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This press release was revised on August 1, 2008.

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FDA Advises Against Consumption of Tomalley from American Lobster (also known as “Maine Lobster”)
Regulators find dangerous levels of toxins that cause Paralytic Shellfish Poisoning in tomalley of American Lobsters. This advisory applies only to tomalley and not to lobster meat.

The U.S. Food and Drug Administration today warned consumers to avoid eating tomalley from American Lobster, regardless of where the lobster was harvested, because of potential contamination with dangerous levels of the toxins that cause Paralytic Shellfish Poisoning (PSP).

American lobster are harvested from the waters of the Atlantic Ocean from Northeastern Canada to South Carolina, inclusive.

The FDA advisory applies only to tomalley, the soft, green substance found in the body cavity of the lobster that functions as the liver and pancreas. Cooking does not eliminate the PSP toxins. However, studies have shown that, even when high levels of PSP toxins are present in lobster tomalley, lobster meat itself is typically unaffected. There is no indication that consumers need to be concerned about PSP toxicity in lobster meat.

Symptoms of PSP include tingling and/or numbness of the mouth, face or neck; muscle weakness; headache; and nausea. In extreme cases, when large amounts of the toxin are consumed, these symptoms can lead to respiratory failure and death. Symptoms usually occur within two hours of exposure to the toxin. Anyone experiencing these symptoms should seek medical attention.

PSP toxins normally occur from time to time in clams and other shellfish and are carefully monitored by state regulatory authorities. The FDA learned of this problem after routine sampling conducted by regulatory authorities in Maine and New Hampshire found dangerous levels of the toxins in lobster tomalley. Some shellfish beds have been closed in recent months due to elevated levels of PSP toxins.

Lobster tomalley normally does not contain dangerous levels of PSP toxins. The current high levels of PSP toxins likely are associated with an ongoing red tide episode in northern New England and eastern Canada. Canadian authorities recommend limited consumption of lobster tomalley. However, authorities in Maine, Massachusetts and New Hampshire have issued advisories cautioning against eating any tomalley.

For more on seafood safety, please refer to http://www.cfsan.fda.gov/seafood1.html.

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