Little Debbie peanut butter crackers recalled

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Posted on 18th January 2009 by Gordon Johnson in Uncategorized

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Date: 1/18/2009

WASHINGTON (AP) — The company that sells Little Debbie snacks announced a recall Sunday of peanut butter crackers because of a potential link to a deadly salmonella outbreak.

The voluntary recall came one day after the government advised consumers to avoid eating cookies, cakes, ice cream and other foods with peanut butter until health officials learn more about the contamination.

The announcement by McKee Foods Corp. of Collegedale, Tenn., about two kinds of Little Debbie products was the latest in a string of voluntary recalls following the most recent guidance by health officials.

McKee said it had not received any complaints about illnesses from people who ate any size peanut butter toasty sandwich crackers or peanut butter cheese sandwich crackers. The recall covers crackers produced on or after July 1.

Officials are focusing on peanut paste, as well as peanut butter, produced at a Blakely, Ga., facility owned by Peanut Corp. of America. Its peanut butter is not sold directly to consumers but distributed to institutions and food companies. But the peanut paste, made from roasted peanuts, is an ingredient in cookies, cakes and other products that people buy in the supermarket.

So far, more than 470 people have gotten sick in 43 states, and at least 90 had to be hospitalized. At least six deaths are being blamed on the outbreak. Salmonella is a bacteria and the most common source of food poisoning in the U.S., causing diarrhea, cramping and fever.

The Kellogg Co., which listed Peanut Corp. as one of its suppliers, has recalled 16 products. McKee said Kellogg manufactured the Little Debbie crackers covered by the recall.

The Kellogg products recalled include Austin and Keebler branded peanut butter sandwich crackers, and some snack-size packs of Famous Amos peanut butter cookies and Keebler Soft Batch Homestyle peanut butter cookies.

Late Saturday, the Midwest supermarket chain Hy-Vee Inc. of West Des Moines, Iowa, said it was voluntarily recalling products made in its bakery departments with peanut butter because they had the potential to be contaminated with salmonella. The recall covered seven states: Iowa, Illinois, Missouri, Kansas, Nebraska, South Dakota and Minnesota.

Perry’s Ice Cream Co., based in Akron, N.Y., said it was recalling select ice cream products containing peanut butter because of the PCA investigation. Its recall covered New York, Pennsylvania, New Jersey, Maryland and Virginia.

Most peanut butter sold in jars at supermarkets appears to be safe, the Food and Drug Administration said Saturday.

Peanut Corp. has recalled all peanut butter produced at the Georgia plant since Aug. 8 and all peanut paste produced since Sept. 26.

Health officials are focusing on 30 companies out of a total of 85 that received peanut products from the Georgia plant.

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On the Net:

FDA: http://tinyurl.com/8srctw

Copyright 2009 The Associated Press.

FDA scientists complain to Obama of 'corruption'

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Posted on 12th January 2009 by Gordon Johnson in Uncategorized

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Date: 1/8/2009

By RICARDO ALONSO-ZALDIVAR
Associated Press Writer

WASHINGTON (AP) — In an unusually blunt letter, a group of federal scientists is complaining to the Obama transition team of widespread managerial misconduct in a division of the Food and Drug Administration.

“The purpose of this letter is to inform you that the scientific review process for medical devices at the FDA has been corrupted and distorted by current FDA managers, thereby placing the American people at risk,” said the letter, dated Wednesday and written on the agency’s Center for Devices and Radiological Health letterhead.

The center is responsible for medical devices ranging from stents and breast implants to MRIs and other imaging machinery. The concerns of the nine scientists who wrote to the transition team echo some of the complaints from the FDA’s drug review division a few years ago during the safety debacle involving the painkiller Vioxx.

The FDA declined to publicly respond to the letter, but said it is working to address the concerns.

In their letter the FDA dissidents alleged that agency managers use intimidation to squelch scientific debate, leading to the approval of medical devices whose effectiveness is questionable and which may not be entirely safe.

“Managers with incompatible, discordant and irrelevant scientific and clinical expertise in devices…have ignored serious safety and effectiveness concerns of FDA experts,” the letter said. “Managers have ordered, intimidated and coerced FDA experts to modify scientific evaluations, conclusions and recommendations in violation of the laws, rules and regulations, and to accept clinical and technical data that is not scientifically valid.”

A copy of the letter, with the names of the scientists redacted, was provided to The Associated Press by a congressional official.

“Currently, there is an atmosphere at FDA in which the honest employee fears the dishonest employee, and not the other way around,” the scientists wrote.

FDA spokeswoman Judy Leon said in response: “We have been working very closely with members of the transition team and any concerns or questions they have on any issue, we will address directly with the team. Separately, the agency is actively engaged in a process to explore the staff members’ concerns and take appropriate action.”

Senior Democratic and Republican lawmakers are urging Obama to appoint a commissioner who will shake up the FDA and restore the confidence of its working-level scientists and medical experts. But industry officials fear that approval of new drugs and devices could be delayed by endless scientific disputes — which is the agency’s reputation.

The FDA dissidents have previously taken their concerns to Congress and found support from lawmakers in the House.

In the letter the group singled out mammography computer-aided detection devices as an example of a technology that should not have gone forward. The devices were supposed to improve breast cancer detection, but instead studies showed they were associated with false alarms that led to unnecessary breast biopsies.

Since 2006, FDA experts have recommended five times against approving the devices without better clinical evidence, the letter said. In March of last year, a panel of outside advisers supported some of the concerns of the FDA’s in-house scientists. Nonetheless, FDA managers overruled the objections and ordered approval.

Top FDA managers “committed the most outrageous misconduct by ordering, coercing and intimidating FDA physicians and scientists to recommend approval, and then retaliating when the physicians and scientists refused to go along,” the letter said.

A spokeswoman said the Obama transition team had no comment.

Copyright 2009 The Associated Press.

FDA seeks advice to improve tracking of produce

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Posted on 17th October 2008 by Gordon Johnson in Uncategorized

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Date: 10/16/2008 4:16 PM

By KEVIN FREKING
Associated Press Writer

WASHINGTON (AP) _ Prompted by this summer’s salmonella outbreak, the government has begun investigating how to quickly identify the source of contaminated food and stop it from getting to consumers.

At the first public hearing on the issue Thursday, representatives from the produce industry cited progress toward labeling on every case of fruit and vegetables that would make it easier to trace tainted food from the dinner table back to the farm.

Consumer advocates want more: marking individual tomatoes, heads of lettuce and other produce from an industry subject to 900 safety recalls over the past two years.

“We need better information going to the consumer so he can identify fruits and vegetables when it’s in his refrigerator and in his cabinet shelves,” said David Plunkett, senior staff attorney at the Center for Science in the Public Interest.

The salmonella outbreak that sickened at least 1,440 people exposed flaws in the nation’s food safety system. Government investigators found strong evidence to implicate jalapeno and serrano peppers, and a farm in Mexico, in the largest outbreak of foodborne illness in a decade. An earlier warning advised people against eating various kinds of tomatoes.

The Food and Drug Administration has asked companies and consumers to recommend ways to improve the tracing of produce throughout the distribution system. Agency officials said the large number of food recalls and food-borne illnesses of recent years is a sign that health officials are better at finding problems.

“We are going to see more of these (outbreaks) rather than fewer,” said Stephen Sundlof, director of the FDA’s Center for Food Safety and Applied Nutrition. “We just need to respond sooner when they do occur.”

One of the questions the FDA is asking is whether an identifier should be assigned to fresh produce, and if so, at what stage in the supply chain. The industry agrees with that concept, said Kathy Means of the Produce Marketing Association. She said it is in the industry’s best interest to quickly track problems.

“They have every incentive to want to do this,” Means said.

Means said each container of produce should contain a label with a bar code that would allow businesses and the FDA to immediately identify the owner of that product — from manufacturers to packers to retailers. She said individual companies have their own system for tracking products, but the system is not uniform. She also urged the agency to let the industry enact its plan rather than seek new federal rules. Some companies are ready to put in place the barcode system immediately while others have a long way to go.

“This is going to be hundreds of millions of dollars over a few years,” she said.

Some legal underpinnings for a national tracing system are in place.

A federal bioterrorism law requires food to be traced one step forward and one step back — who supplied it, and where it went — so that, in theory, regulators can follow the trail. Industry officials said they believed that law was sufficient to get companies to enact the kind of record keeping that would keep them in compliance with the law, but so far, they have heard of little enforcement by the government to ensure that companies were complying.

Sundlof said the law authorized the FDA to check whether businesses were complying only when health dangers had surfaced. He said on a few occasions this year when potential health problems were identified, the agency exercised its authority

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On the Net:

Food and Drug Administration: http://www.fda.gov

Produce Marketing Association: http://www.pma.com/

Copyright 2008 The Associated Press.

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