Food Poisoning Lawyer & Attorney : Marler Clark : Food Poison Journal

The FDA has announced the recall of Haifa Smoked Fish brand vacuum packaged Whole Schmaltz Herring with the lot number 20, because the product was found to be uneviscerated.  The risk to consumers is that, due to the errors in production, the fish may be contaminated with clostridium botulinum.

The lot being recalled is a product of Norway, individually vacuum-packed in clear plastic pouches with lot # 20 indicated on the label and distributed through various food retailers in the NY and NJ area. 

The Whole Schmaltz Herring was sampled by a New York State Agriculture and Markets Food Inspector during a routine inspection. Subsequent analysis of the product by New York State Food Laboratory personnel confirmed that Whole Schmaltz Herring was not properly eviscerated prior to processing. 

The sale of uneviscerated fish is prohibited under New York State Agriculture and Markets regulations because of Clostridium Botulinum spores are more likely to be concentrated in the viscera than any other portion of the fish. Uneviscerated fish has been linked to outbreaks of botulism poisoning. 

Botulism is a serious and potentially fatal form of food poisoning, causes the following symptoms: general weakness, dizziness, double-vision and trouble with speaking or swallowing. Difficulty in breathing, weakness of other muscles, abdominal distension and constipation may also be common symptoms. People experiencing these problems should seek immediate medical attention. 

Haifa Smoked Fish, Inc's troubled past

On November 13, 2009, The U.S. Department of Justice, on behalf of the U.S. Food and Drug Administration, filed a complaint for permanent injunction against seafood processor Haifa Smoked Fish Inc. of Jamaica, N.Y., and two of its top officers for violations of the Federal Food, Drug and Cosmetic Act.

The injunction was sought to prevent the company from further manufacture, distribution, and sale of its products. “This company has consistently failed to make corrections to improve the insanitary conditions under which it processes smoked fish products, despite frequent warnings to do so,” said Michael Chappell, the FDA’s acting associate commissioner for regulatory affairs. “The FDA will not tolerate food companies that fail to provide adequate safeguards to protect the public.”

The company processes and distributes brined, cold-smoked, and hot-smoked fish and fishery products. The violations documented by the FDA pose a public health hazard because, without adequate controls, products made by Haifa Smoked Fish could become contaminated with (L. mono) or other pathogens and could cause serious illnesses.

“The public must be able to trust that the food in their grocery stores is safe for them to eat,” said Benton J. Campbell, the United States Attorney for the Eastern District of New York. “We will continue to work with the FDA to ensure that companies that produce food under dangerous or insanitary conditions take corrective action to clean up their act.”

Since 2001, the FDA and the New York State Department of Agriculture and Markets (NYSDAM) have inspected the Haifa Smoked Fish facility on numerous occasions. The inspections revealed insanitary conditions that could lead to the contamination of the finished product with L. monoor other pathogenic microorganisms. The act refers to unsanitary conditions as insanitary.

FDA analyses of samples taken during the inspections revealed that food products and environmental surfaces, including food-contact surfaces, were contaminated with L. mono. The company also continually failed to comply with FDA’s Hazard Analysis and Critical Control Point (HACCP) regulations. HAACP regulations require that seafood processors identify all food safety hazards likely to occur for each kind of seafood product, and develop and implement adequate plans to prevent and control those hazards.

The FDA issued warning letters to Haifa Smoked Fish in 2001 and 2004. In response, company officers promised to correct the violations. Subsequent inspections, however, revealed that the company did not make the corrections.
 

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It may surprise some people to learn that the often-lethal toxins produced by the Clostridium botulinum bacteria, which cause botulism illnesses, are a chief ingredient in certain cosmetic/medical products.  In fact, the FDA recently updated its safety warnings about medical products that contain botulism toxins.  The FDA advisory concerns four drugs specifically: Botox, Botox Cosmetic, Myobloc, and Dysport.  The safety warning states, in part, as follows: 

The boxed warning cautions that the effects of the botulinum toxin may spread from the area of injection to other areas of the body, causing symptoms similar to those of botulism. Those symptoms include potentially life-threatening swallowing and breathing difficulties and even death.

These symptoms have mostly been reported in children with cerebral palsy being treated with botulinum toxin for muscle spasticity, a use of the drugs that has not been approved by FDA. Symptoms have also been reported in adults treated both for approved and unapproved uses.

***

No definitive serious adverse event reports of distant spread of toxin effect have been associated with dermatologic use of Botox/Botox Cosmetic at the recommended doses (for frown lines between the eyebrows or severe underarm sweating). As well, no definitive serious adverse event reports of distant spread of toxin effect have been associated with Botox when used at approved doses for eyelid twitches or for crossed eyes.

A few words about botulism:

Botulism is a rare but serious paralytic illness caused by a nerve toxin that is produced by the bacterium Clostridium botulinum.  (see www.about-botulism.com)  Clostridium botulinum is the name of a group of bacteria commonly found in soil. It is an anaerobic, gram-positive, spore-forming rod that produces a potent neurotoxin. These rod-shaped organisms are intolerant of oxygen. The bacteria form spores, which allow them to survive in a dormant state until exposed to conditions that can support their growth. The organism and its spores are widely distributed in nature. They occur in both cultivated and forest soils, bottom sediments of streams, lakes, and coastal waters, in the intestinal tracts of fish and mammals, and in the gills and viscera of crabs and other shellfish.

Four types of botulism are recognized: foodborne, infant, wound, and a form of botulism whose classification is as yet undetermined. Foodborne botulism is the name of the disease (actually a foodborne intoxication) caused by the consumption of foods containing the neurotoxin produced by C. botulinum.

Foodborne botulism (as distinct from wound botulism and infant botulism) is a severe type of food poisoning caused by the ingestion of foods containing the potent neurotoxin formed during growth of the organism. The toxin is heat labile and can be destroyed if heated at 80°C for 10 minutes or longer. The incidence of the disease is low, but the disease is of considerable concern because of its high mortality rate if not treated immediately and properly. Most of the 10 to 30 outbreaks that are reported annually in the United States are associated with inadequately processed, home-canned foods, but occasionally commercially produced foods have been involved in outbreaks. Sausages, meat products, canned vegetables and seafood products have been the most frequent vehicles for human botulism.

How are botulism toxins used medically?

Clostridium botulinum bacteria produce seven different varieties of toxins, A through G.  Botulism toxins are the most acutely toxic substance known; a single teaspoon of the stuff is potent enough to kill about one-sixth of the world's population.  The toxins work by attaching themselves at neuromuscular junctions--i.e. the nerve endings of muscles.  There the toxins disrupt nerve impulses, thereby causing what's called flaccid (sagging) paralysis of the affected muscles.

There are surprisingly many ways that this devastating, often lethal neurotoxin, is used in medicine.  Aside from the common uses of Botox, botulism toxins have been used medically to treat excessive muscle contractions or twitching following a brain or spinal cord injury or in the context of cerebral palsy; strabismus (crossed eyes); as well as diseases of excessive sweating or drooling by reducing glandular secretions.   And these are just a few.  

But at what cost, or risk, are these lethal neurotoxins used for medical benefit?  The administration of a potent neurotoxin cannot be without its risks, and there are certainly plausible routes--e.g. the circulating bloodstream--by which the toxins could invade "more important" muscles and organs, like the heart or lungs.  Although the FDA qualifies its warning by stating "No definitive serious adverse event reports of distant spread of toxin effect have been associated with dermatologic use of Botox/Botox Cosmetic at the recommended doses," I suppose these kinds of potentially lethal complications are the "adverse events" being spoken of.   

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I moved to Seattle in 2002 and have never experienced a heat wave in late May and early June like the one we are enjoying now. There are few places I'd rather be than Seattle in the summertime, and to our benefit this year, everyone in the Seattle area who planted their garden around Mother's Day is enjoying watching their tomatoes bloom, mint grow full, and and snow peas sprout.

Where I grew up, every one of my neighbors had a huge, amazing garden full of strawberries, corn, potatoes, pumpkins, and a variety of other vegetables. We kids complained every summer while we weeded rows and picked potato bugs off leaves, but we loved the fresh produce on our dinner tables. Unfortunately, most of our moms decided to stop gardening when we kids got old enough to hold jobs and the free weeding disappeared. One of my neighbors, however, continues in the tradition of her Midwest roots and grows massive amounts of tomatoes, pickles, and other veggies that are great for canning and can be enjoyed year-round.

Because my neighbor has canned for as long as she can remember, she is fully aware of the food safety risks improperly canned foods can pose to an unassuming person. I never worry about suffering botulism poisoning when I eat her canned salsa, but people who are new to canning should read up before jumping in to what can be an extremely dangerous endeavor.

Connie Aclin, extension educator with the LSU AgCenter, wrote a recent article about the necessity for following proper canning procedures to prevent foodborne illness, particularly botulism, that appeared in the Shreveport Times:

For example, pressure canning is the only recommended method for canning meat, poultry, seafood and vegetables. The bacterium Clostridium botulinum is destroyed in low-acid foods when they are processed at the correct time and pressure in pressure canners. Other methods, like boiling water bath or "open-kettle" methods for these foods poses a real risk for botulism poisoning.

Whether food should be processed in a pressure canner or boiling-water canner to control botulinum bacteria depends on the acidity in the food. Acidity may be natural, as in most fruits, or added, as in pickled foods. Low-acid canned foods contain insufficient acidity to prevent the growth of these bacteria.

Botulism is a serious, sometimes deadly, illness caused by the bacterium Clostridium botulinum. When ingested, the bacterium produces a toxin, which causes paralysis. Classic symptoms of botulism include double vision, blurred vision, drooping eyelids, slurred speech, difficulty swallowing, dry mouth, and muscle weakness. Infants with botulism appear lethargic, feed poorly, are constipated, and have a weak cry and poor muscle tone. These are all symptoms of the muscle paralysis caused by the bacterial toxin. If untreated, these symptoms may progress to cause paralysis of the arms, legs, trunk, and respiratory muscles. In foodborne botulism, symptoms generally begin 18 to 36 hours after consuming contaminated food, but they can occur as early as 6 hours or as late as 10 days after consumption.

Botulinum toxin causes flaccid paralysis by blocking motor nerve terminals at the myoneural junction. The flaccid paralysis progresses symmetrically downward, usually starting with the eyes and face, then moving to the throat, chest, and extremities. When the diaphragm and chest muscles become fully involved, respiration is inhibited and unless the patient receives treatment in time, death from asphyxia results.

If you're planning to can this summer of fall, call your local university extension office about proper canning procedures to prevent botulism. The Oregon State University Extension offers online information and a hotline you can call with canning questions.

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New Era Canning Company said it was recalling 171 cases of GFS Fancy Blue Lake Cut Green Beans with the lot code 19H7FL. Each case contained six cans in 6-pound, 5-ounce sizes.

The canned green beans were distributed to foodservice customers in Alabama, Arkansas, Georgia, Illinois, Indiana, Kentucky, Mississippi, Missouri, North Carolina, Tennessee and Virginia, a company statement said. They were sold through GFS Marketplace stores in Indiana, Kentucky and Tennessee.

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The company was green-lighted to reopen the plant last week by both the U.S. Food and Drug Administration and the U.S. Department of Agriculture, said Dave Melbourne, a senior vice president at the company, in a prepared statement.

However, the production line that made the hot dog chili sauce will not placed into operation yet, company officials said.

"The investigation conducted by Castleberry's and by the regulatory agencies determined that mechanical issues with one processing system were the cause of any contamination," Melbourne said.

Melbourne did not give additional detail about the mechanical issues.

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