FDA Issues Guidance for Produce Manufacturers

In the wake of several public-health scares related to contaminated produce, the U.S. Food and Drug Administration (FDA) has issued a guidance document intended to protect product safety during the processing of fresh-cut fruit and vegetables. The FDA’s new document, “Guide to Minimize Microbial Food Safety Hazards of Fresh-cut Fruits and Vegetables,” offers a slate of recommendations to “minimize the potential for microbial contamination.”

According to the FDA, the fresh-cut produce sector is the fastest-growing segment of the entire produce industry and is responsible for more than a quarter of all produce-related contamination outbreaks in the past decade. The agency defines fresh-cut produce as “minimally processed” fruits or vegetables that have been peeled, sliced, chopped, shredded, or trimmed before being packaged for consumer or retail use (e.g. shredded lettuce, sliced tomatoes, salad mixes, peeled baby carrots, cut melons and grapefruit).
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Peanut Butter Recall Expands as Law Firms Continue to Investigate Salmonella Claims

On March 10, 2007, the FDA warned consumers who have purchased Peter Pan or Great Value peanut butter products since October 2004 to discard them, and not to eat any peanut butter with a product code beginning with 2111. Earlier this month, the FDA said it found the strain of salmonella that tainted peanut butter made at the ConAgra Foods plant in Sylvester, Georgia. Government and industry officials have said the contamination may have been caused by dirty jars or equipment. On February 14, 2007, ConAgra Foods recalled lots of Peter Pan and Great Value peanut butter due to salmonella contamination and widespread reports of related illness in multiple states.

The recalled peanut butter jars have a product code beginning with “2111” on the jar lid. Consumers are being advised to avoid the recalled peanut butter. This lot of peanut butter was 1st manufactured in October 2004 and continued through the February, 2007 recall. ConAgra manufactures both the Peter Pan and Great Value brands in the company’s Sylvester, Georgia facility. The FDA has sent investigators to ConAgra’s processing plant in Sylvester, Georgia to review records, collect product samples and conduct tests for Salmonella Tennessee.
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FDA Warns of Serious Side Effects Related to Popular Anemia Drugs

FDA Warns of Serious Side Effects Related to Popular Anemia DrugsThe U.S. Food and Drug Administration (FDA) has issued a new warning about erythropoiesis-stimulating agents (ESAs), which are drugs that are used to treat anemia. The warnings relate to darbepoetin alfa (Aranesp) and epoetin alfa (Epogen and Procrit). All three of the drugs are made by Amgen Inc., although Procrit is distributed and marketed by a Johnson & Johnson subsidiary.

“Recently completed studies describe an increased risk of death, blood clots, strokes, and heart attacks in patients with chronic kidney failure when ESAs were given at higher than recommended doses,” the FDA said. “In other studies, more rapid tumor growth occurred in patients with head and neck cancer who received these higher doses.
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DOJ Report: FBI Abused Its Patriot Act Power

It’s been a dreadful week for Bush Administration cronies at the Department of Justice and a frightening week for those concerned about the integrity and competence of the nation’s top law-enforcement body. Earlier this week, Congress held hearings about the December firings of eight respected U.S. attorneys, which many lawmakers believe may have been politically motivated. Today, the Justice Department released a nearly 200-page report by the DOJ’s Inspector General that chastised the Federal Bureau of Investigation (FBI) for improper use of National Security Letters (NSLs) in the acquisition of private information about both U.S. residents and non-residents.

According to the report, investigators in the DOJ’s Office of the Inspector General (OIG) “found that the FBI used NSLs in violation of applicable NSL statutes, Attorney General guidelines, and internal FBI policies.” A large number of the infractions, according to the OIG, violated the Electronic Communications Privacy Act (ECPA): “In addition, we found that the FBI circumvented the requirements of the ECPA NSL statute when it issued at least 739 ‘exigent letters’ to obtain telephone toll billing records and subscriber information from three telephone companies without first issuing NSLs.” Exigent letters are produced when FBI agents feel they need immediate information, and the OIG found that these claims were exaggerated in many of these cases.
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Congress to Question Justice Department Officials

In the wake of contentious Congressional hearings this week, the Senate Judiciary Committee has announced its intention to question several Justice Department officials about the mass firings that claimed the jobs of eight U.S. attorneys in a December purge. The committee has been considering using its subpoena power in order to force officials to testify, although it appeared on Thursday that they were backing off that approach and leaning toward securing testimonies on a voluntary basis.

The White House, Attorney General Alberto Gonzales, and the Department of Justice have been the recipients of widespread criticism over their handling of the firings, which many fear were politically motivated. Even some of the Administration’s closest Republican allies in Congress have questioned the legitimacy of the firings.
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FDA Warns of Arsenic in Jermuk Mineral Water

The U.S. Food and Drug Administration (FDA) has alerted consumers to a recall of Jermuk brand mineral water due to high levels of arsenic in the product. Arsenic is a known carcinogen, and overexposure to arsenic can lead to short-term symptoms including nausea, vomiting, diarrhea, and stomach pain. Prolonged exposure can lead to kidney, liver, skin, cardiovascular, and nervous-systems problems and possibly cancer and death.

At this point, three different products are subject to the recall: Jermuk Original Sparkling Natural Mineral Water Fortified with Natural Gas from the Spring (sold in the U.S. by Zetlian Bakery, Inc.); Jermuk Sodium Calcium Bicarbonate and Sulphate Mineral Water (sold by Importers Direct Wholesale Co.); and Jermuk, Natural Mineral Water Sparkling (sold by Kradjian Importing Company).
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AP: FDA Commissioner Lukewarm on Tobacco Regulation

Last month, a bipartisan group of lawmakers introduced legislation that would put tobacco regulation under the responsibilities of the U.S. Food and Drug Administration (FDA). However, the man who would oversee the FDA’s tobacco regulation, FDA Commissioner Andrew von Eschenbach, isn’t sure that it’s such a good idea.

In an interview with the Associated Press this week, von Eschenbach seemed unwilling for the agency to take on that task. “We have the opportunity to take a very important comprehensive public-health approach to this problem,” he told the AP. “And it’s not a matter of giving FDA regulation or authority. It’s a matter of addressing the public-health problem that’s before us.”
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Congress Investigates Justice Department Firings

Last December, eight U.S. attorneys were fired by the Justice Department for unspecified reasons. Many observers believe that the firings were political in nature. This week, two separate Congressional committees have been holding hearings to determine exactly why the prosecutors were terminated and if the firings were warranted in the first place. If the Justice Department is implicated in making employment decisions based on politics and loyalty, a full-blown scandal will likely emerge from these hearings.

Six of the eight attorneys were subpoenaed by Congress this week, claiming that their firings resulted from heavy political pressure by Republican lawmakers who were unhappy with their legal decision-making and hoping to replace the ousted attorneys with individuals more sympathetic to their cause. In addition, a report filed by McClatchy Newspapers quoted two unnamed attorneys as saying that the Justice Department threatened to disclose potentially damaging information about them in order to keep them quiet about the situation.
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Study: Lung Cancer Screening Ineffective, Possibly Dangerous

A disheartening new study published this week in the Journal of the American Medical Association (JAMA) has found that lung-cancer screening done by CT scans has not had the life-saving benefits it was believed to have. In addition, use of CT scans may lead to unnecessary and potentially dangerous medical procedures.

“Screening for lung cancer with low-dose CT may increase the rate of lung cancer diagnosis and treatment, but may not meaningfully reduce the risk of advanced lung cancer or death from lung cancer,” the study’s authors conclude.

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ReNu MultiPlus Contact-Lens Solution Recalled

Bausch & Lomb announced today that it is recalling 1.5 million bottles of ReNu MultiPlus contact-lens solution due to trace levels of iron in the product. The company said that the iron may cause “discoloration” of the solution and may cause its effectiveness to deteriorate before the printed expiration date. No serious injuries or adverse effects have been reported at this point.

The recall affects 12 lots of the product, which were produced at the company’s Greenville, S.C., plant and sold in the U.S., Canada, Latin America, Korea, and Taiwan. “The company initiated an investigation after receiving three customer reports of discolored solution,” Bausch & Lomb said in a statement. “The root cause of the discoloration was determined to be an elevated level of trace iron in a single batch of raw material sourced from an outside supplier. The elevated level of trace iron could combine with other compounds in the solution to cause discoloration, which signals that the solution may be losing effectiveness over time.”
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