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consumer alert: Illinois Firm Recalls Beef Products Due To Possible E. coli O157:H7 Contamination

                                                                                                      

Recall Release	CLASS I RECALL
FSIS-RC-016-2008	HEALTH RISK: HIGH

            Congressional and Public Affairs
            (202) 720-9113
            Peggy Riek

WASHINGTON, May 16, 2008 - JSM Meat Holdings Company, Inc., a Chicago, Ill., firm, is voluntarily recalling an undetermined amount of beef products intended for use in ground products because they may be contaminated with E. coli O157:H7, the U.S. Department of Agriculture's Food Safety and Inspection Service announced today.          

  The following products are subject to recall:

• 30-, 60- pound boxes, combo boxes or 47-gallon barrels of "MORREALE MEAT" beef products labeled as "Boneless Chucks," "Boneless Clods," "Flat Rounds," "Gooseneck Rounds," "Knuckle," "Heel Meat," "Scotties," "Trimmings 50," "Trimmings 60," "Trimmings 65," "Trimmings 70," "Trimmings 75," "Trimmings 80," "Trimmings 85," or "Trimmings 90."

	Preparing Ground Beef For Safe Consumption USDA Meat and Poultry Hotline 1-888-MPHOTLINE or visit www.fsis.usda.gov Although these products are not available at retail establishments, consumers preparing ground beef products should heed the following advice. Wash hands with warm, soapy water for at least 20 seconds before and after handling raw meat and poultry. Wash cutting boards, dishes and utensils with hot, soapy water. Immediately clean spills. Keep raw meat, fish and poultry away from other food that will not be cooked. Use separate cutting boards for raw meat, poultry and egg products and cooked foods. Consumers should only eat ground beef or ground beef patties that have been cooked to a safe internal temperature of 160°F.  Color is NOT a reliable indicator that ground beef or ground beef patties have been cooked to a temperature high enough to kill harmful bacteria such as E. coli O157:H7. The only way to be sure ground beef is cooked to a high enough temperature to kill harmful bacteria is to use a thermometer to measure the internal temperature. Refrigerate raw meat and poultry within two hours after purchase or one hour if temperatures exceed 90°F. Refrigerate cooked meat and poultry within two hours after cooking.

The beef products bear the establishment number "EST. 6872" inside the USDA mark of inspection.  These beef products were distributed to establishments for further processing in Florida, Georgia, Illinois, Indiana, Iowa, Massachusetts, Michigan, Missouri, Nebraska, Pennsylvania, and Wisconsin.

The problem was discovered by FSIS.  FSIS has received no reports of illnesses associated with consumption of this product.  Anyone with signs or symptoms of foodborne illness should consult a medical professional.

E. coli O157:H7 is a potentially deadly bacteria that can cause bloody diarrhea, dehydration, and in the most severe cases, kidney failure. The very young, seniors and persons with weak immune systems are the most susceptible to foodborne illness.

Media and consumers with questions about the recall should contact company President Steve Hurckes, Sr. at (312) 421-3664, ext. 214.

Consumers with food safety questions can "Ask Karen," the FSIS virtual representative available 24 hours a day at AskKaren.gov.  The toll-free USDA Meat and Poultry Hotline 1-888-MPHotline (1-888-674-6854) is available in English and Spanish and can be reached from l0 a.m. to 4 p.m. (Eastern Time) Monday through Friday.  Recorded food safety messages are available 24 hours a day.

FDA Takes Action against Cream Cheese Companies, Executives

Media release May 16, 2008
Repeated federal violations and failure to correct drove action

The U.S. Food and Drug Administration today announced the shut down of cream cheese and seafood operations at Lifeway Foods, Inc. and its subsidiary, LFI Enterprises, Inc., both Illinois companies, until they are found compliant with food-safety laws. A consent decree of permanent injunction, signed by both corporations and two of their top executives, Julie and Edward Smolyansky (the defendants), halts cream cheese and seafood processing in facilities in Skokie, Ill., and Philadelphia, Pa.

The FDA's enforcement action follows the defendants' extensive history of violations of the Federal Food, Drug, and Cosmetic Act dating back to at least 2004. The complaint, filed by the U.S. Department of Justice, alleges that the defendants:

• Labeled and distributed cream cheese products with inadequate labels, including labels that did not disclose major food allergens, trans fat levels, and complete ingredient lists;
• Processed and distributed products with seafood, including whitefish salad, ground nova salmon, and lox cream cheese and lox cream cheese spreads, without adequate Hazard Analysis and Critical Control Point (HACCP) plans to ensure the safe and sanitary processing of seafood containing products; and
• Failed to document that they monitored sanitation conditions to keep food contact surfaces clean, to prevent cross-contamination from unsanitary objects, and to maintain hand washing, hand sanitizing, and toilet facilities.

"We simply can't allow companies to put the public's health at risk by not having adequate procedures and plans to produce safe food and proper labeling," said Margaret O'K. Glavin, associate commissioner for regulatory affairs. "We will work to take action against companies and their executives that violate the law."

Under the consent decree, operations may resume only after the FDA determines that the defendants have come into full compliance will all food-safety requirements. The consent decree requires the defendants to hire a seafood-processing expert to prepare a HACCP plan and to submit the plan to the FDA.

The HACCP violations pose a public health hazard because, without adequate controls, the defendants' seafood products could foster dangerous bacteria, such as Vibrio species, Salmonella, Escherichia coli, Campylobacter jejuni, Staphylococcus aureus, and Listereria monocytogenes. Food products with these kinds of pathogens can cause serious illnesses for people who eat them. Further, foods sold with labels that do not disclose major food allergens and complete ingredient lists can cause severe or life-threatening allergic reactions in people who are allergic to the undisclosed allergens.

The decree does not include other products manufactured by Lifeway including kefir, Farmers cheese, and spreadable cheese products.

The decree was signed by Judge Wayne R. Andersen on May 15, 2008, in the U.S. District Court for the Northern District of Illinois.

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New York Firm Recalls Ground Beef Products That May Contain Pieces of Plastic

                                 

Recall Release	CLASS I RECALL
FSIS-RC-015-2008	HEALTH RISK: HIGH

Congressional and Public Affairs
(202) 720-9113
            Amanda Eamich

WASHINGTON, May 12, 2008 - Fairbank Reconstruction Corp., an Ashville, NY, establishment, is voluntarily recalling approximately 22,481 pounds of ground beef products that may contain pieces of plastic, the U.S. Department of Agriculture's Food Safety and Inspection Service announced today.

The following products are subject to recall: [View Labels (PDF Only)]             

• 1.2-pound trays of "Shaw's Fresh Ground Sirloin 90/10." The labels on the bottom of the package bear a Julian Date of "124" on the bottom right hand corner, as well as the establishment number "EST. 492" inside the USDA mark of inspection.
• 1.3-pound trays of "Shaw's Fresh Ground Beef 80/20." The labels on the bottom of the package bear a Julian Date of "124" on the bottom right hand corner, as well as the establishment number "EST. 492" inside the USDA mark of inspection.
• 1-pound trays of "Shaw's Fresh Ground Beef Patties 80/20." The labels on the bottom of the package bear a Julian Date of "124" on the bottom right hand corner, as well as the establishment number "EST. 492" inside the USDA mark of inspection.
• 3-pound trays of "Shaw's Fresh Ground Beef Patties Family Pack 80/20." The labels on the bottom of the package bear a Julian Date of "124" on the bottom right hand corner, as well as the establishment number "EST. 492" inside the USDA mark of inspection.
• 1.3-pound trays of "Price Chopper Fresh Ground Beef Sirloin Patties, 90% Lean 10% Fat." The labels on the bottom of the package bear a "Sell-by" date of "05/13/08" as well as the establishment number "EST. 492" inside the USDA mark of inspection.
• 1.3- and 3-pound trays of "Price Chopper Fresh Homestyle Ground Beef Round Patty, 85% Lean 15% Fat." The labels on the bottom of the package bear a "Sell-by" date of "05/13/08" as well as the establishment number "EST. 492" inside the USDA mark of inspection.
• 3-pound trays of "Price Chopper Pub Style Ground Beef Chuck Patty, 80% Lean 20% Fat." The labels on the bottom of the package bear a "Sell-by" date of "05/13/08" as well as the establishment number "EST. 492" inside the USDA mark of inspection.
• 1.3-pound trays of "Price Chopper Fresh Homestyle Ground Beef Chuck Patty, 80% Lean, 20% Fat." The labels on the bottom of the package bear a "Sell-by" date of "05/13/08" as well as the establishment number "EST. 492" inside the USDA mark of inspection.
• 5.3-pound trays of "BJ'S Fresh Ground Beef, 100% Beef, Contains 15% Fat." The labels bear a "Sell-by" date of "05/15/08" as well as the establishment number "EST. 492" inside the USDA mark of inspection.
• 1-pound trays of "Fairbank Farms Ground Chuck Patties, 100% Beef, Contains 20% Fat." The labels on the bottom of the package bear a "Sell-by" date of "05/15/08" as well as the establishment number "EST. 492" inside the USDA mark of inspection.

The products were produced on May 3, and were distributed to retail establishments in Connecticut, Maryland, Massachusetts and New York.

The problem was discovered after the company received consumer complaints. FSIS has not received any consumer complaints at this time. No injuries have been reported at this time. Anyone concerned about an injury from consumption of the products should contact a physician.

Consumers with questions about the recall should contact the Fairbank Farms' toll-free hotline at (800) 724-1136. Media with questions about the recall should contact Company Representative at Agnes Schafer (816) 512-2291.

Consumers with food safety questions can "Ask Karen," the FSIS virtual representative available 24 hours a day at AskKaren.gov. The toll-free USDA Meat and Poultry Hotline 1-888-MPHotline (1-888-674-6854) is available in English and Spanish and can be reached from l0 a.m. to 4 p.m. (Eastern Time) Monday through Friday. Recorded food safety messages are available 24 hours a day.     #

Consumer Alert: Ground Beef Recall

Recall Release	CLASS I RECALL
FSIS-RC-014-2008	HEALTH RISK: HIGH

Congressional and Public Affairs
(202) 720-9113
Peggy Riek 

WASHINGTON, May 8, 2008 - Palama Holdings, LLC, a Kapolei, Hawaii, firm, is voluntarily recalling approximately 68,670 pounds of ground beef products because they may be contaminated with E. coli O157:H7, the U.S. Department of Agriculture's Food Safety and Inspection Service announced today.

The following products are subject to recall: [View Labels (PDF Only)]

	Preparing Ground Beef For Safe Consumption USDA Meat and Poultry Hotline 1-888-MPHOTLINE or visit www.fsis.usda.gov Although these products are not available at retail establishments, consumers preparing ground beef products should heed the following advice. Wash hands with warm, soapy water for at least 20 seconds before and after handling raw meat and poultry. Wash cutting boards, dishes and utensils with hot, soapy water. Immediately clean spills. Keep raw meat, fish and poultry away from other food that will not be cooked. Use separate cutting boards for raw meat, poultry and egg products and cooked foods. Consumers should only eat ground beef or ground beef patties that have been cooked to a safe internal temperature of 160°F.  Color is NOT a reliable indicator that ground beef or ground beef patties have been cooked to a temperature high enough to kill harmful bacteria such as E. coli O157:H7. The only way to be sure ground beef is cooked to a high enough temperature to kill harmful bacteria is to use a thermometer to measure the internal temperature. Refrigerate raw meat and poultry within two hours after purchase or one hour if temperatures exceed 90°F. Refrigerate cooked meat and poultry within two hours after cooking.

• 6- and 10-pound boxes containing 1/4-pound and 1/3-pound "May's Teriyaki Beef Patties." The boxes include a product code of "157400," "157600," or "157700," as well as a production date of "4/9/2008," "4/10/2008," "4/11/2008," "4/15/2008," "4/16/2008," "4/17/2008," "4/18/2008," or "4/21/2008." Each box bears the establishment number "EST. 11077" inside the USDA mark of inspection.
• 24-pound bulk boxes of "May's Beef Picnic Patties." The boxes will include product code "158700" as well as a production date of "4/11/2008" or "4/18/2008."  Each box bears the establishment number "EST. 11077" inside the USDA mark of inspection.
• 10-pound boxes of "May's Beef Pattie, 3:1 Layer Pack."  These boxes include the product code "158325" as well as a production date of "4/10/2008," or "4/17/2008."  Each box bears the establishment number "EST. 11077" inside the USDA mark of inspection.
• 3-pound trays of "May's GROUND BEEF Family Pack." The packages include the product code "410751," as well as the production date "4/16/2008." The packages also bear the establishment number "EST. 11077" inside the USDA mark of inspection.
• 5- and 10-pound chubs of May's brand coarse ground and fine ground beef products. These products bear a product code of "141115," "141120," "143915", "141420," "144150," "144155," "144200," "144205," "144209," "145410," "145420," "151115," "151415," "151430", or "153220." The products will also bear a production date of "4/9/2008," "4/15/2008," "4/16/2008," "4/17/2008," "4/18/2008," or "4/21/2008."

The bulk pack chubs of ground beef products may have been distributed for further processing and therefore may not bear the recalling firm's establishment number "EST. 11077" inside the USDA mark of inspection.

The ground beef products subject to recall were produced from April 9, 2008, through April 21, 2008.  The products subject to recall were distributed to retail, food service establishments and commissaries in Hawaii.

The problem was discovered through company testing. FSIS has not received any reports of illness.  Anyone concerned about an illness should contact a physician.

Consumers with questions about the recall should contact company Vice President of Sales Lionel Yokoyama at (808) 682-8368.

Consumer Alert: New York Firm Recalls Beef and Chicken

http://www.fsis.usda.gov/PDF/Recall_013-2008_Release.pdf

Help Wanted: FDA Embarks on Major Hiring Initiative for its Public Health Mission Agency will fill more than 1,300 positions within the next several months

Media Release

Biologists, chemists, medical officers, mathematical statisticians and investigators are among the experts in demand as the U.S. Food and Drug Administration begins a multi-year hiring initiative.

The FDA is hiring hundreds of individuals with science and medical backgrounds to help meet the agency's responsibilities to assure the safety and/or efficacy of human and veterinary drugs, biological products, medical devices, food, cosmetics and products that emit radiation.

"It takes a large pool of talented people for the FDA to protect and promote the public health," said John Dyer, FDA's Deputy Commissioner for Operations and Chief Operating Officer. "Each month there is a delay in bringing critical staff on board impairs the agency's ability to fulfill this mission."

In fiscal year 2008 alone, the FDA is looking to fill more than 600 new positions and to backfill over 700 others to implement the FDA Amendments Act of 2007, the Food Protection Plan and the Import Safety Action Plan. That's nearly triple the number of people hired from 2005-2007.

The Office of Personnel Management has granted Direct-Hire Authority to the FDA, an operating division of the Department of Health and Human Services. OPM's actions reflect the Administration's commitment to strengthening the agency quickly.

Direct-Hire Authority is an appointing authority OPM can give to federal agencies for filling vacancies when a critical hiring need or severe shortage of candidates exists. It expedites hiring of qualified candidates by eliminating certain rating and ranking preferences. Qualified candidates could be on the job in as little as three weeks.

The critical need occupations are medical officers, consumer safety officers, chemists, nurse consultants, biologists, microbiologists, health/regulatory/general health scientists, mathematical statisticians, epidemiologists, pharmacologists, pharmacists and veterinary medical officers. Many of these positions are located in the Washington metropolitan area, specifically Rockville, Silver Spring and College Park, Md., as well as across the country in the FDA's five regions, 20 districts, more than 179 resident posts, and the newly created FDA offices overseas.

Positions will be available throughout the agency, including in the Center for Biologics Evaluation and Research, the Center for Drug Evaluation and Research, the Center for Devices and Radiological Health, the Center for Food Safety and Nutrition, the Center for Veterinary Medicine, the National Center for Toxicological Research, the Office of the Commissioner and the Office of Regulatory Affairs.

The FDA will be participating in and holding job fairs throughout the country. To find a job fair near you, visit www.fda.gov/jobs/jobfairs08.html. For general information and to apply for one of the positions listed above, submit your questions and electronic curriculum vitae with a cover letter via email at JOINOURTEAM@FDA.GOV

For further information:  The Food and Drug Administration Amendments Act of 2007;    The Food Protection Plan; and The Import Safety Action Plan.

Consumer News: Audit Finds Problems At 2 Large Beef Processors

Apr 30, 2008 8:41 am US/Eastern

http://cbs3.com

                       

CBS News Quiz: Food Safety

                       

WASHINGTON (AP) ― A government inspection of slaughterhouses found significant problems with the treatment of cattle and two of the nation's largest beef processors - both of which provide meat for the National School Lunch Program - were slapped with humane handling violations.

One of those companies' violations was rescinded after the company appealed, The Associated Press has learned.
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Where's My Refund?

IRS Media Release

You filed your tax return and you're expecting a refund. You have just one question and you want the answer now - Where's My Refund? Whether you opted for direct deposit or asked IRS to mail you a check, you can track your refund through this secure Web site. Don’t fall for any email scams about your refund! IRS never initiates emails! Click here for more info about email and Phishing scams To get to your personal refund information, be ready to enter your: Social Security Number (or IRS Individual Taxpayer Identification Number) Filing status (Single, Married Filing Joint Return, Married Filing Separate Return, Head of Household, or Qualifying Widow(er)) Exact refund amount shown on your return If you don’t receive your refund within 28 days from the original IRS mailing date shown on Where’s My Refund?, you can start a refund trace online. If Where’s My Refund? shows that IRS was unable to deliver your refund, you can change your address online. Where’s My Refund? will prompt you when these features are available for your situation. Okay now, Where's My Refund? or    ¿ Dónde está mi reembolso? Note: If you have trouble while using this application, please check the Requirements to make sure you have the correct browser software for this application to function properly and check to make sure our system is available.

Baby Boomer Time Bomb: Too many aging patients, too few geriatricians

source www.ama-assn.org

An IOM study predicts severe work force shortages, fueled in part by low reimbursements.

Elizabeth Eckstrom, MD, had been a general internist for 10 years when she did a geriatrics fellowship, after research into fall prevention piqued her interest in older adults. Now that she is a geriatrician, she earns less than she did before.

But she thinks the change is still worth it.

http://www.ama-assn.org/amednews/2008/05/05/prl10505.htm

Consumer Warning: Bisphenol A Tips & Answers

http://www.enviroblog.org

 

Wal-Mart and Toys 'R' Us are phasing it out, and Canada's moving toward a ban. What's it all about? Bisphenol A (BPA), a toxic chemical found in some plastics that's linked to cancer and reproductive problems.

EWG's innovative research has pushed BPA into public view and led to congressional investigations. We'll continue to fight to get it out of canned food, plastic, and baby formula cans.

In the meantime, get more info and tips with our BPA Cheatsheet.

FDA Strengthens Safeguards for Consumers of Beef

Consumer Inquiries: 888-INFO-FDA

Media Release April 23
Issues Regulation on Animal Feeds with Added Safeguards Against BSE

The U.S. Food and Drug Administration today issued a final regulation barring certain cattle materials from all animal feed, including pet food. The final rule further protects animals and consumers against bovine spongiform encephalopathy (BSE, also known as "mad cow disease")

“This FDA action serves to further protect the U.S. cattle population from the already low risk of BSE,” said Dr. Bernadette Dunham, Director of FDA’s Center for Veterinary Medicine. “The new rule strengthens existing safeguards.’’

The materials that can no longer be used in animal feed are the tissues that have the highest risk for carrying the agent thought to cause BSE.  These high risk cattle materials are the brains and spinal cords from cattle 30 months of age and older.  The entire carcass of cattle not inspected and passed for human consumption is also prohibited, unless the cattle are less than 30 months of age, or the brains and spinal cords have been removed. The risk of BSE in cattle less than 30 months of age is considered to be exceedingly low.

The removal of high-risk materials from all animal feed will further protect against inadvertent transmission of the agent thought to cause BSE, which could occur through cross-contamination of ruminant feed (intended for animals with four-chambered stomachs, such as cattle) with non-ruminant feed or feed ingredients during manufacture and transport, or through misfeeding of non-ruminant feed to ruminants on the farm.  The added measure of excluding high-risk materials from all animal feeds prevents any accidental feeding of such ingredients to cattle.

Today’s regulation finalizes a proposed rule that the FDA issued for public comment in October 2005. The final rule is effective 12 months from today to allow the livestock, meat, rendering, and feed industries time to adapt their practices to comply with the new regulation. Under the new requirements of the final rule,  renderers that process cattle not inspected and passed for human consumption must make available for FDA inspection their written protocols for determining the age of cattle and demonstrating that the brain and spinal cords of cattle have been effectively removed.

Scientific studies have linked BSE to cases of variant Creutzfeldt-Jakob Disease (vCJD) in humans, an invariably fatal disease that mostly likely results from human consumption of infectious material from cattle with BSE.  A 1997 rule prohibited specific risk materials from use in the human food supply. There have been no vCJD cases linked to consumption of U.S. beef and the risk of BSE among U.S. cattle is low.

FDA regulates feed and drugs. The U.S. Department of Agriculture (USDA) and FDA together promulgate and enforce the regulations that ensure the exclusion of specific risk materials from the human food supply.

For a copy of the final rule and other information about the FDA's work on BSE, go to www.fda.gov/oc/opacom/hottopics/bse.html.

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Consumer News: FDA Approves Cimzia to Treat Crohn’s Disease

Consumer Inquiries: 888-INFO-FDA

Media Release, April 22, 2008

A new drug has been approved to help sufferers of Crohn’s disease, the U.S. Food and Drug Administration announced today. Cimzia (certolizumab pegol) received approval for adults with moderate to severe Crohn’s disease who have not responded to conventional therapies. This product was approved with a Medication Guide.

Crohn’s disease is a chronic, inflammatory bowel disease that affects more than 1 million men and women worldwide. It has no cure and its cause is unknown. Crohn’s can cause diarrhea, fever, rectal bleeding, malnutrition, narrowing of the intestinal tract, obstructions, abscesses, cramping, and abdominal pain. It also can lead to abnormal connections (fistulas) leading from the intestine to the skin or internal organs.

“Crohn’s is a debilitating disease that disrupts the quality of life for its sufferers,” said Julie Beitz, M.D., director of the Office of Drug Evaluation III for the FDA’s Center for Drug Evaluation and Research. “This drug works to reduce the signs and symptoms of Crohn’s, but it also carries risks that will require patients on it to be closely monitored by their physicians or other health care professionals.”

Patients treated with Cimzia will receive an injection every two weeks for the first three injections. Once benefit has been established, Cimzia should be given once every four weeks.

The most common side effects of Cimzia are headache, upper respiratory infections, abdominal pain, injection site reactions and nausea.

Patients taking Cimzia are at increased risk for serious adverse effects, including serious infections that can lead to hospitalization or death. Because Cimzia affects the immune system, it can lower the body’s ability to fight infections, such as tuberculosis and other opportunistic infections. Cimzia is a blocker of TNF (tumor necrosis factor) and may cause lymphomas (a form of cancer) and other malignancies. Although an increased risk of tumors was not seen in studies of Cimzia, the modest size and relatively short duration of the controlled studies prevents any firm conclusion.  Post-marketing studies and clinical trials will be required to obtain long-term safety data.

Patients taking Cimzia should be educated about how to identify an infection and be instructed to contact their health care professional at the first sign of infection while on Cimzia. In cases of serious infections, the drug should be discontinued immediately.

Cimzia is manufactured by UCB, Inc., Smyrna, GA.

For more information on Crohn’s disease, visit: 
Crohn’s Disease–National Institute of Diabetes and Digestive and Kidney Diseases
www.digestive.niddk.nih.gov/ddiseases/pubs/crohns/index.htm

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FDA Approves First Compact Heart Assist Device

Consumer Inquiries: 888-INFO-FDA

Media Release, April 22

The U.S. Food and Drug Administration today approved a heart assist device with a novel design that is the first to mechanically support the weakened heart of a small-sized adult man or woman with heart failure who is at risk of dying while awaiting a heart transplant.

Heart assist devices are surgically implanted mechanical pumps that help the heart’s ventricle do its work of pumping blood to the rest of the body. Previous models were too large to be placed in the upper abdomen of some women and small-sized men. But the Thoratec HeartMate II Left Ventricular Assist System employs a first-of-a- kind design. Instead of the standard pulsatile pump that simulates the action of the heart, the device uses a continuous flow pump that constantly moves blood with a single moving part, a spinning rotor. This allows the device to be slimmed down to a mere three inches in length and a weight of approximately one pound.

“The HeartMate II is an important advance in mechanical heart technology,” said Daniel Schultz, M.D., director of FDA’s Center for Devices and Radiological Health. “Until now, some heart transplant candidates have been underserved due to the large size of previously approved heart assist devices.”

An electrical cable that powers the blood pump passes through the patient’s skin to an external controller that the patient wears on his or her waist.  The controller is powered either by batteries or connected to an electrical power outlet. Blood flow is set through the pump based on the patient’s need, and the controller monitors pump performance, sounding alarms if it detects dangerous conditions or a possible malfunction.  The system can operate on two external batteries, allowing the patient to move freely for up to three hours.

In a clinical study of 126 patients at 26 transplant centers, 57 percent of patients with the HeartMate II survived to heart transplant, which is comparable to the survival of patients treated with currently approved heart assist devices.

The product’s manufacturer, Thoratec Corporation of Pleasanton, Calif., is required to conduct a post-approval study to further evaluate the HeartMate II’s performance during commercialization.

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CONSUMER ALERT: Salmonella Illnesses in Multiple States may be Linked to Recently Recalled Cereal

FDA News Release

The Food and Drug Administration (FDA) today announced that at least 23 people in 14 states have been diagnosed with salmonellosis that was caused by the same strain of Salmonella that was found in the recently recalled unsweetened Puffed Rice and unsweetened Puffed Wheat Cereals produced by Malt-O-Meal.

The recalled products were distributed nationally under the Malt-O-Meal brand name as well as under private label brands including Acme, America's Choice, Food Club, Giant, Hannaford, Jewel, Laura Lynn, Pathmark, Shaw's, ShopRite, Tops and Weis Quality. The cereals have “Best If Used By” dates from April 8, 2008 (coded as "APR0808") through March 18, 2009 (coded as "MAR1809"). 

Consumers should throw out any product in their homes from these recalled lots. Grocery stores and other retailers should promptly remove the cereals from their shelves.

Salmonella is a type of bacteria that can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened immune systems.

Symptoms of foodborne Salmonella infection include nausea, vomiting, fever, diarrhea, and abdominal cramps. In persons with poor health or weakened immune systems, Salmonella can invade the bloodstream and cause life-threatening infections. 

Individuals who believe they may have experienced an illness consistent with the symptoms described above after consuming a puffed wheat or puffed rice cereal made by Malt-O-Meal should contact their  health care practitioner immediately and report the illness to their state or local health authorities.

On April 5, 2008, Malt-O-Meal voluntarily recalled the cereals because the company’s routine testing found Salmonella in a product produced on March 24, 2008. www.fda.gov/oc/po/firmrecalls/maltomeal04_08.html 

The FDA is working with Malt-O-Meal to determine the cause of the contamination and with the states and the Centers for Disease Control and Prevention to identify and prevent additional illnesses.

A full list of recalled products can be found at www.malt-o-meal.com/recallinfo.

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FDA Finds Hazardous Levels of Selenium in Samples of "Total Body Formula" and "Total Body Mega Formula"

 
Dietary supplement products linked to adverse reactions

The U.S. Food and Drug Administration announced today that it has found hazardous levels of selenium in samples of certain flavors of the dietary supplement products “Total Body Formula” and “Total Body Mega Formula.” The FDA has received 43 reports of persons from nine states who experienced serious adverse reactions using these products.

On March 27, the FDA warned consumers not to purchase or use “Total Body Formula” in flavors Tropical Orange and Peach Nectar and “Total Body Mega Formula” in the Orange/Tangerine flavor of these products after receiving reports of adverse reactions in users in Florida and Tennessee (www.fda.gov/bbs/topics/NEWS/2008/NEW01812.html). The adverse reactions generally occurred after five to 10 days of daily ingestion of the product, and included significant hair loss, muscle cramps, diarrhea, joint pain, deformed fingernails, and fatigue.

Selenium, a naturally occurring mineral, is needed only in very small amounts for good health. Selenium can boost the immune system. Generally, normal consumption of food and water provides adequate selenium to support good health. Excessive intake of selenium is known to cause symptoms to include significant hair loss, muscle cramps, diarrhea, joint pain, fatigue, loss of finger nails and blistering skin.

Presently, FDA has 43 reports of adverse reactions including cases from Alabama, Florida, Georgia, Kentucky, Michigan, New Jersey, North Carolina, Tennessee, and Texas. 

Analyses of samples of the products by FDA laboratories have now found most of the samples contain extremely high levels of selenium--up to 40,800 micrograms per recommended serving, or more than 200 times the amount of selenium per serving (i.e., 200 micrograms) indicated on the labels of the products.

The FDA continues to investigate the matter to determine how excessive amounts of selenium were added to the products. 

FDA is advising consumers to stop using “Total Body Formula” in flavors Tropical Orange and Peach Nectar and “Total Body Mega Formula” in the Orange/Tangerine flavor  and discard them by placing them in a trash receptacle outside of the home. “Total Body Formula” products are sold in eight-ounce and 32-ounce plastic bottles. “Total Body Mega Formula” is sold in 32-ounce plastic bottles. Both product lines are distributed by Total Body Essential Nutrition of Atlanta, which is listed on the products' labels.

Consumers who have been taking the products and have experienced adverse reactions should consult their health care professional. Consumers and health care professionals are encouraged to report adverse events to the FDA's MedWatch program at 800-FDA-1088 or online at www.fda.gov/medwatch/how.htm.

The sole distributor of the “Total Body Formula” and “Total Body Mega Formula” products has voluntarily recalled the affected products. According to the company, the products were distributed nationwide.

More information about selenium and its toxic effects is available at this link to the Centers for Disease Control and Prevention's Agency for Toxic Substances and Disease Registry:  www.atsdr.cdc.gov/tfacts92.html. 

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Federal authorities seize more than $100,000 of unapproved drugs marketed as “natural supplements”

Media Release
Products contain active ingredients in prescription erectile dysfunction drugs

At the request of the U.S. Food and Drug Administration, today U.S. Marshals seized more than 14,000 dosage units of Shangai Regular, Shangai Ultra, Super Shangai, Naturalë Super Plus, and Lady Shangai.  Although labeled as natural supplements, the seized products were all marketed to treat erectile dysfunction (ED), impotency, and/or to provide sexual enhancement, which caused them to be drugs under the Federal Food, Drug, and Cosmetic Act.

The seized products, valued at more than $100,000, contain undeclared active ingredients found in FDA-approved prescription drugs for ED, or similar substances. Use of these products may result in serious side effects and may interact in dangerous ways with medications that a consumer may already be taking.

“The FDA will not tolerate companies marketing unapproved drugs -- products that have not proven to be safe or effective -- as dietary supplements,” said Margaret O’K. Glavin, associate commissioner for regulatory affairs. “The agency will pursue necessary legal action to make sure companies and their executives manufacture and distribute safe drug products.”

The seized products, which originated in China, are packaged and distributed by Shangai Distributors, Inc. of Coamo, Puerto Rico. Although the products’ labels state they are natural supplements, these products are drugs and their sale is illegal without FDA approval. Before a new drug product may be legally marketed, it must be shown to be safe and effective. 

In response to a consumer complaint, the FDA conducted an inspection of Shangai Distributors Inc., in November 2007. The FDA’s investigation and testing revealed that the seized products contained active drug ingredients found in FDA-approved ED prescription drugs and/or a substance with a structure similar to such drugs that may cause similar side effects and drug interactions. None of the drug ingredients are listed on the labels of any of the seized products.

The undeclared ingredients in these products may interact with nitrates found in some prescription drugs (such as nitroglycerin) and can lower blood pressure to dangerous levels.  Consumers with diabetes, high blood pressure, high cholesterol, or heart disease often take nitrates.  ED is a common problem in men with these medical conditions. Because they may have been advised against taking ED drugs, they may seek out products like these because they are marketed as “all natural” or as not containing the active ingredients in approved, prescribed ED drugs.  Additionally, because the manufacturing source of the active ingredients in these products is unknown, consumers should be aware that the safety, efficacy, and purity of these ingredients can not be validated.

Despite being advised of the findings and the potential adverse health risk posed by the seized products and that regulatory action was possible, the company did not take any action to correct the violations. The FDA issued a press release on December 28, 2007 advising consumers not to buy or use the products.  Prior to the seizure, the Puerto Rico Department of Health embargoed the seized products to protect the citizens of Puerto Rico and to support the FDA’s enforcement actions.

The FDA advises consumers who have used any of these products to discontinue use and consult their health care providers if they have experienced any adverse events that they believe are related to the use of these products.  Consumers and health care professionals can report adverse events to FDA’s MedWatch program at 800-FDA-1088 or online at www.fda.gov/medwatch/report.htm.  FDA recommends that consumers talk to their health care provider about FDA-approved treatments for erectile dysfunction.  FDA may take further regulatory actions to protect consumers from these illegal products.

The complaint was filed by Assistant U.S. Attorney Jose M. Pizarro, deputy chief, Civil Division, United States Attorney’s Office, District of Puerto Rico.”

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Consumer Recall: Cattle Heads.....dont laugh......they forgot to take their tonsils out

                                 

Recall Release	CLASS II RECALL
FSIS-RC-012-2008	HEALTH RISK: LOW

Congressional and Public Affairs
(202) 720-9113
            Amanda Eamich

            

WASHINGTON, April 4, 2008 - Elkhorn Valley Packing LLC, a Harper, Kan., establishment, is voluntarily recalling approximately 406,000 pounds of frozen cattle heads with tonsils not completely removed,  which is not compliant with regulations that require the removal of tonsils from cattle of all ages, the U.S. Department of Agriculture's Food Safety and Inspection Service announced today.

Tonsils are considered a specified risk material (SRM) and must be removed from cattle of all ages in accordance with FSIS regulations.  SRMs are tissues that are known to contain the infective agent in cattle infected with BSE, as well as materials that are closely associated with these potentially infective tissues. Therefore, FSIS prohibits SRMs from use as human food to minimize potential human exposure to the BSE agent.

The products subject to recall include: [View Label | Larger Image (PDF)]

• Various weight bulk boxes of "BEEF WHOLE HEADS, KEEP REFRIGERATED." Each shipping package bears the establishment numbers "EST. 19549A" inside the USDA mark of inspection, as well as a package code of "91700" or "93700."

The company is recalling all products packed before March 28, 2008, with the package code "91700" or "93700." These products were sent to distributors and wholesalers nationwide.

The problem was discovered at a State-inspected processing establishment that received some of the recalled products and verified that there had been incomplete removal of the tonsils.  FSIS has received no reports of illness at this time.

Media and consumers with questions about the recall should contact company President Mike Grant at (620) 896-2300.

Consumers with food safety questions can "Ask Karen," the FSIS virtual representative available 24 hours a day at AskKaren.gov. The toll-free USDA Meat and Poultry Hotline 1-888-MPHotline (1-888-674-6854) is available in English and Spanish and can be reached from l0 a.m. to
4 p.m. (Eastern Time) Monday through Friday. Recorded food safety messages are available 24 hours a day.

Consumer Warning: Chicken Recalled

WASHINGTON, March 29, 2008 - Koch Foods, a Fairfield, Ohio, establishment, is recalling approximately 1,420 pounds of frozen chicken breast products because they were packaged with the incorrect label. The frozen, pre-browned, raw products were labeled as "precooked" and therefore do not provide proper preparation instructions. These raw products may appear fully cooked.

The following product is subject to recall:

• 10-pound cases of "Koch Foods Fully Cooked Breaded Chicken Breast Fillet with Rib Meat" containing two 5-pound bags. Each case bears the establishment number "P-20795" inside the USDA mark of inspection, a production code of "24837-2", a date code of "B03982" and as well as a product code of "86861" printed on the label.

The frozen chicken products were produced on Feb. 8, 2008, and were shipped to distribution centers in Connecticut, Maine, Massachusetts, Michigan, Pennsylvania and Tennessee, intended for use by food service institutions.

                        

	Recommendations for Preventing Salmonellosis Wash hands with warm, soapy water for at least 20 seconds before and after handling raw meat and poultry. Also wash cutting boards, dishes and utensils with hot soapy water. Clean up spills right away. Keep raw meat, fish and poultry away from other food that will not be cooked. Use separate cutting boards for raw meat, poultry and egg products and cooked foods. Cook raw meat and poultry to safe internal temperatures before eating. The safe internal temperature for meat such as beef and pork is 160° F, and 165° F for poultry, as determined with a food thermometer. Refrigerate raw meat and poultry within two hours after purchase (one hour if temperatures exceed 90° F). Refrigerate cooked meat and poultry within two hours after cooking.

The problem was discovered by the company. FSIS has received no reports of illness due to consumption of these products. Anyone concerned about an illness should contact a physician.

Media with questions about the recall should contact company Chief Financial Officer Mark Kaminsky at (847) 384-5940. Consumers with questions about the recall should contact company Vice President of Sales John Marler at (601) 732-3056.

FSIS is reminding consumers that all poultry products should be cooked to a safe minimum internal temperature of 165° Fahrenheit as determined by a food thermometer. Using a food thermometer is the only way to know that food has reached a high enough temperature to destroy foodborne bacteria.

Consumption of food contaminated with Salmonella can cause salmonellosis, one of the most common bacterial foodborne illnesses. Salmonella infections can be life-threatening, especially to those with weak immune systems, such as infants, the elderly and persons with HIV infection or undergoing chemotherapy. The most common manifestations of salmonellosis are diarrhea, abdominal cramps, and fever within eight to 72 hours. Additional symptoms may be chills, headache, nausea and vomiting that can last up to seven days.

FDA Warns Public about Salmonella Risk from cantaloupe

Media Release

The U.S. Food and Drug Administration has issued an import alert regarding entry of cantaloupe from Agropecuaria Montelibano, a Honduran grower and packer, because, based on current information, fruit from this company appears to be associated with a Salmonella Litchfield outbreak in the United States and Canada. The import alert advises FDA field offices that all cantaloupes shipped to the United States by this company are to be detained.

In addition, the FDA has contacted importers about this action and is advising U.S. grocers, food service operators, and produce processors to remove from their stock any cantaloupes from this company. The FDA also advises consumers who have recently bought cantaloupes to check with the place of purchase to determine if the fruit came from this specific grower and packer. If so, consumers should throw away the cantaloupes.

To date, the FDA has received reports of 50 illnesses in 16 states and nine illnesses in Canada linked to the consumption of cantaloupes. No deaths have been reported; however, 14 people have been hospitalized. The states are Arizona, California, Colorado, Georgia, Illinois, Missouri, New Jersey, New Mexico, New York, Ohio, Oklahoma, Oregon, Tennessee, Utah, Washington, and Wisconsin.

The FDA is taking this preventive measure while the agency continues to investigate this outbreak in cooperation with the Centers for Disease Control and Prevention and state partners. Such intervention is a key component of FDA’s Food Protection Plan.

Symptoms of foodborne Salmonella infection include nausea, vomiting, fever, diarrhea, and abdominal cramps. In persons with poor health or weakened immune systems, Salmonella can invade the bloodstream and cause life-threatening infections. Individuals who have recently eaten cantaloupe and experienced any of these symptoms should contact their health care professional.

The FDA recommends that consumers take the following steps to reduce the risk of contracting Salmonella or other foodborne illnesses from cantaloupes:

• Purchase cantaloupes that are not bruised or damaged. If buying fresh-cut cantaloupe, be sure it is refrigerated or surrounded by ice.
  
       
•     After purchase, refrigerate cantaloupes promptly.
  
       
•     Wash hands with hot, soapy water before and after handling fresh cantaloupes.
  
       
• Scrub whole cantaloupes by using a clean produce brush and cool tap water immediately before eating. Don't use soap or detergents.
  
       
• Use clean cutting surfaces and utensils when cutting cantaloupes. Wash cutting boards, countertops, dishes, and utensils with hot water and soap between the preparation of raw meat, poultry, or seafood and the preparation of cantaloupe.
  
       
•     If there happens to be a bruised or damaged area on a cantaloupe, cut away those parts before eating it.
  
       
•     Leftover cut cantaloupe should be discarded if left at room temperature for more than two hours.
  
       
•     Use a cooler with ice or use ice gel packs when transporting or storing cantaloupes outdoors.

  For more information on produce safety, please visit:
http://www.cfsan.fda.gov/~dms/prodsafe.html.  

For additional information on FDA’s Import Program, please visit: http://www.fda.gov/ora/import/default.htm.

Two Parents With Alzheimer's Raises Child's Risk

Any additional family history boosts odds of getting the disease earlier, study finds

URL of this page: http://www.nlm.nih.gov/medlineplus/news/fullstory_62040.html  (*this news item will not be available after 06/08/2008)

HealthDayMonday, March 10, 2008

MONDAY, March 10 (HealthDay News) -- If both parents have Alzheimer's disease, their children face an increased risk of developing the condition, a new study suggests.

Overall, 42 percent of offspring whose parents both had Alzheimer's went on to develop the disease themselves by age 70, the researchers found.

The risk is also greater of developing the disease early if additional relatives had Alzheimer's disease, researchers say.

Most experts agree that genetics plays a role in Alzheimer's disease, but the degree to which genetics is responsible for the disease is still unclear.

Bird's group is trying to determine the genetic factors at play in Alzheimer's disease. So far, only one genetic factor has been documented, Bird said. "The hope is, there will be others and they will be found," he said. "Presumably, these children would have a higher concentration of those factors. So, that's what ought to be looked for."

The report appears in the March issue of the Archives of Neurology.

In the study, Bird's team collected data on the grown children in 111 families where both parents had Alzheimer's disease.

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New York Firm Recalls Meat and Poultry Products for Listeria Monocytogenes

March 4, 2008

 

Read Media Release                                                CLASS I RECALL         FSIS-RC-09-2008         HEALTH RISK: HIGH           WASHINGTON, Mar. 4, 2008 - Gourmet Boutique, L.L.C., a Jamaica, N.Y.,   firm, is voluntarily recalling approximately 6,970 pounds of meat and poultry   products that may be contaminated with Listeria monocytogenes, the   U.S. Department of Agriculture's Food Safety and Inspection Service announced   today.     The following products are subject to recall: [View Labels, PDF Only]   6-pound bulk packages of        "GOURMET BOUTIQUE HONEY CHICKEN SALAD." Each package bears the        establishment number "P-18799" inside the USDA mark of inspection.        3-pound bulk packages of        "GOURMET BOUTIQUE CHICKEN MARSALA." Each package bears the        establishment number "P-18799" inside the USDA mark of        inspection. 3-pound bulk packages of        "GOURMET BOUTIQUE GRILLED CHICKEN BREAST IN TERIYAKI SAUCE, PORTION        CONTROL." Each package bears the establishment number        "P-18799" inside the USDA mark of inspection. 6-pound bulk packages of        "GOURMET BOUTIQUE GRILLED LEMON CHICKEN, PORTION CONTROL."        Each package bears the establishment number "P-18799" inside        the USDA mark of inspection. 6-pound bulk packages of        "GOURMET BOUTIQUE GRILLED LEMON CHICKEN, PORTION CONTROL, Keep        Frozen." Each package bears the establishment number        "P-18799" inside the USDA mark of inspection. 3-pound bulk packages of        "GOURMET BOUTIQUE Home Style Chicken Salad." Each package        bears the establishment number "P-18799" inside the USDA mark        of inspection. 4-pound bulk packages of        "GOURMET BOUTIQUE Grilled Chicken B&E PRET A MANGER." Each        package bears the establishment number "P-18799" inside the USDA        mark of inspection. 3.5-pound bulk packages of        "GOURMET BOUTIQUE Breaded and Fried Chicken Cutlet." Each        package bears the establishment number "P-18799" inside the        USDA mark of inspection. 3.125-pound bulk packages of        "GOURMET BOUTIQUE ITALIAN STALLION TWISTER." Each package        bears the establishment number "EST. 18799" inside the USDA        mark of inspection. 8-pound bulk packages of        "GOURMET BOUTIQUE Meatloaf with Gravy KIT." Each package bears        the establishment number "EST. 18799" inside the USDA mark of        inspection. 4.6-pound bulk packages of        "GOURMET BOUTIQUE CHICKEN BURRITO." Each package bears the        establishment number "P-18799" inside the USDA mark of        inspection. 3.125-pound bulk packages of        "GOURMET BOUTIQUE TURKEYCLUB TWISTER." Each package bears the        establishment number "P-18799" inside the USDA mark of        inspection.

Michigan Firm Recalls Frozen Chicken Entrées For Possible Listeria Contamination

Media release
WASHINGTON, Mar. 2, 2008 – Meijer Distribution Center, a Grand Rapids, Mich. firm, is voluntarily recalling approximately 2,184 pounds of frozen chicken entrées that may be contaminated with Listeria monocytogenes, the U.S. Department of Agriculture’s Food Safety and Inspection Service announced today.

The following product is subject to recall: [View Label]

• 12-ounce packages of “Discover Cuisine ™ Red Curry Chicken & Jasmine Rice.” Each package bears the Canadian establishment number “Est. 302” inside the Canadian Food Inspection Agency mark of inspection as well as a “Best By” date of “12 18 08.”

The frozen chicken entrées were produced on Oct. 18, 2007, and were sent to distributors and retail establishments in Illinois, Indiana, Michigan and Ohio.

The problem was discovered through FSIS microbiological sampling. FSIS has received no reports of illnesses associated with consumption of this product.

Consumption of food contaminated with Listeria monocytogenes can cause listeriosis, an uncommon but potentially fatal disease. Healthy people rarely contract listeriosis. However, listeriosis can cause high fever, severe headache, neck stiffness and nausea. Listeriosis can also cause miscarriages and stillbirths, as well as serious and sometimes fatal infections in those with weakened immune systems, such as infants, the elderly and persons with HIV infection or undergoing chemotherapy.
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Update: Ford’s Voluntary Recall Involving Speed Control Deactivation Switch

 

Update: February 27, 2008

Cars:

• Parts for the speed control switch recall will be available for some passenger cars in March, 2008. Affected customers will receive a postcard from recall headquarters instructing them to make an appointment with their dealer to have the recall completed. However, Ford urges owners of recalled vehicles to bring their vehicle to their dealer as soon as possible to have the speed control switch disconnected to eliminate the risk of fire.

Trucks:

• Parts for the speed control switch recall will be available for trucks in June, 2008. Affected customers will receive a postcard from recall headquarters instructing them to make an appointment with their dealer to have the recall completed. However, Ford urges owners of recalled vehicles to bring their vehicle to their dealer as soon as possible to have the speed control switch disconnected to eliminate the risk of fire.

Ford is conducting a voluntary safety recall involving speed control deactivation switch systems in 9.6 million vehicles.

• The service action involves the installation of a fused wiring harness into the speed control electrical circuit, or the replacement of the deactivation switch if it is found to be leaking. This is a quick repair, and will be performed on vehicles built between 1992 and 2004.
• Ford dealers will provide this service to all affected vehicles at no charge to the customers. Owners of all affected vehicles will be notified by mail.
• Which vehicles are involved in this recall?
  A. This recall includes the following vehicles*:
• Trucks:
  1997-2002 Expedition
  1998-2002 Navigator
  2002-2003 Blackwood
  1993-1996 Bronco
  2000-2003 Excursion (built prior to 11/4/02)
  1992-2003 Econoline E-150/250/350
  1996-2003 Econoline E450
  2002-2003 Econoline E550
  1998-2002 Ranger
  1998-2001 Explorer/Mount