-PLUS
 
bovine heart PMG, bovine liver, porcine stomach, bovine orchic extract, bovine spleen, ovine spleen, bovine adrenal Cytosol extract, BOVINE BRAIN
 
NEUROPLEX
 
bovine orchic Cytosol extract, bovine spleen, BOVINE BRAIN PMG EXTRACT, BOVINE ANTERIOR PITUITARY, bovine liver, BOVINE PITUITARY PMG EXTRACT, AND MORE BOVINE BRAIN...
 
NEUROTROPHIN PMG
 
BOVINE BRAIN PMG
 
NIACINAMIDE B6 VM
 
bovine liver, porcine stomach, bovine spleen ovine spleen, BOVINE BRAIN
 
OCULOTROPHIN PMG BOVINE EYE PMG
 
ORCHEX
 
bovine liver, bovine orchic Cytosol extract, porcine stomch, bovine spleen, ovine spleen, BOVINE BRAIN
 
OSTARPLEX
 
veal bone PMG extract, veal bone PMG extract, bovine liver, porcine stomach, bovine adrenal, bovine spleen, ovine spleen, BOVINE BRAIN
 
PARAPLEX
 
bovine pancreas PMG extract, porcine duodenum, bovine adrenal PMG, BOVINE PITUITARY PMG EXTRACT, bovine thyroid PMG extract
 
PITUITROPHIN PMG
 
RUMAPLEX
 
BOVINE BRAIN, veal bone PMG extract, bovine adrenal, bovine prostate Cytosol extract, veal bone meal, bovine liver PMG extract, bovine spleen, ovine spleen, bovine liver
 
SENAPLEX
 
bovine liver PMG extract, bovine adrenal, BOVNE BRAIN, veal bone meal, bovine kidney, bovine orchic extract, bovine spleen, ovine spleen ..........
 
THESE are just a few of MANY of just this ONE COMPANY.
 
FOR the following reason, I implore that the FDA take serious action in further protecting the consumer from the TSE agent via nutritional supplements.
 
Does all that e-mail spam promising sexual vitality actually hide serious risk of contracting MAD COW DISEASE?
 
Volume 361, Number 9368 03 May 2003
 
Correspondence
 
Tighter regulation needed for dietary supplements in USA
 
Sir--Mary Palmer and colleagues (Jan 11, p 101)1 found that dietary supplements have the potential to cause serious adverse effects. The investigators state that research on the hazards and risks of dietary supplements should be a priority. The safety of individuals who consume these products is important, and organisations such as the US Food and Drug Administration (FDA) need to take initiative by enforcing stricter regulations on supplements. Several commonly used products--for example ginkgo biloba, St John's Wort, and ephedrine--can have serious adverse effects.2 Although the FDA requires multiple studies on the safety and efficacy for pharmaceutical products before placing them on the market, standards are less robust for dietary supplements. In the USA, under the Dietary Supplement Health and Education Act (DSHEA) of 1994, supplements are subject to the same regulatory requirements as food. There are no provisions that require FDA approval for the safety or effectiveness of supplements,3 which leaves consumers and manufacturers essentially responsible for the health effects of these products. The DSHEA of 1994 needs to be revised so that dietary supplements are subject to the same regulations as pharmacological drugs. The FDA needs to review clinical studies on the safety and efficacy of dietary supplements. Organisations such as Public Citizen and the American Medical Association are already taking steps to achieve these changes. However, they face immense opposition from groups such as the National Nutritional Foods Association, the American Herbal Association, and the Council for Responsible Nutrition. To overcome such resistance, consumer organisations, health-care providers, and government agencies need to approach this subject in unison. The public needs to be able to assess the risks and benefits of dietary supplements before consuming them. Health-care providers and the more than 100 million Americans who consume these products4 should encourage the FDA to treat supplements with the stringent regulations it enforces on pharmaceutical products.
 
Nipa Kinariwala
 
----------------------------------------------------------
 
700 Bolinwood Drive, Apartment 12A, Chapel Hill, NC 27514, USA (e-mail nskinari at aol.com) 1 Palmer ME, Haller C, McKinney PE, et al. Adverse events associated with dietary supplements: an observational study. Lancet 2003; 361: 101-06. [Text ] 2 Cupp MJ. Herbal remedies: adverse effects and drug interactions. Am Fam Physician 1999; 59: 1239-45. [PubMed ] 3 Unites States Food and Drug Administration. Overview of dietary supplements. Jan 3, 2001. http://www.cfsan.fda.gov/~dms/ds-oview.html (accessed Feb 20, 2002). 4 Pear R. Feds call for tighter control over nutritional supplements. Organic Consumers Association, April 17, 2001. http://www.organicconsumers.org/Organic/dietsupp.cfm (accessed Feb 20, 2002).
 
 
 
 
snip...end tss letter to fda.
 
 
=================== 2013 ================
 
 
Wednesday, March 20, 2013
 
GAO-13-244, Mar 18, 2013 Dietary Supplements FDA May Have Opportunities to Expand Its Use of Reported Health Problems to Oversee Product
 
From: Terry S. Singeltary Sr.
 
Sent: Tuesday, March 19, 2013 2:46 PM
 
To: mailto:gomezj%40gao.gov Cc: mailto:siggerudk%40gao.gov ; mailto:youngc1%40gao.gov ; mailto:oighotline%40gao.gov
 
 
 
Monday, February 01, 2010
 
Import Alert 17-04 BSE CJD HIGH RISK TISSUES, Nutritional Supplements and Cosmetics Import Alert 17-04
 
 
 
Thursday, March 19, 2009
 
Chronic Wasting Disease Prions in Elk Antler Velvet (Nutritional Supplements and CJD)
 
10.3201/eid1505.081458 Suggested citation for this article: Angers RC, Seward TS, Napier D, Green M, Hoover E, Spraker T, et al. Chronic wasting disease prions in elk antler velvet. Emerg Infect Dis. 2009 May; [Epub ahead of print]
 
 
 
Docket Management Docket: 96N-0417 - Current Good Manufacturing Practice in Manufacturing, Packing, or Holding Dietary Ingredients a
 
Comment Number: EC –2
 
Accepted - Volume 7
 
 
 
 
Docket Management Docket: 96N-0417 - Current Good Manufacturing Practice in Manufacturing, Packing, or Holding Dietary Ingredients a Comment Number: EC -2 Accepted - Volume 7
 
snip...
 
what did Paul Brown say about this previously;
 
i bring your attention to (page 500) Dr. Paul Brown statements;
 
253 1 DR. BOLTON: I have an additional question about 2 that. What is the assurance that additional locally sourced 3 tracheas are not added into that manufacturing process, thus 4 boosting the yield, if you will, but being returned to the 5 U.S. as being produced from U.S.-sourced raw material? 6 DR. McCURDY: Are there data to indicate how many 7 grams, or whatever, of infected brain are likely to infect 8 an organism, either animal or man, when taken orally? 9 DR. BROWN: If I am not mistaken, and I can be 10 corrected, I think a half a gram is enough in a cow, orally; [FULL TEXT ABOUT 600 PAGES] 3681t2.rtf http://www.fda.gov/ohrms/dockets/ac/cber01.htm
 
snip...
 
 
 
Unregulated "foods" such as 'nutritional supplements' containing various extracts from ruminants, whether imported or derived from 3 US cattle/sheep/cervids ("antler velvet" extracts!) should be forbidden or at least very seriously regulated.
 
(neighbors Mom, whom also died from CJD, had been taking bovine based supplement, which contained brain, eye, and many other bovine/ovine tissues for years, 'IPLEX').
 
 
 
 
my plight with metabolife and there 'bovine complex' about risk factors of TSE in there product ;
 
 
Terry S. Singeltary Sr. wrote:
 
 
> ######## Bovine Spongiform Encephalopathy > #########
 
 
> > 1. Dietary Supplements: Review of Health-Related Call Records for
 
 
> Users of Metabolife 356. GAO-03-494, March 31.
 
 
 
 
 
 
> > -------- Original Message --------
 
 
> > Subject: METABOLIFE AND TSEs GAO-03-494 ''URGENT DATA''
 
> Date: Thu, 01 May 2003 11:23:01 –0500
 
> From: "Terry S. Singeltary Sr."
 
> To: NelliganJ at gao.gov
 
> > The General Accounting Office (GAO) today released the following reports
 
> and testimonies: >
 
> REPORTS >
 
> 1. Dietary Supplements: Review of Health-Related Call Records for
 
> Users of Metabolife 356. GAO-03-494, March 31.
 
 
 
 
 
 
 
 
> GREETINGS GAO:
 
 
> i was suprised that i did not see any listing of bovine tissue in metabolife
 
> on it's label. have they ceased using these desiccated tissues??
 
> > i see that the lable on this product METABOLIFE 356,
 
> does not state that it has any tissues of desiccated bovine organs? i no the product use to, so i am curious if they have
 
> ceased the use of the tissues of cattle they _use_ to use (see below)??
 
 
 
> METABOLIFE 356
 
> BOVINE COMPLEX/GLANDULAR SYSTEM
 
> OVARIES, PROSTATE, SCROTUM AND ADRENAL
 
> USDA SOURCE CATTLE
 
> > i tried warning them years ago of this potential threat of CJD/TSEs;
 
 
 
> > From: Randy Smith
 
> To: "'flounder at wt.net'"
 
> Subject: Metabolife
 
> Date: Mon, 7 Dec 1998 14:21:35 –0800
 
> > Dear Sir,
 
> > We are looking at reformulation. I agree that slow virus diseases
 
> present a problem in some areas of the world.
 
> > Our product uses healthy USDA inspected cattle for the glandular
 
> extract.
 
> > If you have any links to more information on this subject I would like
 
> to examine them.
 
> > Thank you for your interest and concern,
 
> > Dr. Smith
 
> ============
 
> > From: Randy Smith
 
> To: "'flounder at wt.net'"
 
> Subject: RE: [Fwd: Your submission to the Inquiry]
 
> Date: Wed, 9 Dec 1998 10:37:07 –0800
 
> > Terry,
 
> > Thank you for your note and the information links you forwarded to me.
 
> I am new to Metabolife International, however hopefully as my role here
 
> enlarges I well have a greater impact on formulation and product
 
> development.
 
> > Metabolife International does believe in placing safety first. And I am
 
> going to do my best to see that we continue to do so.
 
> > Sincerely,
 
> Dr. Smith
 
> ============
 
> -----Original Message-----
 
> From: Terry S. Singeltary Sr. [mailto:flounder at wt.net]
 
> Sent: Wednesday, December 09, 1998 5:49 PM
 
> To: rsmith at metabolife.com
 
> Subject: [Fwd: Your submission to the Inquiry]
 
> > Dr. Smith, I am truly impressed with you honesty, THANKS.....I am not
 
> just spouting off about the potential dangers, here. THEY ARE REAL.....I
 
> have forwarded an e-mail from the BSE Inquiry, in which I made a
 
> statement about them........You might want to go to the site and read
 
> through it........IT WILL TAKE A WHILE........ THINGS ARE HAPPENING HERE
 
> SIR, THAT YOU ARE NOT AWARE OF, AND AS MOST PEOPLE ARE
 
> NOT...............I JUST HOPE, THAT THE REFORMULATION YOU SPEAK OF, IS
 
> IN FACT GOING TO TAKE PLACE.
 
> The Department of Health, here in the U.S., is also worried about the
 
> potential dangers involved hear............Terry/MADSON
 
 
> ==================================================
 
 
> From: Randy Smith
 
> To: "'flounder at wt.net'"
 
> Subject: RE: [Fwd: MEDICINES "GREATER BSE RISK THAN BEEF"!!!!]
 
> Date: Fri, 18 Dec 1998 09:55:17 –0800
 
> Return-Receipt-To: Randy Smith
 
> > Thanks very much for the info. I appreciate all these articles I can
 
> get. It does sound very familiar - just follow the green ($) trail.
 
 
> > -----Original Message-----
 
 
> From: Terry S. Singeltary Sr. [mailto:flounder at wt.net]
 
> Sent: Friday, December 18, 1998 5:15 PM
 
> To: rsmith at metabolife.com
 
> Subject: [Fwd: MEDICINES "GREATER BSE RISK THAN BEEF"!!!!]
 
> > Randy, thought you might be interested in this...............MADSON!!!!!1
 
> > snip...
 
 
> ===============================
 
 
> Sender: "Patricia Cantos"
 
> To: "Terry S Singeltary Sr. (E-mail)"
 
> Subject: Your submission to the Inquiry
 
> Date: Fri, 3 Jul 1998 10:10:05 +0100
 
> > 3 July 1998
 
> Mr Terry S Singeltary Sr.
 
> E-Mail: Flounder at wt.net
 
> Ref: E2979
 
> > Dear Mr Singeltary,
 
> > Thank you for your E-mail message of the 30th of June 1998 providing the
 
> Inquiry with your further comments. Thank you for offering to provide the
 
> Inquiry with any test results on the nutritional supplements your
 
> mother was taking before she died.
 
 
> > As requested I am sending you our general Information Pack and a copy of the
 
> Chairman's letter. Please contact me if your system cannot read the attachments.
 
> > Regarding your question, the Inquiry is looking into many aspects of the > scientific evidence on BSE and nvCJD. I would refer you to the > transcripts > of evidence we have already heard which are found on our internet site at >
 
 
 
 
> > Could you please provide the Inquiry with a
 
> copy of
 
> the press article you refer to in your e-mail? If not an approximate date
 
> for the article so that we can locate it?
 
> In the meantime, thank you for you comments. Please do not hesitate to
 
> contact me on 0171 261 8332 should you have any queries.
 
> > Yours sincerely
 
> Patricia Cantos
 
> Families Team Leader
 
> Attachments
 
> TSS
 
 
 
> ==============
 
 
 
> -------- Original Message --------
 
 
 
> Subject: re: METABOLIFE AND TSEs GAO-03-494 ''URGENT DATA''
 
> Date: Thu, 01 May 2003 16:04:35 –0400
 
> From: "Marcia G Crosse"
 
> To:
 
> CC: "Charles W Davenport" , "Carolyn Feis Korman" > , "Martin Gahart" >
 
 
> Mr. Singletary,
 
> > We were informed by representatives of Metabolife, Inc. that Metabolife
 
> 356 was reformulated to remove bovine complex as an ingredient in the
 
> product, approximately September 2001. We did not independently verify
 
> the contents of the product.
 
 
> > Sincerely,
 
> Marcia Crosse
 
> Acting Director
 
> Health CarePublic Health and Science Issues
 
> U.S. General Accounting Office
 
> 441 G Street, N.W.
 
> Washington, D.C. 20548
 
 
> ===================
 
 
> > -------- Original Message --------
 
> Subject: Re: METABOLIFE AND TSEs GAO-03-494 ''URGENT DATA''
 
> Date: Thu, 01 May 2003 15:48:52 –0500
 
> From: "Terry S. Singeltary Sr."
 
> To: Marcia G Crosse
 
> CC: Charles W Davenport , Carolyn Feis Korman > , Martin Gahart > References: >
 
> THANK YOU!
 
> > MIRACLES DO HAPPEN! ;-)
 
> > now all we need to do is; >
 
> snip......
 
> > one small step for man, one giant leap for mankind ;-)
 
> > however; >
 
> ''We did not independently verify the contents of the product''
 
> > ??
 
>
 
> TSS >
 
 
 
 
 
 
 
 
Could you get mad cow from a pill ? Some doctors say a class of pills that promise smarts, energy, and sexual vitality may cause mad-cow disease.
 
The government isn't worried. Should you be?
 
June 1, 2001
 
Health Magazine
 
by Susan Freinkel
 
 
 
 
The German Magazine Der Spiegel came out to the house here and interviewed me in 2001 (I think), about that token purina mad cow feed mill blunder, and they were very concerned about these type supplements that carried the SRMs that could very well carry the TSE prion agent. ...please see ;
 
 
GERMAN DER SPIEGEL MAGAZINEDie
 
BSE-Angst erreicht Amerika: Trotz strikter Auflagen gelangte in Texas verbotenes Tiermehl ins Rinderfutter - die Kontrollen der Aufsichtsbehörden sind lax.
 
 
 
 
 
DER SPIEGEL (9/2001) - 24.02.2001 (9397 Zeichen) USA: Loch in der Mauer Die BSE-Angst erreicht Amerika: Trotz strikter Auflagen gelangte in Texas verbotenes Tiermehl ins Rinderfutter - die Kontrollen der Aufsichtsbehördensind lax.Link auf diesen Artikel im Archiv:
 
 
"Löcher wie in einem Schweizer Käse" hat auch Terry Singeltary im Regelwerk der FDA ausgemacht. Der Texaner kam auf einem tragischen Umweg zu dem Thema: Nachdem seine Mutter 1997 binnen weniger Wochen an der Creutzfeldt-Jakob-Krankheit gestorben war, versuchte er, die Ursachen der Infektion aufzuspüren. Er klagte auf die Herausgabe von Regierungsdokumenten und arbeitete sich durch Fachliteratur; heute ist er überzeugt, dass seine Mutter durch die stetige Einnahme von angeblich kräftigenden Mitteln erkrankte, in denen - völlig legal - Anteile aus Rinderprodukten enthalten sind.
 
Von der Fachwelt wurde Singeltary lange als versponnener Außenseiter belächelt. Doch mittlerweile sorgen sich auch Experten, dass ausgerechnet diese verschreibungsfreien Wundercocktails zur Stärkung von Intelligenz, Immunsystem oder Libido von den Importbeschränkungen ausgenommen sind. Dabei enthalten die Pillen und Ampullen, die in Supermärkten verkauft werden, exotische Mixturen aus Rinderaugen; dazu Extrakte von Hypophyse oder Kälberföten, Prostata, Lymphknoten und gefriergetrocknetem Schweinemagen. In die USA hereingelassen werden auch Blut, Fett, Gelatine und Samen. Diese Stoffe tauchen noch immer in US-Produkten auf, inklusive Medizin und Kosmetika. Selbst in Impfstoffen waren möglicherweise gefährliche Rinderprodukte enthalten. Zwar fordert die FDA schon seit acht Jahren die US-Pharmaindustrie auf, keine Stoffe aus Ländern zu benutzen, in denen die Gefahr einer BSE-Infizierung besteht. Aber erst kürzlich verpflichteten sich fünf Unternehmen, darunter Branchenführer wie GlaxoSmithKline, Aventis und American Home Products, ihre Seren nur noch aus unverdächtigem Material herzustellen.
 
"Its as full of holes as Swiss Cheese" says Terry Singeltary of the FDA regulations. ...
 
 
 
 
 
 
 
 
 
 
STILL IS FULL OF HOLES 2013 ;
 
 
 
Thursday, June 6, 2013
 
BSE TSE PRION USDA FDA MAD COW FEED COMPLIANCE REPORT and NAI, OAI, and VAI ratings as at June 5, 2013
 
Greetings,
 
since our fine federal friends have decided not to give out any more reports on the USA breaches of the feed ban and surveillance etc. for the BSE TSE prion mad cow type disease in the USDA livestock, I thought I might attempt it. I swear, I just don’t understand the logic of the SSS policy, and that includes all of it. I assure you, it would be much easier, and probably better for the FDA and the USDA INC., if they would simply put some kind of report out for Pete’s sake, instead of me doing it after I get mad, because I am going to put it all out there. the truth.
 
PLEASE BE ADVISED, any breach of any of the above classifications OAI, VAI, RTS, CAN lead to breaches into the feed BSE TSE prion protocols, and CAN lead to the eventual suspect tainted feed reaching livestock. please, if any USDA official out there disputes this, please explain then how they could not. paperwork errors can eventually lead to breaches of the BSE TSE prion mad cow feed ban reaching livestock, or contamination and exposure there from, as well.
 
I would sure like to see the full reports of just these ;
 
4018 CHI-DO 3007091297 Rancho Cantera 2866 N Sunnyside Rd Kent IL 61044-9605 OPR FR, OF HP 11/26/2012 OAI Y
 
9367 3008575486 Rocky Ford Pet Foods 21693 Highway 50 East Rocky Ford CO 81067 OPR RE, TH HP 2/27/2013 OAI N
 
9446 DEN-DO 1713202 Weld County Bi Products, Inc. 1138 N 11th Ave Greeley CO 80631-9501 OPR RE, TH HP 10/12/2012 OAI N
 
9447 DEN-DO 3002857110 Weld County Bi-Products dba Fort Morgan Pet Foods 13553 County Road 19 Fort Morgan CO 80701-7506 OPR RE HP 12/7/2011 OAI N
 
see full list of the fda mad cow bse feed follies, toward the bottom, after a short brief update on the mad cow bse follies, and our good friend Lester Crawford that was at the FDA.
 
ALSO, I would kindly like to comment on this FDA BSE/Ruminant Feed Inspections Firms Inventory (excel format)4 format, for reporting these breaches of BSE TSE prion protocols, from the extensive mad cow feed ban warning letters the fda use to put out for each violations. simply put, this excel format sucks, and the FDA et al intentionally made it this difficult to follow the usda fda mad cow follies. this is an intentional format to make it as difficult as possible to follow these breaches of the mad cow TSE prion safety feed protocols. to have absolutely no chronological or numerical order, and to format such violations in a way that they are almost impossible to find, says a lot about just how far the FDA and our fine federal friends will go through to hide these continued violations of the BSE TSE prion mad cow feed ban, and any breaches of protocols there from. once again, the wolf guarding the henhouse $$$
 
NAI = NO ACTION INDICATED
 
OAI = OFFICIAL ACTION INDICATED
 
VAI = VOLUNTARY ACTION INDICATED
 
RTS = REFERRED TO STATE
 
Inspections conducted by State and FDA investigators are classified to reflect the compliance status at the time of the inspection, based upon whether objectionable conditions were documented. Based on the conditions found, inspection results are recorded in one of three classifications:
 
OAI (Official Action Indicated) when inspectors find significant objectionable conditions or practices and believe that regulatory sanctions are warranted to address the establishment’s lack of compliance with the regulation. An example of an OAI classification would be findings of manufacturing procedures insufficient to ensure that ruminant feed is not contaminated with prohibited material. Inspectors will promptly re-inspect facilities classified OAI after regulatory sanctions have been applied to determine whether the corrective actions are adequate to address the objectionable conditions.
 
VAI (Voluntary Action Indicated) when inspectors find objectionable conditions or practices that do not meet the threshold of regulatory significance, but warrant an advisory to inform the establishment that inspectors found conditions or practices that should be voluntarily corrected. VAI violations are typically technical violations of the 1997 BSE Feed Rule. These violations include minor recordkeeping lapses or conditions involving non-ruminant feeds.
 
NAI (No Action Indicated) when inspectors find no objectionable conditions or practices or, if they find objectionable conditions, those conditions are of a minor nature and do not justify further actions.
 
 
 
 
 
 
From: TSS (216-119-138-121.ipset18.wt.net)
 
Subject: Re: CJD/aka madcow DISEASE $$$ Nutritional Supplements (letter from FDA)
 
Date: January 22, 2001 at 2:46 pm PST
 
In Reply to: Re: CJD/aka madcow DISEASE $$$ Nutritional Supplements posted by TSS on January 22, 2001 at 11:15 am:
 
I have been on a crusade so to speak, for going on to 3 years. trying to convince the world of the threat of human TSE's. The U.S. is not immune to these deadly disease's. My name is Terry S. Singeltary Sr., and on 12/14/97 i lost my mother to heidenhain variant creutzfeldt jakob disease.
 
Exactly one year earlier, to the day 12/14/96, my neighbor lost his mother to CJD. Both cases confirmed, in fact my Mothers brain is scattered across America for research.
 
To cut to the thick of things, i am writing this particular letter in reference of the meetings on nutritional supplements and their potential risks of human TSE, through desiccated animal tissue/organs. This industry is mostly unregulated, and only regulated as foods, and this is not good enough. Since when is BOVINE SCROTUM/100% natural herb? it's not. and these manufacturers of these drug also claim, without proof, that their supplement will cure everything from the common cold to aids. This must stop as well.
 
Now, i do not know how my Mother became infected with the prion protein or hvCJD, personally i think it was through contaminated instruments during a surgery. I don't know how my neighbors mother became infected with the CJD prion protein, but i will tell you she could have become infected through the nutritional supplements she had been taking for years, (IPLEX).
 
Iplex ingredients; Vacuum Dried Bovine BRAIN, Bone Meal, Bovine EYE, Veal Bone, Bovine Liver Powder, Bovine Adrenal, Vacuum Dried Bovine Kidney, Vacuum Dried Porcine Stomach.
 
This is just one of many supplements that contain these potentially lethal organs, if infected with a TSE. With what little is known about human/animal TSE's, it would be wise to stop these ingredients from being introduced to the public, with no apparent or proven method of assuring the product is free of the prion protein. it is urgent, that this is done immediately.
 
they have known of this potential route of infection since 1992, or longer. the letter below from Fred Shank about this problem, is not intended to intimidate anyone, but only to prove they were worried back then and nothing was done. they are still worried 8 years later, and _still_ nothing has been done.
 
this is very much long overdue about the nutritional supplements. once again, i will post, how the public has been mis-lead by this industry. This industry has _very little_ regulations. They are not regulated as pharmaceuticals, but as foods. The Herbal/Nutritional Supplements industry have been responsible for many sickness/deaths, do to the FDA lack of control over this industry.
 
Another fine example would be; they are still to this day, allowed to claim complete HERBAL INGREDIENTS/ALL NATURAL. Since when is a bovine scrotum, all natural, re-METABLOLIFE ingredient. they list this product as all natural '100% HERBAL'. Ingredients-bovine complex/glandular system, ovaries, prostate, scrotum, and adrenal.
 
An interesting note about this supplement. Most of us know by now, my mother died from heidenhain variant creutzfeldt jakob disease, but, my neighbors mother had been taking these Iplex supplements for years, and she _also_ died from creutzfeldt jakob disease. The particular batch of these supplements that was located after her death, were tested. of those, no contaminants of the prion agent were found. But, in the N.I.H. same breath, they said that their testing techniques may have not been strong enough to pick up low infectivity levels. Also, could have been another batch. She had been taking these for a long period of time.
 
So, the possibility is there? I also would like to post a letter about this from the Gov. to the Industry;
 
Letter to Manufacturers of Biological Products - Recommendations Regarding Bovine Spongiform Encephalopathy (BSE)
 
Department of Health and Human Services Public Health Service Food and Drug Administration 1401 Rockville Pike Rockville, MD 20852-1448
 
April 19, 2000
 
To Manufacturers of Biological Products
 
The Food and Drug Administration (FDA) has issued letters (date May 3, 1991, December 17, 1993, and May 9, 1996) and a guidance document (September 1997) requesting that materials derived from ruminants which have resided in or originated from countries where Bovine Spongiform Encephalopathy (BSE) has been diagnosed not be used in the manufacture of FDA-regulated products intended for administration to humans. The United States Department of Agriculture (USDA) also issued an interim rule on January 6, 1998, restricting the importation of ruminants, meat and meat products from ruminants, and certain ruminant products and byproducts from all countries of Europe. Because of the serious nature of this issue, the Center for Biologics Evaluation and Research (CBER) believes it critical to update the current recommendations.
 
CBER strongly recommends that manufacturers take whatever steps are necessary to assure that materials derived from all species of ruminant animals born, raised or slaughtered in countries where BSE is known to exist, or countries where the USDA has been unable to assure FDA that BSE does not exist, are not used in the manufacture of FDA-regulated products intended for administration to humans. The Agency has previously recommended that manufacturers take the following steps to prevent this occurrence:
 
1.Identify all ruminant-derived materials (e.g., culture medium, transferrin, albumin, enzymes, lipids) used in the manufacture of regulated products. FDA considers the manufacture of biological products to include the preparation of master (including the original cell line) and working cell banks, as well as materials used in fermentation, harvesting, purification and formulation of the products.
 
2.Document the country of origin and all countries where the live animal source has resided for each ruminant-derived material used in the manufacture of the regulated product. The regulated-product manufacturer should obtain this information from the supplier of the ruminant-derived product. The regulated-product manufacturer should also obtain the appropriate veterinary regulatory inspection certification of slaughter, as required by the country of origin of live animals, from the supplier. Documentation should be maintained for any new or in-process lots of licensed, cleared or approved products; products pending clearance or approval; and investigational products intended to be administered to humans.
 
3.Maintain traceable records for each lot of ruminant material and each lot of FDA-regulated product manufactured using these materials. These records should be part of the product batch records and available for FDA inspection. Such records should be maintained for products manufactured at foreign as well as domestic facilities.
 
It is the responsibility of the manufacturer to obtain up-to-date information regarding countries where BSE is known to exist, or countries where the USDA has been unable to assure FDA that BSE does not exist. This information is available from the USDA's Animal and Plant Health Inspection Service (APHIS) at telephone number 301-734-8364, website address http://www.aphis.usda.gov/ncie , and codified at 9 CFR 94.18 (see attached).
 
Specific product-related questions should be directed to the appropriate application division within CBER's product offices. The phone numbers are:
 
Dr. David Asher, Office of Blood Research and Review 301-827-3524 Dr. Paul Richman, Office of Vaccines Research and Review 301-827-3070 James Crim, Office of Therapeutics Research and Review 301-827-5101
 
Thank you for your attention to this matter.
 
Sincerely,
 
---- signature ---
 
Kathryn C. Zoon, Ph.D. Director Center for Biologics Evaluation And Research
 
 
Attachment
 
 
 
 
Subject: Re: human/animal TSEs $$$ Nutritional Supplements $ STANDARDPROCESS CO.
 
Date: Mon, 22 Jan 2001 10:43:39 –0800
 
From: "Terry S. Singeltary Sr."
 
Reply-To: Bovine Spongiform Encephalopathy
 
To: BSE-L@uni-karlsruhe.de References: 1 , 2
 
######### Bovine Spongiform Encephalopathy #########
 
Greetings again,
 
hmmm, the FDA says;
 
Q. Does FDA routinely analyze the contents of Dietary Supplements?
 
FDA has limited resources to analyze the composition of food products, including dietary supplements. So, FDA focuses first on public health emergencies and products that may have caused injury or illness. Then products thought to be fraudulent or in violation of the law are analyzed. FDA uses the remaining funds for routine monitoring of products pulled from store shelves. FDA does not analyze supplement products before they are sold to consumers. The manufacturer is responsible for ensuring that the ingredient list is accurate and that the ingredients are safe. They are also required to make sure that the content matches the amount declared on the label.
 
FDA does not have adequate resources to analyze dietary products sent by consumers who want to know their content. Instead, consumers may contact the manufacturer or a commercial laboratory.
 
snip...
 
Are all ingredients required to be declared on the label and what kind of claims can be made on the labels of dietary supplements?
 
Other ingredients in the product must be listed in the ingredient statement beneath the "Supplement Facts" panel. The types of ingredients listed there would include gelatin, sugars, starch, colors, stabilizers and preservatives.
 
What kinds of claims can be made on the labels of Dietary Supplements?
 
As with other food products, the manufacturer can put certain claims on the product label. These claims tell consumers about the nutritional value of the product. Claims defined by FDA to describe the nutrient content of a product, like "good source" or "high", can appear on the label if one serving meets the definition. There are specific rules as to which substances can be listed using these nutrient content claims.
 
Manufacturers can also put FDA-approved "health claims" on a product label. Health claims describe the connection between a nutrient or food substance and a disease or health-related condition. Claims about these diet/disease relationships can appear on the label if the content of the product meets the FDA requirements and if the claim is one of the approved health claims.
 
Why do some supplements have wording that says: "This statement has not been evaluated by the FDA. This product is not intended to diagnose, treat, cure, or prevent any disease"?
 
Certain statements may be included on the label that give the manufacturer's description of the role of the dietary supplement. These statements are not authorized by FDA. The manufacturer is responsible for ensuring that these statements are accurate and truthful. For this reason, the law says that if a dietary supplement label includes this information, it must also state that FDA has not evaluated the statement.
 
Who assures the safety of dietary supplements?
 
As with food, federal law requires manufacturers of dietary supplements to ensure that the products they put on the market are safe. But supplement manufacturers do not have to provide information to FDA to get a product on the market, unlike the food additive process often required of new food ingredients.
 
FDA review and approval of supplement ingredients and products is not required before marketing.
 
 
 
now, who ya gonna believe??
 
If the FDA cannot regulate these industry's, what good is the FDA??
 
with sad regards, Terry S. Singeltary Sr., Bacliff, Texas USA
 
 
==============================================
 
 
Wednesday, September 25, 2013
 
*** Inspections, Compliance, Enforcement, and Criminal Investigations BSE TSE PRION 2013
 
 
 
Wednesday, October 30, 2013
 
*** SPECIFIED RISK MATERIAL (SRM) CONTROL VERIFICATION TASK FSIS NOTICE 70-13 10/30/13
 
 
 
Tuesday, September 24, 2013
 
*** NORDION (US), INC., AND BIOAXONE BIOSCIENCES, INC., Settles $90M Mad Cow TSE prion Contamination Suit Cethrin(R)
 
Case 0:12-cv-60739-RNS Document 1 Entered on FLSD Docket 04/26/2012 Page 1 of 15
 
snip...
 
NATURE OF THE CASE
 
1. This is an action for negligence against the Defendants arising from the improper and negligent use of contaminated material in the preparation of the Bacterial Master Cell Bank ("MCB") for a new breakthrough drug, Cethrin" (BA-21 0), researched and developed by BIOAXONE. Cethrin is a biologic drug that will provide the most advanced treatment for patients who have suffered acute spinal cord injury. Defendants negligently prepared the MCB using kanamycin they purchased that was made in China and that contained beef broth and avian products. The MCB is contaminated with beef broth and avian products that cause human disease including bovine spongiform encephalopathy ("BSE"), commonly known as mad cow disease, which created an unreasonably dangerous risk of the development of BSE in patients to whom the Cethrin made from the contaminated MCB would be administered.
 
Case 0:12-cv-60739-RNS Document 1 Entered on FLSD Docket 04/26/2012 Page 3 of 15
 
JURISDICTION AND VENUE
 
28. At all times prior to October 16, 2008, MDS/RICERCA had actual or constructive knowledge that the kanamycin it purchased and used in the preparation of the MCB for BIOAXONE was contaminated and was not fit or intended for use in humans.
 
29. At all times prior to October 16,2008, MDS/RICERCA had actual or constructive knowledge that the purchase and use of contaminated kanamycin in the preparation of the MCB for BIOAXONE created an unreasonably dangerous and foreseeable risk of adventitious agents that cause human disease including the development of BSE or mad cow disease in humans.
 
Case 0:12-cv-60739-RNS Document 1 Entered on FLSD Docket 04/26/2012 Page 9 of 15
 
 
snip...see full text and more here ;'
 
 
Tuesday, September 24, 2013
 
*** NORDION (US), INC., AND BIOAXONE BIOSCIENCES, INC., Settles $90M Mad Cow TSE prion Contamination Suit Cethrin(R)
 
Case 0:12-cv-60739-RNS Document 1 Entered on FLSD Docket 04/26/2012 Page 1 of 15
 
 
 
with great sadness and disgust, I must inform you that our federal government has failed us again, and chose the industry over sound science, with regards to TSE prion disease, aka mad cow type disease...tss
 
 
Saturday, November 2, 2013
 
APHIS Finalizes Bovine Import Regulations in Line with International Animal Health Standards while enhancing the spread of BSE TSE prion mad cow type disease around the Globe
 
 
 
 
Tuesday, October 29, 2013
 
***Risk of Prion Disease Transmission through Bovine-Derived Bone Substitutes: A Systematic Review
 
 
 
Saturday, November 2, 2013
 
***APHIS Finalizes Bovine Import Regulations in Line with International Animal Health Standards while enhancing the spread of BSE TSE prion mad cow type disease around the Globe
 
 
 
Saturday, November 2, 2013
 
***Exploring the risks of a putative transmission of BSE to new species
 
 
 
Wednesday, October 30, 2013
 
***SPECIFIED RISK MATERIAL (SRM) CONTROL VERIFICATION TASK FSIS NOTICE 70-13 10/30/13
 
 
 
Monday, August 26, 2013
 
***The Presence of Disease-Associated Prion Protein in Skeletal Muscle of Cattle Infected with Classical Bovine Spongiform Encephalopathy
 
 
 
Saturday, November 2, 2013
 
*** Recommendation of the Swiss Expert Committee for Biosafety on the classification of activities using prion genes and prion protein January 2013 ***
 
 
 
Wednesday, October 09, 2013
 
*** WHY THE UKBSEnvCJD ONLY THEORY IS SO POPULAR IN IT'S FALLACY, £41,078,281 in compensation REVISED ***
 
 
 
Thursday, October 10, 2013
 
*** CJD REPORT 1994 increased risk for consumption of veal and venison and lamb ***
 
 
 
Monday, October 14, 2013
 
*** Researchers estimate one in 2,000 people in the UK carry variant CJD proteins ***
 
 
 
Friday, August 16, 2013
 
*** Creutzfeldt-Jakob disease (CJD) biannual update August 2013 U.K. and Contaminated blood products induce a highly atypical prion disease devoid of PrPres in primates
 
 
 
WHAT about the sporadic CJD TSE proteins ?
 
WE now know that some cases of sporadic CJD are linked to atypical BSE and atypical Scrapie, so why are not MORE concerned about the sporadic CJD, and all it’s sub-types $$$
 
 
Sunday, August 11, 2013
 
Creutzfeldt-Jakob Disease CJD cases rising North America updated report August 2013
 
 
*** Creutzfeldt-Jakob Disease CJD cases rising North America with Canada seeing an extreme increase of 48% between 2008 and 2010
 
 
 
 
Sunday, October 13, 2013
 
CJD TSE Prion Disease Cases in Texas by Year, 2003-2012
 
 
 
Tuesday, October 29, 2013
 
*** VARIANT CJD PRESENTS DIFFERENTLY IN OLDER PATIENTS
 
 
 
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