Wednesday, August 5, 2015

Federal judge enters permanent injunction against Wisconsin dietary supplement manufacturers prohibited cattle materials BSE TSE Prion

Federal judge enters permanent injunction against Wisconsin dietary supplement manufacturers prohibited cattle materials BSE TSE Prion
 
 
In addition, our review of your atri-zinc chelate plus, atri k-chelate, atri cu-chelate, atri-cal chelate, atri mag chelate plus, aller-cal, glan-male plus, glyco-b, pineal plus, atri-acidic, hypothalamus 50, and Nutripak CALCIUM CHELATE, Nutripak HYPOTHALAMUS 50 and Nutripak GLAND FEM products revealed that these products are adulterated within the meaning of section 402(a)(4), 21 U.S.C. § 342(a)(4), of the Act. These products are adulterated within the meaning of section 402(a)(4) because they are manufactured from, processed with, or otherwise contain material from cattle, but you have failed to establish and maintain records sufficient to demonstrate that they are not manufactured from, processed with, or do not otherwise contain prohibited cattle materials.
 
snip...
 
[1] Specified risk materials include the brain, skull, eyes, trigeminal ganglia, spinal cord, vertebral column (excluding the vertebrae of the tail, the transverse processes of the thoracic and lumbar vertebrae, and the wings of the sacrum), and dorsal root ganglia of cattle 30 months of age and older, and the tonsils and distal ileum of the small intestine of all cattle.
 
snip...
 
Recordkeeping Requirements for Human Food Containing Material from Cattle In addition, FDA reviewed the ingredients used in the following products you manufacture: atri-zinc chelate plus, atri k-chelate, atri cu-chelate, atri-cal chelate, atri mag chelate plus, aller-cal, glan-male plus, glyco-b, hypothalamus 50, pineal plus, atri-acidic, Nutripak CALCIUM CHELATE, Nutripak HYPOTHALAMUS 50, and Nutripak GLAND FEM. Based on the labeling for these products and information our investigator learned during the inspection, FDA has determined that these products are manufactured from, processed with, or otherwise contain material from cattle. Specifically: Your atri-zinc chelate plus product contains “Raw Brain Concentrate (Bovine)” and “Raw Pituitary Concentrate (Bovine);”
 
Your atri k-chelate product contains “Raw Brain Concentrate (Bovine)” and “Raw Pituitary Concentrate (Bovine);”
 
Your atri cu-chelate product contains “Raw Brain Concentrate (Bovine)” and “Raw Pituitary Concentrate (Bovine);”
 
Your atri-cal chelate product contains “Raw Brain Concentrate (Bovine)” and “Raw Pituitary Concentrate (Bovine);” Your atri mag chelate plus product contains “Raw Brain Concentrate (Bovine)” and “Raw Pituitary Concentrate (Bovine);”
 
Your aller-cal product contains “Raw Pituitary Concentrate (Bovine),” “Raw Adrenal Concentrate (Bovine),” and “Raw Parathyroid Concentrate (Bovine);”
 
Your glan-male plus product contains “Raw Adrenal Concentrate (Bovine)” and “Raw Pituitary Concentrate (Bovine);”
 
Your glyco-b product contains “Raw Brain Concentrate (Bovine),” “Raw Adrenal Concentrate (Bovine),” “Raw Liver Concentrate (Bovine),” and “Raw Pancreas Concentrate (Bovine);”
 
Your hypothalamus 50 product contains “Raw Hypothalamus Concentrate (Bovine);”
 
Your pineal plus product contains “Raw Whole Pituitary Concentrate (Bovine)” and “Raw Pineal Tissue Concentrate (Bovine);”
 
Your atri-acidic product contains “Raw Duodenum Concentrate (Bovine);”
 
Your Nutripak HYPOTHALAMUS 50 product contains “Raw Hypothalamus Concentrate (Bovine);”
 
Your Nutripak CALCIUM CHELATE product contains “Raw spleen concentrate (Bovine),” “Raw brain concentrate (Bovine),” “Raw liver concentrate (Bovine),” “Raw heart concentrate (Bovine),” “Raw Kidney Concentrate (Bovine),” “Raw Pancreas Concentrate (Bovine),” “Raw Duodenum Concentrate (Bovine),” “Raw Thymus Concentrate (Bovine),” “Raw Adrenal Concentrate (Bovine),” and “Raw Pituitary Concentrate (Bovine);”
 
Your Nutripak GLAND FEM product contains “Raw Adrenal Concentrate (Bovine),” “Raw Pituitary Concentrate (Bovine),” and “Raw Ovary Concentrate (Bovine).” Under 21 CFR 189.5(d)(1), these products that you manufacture are adulterated within the meaning of section 402(a)(4) of the Act, 21 U.S.C. § 342(a)(4), in that you have failed to establish and maintain records sufficient to demonstrate that they are not manufactured from, processed with, or do not otherwise contain prohibited cattle materials, as required by 21 CFR 189.5(c). Prohibited cattle material includes specified risk materials, small intestine of all cattle (unless the distal ileum portion of the small intestine has been removed as specified in FDA regulations), material from non-ambulatory disabled cattle, material from cattle not inspected and passed, or mechanically separated (beef). See 21 CFR 189.5(a)(1).[1] The recordkeeping requirement in 21 CFR 189.5(c) applies to human food, including dietary supplements. Furthermore, we note that under the dietary supplement CGMP regulations, for both cattle-derived and other animal-derived materials, you must comply with 21 CFR 111.70, which requires dietary supplement manufacturers to establish specifications for any point, step, or stage in the manufacturing process where control is necessary to ensure the quality of the dietary supplement. Thus, you must establish specifications for animal-derived materials that are necessary to ensure the quality of the dietary supplement. See 72 Federal Register 34752, 34839.
 
SNIP...END...TSS
 
 
FDA News Release
 
Federal judge enters permanent injunction against Wisconsin dietary supplement manufacturers Atrium Inc., Aspen Group Inc. and Nutri-Pak of Wisconsin Inc. failed to follow FDA regulations
 
For Immediate Release August 4, 2015
 
Release Three dietary supplement companies, under the same ownership and located in Wautoma, Wisconsin, will not be allowed to manufacture or sell dietary supplement products until FDA has determined that the businesses are in compliance with federal manufacturing regulations and other requirements, according to a federal court order signed Aug. 4, 2015.
 
U.S. District Judge William C. Griesbach for the Eastern District of Wisconsin entered a consent decree of permanent injunction against Atrium Inc., Aspen Group Inc., Nutri-Pak of Wisconsin Inc., and their owners, James F. and Roberta A. Sommers.
 
The complaint, filed by the U.S. Department of Justice, alleges that U.S. Food and Drug Administration inspections of Atrium, Aspen, and Nutri-Pak found numerous violations of the agency’s current Good Manufacturing Practice regulations, including failure to properly identify ingredients used in certain dietary supplements, failure to qualify suppliers and failure to properly manufacture and label dietary supplements. The complaint also alleges that these violations caused the companies’ dietary supplements to be misbranded and adulterated under the Federal Food, Drug, and Cosmetic Act.
 
Dietary supplements manufactured by the businesses include Atrium brands Chole-Sterin, Di-Acid Stim, Ocu-Comp, and Super-Flex; Aspen brand Flexile-Plus; and Nutri-Pak brands Glucobiotic Supreme and Ocu-Comp.
 
The FDA issued Atrium Inc. a Warning Letter on Nov. 2, 2012, citing the company for failure to follow the FDA’s current Good Manufacturing Practice regulations for dietary supplements. Follow-up inspections of Atrium, Aspen Group and Nutri-Pak of Wisconsin in 2013 and 2014 found continued violations.
 
“When companies violate good manufacturing practice requirements, they put consumers at risk,” said Melinda Plaisier, associate commissioner for the FDA’s Office of Regulatory Affairs. “Our goal at the FDA is to protect public health by ensuring that dietary supplements are manufactured, labeled and distributed in accordance with federal regulations.”
 
The consent decree requires the defendants to destroy all dietary supplements in their possession under supervision from the FDA. Before the companies can resume making or selling dietary supplements, they must hire an independent expert and defendants may not resume operations until they receive permission to do so from the FDA.
 
The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency is also responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.
 
###
 
 
 
 
Atrium Inc. 11/2/12 Department of Health and Human Services logoDepartment of Health and Human Services Public Health Service Food and Drug Administration Minneapolis District Office Central Region 250 Marquette Avenue, Suite 600 Minneapolis, MN 55401 Telephone: (612) 334-4100 FAX: (612) 334-4142
 
 
 
 November 2, 2012
 
WARNING LETTER CERTIFIED MAIL RETURN RECEIPT REQUSTED
 
Refer to MIN 13 – 06 James F. Sommers Owner and President Atrium, Inc. 440 S. Townline Road Wautoma, Wisconsin 54982-6922
 
Dear Mr. Sommers:
 
On January 10-11, 18 and 24, 2012, the U.S. Food and Drug Administration (FDA) conducted an inspection of your dietary supplement manufacturing plant located at 440 S. Townline Road, Wautoma, Wisconsin.
During the inspection we evaluated the manufacturing of the ASPEN CHOLE-STERIN, Eversco Kalmz, chole-sterin supreme Red Yeast Rice, adreno medulla plus, and chole-sterin supreme Phyto Sterol Red Yeast Rice products manufactured at your facility. Because you label these products as dietary supplements, we evaluated whether the products were prepared, packed, and held under conditions that comply with the Current Good Manufacturing Practice (CGMP) regulations for dietary supplements in Title 21, Code of Federal Regulations (21 CFR) Part 111. However, this letter should not be interpreted to mean that FDA agrees with your characterization of the products or their ingredients.
 
During the inspection, our investigator found a number of violations of the dietary supplement CGMP regulations. These violations cause the products manufactured at your facility to be adulterated within the meaning of section 402(g)(1) of the Federal Food, Drug, and Cosmetic Act (the Act), 21 U.S.C. § 342(g)(1), in that they have been prepared, packed, or held under conditions that do not meet the CGMP regulations for dietary supplements.
 
In addition, our review of your atri-zinc chelate plus, atri k-chelate, atri cu-chelate, atri-cal chelate, atri mag chelate plus, aller-cal, glan-male plus, glyco-b, pineal plus, atri-acidic, hypothalamus 50, and Nutripak CALCIUM CHELATE, Nutripak HYPOTHALAMUS 50 and Nutripak GLAND FEM products revealed that these products are adulterated within the meaning of section 402(a)(4), 21 U.S.C. § 342(a)(4), of the Act. These products are adulterated within the meaning of section 402(a)(4) because they are manufactured from, processed with, or otherwise contain material from cattle, but you have failed to establish and maintain records sufficient to demonstrate that they are not manufactured from, processed with, or do not otherwise contain prohibited cattle materials.
 
Furthermore, during our inspection, FDA also collected samples and labeling for several of your products, and we conducted a review of your websites www.atriuminc.com, www.nutripakonline.com, and www.aspennutrients.com in July 2012. Based on our review of your labeling and websites, we have determined that several of your products are promoted for conditions that cause the products to be drugs under section 201(g)(1)(B) of the Act, 21 U.S.C. § 321(g)(1)(B). The therapeutic claims on your labeling establish that these products are drugs because they are intended for use in the cure, mitigation, treatment, or prevention of disease. The marketing of your products with these claims violates the Act. You can find the Act and its implementing regulations through links on FDA’s home page at http://www.fda.gov.
 
We also note that we received your letter dated February 14, 2012, responding to the form FDA-483 Inspectional Observations (FDA-483) that we issued on January 24, 2012. We address your response below.
 
Dietary Supplement CGMP Violations
 
1. You failed to establish required specifications for points, steps, or stages in the manufacturing process where control is necessary to ensure the quality of the dietary supplement, as required by 21 CFR 111.70. Specifically:
 
You failed to establish component specifications for each component that you use in the manufacture of a dietary supplement, as required by 21 CFR 111.70(b). Our investigator observed that you have no such specifications.
 
You failed to establish product specifications for the identity, purity, strength, and composition for each dietary supplement product you manufacture, as required by 21 CFR 111.70(e). For example, you did not provide any finished product specifications for the following products:
 
o ASPEN CHOLE-STERIN, lot 0613
 
o chole-sterin supreme Phyto Sterol Red Yeast Rice - Yellow Label, lot 0964
 
o chole-sterin supreme Red Yeast Rice - White Label, lot 0965
 
o adreno medulla plus, lot 1566
 
In addition, we note that manufacturers are responsible for more than establishing specifications. Once you have established the specifications under 21 CFR 111.70, you must determine whether the specifications have been met, as required by 21 CFR 111.73.
 
Although your February 14, 2012, response to the FDA-483 addresses these violations, your response is inadequate. You state that you will address your failure to establish product specifications for each dietary supplement product you manufacture by instituting (b)(4) method for determining final product specifications by using (b)(4). However, you must prepare and follow a written master manufacturing record (MMR) for each unique formulation of a dietary supplement, and for each batch size, to ensure uniformity in the finished batch, from batch to batch; the MMR must establish controls and procedures to ensure that each batch of dietary supplement meets specifications to ensure that the finished dietary supplement consistently meets the established specifications for identity, purity, strength, and composition (see 21 CFR 111.205). Your proposed solution, however, will not ensure that you meet established specifications in the MMR to ensure the quality of the dietary supplement from batch to batch. You are describing a situation where you are changing your specifications based on (b)(4). As to your failure to establish specifications for each component, you state that you purchased a (b)(4) “with 21 CFR Part 111 technically compliant software suite.” The (b)(4) spectrometer is acceptable for determining the identity of a component; however, the various tests you propose will not determine what specification initially needs to be established for the component.
 
2. You failed to prepare a written MMR for each batch size of a dietary supplement that you manufacture, to ensure uniformity in the finished batch, from batch to batch, as required by 21 CFR 111.205(a). Specifically:
 
For batch record #1566 of adreno medulla plus, the MMR was for a (b)(4) tablet batch, but the operators made a (b)(4) tablet batch. No MMR exists for a (b)(4) tablet batch.
 
For batch #1279 of Eversco Kalmz, the MMR was for a (b)(4) capsule batch. The semi-auto capsule filling machine log shows batch #1279 made (b)(4) capsules on 9/8/11. When asked by our investigator how this was possible, we were told that your firm actually manufactured a batch larger than (b)(4) to fill a larger order. However, no MMR exists for a larger batch size.
 
Additionally, your MMRs for your adreno medulla plus, Eversco Kalmz, chole-sterin supreme Phyto Sterol Red Yeast Rice and chole-sterin supreme Red Yeast Rice failed to contain the following required information, as specified in 21 CFR 111.210. Specifically:
 
You must include a description of the packaging and a representative label, or a cross-reference to the physical location of the actual or representative label, 21 CFR 111.210(g). However, your MMRs failed to include this information.
 
You must include written instructions for specifications for each point, step, or stage in the manufacturing process where control is necessary to ensure the quality of the dietary supplement, 21 CFR 111.210(h)(1). However, your MMRs failed to include this information.
 
You must include written instructions for procedures for sampling and a cross-reference to procedures for tests or examinations, 21 CFR 111.210(h)(2). However, your MMRs failed to include this information.
 
You must include written instructions for specific actions necessary to perform and verify points, steps, or stages in the manufacturing process where control is necessary to ensure the quality of the dietary supplement, 21 CFR 111.210(h)(3). However, your MMRs failed to include this information.
 
You must include written instructions for corrective action plans for use when a specification is not met, 21 CFR 111.210(h)(5). However, your MMRs failed to include this information.
 
We acknowledge that your February 14, 2012, response to the FDA 483 addresses this violation, stating that MMRs are being written. This response is incomplete. You have not provided copies of your revised MMRs or a timeline for the completion of this corrective action. Without such documentation, we cannot verify whether you have, in fact, taken corrective action.
 
3. Your batch production records (BPRs) for your adreno medulla plus, Eversco Kalmz, chole-sterin supreme Phyto Sterol Red Yeast Rice and chole-sterin supreme Red Yeast Rice products failed to include required information relating to the production and control of each batch, as required by 21 CFR 111.255(b) and 21 CFR 111.260. Specifically: You must include the identity of equipment and processing lines used in producing the batch, 21 CFR 111.260(b). However, your BPRs failed to include this information.
 
You must include the date and time of the maintenance, cleaning, and sanitizing of the equipment and processing lines, or a cross-reference to records, such as individual equipment logs, where this information is retained, 21 CFR 111.260(c). However, your BPRs failed to include this information.
 
You must include the unique identifier that you assigned to each component. The lot number of capsules used is not recorded, 21 CFR 111.260(d). However, your BPRs failed to include this information.
 
You must include a statement of the actual yield, 21 CFR 111.260(f). However, your BPRs failed to include this information. You must include the actual results obtained during any monitoring operation, 21 CFR 111.260(g). For example, tablet press and encapsulator operators reported they perform weight checks every (b)(4) minutes during a production run. Results of this monitoring are not documented.
 
You must include documentation, at the time of performance, of the manufacture of the batch, including the initials of the person responsible for adding a component to the batch, 21 CFR 111.260(j)(2)(iii). However, your BPRs failed to include this information.
 
You must include documentation, at the time of performance, of packaging and labeling operations, including the unique identifier that you assigned to packaging used and the quantity of the labels used, 21 CFR 111.260(k)(1). However, your BPRs failed to include this information.
 
You must include documentation, at the time of performance, of an actual or representative label, or a cross-reference to the physical location of the actual or representative label specified in the MMR, 21 CFR 111.260(k)(2). However, your BPRs failed to include this information.
 
You must include documentation, at the time of performance, that quality control personnel reviewed the batch production record, 21 CFR 111.260(l)(1). However, your BPRs failed to include this information.
 
Although your February 14, 2012, response to the FDA-483 addressed this violation, your response is inadequate. You have not provided our office any copies of your revised BPRs or a timeline for the completion of this corrective action. By not including a means for us to verify the status of your corrective action plan, we cannot determine if it is being implemented.
 
4. You failed to establish and follow written procedures for the responsibilities of the quality control operations, including written procedures for conducting a material review and making a disposition decision, and for approving or rejecting any reprocessing, as required by 21 CFR 111.103. Specifically, you have no written procedures for quality control operations.
 
We acknowledge that your February 14, 2012, response to the FDA-483 addresses this violation, but we find it to be inadequate. You state in your response that “standard operating procedures [SOPs] will be written or modified for various QC operations” and “QC will be implemented in critical points throughout the manufacturing process including raw material incoming, formulation chart, weighing mixing records, compression or filling records, labeling and packing and final product release.” However, your proposed SOPs do not fulfill the requirements in Subpart F of the dietary supplement CGMP regulations. For instance, the SOPs do not include procedures for the visual examinations required in 21 CFR 111.155(a)-(b), or for quarantining of components, as required in 21 CFR 111.155(c).
 
5. You failed to examine, before labeling operations, your labels for each batch of dietary supplement to determine whether the labels conform to the MMR, as required by 21 CFR 111.410(c). Our investigator determined that you failed to conduct such examinations because several MMRs call for the use of rice powder, but the finished product labels failed to declare rice powder as an ingredient.
 
ASPEN CHOLE-STERIN, lot 0613
 
chole-sterin supreme Phyto Sterol Red Yeast Rice - Yellow Label, lot 0964
 
chole-sterin supreme Red Yeast Rice - White Label, lot 0965
 
Although your February 14, 2012, response to the FDA-483 addresses this violation, providing that you are in the process of replacing all labels, this response is incomplete. You have not provided our office with copies of your revised or proposed labels declaring rice powder as an ingredient. We are therefore unable to verify whether you have taken the necessary corrective action. We will verify the steps you have outlined in your action plan at our next scheduled inspection.
 
6. You failed to establish written procedures, as required by 21 CFR 111.553, to fulfill the requirements of 21 CFR 111.560 concerning the review and investigation of product complaints. Specifically, your firm verbally confirmed to our investigator that you do not have written procedures to address product complaints.
 
Your February 14, 2012, response to the FDA-483 addresses this violation but is not adequate. Your response states the following: “Upon receiving a customer complain[t] concerning a product, a faxable form is sent to the customer to be filled out or it can be filled out over the phone. Once the product of concern has been identified, a sample of the product is sent to Master Formulator (b)(6) and a call tag is placed on the product. (b)(6) diagnoses the problem and makes a disposition. In all cases, a new product is then sent to the customer from a different lot of the same product.” This response fails to address the procedures you will take to investigate product complaints.
 
Recordkeeping Requirements for Human Food Containing Material from Cattle
 
In addition, FDA reviewed the ingredients used in the following products you manufacture: atri-zinc chelate plus, atri k-chelate, atri cu-chelate, atri-cal chelate, atri mag chelate plus, aller-cal, glan-male plus, glyco-b, hypothalamus 50, pineal plus, atri-acidic, Nutripak CALCIUM CHELATE, Nutripak HYPOTHALAMUS 50, and Nutripak GLAND FEM. Based on the labeling for these products and information our investigator learned during the inspection, FDA has determined that these products are manufactured from, processed with, or otherwise contain material from cattle. Specifically:
 
Your atri-zinc chelate plus product contains “Raw Brain Concentrate (Bovine)” and “Raw Pituitary Concentrate (Bovine);”
 
Your atri k-chelate product contains “Raw Brain Concentrate (Bovine)” and “Raw Pituitary Concentrate (Bovine);”
 
Your atri cu-chelate product contains “Raw Brain Concentrate (Bovine)” and “Raw Pituitary Concentrate (Bovine);”
 
Your atri-cal chelate product contains “Raw Brain Concentrate (Bovine)” and “Raw Pituitary Concentrate (Bovine);”
 
Your atri mag chelate plus product contains “Raw Brain Concentrate (Bovine)” and “Raw Pituitary Concentrate (Bovine);”
 
Your aller-cal product contains “Raw Pituitary Concentrate (Bovine),” “Raw Adrenal Concentrate (Bovine),” and “Raw Parathyroid Concentrate (Bovine);”
 
Your glan-male plus product contains “Raw Adrenal Concentrate (Bovine)” and “Raw Pituitary Concentrate (Bovine);”
 
Your glyco-b product contains “Raw Brain Concentrate (Bovine),” “Raw Adrenal Concentrate (Bovine),” “Raw Liver Concentrate (Bovine),” and “Raw Pancreas Concentrate (Bovine);”
 
Your hypothalamus 50 product contains “Raw Hypothalamus Concentrate (Bovine);”
 
Your pineal plus product contains “Raw Whole Pituitary Concentrate (Bovine)” and “Raw Pineal Tissue Concentrate (Bovine);”
 
Your atri-acidic product contains “Raw Duodenum Concentrate (Bovine);”
 
Your Nutripak HYPOTHALAMUS 50 product contains “Raw Hypothalamus Concentrate (Bovine);”
 
Your Nutripak CALCIUM CHELATE product contains “Raw spleen concentrate (Bovine),” “Raw brain concentrate (Bovine),” “Raw liver concentrate (Bovine),” “Raw heart concentrate (Bovine),” “Raw Kidney Concentrate (Bovine),” “Raw Pancreas Concentrate (Bovine),” “Raw Duodenum Concentrate (Bovine),” “Raw Thymus Concentrate (Bovine),” “Raw Adrenal Concentrate (Bovine),” and “Raw Pituitary Concentrate (Bovine);”
 
Your Nutripak GLAND FEM product contains “Raw Adrenal Concentrate (Bovine),” “Raw Pituitary Concentrate (Bovine),” and “Raw Ovary Concentrate (Bovine).”
 
Under 21 CFR 189.5(d)(1), these products that you manufacture are adulterated within the meaning of section 402(a)(4) of the Act, 21 U.S.C. § 342(a)(4), in that you have failed to establish and maintain records sufficient to demonstrate that they are not manufactured from, processed with, or do not otherwise contain prohibited cattle materials, as required by 21 CFR 189.5(c). Prohibited cattle material includes specified risk materials, small intestine of all cattle (unless the distal ileum portion of the small intestine has been removed as specified in FDA regulations), material from non-ambulatory disabled cattle, material from cattle not inspected and passed, or mechanically separated (beef). See 21 CFR 189.5(a)(1).[1] The recordkeeping requirement in 21 CFR 189.5(c) applies to human food, including dietary supplements.
 
Furthermore, we note that under the dietary supplement CGMP regulations, for both cattle-derived and other animal-derived materials, you must comply with 21 CFR 111.70, which requires dietary supplement manufacturers to establish specifications for any point, step, or stage in the manufacturing process where control is necessary to ensure the quality of the dietary supplement. Thus, you must establish specifications for animal-derived materials that are necessary to ensure the quality of the dietary supplement. See 72 Federal Register 34752, 34839.
 
Unapproved New Drugs
 
During the inspection at your facility, our investigators collected labels associated with many of your products. Based on our review of your product labels and review of your websites www.atriuminc.com, www.nutripakonline.com and www.aspennutrients.com, in July 2012, we have determined that the products ASPEN CHOLE-STERIN, resveratrol supreme, atri-probiotic supreme, Parasit-X, Glucobetic and ASPEN CALCIUM with Red Yeast Rice are promoted for conditions that cause them to be drugs within the meaning of section 201(g)(1)(B) of the Act, 21 U.S.C. § 321(g)(1)(B). The therapeutic claims on your labels establish that these products are drugs because they are intended for use in the cure, mitigation, treatment, or prevention of disease. The marketing of these dietary supplement products with these claims violates the Act.
 
Examples of some of the claims observed on your product labeling include: ASPEN CHOLE-STERIN (60 capsules):
 
“MAY LOWER LDL CHOLESTEROL”
 
“MAY IMPROVE HDL/LDL RATIO”
 
“NATURAL CHOLESTEROL BLOCKER”
 
resveratrol supreme (100 Capsules)
“[T]hat also can help with cholesterol and anti-cancer.”
 
atri-probiotic supreme (60 Capsules)
“Use as aid…under conditions of digestive disorders & following antibiotic therapy”
 
Parasit-X (90 Capsules)
“Each capsule contains a botanical formaul [sic] to help with cleansing of parasites.”
 
“For routine semi-annual parasite prevention….”
 
 Glucobetic (90 Capsules)
“[T]o normalize elevated blodd [sic] sugar levels.”
 
In addition, the label for your product Aspen CALCIUM with Red Yeast Rice states that “RED YEAST RICE has 0.4% Lovastatin.” Lovastatin is the active pharmaceutical ingredient in (b)(4) and its generic counterparts, which are FDA-approved drugs used to treat patients with primary hypercholesterolemia. Traditional red yeast rice does not contain more than trace amounts of lovastatin, if any. Since Lovastatin’s approval as a new drug preceded its marketing as a food or dietary supplement, your Aspen CALCIUM with Red Yeast Rice product is disqualified from the dietary supplement definition.
 
Consequently, your products are not generally recognized as safe and effective for the above referenced uses and, therefore, the products are “new drugs” under section 201(p) of the Act, 21 U.S.C. § 321(p). New drugs may not be legally marketed in the U.S. without prior approval from FDA as described in section 505(a) of the Act, 21 U.S.C. § 355(a). FDA approves a new drug on the basis of scientific data submitted by a drug sponsor to demonstrate that the drug is safe and effective.
 
The above violations are not intended to be an all-inclusive list of violations at your facility or deficiencies in your products or their labeling. It is your responsibility to ensure that all the products you manufacture or distribute meet all of the requirements of the Act and its implementing regulations. You should take prompt action to correct the above violations. If you do not promptly correct them, you may be subject to regulatory action without further notice, such as seizure and/or injunction.
 
Please be advised a description of the new drug approval process can be found on FDA’s internet website at http://www.fda.gov/cder/regulatory/applications/default.htm. Any questions you may have regarding this process should be directed to the Food and Drug Administration, Division of Drug Information (HFD-240), Center for Drug Evaluation and Research, 5600 Fishers Lane, Rockville, Maryland 20857.
 
Section 743 of the Act, 21 U.S.C. § 379j-31, authorizes FDA to assess and collect fees to cover FDA’s costs for certain activities, including re-inspection-related costs. A re-inspection is one or more inspections conducted subsequent to an inspection that identified non-compliance materially related to a food safety requirement of the Act, specifically to determine whether compliance has been achieved. Re-inspection-related costs means all expenses, including administrative expenses, incurred in connection with FDA’s arranging, conducting, and evaluating the results of the re-inspection and assessing and collecting the re-inspection fees, 21 U.S.C. § 379j-31(a)(2)(B). For a domestic facility, FDA will assess and collect fees for re-inspection-related costs from the responsible party for the domestic facility. The inspection noted in this letter identified non-compliance materially related to a food safety requirement of the Act. Accordingly, FDA may assess fees to cover any re-inspection-related costs.
 
You should notify this office in writing within 15 working days of receipt of this letter as to the steps that you have taken to correct the above-listed violations and to assure that similar violations will not recur. If corrective action cannot be completed within 15 working days, please state the reason for the delay and the time within which the corrections will be completed. Furthermore, please advise this office what actions you will take to address product that you have already distributed.
 
Please send your reply to the Food and Drug Administration, Attention: Tyra S. Wisecup, Compliance Officer, at the address on the letterhead. If you have questions regarding any issues in this letter, please contact Ms. Wisecup at (612) 758-7114. Sincerely, /S/ Michael Dutcher, DVM Director Minneapolis District
 
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[1] Specified risk materials include the brain, skull, eyes, trigeminal ganglia, spinal cord, vertebral column (excluding the vertebrae of the tail, the transverse processes of the thoracic and lumbar vertebrae, and the wings of the sacrum), and dorsal root ganglia of cattle 30 months of age and older, and the tonsils and distal ileum of the small intestine of all cattle. - Page Last Updated: 11/15/2012
 
 
 
 
 
I made a submission to the BSE Inquiry long ago during the BSE Inquiry days, and they seemed pretty interested. see on down ;
 
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...
 
snip...end...tss
 
everyone I tell this too gets it screwed up...MY MOTHER WAS NOT TAKING THOSE SUPPLEMENTS IPLEX (that I ever knew of). this was my neighbors mother that died exactly one year _previously_ and to the day of sporadic CJD that was diagnosed as Alzheimer’s at first. my mother died exactly a year later from the Heidenhain Variant of Creutzfeldt Jakob Disease hvCJD, and exceedingly rare strains of the ever growing sporadic CJD’s. _both_ cases confirmed. ...kind regards, terry
 
TSEs i.e. mad cow disease's BSE/BASE and NUTRITIONAL SUPPLEMENTS
 
IPLEX, mad by standard process;
 
vacuum dried bovine BRAIN, bone meal, bovine EYE, veal Bone, bovine liver powder, bovine adrenal, vacuum dried bovine kidney, and vacuum dried porcine stomach.
 
also;
 
what about potential mad cow candy bars ?
 
see their potential mad cow candy bar list too...
 
THESE are just a few of MANY of just this ONE COMPANY...TSS
 
DEPARTMENT OF HEALTH AND HUMAN SERVICES
 
FOOD AND DRUG ADMINISTRATION CENTER FOR BIOLOGICS EVALUATION AND RESEARCH
 
TRANSMISSIBLE SPONGIFORM ENCEPHALOPATHIES ADVISORY COMMITTEE
 
Friday, January 19, 2001 snip...
 
17 But I think that we could exhibit some quite
 
18 reasonable concern about blood donors who are taking dietary
 
19 supplements that contain a certain amount of unspecified-
 
20 origin brain, brain-related, brain and pituitary material.
 
21 If they have done this for more than a sniff or something
 
22 like that, then, perhaps, they should be deferred as blood
 
23 donors.
 
24 That is probably worse than spending six months in
 
25 the U.K.
 
1/19/01
 
3681t2.rtf(845) page 501
 
 
Docket Management Docket: 96N-0417 - Current Good Manufacturing Practice in Manufacturing, Packing, or Holding Dietary Ingredients a Comment Number: EC -2 Accepted - Volume 7
 
 
 
see full text ;
 
 
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 ================
 
my plight with Metabolife, the GAO et al, and my submission to the BSE inquiry, about mad cow in a pill ;
 
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
 
 
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...
 
===============================
 
-------- 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. ...
 
 
 
 
Sunday, November 10, 2013
 
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 $
 
 
PRION 2015 ORAL AND POSTER CONGRESSIONAL ABSTRACTS
 
THANK YOU PRION 2015 TAYLOR & FRANCIS, Professor Chernoff, and Professor Aguzzi et al, for making these PRION 2015 Congressional Poster and Oral Abstracts available freely to the public. ...Terry S. Singeltary Sr.
 
O.05: Transmission of prions to primates after extended silent incubation periods: Implications for BSE and scrapie risk assessment in human populations
 
Emmanuel Comoy, Jacqueline Mikol, Val erie Durand, Sophie Luccantoni, Evelyne Correia, Nathalie Lescoutra, Capucine Dehen, and Jean-Philippe Deslys Atomic Energy Commission; Fontenay-aux-Roses, France
 
Prion diseases (PD) are the unique neurodegenerative proteinopathies reputed to be transmissible under field conditions since decades. The transmission of Bovine Spongiform Encephalopathy (BSE) to humans evidenced that an animal PD might be zoonotic under appropriate conditions. Contrarily, in the absence of obvious (epidemiological or experimental) elements supporting a transmission or genetic predispositions, PD, like the other proteinopathies, are reputed to occur spontaneously (atpical animal prion strains, sporadic CJD summing 80% of human prion cases). Non-human primate models provided the first evidences supporting the transmissibiity of human prion strains and the zoonotic potential of BSE. Among them, cynomolgus macaques brought major information for BSE risk assessment for human health (Chen, 2014), according to their phylogenetic proximity to humans and extended lifetime. We used this model to assess the zoonotic potential of other animal PD from bovine, ovine and cervid origins even after very long silent incubation periods. We recently observed the direct transmission of a natural classical scrapie isolate to macaque after a 10-year silent incubation period, with features similar to some reported for human cases of sporadic CJD, albeit requiring fourfold longe incubation than BSE. Scrapie, as recently evoked in humanized mice (Cassard, 2014), is the third potentially zoonotic PD (with BSE and L-type BSE), ***thus questioning the origin of human sporadic cases. We will present an updated panorama of our different transmission studies and discuss the implications of such extended incubation periods on risk assessment of animal PD for human health.
 
===============
 
***thus questioning the origin of human sporadic cases...TSS
 
===============
 
O.08: H-type bovine spongiform encephalopathy associated with E211K prion protein polymorphism: Clinical and pathologic features in wild-type and E211K cattle following intracranial inoculation
 
S Jo Moore, M Heather West Greenlee, Jodi Smith, Eric Nicholson, Cathy Vrentas, and Justin Greenlee United States Department of Agriculture; Ames, IA USA
 
In 2006 an H-type bovine spongiform encephalopathy (BSE) case was reported in an animal with an unusual polymorphism (E211K) in the prion protein gene. Although the prevalence of this polymorphism is low, cattle carrying the K211 allele are predisposed to rapid onset of H-type BSE when exposed. The purpose of this study was to investigate the phenotype of this BSE strain in wild-type (E211E) and E211K heterozygous cattle. One calf carrying the wild-type allele and one E211K calf were inoculated intracranially with H-type BSE brain homogenate from the US 2006 case that also carried one K211 allelle. In addition, one wild-type calf and one E211K calf were inoculated intracranially with brain homogenate from a US 2003 classical BSE case. All animals succumbed to clinical disease. Survival times for E211K H-type BSE inoculated catttle (10 and 18 months) were shorter than the classical BSE inoculated cattle (both 26 months). Significant changes in retinal function were observed in H-type BSE challenged cattle only. Animals challenged with the same inoculum showed similar severity and neuroanatomical distribution of vacuolation and disease-associated prion protein deposition in the brain, though differences in neuropathology were observed between E211K H-type BSE and classical BSE inoculated animals. Western blot results for brain tissue from challenged animals were consistent with the inoculum strains. ***This study demonstrates that the phenotype of E211K H-type BSE remains stable when transmitted to cattle without the E211K polymorphism, and exhibits a number of features that differ from classical BSE in both wild-type and E211K cattle.
 
==============
 
***This study demonstrates that the phenotype of E211K H-type BSE remains stable when transmitted to cattle without the E211K polymorphism, and exhibits a number of features that differ from classical BSE in both wild-type and E211K cattle.***
 
PLEASE SEE ;
 
Wednesday, May 27, 2015
 
BSE Case Associated with Prion Protein Gene Mutation
 
 
==============
 
P.108: Successful oral challenge of adult cattle with classical BSE
 
Sandor Dudas1,*, Kristina Santiago-Mateo1, Tammy Pickles1, Catherine Graham2, and Stefanie Czub1 1Canadian Food Inspection Agency; NCAD Lethbridge; Lethbridge, Alberta, Canada; 2Nova Scotia Department of Agriculture; Pathology Laboratory; Truro, Nova Scotia, Canada
 
Classical Bovine spongiform encephalopathy (C-type BSE) is a feed- and food-borne fatal neurological disease which can be orally transmitted to cattle and humans. Due to the presence of contaminated milk replacer, it is generally assumed that cattle become infected early in life as calves and then succumb to disease as adults.
 
Here we challenged three 14 months old cattle per-orally with 100 grams of C-type BSE brain to investigate age-related susceptibility or resistance. During incubation, the animals were sampled monthly for blood and feces and subjected to standardized testing to identify changes related to neurological disease.
 
At 53 months post exposure, progressive signs of central nervous system disease were observed in these 3 animals, and they were euthanized. Two of the C-BSE animals tested strongly positive using standard BSE rapid tests, however in 1 C-type challenged animal, Prion 2015 Poster Abstracts S67 PrPsc was not detected using rapid tests for BSE. Subsequent testing resulted in the detection of pathologic lesion in unusual brain location and PrPsc detection by PMCA only.
 
Our study demonstrates susceptibility of adult cattle to oral transmission of classical BSE. We are further examining explanations for the unusual disease presentation in the third challenged animal.
 
========================
 
***Our study demonstrates susceptibility of adult cattle to oral transmission of classical BSE. ***
 
P.86: Estimating the risk of transmission of BSE and scrapie to ruminants and humans by protein misfolding cyclic amplification
 
Morikazu Imamura, Naoko Tabeta, Yoshifumi Iwamaru, and Yuichi Murayama National Institute of Animal Health; Tsukuba, Japan
 
To assess the risk of the transmission of ruminant prions to ruminants and humans at the molecular level, we investigated the ability of abnormal prion protein (PrPSc) of typical and atypical BSEs (L-type and H-type) and typical scrapie to convert normal prion protein (PrPC) from bovine, ovine, and human to proteinase K-resistant PrPSc-like form (PrPres) using serial protein misfolding cyclic amplification (PMCA).
 
Six rounds of serial PMCA was performed using 10% brain homogenates from transgenic mice expressing bovine, ovine or human PrPC in combination with PrPSc seed from typical and atypical BSE- or typical scrapie-infected brain homogenates from native host species. In the conventional PMCA, the conversion of PrPC to PrPres was observed only when the species of PrPC source and PrPSc seed matched. However, in the PMCA with supplements (digitonin, synthetic polyA and heparin), both bovine and ovine PrPC were converted by PrPSc from all tested prion strains. On the other hand, human PrPC was converted by PrPSc from typical and H-type BSE in this PMCA condition.
 
Although these results were not compatible with the previous reports describing the lack of transmissibility of H-type BSE to ovine and human transgenic mice, ***our findings suggest that possible transmission risk of H-type BSE to sheep and human. Bioassay will be required to determine whether the PMCA products are infectious to these animals.
 
================
 
***our findings suggest that possible transmission risk of H-type BSE to sheep and human. ***
 
ALSO, PLEASE SEE ;
 
31 Jan 2015 at 20:14 GMT
 
*** Ruminant feed ban for cervids in the United States? ***
 
31 Jan 2015 at 20:14 GMT
 
 
 
Saturday, May 30, 2015
 
PRION 2015 ORAL AND POSTER CONGRESSIONAL ABSTRACTS
 
 
 
Wednesday, June 10, 2015
 
Zoonotic Potential of CWD Prions
 
LATE-BREAKING ABSTRACTS
 
PRION 2015 CONFERENCE FT. COLLINS CWD RISK FACTORS TO HUMANS
 
*** LATE-BREAKING ABSTRACTS PRION 2015 CONFERENCE ***
 
O18
 
Zoonotic Potential of CWD Prions
 
Liuting Qing1, Ignazio Cali1,2, Jue Yuan1, Shenghai Huang3, Diane Kofskey1, Pierluigi Gambetti1, Wenquan Zou1, Qingzhong Kong1 1Case Western Reserve University, Cleveland, Ohio, USA, 2Second University of Naples, Naples, Italy, 3Encore Health Resources, Houston, Texas, USA
 
Chronic wasting disease (CWD) is a widespread and expanding prion disease in free-ranging and captive cervid species in North America. The zoonotic potential of CWD prions is a serious public health concern. Current literature generated with in vitro methods and in vivo animal models (transgenic mice, macaques and squirrel monkeys) reports conflicting results. The susceptibility of human CNS and peripheral organs to CWD prions remains largely unresolved. In our earlier bioassay experiments using several humanized transgenic mouse lines, we detected protease-resistant PrPSc in the spleen of two out of 140 mice that were intracerebrally inoculated with natural CWD isolates, but PrPSc was not detected in the brain of the same mice. Secondary passages with such PrPSc-positive CWD-inoculated humanized mouse spleen tissues led to efficient prion transmission with clear clinical and pathological signs in both humanized and cervidized transgenic mice. Furthermore, a recent bioassay with natural CWD isolates in a new humanized transgenic mouse line led to clinical prion infection in 2 out of 20 mice. These results indicate that the CWD prion has the potential to infect human CNS and peripheral lymphoid tissues and that there might be asymptomatic human carriers of CWD infection.
 
==================
 
***These results indicate that the CWD prion has the potential to infect human CNS and peripheral lymphoid tissues and that there might be asymptomatic human carriers of CWD infection.***
 
==================
 
P.105: RT-QuIC models trans-species prion transmission
 
Kristen Davenport, Davin Henderson, Candace Mathiason, and Edward Hoover Prion Research Center; Colorado State University; Fort Collins, CO USA
 
The propensity for trans-species prion transmission is related to the structural characteristics of the enciphering and heterologous PrP, but the exact mechanism remains mostly mysterious. Studies of the effects of primary or tertiary prion protein structures on trans-species prion transmission have relied primarily upon animal bioassays, making the influence of prion protein structure vs. host co-factors (e.g. cellular constituents, trafficking, and innate immune interactions) difficult to dissect. As an alternative strategy, we used real-time quakinginduced conversion (RT-QuIC) to investigate trans-species prion conversion.
 
To assess trans-species conversion in the RT-QuIC system, we compared chronic wasting disease (CWD) and bovine spongiform encephalopathy (BSE) prions, as well as feline CWD (fCWD) and feline spongiform encephalopathy (FSE). Each prion was seeded into each host recombinant PrP (full-length rPrP of white-tailed deer, bovine or feline). We demonstrated that fCWD is a more efficient seed for feline rPrP than for white-tailed deer rPrP, which suggests adaptation to the new host.
 
Conversely, FSE maintained sufficient BSE characteristics to more efficiently convert bovine rPrP than feline rPrP. Additionally, human rPrP was competent for conversion by CWD and fCWD. ***This insinuates that, at the level of protein:protein interactions, the barrier preventing transmission of CWD to humans is less robust than previously estimated.
 
================
 
***This insinuates that, at the level of protein:protein interactions, the barrier preventing transmission of CWD to humans is less robust than previously estimated.***
 
================
 
 
 
From: Terry S. Singeltary Sr.
 
Sent: Saturday, November 15, 2014 9:29 PM
 
To: Terry S. Singeltary Sr.
 
Subject: THE EPIDEMIOLOGY OF CREUTZFELDT-JAKOB DISEASE R. G. WILL 1984
 
THE EPIDEMIOLOGY OF CREUTZFELDT-JAKOB DISEASE
 
R. G. WILL
 
1984
 
*** The association between venison eating and risk of CJD shows similar pattern, with regular venison eating associated with a 9 FOLD INCREASE IN RISK OF CJD (p = 0.04). (SEE LINK IN REPORT HERE...TSS) PLUS, THE CDC DID NOT PUT THIS WARNING OUT FOR THE WELL BEING OF THE DEER AND ELK ;
 
snip...
 
 
Evidence That Transmissible Mink Encephalopathy Results from Feeding Infected Cattle
 
Over the next 8-10 weeks, approximately 40% of all the adult mink on the farm died from TME.
 
snip...
 
The rancher was a ''dead stock'' feeder using mostly (>95%) downer or dead dairy cattle...
 
 
In Confidence - Perceptions of unconventional slow virus diseases of animals in the USA - APRIL-MAY 1989 - G A H Wells
 
3. Prof. A. Robertson gave a brief account of BSE. The US approach was to accord it a very low profile indeed. Dr. A Thiermann showed the picture in the ''Independent'' with cattle being incinerated and thought this was a fanatical incident to be avoided in the US at all costs. ...
 
 
human cwd will NOT look like nvCJD. in fact, see ;
 
*** These results would seem to suggest that CWD does indeed have zoonotic potential, at least as judged by the compatibility of CWD prions and their human PrPC target. Furthermore, extrapolation from this simple in vitro assay suggests that if zoonotic CWD occurred, it would most likely effect those of the PRNP codon 129-MM genotype and that the PrPres type would be similar to that found in the most common subtype of sCJD (MM1).***
 
 
Sunday, June 14, 2015
 
Larry’s Custom Meats Inc. Recalls Beef Tongue Products That May Contain Specified Risk Materials BSE TSE Prion
 
 
Saturday, March 21, 2015
 
***Canada and United States Creutzfeldt Jakob TSE Prion Disease Incidence Rates Increasing
 
 
*** HUMAN MAD COW DISEASE nvCJD TEXAS CASE NOT LINKED TO EUROPEAN TRAVEL CDC ***
 
Sunday, November 23, 2014
 
*** Confirmed Variant Creutzfeldt-Jakob Disease (variant CJD) Case in Texas in June 2014 confirmed as USA case NOT European
 
the patient had resided in Kuwait, Russia and Lebanon. The completed investigation did not support the patient's having had extended travel to European countries, including the United Kingdom, or travel to Saudi Arabia. The specific overseas country where this patient’s infection occurred is less clear largely because the investigation did not definitely link him to a country where other known vCJD cases likely had been infected.
 
 
see more here ;
 
 
Thursday, January 15, 2015
 
41-year-old Navy Commander with sporadic Creutzfeldt–Jakob disease CJD TSE Prion: Case Report
 
 
Subject: *** Becky Lockhart 46, Utah’s first female House speaker, dies diagnosed with the extremely rare Creutzfeldt-Jakob disease aka mad cow type disease
 
what is CJD ? just ask USDA inc., and the OIE, they are still feeding the public and the media industry fed junk science that is 30 years old.
 
why doesn’t some of you try reading the facts, instead of rubber stamping everything the USDA inc says.
 
sporadic CJD has now been linked to BSE aka mad cow disease, Scrapie, and there is much concern now for CWD and risk factor for humans.
 
My sincere condolences to the family and friends of the House Speaker Becky Lockhart. I am deeply saddened hear this.
 
with that said, with great respect, I must ask each and every one of you Politicians that are so deeply saddened to hear of this needless death of the Honorable House Speaker Becky Lockhart, really, cry me a friggen river. I am seriously going to ask you all this...I have been diplomatic for about 17 years and it has got no where. people are still dying. so, are you all stupid or what??? how many more need to die ??? how much is global trade of beef and other meat products that are not tested for the TSE prion disease, how much and how many bodies is this market worth?
 
Saturday, January 17, 2015
 
*** Becky Lockhart 46, Utah’s first female House speaker, dies diagnosed with the extremely rare Creutzfeldt-Jakob disease
 
 
*** ALERT new variant Creutzfeldt Jakob Disease nvCJD or vCJD, sporadic CJD strains, TSE prion aka Mad Cow Disease United States of America Update December 14, 2014 Report ***
 
 
Tuesday, April 21, 2015
 
*** Transmissible Spongiform Encephalopathy Advisory Committee TSEAC MEETING SCHEDULED FOR June 1, 2015 ***
 
 
 
Sunday, August 02, 2015
 
*** TEXAS CWD, Have you been ThunderStruck, deer semen, straw bred bucks, super ovulation, and the potential TSE Prion connection, what if? ***
 
 
 
2015 FDA UPDATE BSE
 
Tuesday, August 4, 2015
 
*** FDA U.S. Measures to Protect Against BSE ***
 
 

 

Terry S. Singeltary Sr.

 

 

 

Wednesday, August 5, 2015

 

Federal judge enters permanent injunction against Wisconsin dietary supplement manufacturers prohibited cattle materials BSE TSE Prion

 

Singeltary Submission to BSE Inquiry on Nutritional Supplements containing SRM 1998

 


 

 
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