Drug/Pharmaceutical News

UPDATED: January 28, 2009: CNN cites the FDA in reporting that the Peanut Corporation of America knew in 2007 and 2008 that it had a problem with salmonella at its Blakely, Georgia plant. If you have questions about the peanut butter salmonella outbreak, please give us a call at 601.949.9456 or submit a case review form here.

January 23, 2009: The information below is quoted directly from the Federal Food & Drug Administration’s website.

A combination of epidemiological analysis and laboratory testing by state officials in Minnesota and Connecticut, the Food and Drug Administration (FDA), and the Centers for Disease Control and Prevention (CDC) have enabled FDA to confirm that the sources of the outbreak of illnesses caused by Salmonella Typhimurium are peanut butter and peanut paste produced by the Peanut Corporation of America (PCA) at its Blakely, Georgia processing plant.

Peanut butter is sold by PCA in bulk containers ranging in size from five (5) to 1,700 pounds. The peanut paste is sold in sizes ranging from 35-pound containers to product sold by the tanker container. Neither of these products is sold directly to consumers.

However, through its investigation, FDA has determined that PCA distributed potentially contaminated product to more than 70 consignee firms, for use as an ingredient in hundreds of different products, such as cookies, crackers, cereal, candy and ice cream. FDA’s report on its inspection of the PCA facility is available at this link: http://www.fda.gov/ora/frequent/default.htm. Companies all over the country that received product from PCA have issued voluntary recalls of their products. FDA has created a searchable database for these products, which can be found at http://www.accessdata.fda.gov/scripts/peanutbutterrecall/index.cfm, Identification of products subject to recall is continuing and this list is updated frequently.

Product recalls now include some pet food products that contain peanut paste that was made by PCA. While the risk of animals contracting salmonellosis is minimal, there is risk to humans from handling these products. It is important for people to wash their hands–and make sure children wash their hands–before and, especially, after feeding treats to pets. Further information for consumers is located in the Frequently Asked Questions section located on this web site. The pet food products are also included in the searchable data base of recalled products.

Major national brands of jarred peanut butter found in grocery stores are not affected by the PCA recall.

FDA and CDC recommendations for consumers include:

* Do not eat products that have been recalled and throw them away in a manner that prevents others from eating them.
* To determine if commercially-prepared or manufactured peanut butter/peanut paste-containing products (such as cookies, crackers, cereal, candy and ice cream) are subject to recall, consumers are urged first to visit FDA’s website and check the searchable database of recalled products.
* For information on products containing peanut butter from companies not reporting recalls, consumers may wish to consult the company’s website or call the toll-free number listed on most packaging. Information consumers may receive from the companies has not been verified by the FDA.
* If consumers cannot determine if their peanut butter, peanut butter/peanut paste-containing products or institutionally-served peanut butter contains PCA peanut butter/peanut paste, FDA recommends that they do not consume those products.
* Persons who think they may have become ill from eating peanut butter are advised to consult their health care providers.

For Retailers

* Stop selling recalled products.

For Directors of Institutions and Food Service Establishments

* Ensure that they are not serving recalled products.

For Manufacturers

* Inform consumers about whether their products could contain peanut butter or peanut paste from Peanut Corporation of America (PCA). If a manufacturer knows their products do not contain peanut butter or peanut paste from PCA, they should inform consumers of that. For specific guidance: Guidance for Industry: Product Recalls, Including Removals and Corrections

The FDA will closely monitor these events by continuing to work with the firms on the details of their actions, conducting follow-up audits and inspections, monitoring the progress of the firms’ actions, working with state and local regulatory authorities, and notifying our foreign regulatory counterparts of products that have now been confirmed as having been distributed internationally.

Ongoing Investigation

FDA has collaborated with the Centers for Disease Control and Prevention (CDC) and public health officials in various states to investigate the multi-state outbreak of human infections due to Salmonella Typhimurium. An epidemiological investigation by the Minnesota Department of Health isolated and tested subsamples from an open five-pound container of King Nut peanut butter obtained at a nursing home where three patients were sickened by the outbreak strain of Salmonella Typhimurium. The Minnesota Health officials found the peanut butter contained the same strain of Salmonella Typhimurium associated with the illnesses linked to the outbreak.

Because it is always possible that the open container was contaminated by someone or something else in the environment, the FDA and the states began testing unopened containers of the same brand of peanut butter. King Nut distributes peanut butter manufactured by the PCA to institutional facilities, food service industries, and private label food companies in several states.

On January 19, 2009, testing by the Connecticut Department of Health of an unopened container of King Nut peanut butter showed that it too contained the same strain of Salmonella Typhimurium associated with illnesses linked to the outbreak. The fact that the Salmonella Typhimurium was confirmed in an unopened container of peanut butter indicates that peanut butter originating from the processing plant was contaminated.

FDA has initiated inspections at the direct consignees of PCA and King Nut and continues to follow the distribution points for products.

The FDA has no evidence to suggest that the Salmonella Typhimurium contamination originated with any other major manufacturing facility other than PCA. The PCA facility in Blakely, Georgia is not operating at this time and the company has recalled peanut butter and peanut paste produced from July 1, 2008 to the present.

The FDA and food manufacturers are working to identify products that may be affected, and to track the ingredient supply chain of those products to facilitate their removal from the marketplace.

For the latest information on the outbreak and the epidemiological investigation, including number of illnesses and a list of states reporting illnesses, go to the CDC web page at http://www.cdc.gov/salmonella/typhimurium/.

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