2116b9af45f36c44e760b2bfe6139701See, Soy Nut Butter E. coli Outbreak

Twenty-nine people infected with the outbreak strains of E. coli O157:H7 have been reported from 12 states: Arizona 4, California 5, Florida 1, Illinois 1, Massachusetts 1, Maryland 1, Missouri 1, New Jersey 1, Oregon 9, Virginia, 2, Washington 2, and Wisconsin 1.

Illnesses started on dates ranging from January 4, 2017, to March 13, 2017. Ill people range in age from 1 to 57 years, with a median age of 8. Twenty-four of the 29 ill people are younger than 18 years. Among ill people, 59% are male. Twelve ill people have been hospitalized, and nine people developed hemolytic uremic syndrome.

Laboratory testing found the outbreak strains of E. coli O157:H7 in I.M. Healthy brand SoyNut Butter collected from the homes of ill people and from retail locations.

The FDA announced last week that on March 28, 2017, the FDA used authorities granted under the 2011 FDA Food Safety Modernization Act to suspend the food facility registration of Dixie Dew Products, Inc. (Dixie Dew) of Erlanger, Kentucky, because products manufactured in this facility may be contaminated.

Soy nut butter manufactured by Dixie Dew and sold under the brand name I.M, Healthy has been implicated in an outbreak of E. coli O157:H7.

On March 7, 2017, The SoyNut Butter Company recalled all varieties of I.M. Healthy SoyNut Butters and all varieties of I.M. Healthy Granola products. On March 10, 2017, The SoyNut Butter Company expanded its recall to include Dixie Diner’s Club brand Carb Not Beanit Butter. On March 23, 20/20 Lifestyle Yogurt Peanut Crunch Bars were recalled because they contain a recalled ingredient.

A manufacturer shuttered and product recalled, but the impact on consumers is still being felt.  Here is an email (somewhat redacted) that I received late Saturday night.

Our 11-year old son was diagnosed with E. coli. O157:H7 in January after he was admitted to the __________ Hospital on January 11, 2017.  He developed HUS and had multiple system organ failure.  He is still in the pediatric ICU on dialysis and a ventilator.  We believe that this was caused by I.M. Healthy soy nut butter and would like to discuss the possibility of a lawsuit against the manufacturer.

This outbreak will not really be over – for a lifetime – for some.

Screen Shot 2017-03-30 at 4.51.03 PMThe FDA announced this evening that on March 28, 2017, the FDA used authorities granted under the 2011 FDA Food Safety Modernization Act to suspend the food facility registration of Dixie Dew Products, Inc. (Dixie Dew) of Erlanger, Kentucky, because products manufactured in this facility may be contaminated.

Soy nut butter manufactured by Dixie Dew and sold under the brand name I.M, Healthy has been implicated in an outbreak of E. coli O157:H7.

Twenty-nine people infected with the outbreak strains of STEC O157:H7 have been reported from 12 states. Arizona 4, California 5, Florida 1, Illinois 1, Massachusetts 1, Maryland 1, Missouri 1, New Jersey 1, Oregon 9, Virginia, 2, Washington 2, and Wisconsin 1.

Illnesses started on dates ranging from January 4, 2017, to March 13, 2017. Ill people range in age from 1 to 57 years, with a median age of 8. Twenty-four (83%) of the 29 ill people are younger than 18 years. Among ill people, 59% are male. Twelve ill people have been hospitalized, and nine people developed hemolytic uremic syndrome.

The FDA’s decision to suspend the registration of Dixie Dew Products was prompted by the E. coli O157:H7 outbreak and the findings of FDA’s March 2017 inspection of Dixie Dew, which identified insanitary conditions that could lead to contamination with E. coli O157:H7 in finished products.

No food can leave the Dixie Dew facility for sale or distribution while the food facility registration is suspended.

Screen Shot 2017-03-30 at 4.50.32 PMOn March 28, 2017, the FDA issued a Suspension of Food Facility Registration Order to Dixie Dew of Erlanger, Kentucky, after an inspection revealed insanitary conditions at the firm that could affect the safety of finished products.

The FDA inspected the facility between March 3 and 15, 2017.  On March 3, 2017, Dixie Dew refused to allow FDA investigators access to the facility’s environmental sampling and production records; the FDA subsequently issued a Demand for Records under section 414 of the Federal Food, Drug, and Cosmetic Act. After receiving the Demand for Records, Dixie Dew provided FDA investigators with the necessary records. At the close of the inspection, the FDA provided Dixie Dew with a list of the investigators’ inspectional observations (Form FDA 483), noting objectionable conditions seen during the inspection. Dixie Dew responded to the report in writing with a list of actions the firm has taken to correct the conditions; however, FDA found the corrective actions were not adequate to fully address the risks that were identified, and issued the Suspension Order to prevent further illnesses from occurring.

The Suspension Order applies to the entire facility. While the order is in effect, no food product may leave the facility for sale or distribution.

Specific problems noted in the suspension order and Form 483 included (blanks reflect redacted information):

  • investigators observed grossly insanitary conditions that cause your firm’s soy nut butter products to be adulterated;
  • food contact surfaces, floors, walls, and ceilings in the soy nut butter processing and packaging rooms were heavily coated with soy nut butter build-up from previous production runs.
  • firm does not routinely wash and sanitize smaller pipes, pipe fittings, gaskets, seals, “or the rubber _____ plug” when broken down following a production run;
  • firm does not conduct a kill step for SoyNut Butter product remaining  in your firm’s mixing kettle leftover from a production run;
  • plant Manager stated, up to _____ may remain in the kettle overnight or weekend prior to resuming production. You and your Plant Manager stated the kettle is shut off when product remains in the kettle overnight and/or over the weekend;
  • plant manager and maintenance supervisor reported your _____ machine, used for fine mixing of the SoyNut Butter and ________, routinely shuts off during processing. Your Plant Manager stated this occurs one to two times per day and, this problem has persisted for approximately 15 years despite repeated maintenance intended to correct the problem;
  • firm monitors the SoyNut ______ with a ______ thermometer, but plant manager stated he has never verified the accuracy of this instrument;
  • you and your plant manager report,your temperature probe and chart recorder, initially engineered to verify and record _____ of product in the large mixing kettle, is not functioning properly and has not been used for well over a year.

FDA inspectors also noted problems with Dixie Dew’s food safety testing program, noting the company’s “failure to perform microbial testing where necessary to identify possible food contamination.” Inspectors found the testing materials on hand at Dixie Dew had expired in July 2016 and October 2015.

Problems in the Dixie Dew quality control lab were described in detail by FDA inspectors.

“An apparent fly infestation in your firm’s Quality Control and Product Development Laboratory was observed on 3/13/2017. Small apparent flies and fly larvae, too numerous to count, were inside an unplugged chest freezer,” according to the 483 report.

“A sealed blue plastic bag was inside the freezer and according to your plant manager, contained an egg product that became rotten when power was disconnected. The small apparent flies were observed along the laboratory counters and flying throughout the laboratory.”

FDA Form 483 (Inspectional Observations) for Dixie Dew Products, Inc.

Suspension of Food Facility Registration Order

big-map-3-28-17_1Since the last update on March 21, 2017, six more ill people have been reported from four states.

Twenty-nine people infected with the outbreak strains of STEC O157:H7 have been reported from 12 states. Arizona 4, California 5, Florida 1, Illinois 1, Massachusetts 1, Maryland 1, Missouri 1, New Jersey 1, Oregon 9, Virginia, 2, Washington 2, and Wisconsin 1.

Illnesses started on dates ranging from January 4, 2017, to March 13, 2017. Ill people range in age from 1 to 57 years, with a median age of 8. Twenty-four (83%) of the 29 ill people are younger than 18 years. Among ill people, 59% are male. Twelve ill people have been hospitalized, and nine people developed hemolytic uremic syndrome, a type of kidney failure. No deaths have been reported.

Laboratory testing found the outbreak strains of STEC O157:H7 in I.M. Healthy brand SoyNut Butter collected from the homes of ill people and from retail locations.

soynut-butter-productOn March 7, 2017, The SoyNut Butter Company recalled all varieties of I.M. Healthy SoyNut Butters and all varieties of I.M. Healthy Granola products. On March 10, 2017, The SoyNut Butter Company expanded its recall to include Dixie Diner’s Club brand Carb Not Beanit Butter. On March 23, 20/20 Lifestyle Yogurt Peanut Crunch Bars were recalled because they contain a recalled ingredient.

CDC recommends that consumers do not eat, and childcare centers, schools, and other institutions do not serve, any variety or size of I.M. Healthy brand SoyNut Butter, I.M. Healthy brand granola, Dixie Diner’s Club brand Carb Not Beanit Butter, or 20/20 Lifestyle Yogurt Peanut Crunch Bars, regardless of the date of purchase or the date listed on the container. Even if some of the product was eaten or served and no one got sick, throw the rest of it away. Put it in a sealed bag in the trash so that children, pets, or other animals can’t eat it.

big-map-3-17-177 with hemolytic uremic syndrome – 23 with E. coli O157:H7 in Arizona 4, California 5, Maryland 1, Missouri 1, New Jersey 1, Oregon 6, Virginia 2,  Washington 2, Wisconsin 1.

The CDC this morning updated the E. coli O157:H7 outbreak linked to I.M. Healthy and Dixie Dew Soy Nut Butter to twenty-three people infected with the outbreak strains of E. coli O157:H7 from nine states. Arizona 4, California 5, Maryland 1, Missouri 1, New Jersey 1, Oregon 6, Virginia 2,  Washington 2, Wisconsin 1.

Illnesses started on dates ranging from January 4, 2017, to March 5, 2017. Ill people range in age from 1 to 48 years, with a median age of 8. Twenty (87%) of the 23 ill people are younger than 18 years. Among ill people, 61% are male. Ten ill people have been hospitalized and seven people developed hemolytic uremic syndrome (HUS), a type of kidney failure. No deaths have been reported. Illnesses that occurred after February 24, 2017, might not yet be reported due to the time it takes between when a person becomes ill and when the illness is reported.

In interviews, ill people or their family members answered questions about the foods they ate and other exposures in the week before they became ill. Twenty (87%) of the 23 people reached for interview reported either eating I.M. Healthy brand SoyNut Butter at home (14 people) in the week before they became ill, attending a facility that served I.M. Healthy brand SoyNut Butter (2 people), or attending childcare centers that served I.M. Healthy brand SoyNut Butter and I.M. Healthy brand granola coated with SoyNut Butter (4 people). SoyNut Butter is a nut-free substitute for peanut butter. Investigators have reported to CDC two more ill people who either developed HUS or had test showing they were infected with the E. coli O157:H7 bacteria.

Laboratory testing identified E. coli O157:H7 in opened containers of I.M. Healthy brand SoyNut Butter collected from the homes of ill people in California, Oregon, and Washington. Officials in California also isolated E. coli O157:H7 in unopened containers of I.M. Healthy brand SoyNut Butter collected from retail locations. Further testing using pulsed-field gel electrophoresis (PFGE) showed that the E. coli O157:H7 in all of these containers of SoyNut Butter had the same DNA fingerprints as the E. coli O157:H7 isolates from ill people.

 

Screen Shot 2017-03-20 at 11.21.30 AMPlaintiffs in most recent complaint are parents of minor child who developed Hemolytic uremic syndrome, a life-threatening complication of E. coli infection

A lawsuit has been filed on behalf of the Seattle-area parents of a young child who was sickened after eating E. coli O157:H7 contaminated product sold by The SoyNut Butter Company of Illinois. This is the fourth lawsuit filed connected to the SoyNut Butter outbreak, but the first to directly name the product’s manufacturer: Dixie Dew Products of Erlanger, Kentucky. Up until recently, neither the FDA nor SoyNut Butter Company would not disclose the name of the product’s manufacturer. The family is being represented by Newland & Newland, LLP as well as Seattle-based food safety law firm Marler Clark, LLP, PS. The case number is 1:17-cv-02138.

The lawsuit’s plaintiffs are Travis and Morgan Stuller, who are parents to a child identified as L.S. in the complaint. In the days leading up to L.S.’s illness, she regularly consumed SoyNut Butter manufactured and sold by Dixie Dew Products and SoyNut Butter Company, respectively.

On or about February 21, 2017, L.S. developed painful gastrointestinal symptoms, which worsened to include grossly bloody diarrhea. She was seen by her treating physician for ongoing symptoms, but, on March 5, was hospitalized at Seattle Children’s Hospital and remained so until March 8. While in the hospital, an illness of E. coli O157:H7 was confirmed and she was treated for hemolytic uremic syndrome (HUS), a potentially life-threatening condition.

L.S. continues to recover at home, but faces uncertain future medical complications.

According to the Centers for Disease Control (CDC), 16 people from nine states have so far been confirmed as infected with the strain of E. coli O157:H7 connected to the SoyNut Butter outbreak. Like L.S., 14 of the 16 ill people in this outbreak are under the age of 18 and eight have required hospitalization. The affected states include includes Arizona (4), California (4), Maryland (1), Missouri (1), New Jersey (1), Oregon (2), Virginia (1), Washington (1), and Wisconsin (1).  That number is expected to increase in the coming days.

 

Last week I posted this question:

Today the SoyNut Butter Co. released the following:

For over 20 years, the SoyNut Butter Co. has tried to make nut free products that help those with allergies eat like everyone else. Likewise, we chose our contract manufacturer because of their integrity and knowledge of food safety and quality. Unfortunately, we feel that is better to be cautious regarding public safety and urge our customers to heed the expanded recall. We have enjoyed serving you and will do everything we can possibly do to assist the FDA in this outbreak.

So, who is the “real” manufacturer?

I got this email last night:

Screen Shot 2017-03-18 at 10.08.23 AM

I have some more work to do about Dixie Dew.

I never understand why companies and the FDA hide this type of information when it is going to come out anyway.  It makes companies look like they are hiding things and makes the FDA look inept or beholden to business interests.

The Canadian Food Inspection Agency has issued a nationwide recall for SoLo GI brand energy bars is in place because of possible E. coli contamination.

In a news release issued Saturday night, the agency said New Era Nutrition Inc., the company that produces the energy bars recalled the product sold nationally in stores and on the internet.

The products are:

– SoLo GI Lemon Lift 50 g (UPC 8 97024 00060 0)

– SoLo GI Lemon Lift 12 x 50 g (UPC 8 97024 00061 7)

– SoLo GI White Chocolate Cherry 50 g (UPC 8 97024 00109 6)

– SoLo GI White Chocolate Cherry 12 x 50 g (UPC 8 97024 00110 2)

– SoLo GI Pineapple Coconut 50 g (UPC 8 97024 00066 2)

– SoLo GI Pineapple Coconut 12 x 50 g (UPC 8 97024 00067 9)

What was interesting was this comment: “The agency said the recall was triggered by a recall in another country.”  The Agency does not make the link between this recall and the recent outbreak and recalls of the I.M. Healthy Soy Nut Butter in the U.S.  These SoLo bars do include soy.

20170311g_1489281594112_eng

Perhaps a mystery manufacturer of soy nut products is linked to both?

LOGO[1]AP reported this week that Arizona health officials say four cases of E. coli infections involving children at Arizona child care centers appear to be linked to eating soynut butter produced by a Glenview, Illinois-based company that is conducting a voluntary recall.

The Arizona Department of Health Services recommends consumers avoid eating the SoyNut Butter Co.’s I.M. Healthy brand soynut butter.

The department says the four cases occurred in January in Coconino and Maricopa counties and involved children under age 5. All have recovered from the illness.

Soyonut Butter Co.’s voluntary recall is for I.M. Healthy Original Creamy SoyNut Butter with the “Best By” date of Aug. 30 or 31 of 2018.

Lynne Terry reported today that County health officials are investigating an E. coli outbreak at a Montessori school in Northeast Portland that may also be linked to the SoyNut Butter Co.’s I.M. Healthy brand soynut butter.

At least four people at the school, Montessori of Alameda, have been infected, according to the Multnomah County Health Department. They include three preschool children and an adult.

Others have been tested, and the county awaits those results, said Dr. Paul Lewis, the tri-county health officer, in an email.

CDC, multiple states, and the U.S. Food and Drug Administration (FDA) are investigating a multistate outbreak of Shiga toxin-producing Escherichia coliO157:H7 (STEC O157:H7) infections.

Sixteen people infected with the outbreak strains of STEC O157:H7 have been reported from nine states:  Washington, Oregon, California, Arizona, Wisconsin, Missouri, Virginia, Maryland and New Jersey

Eight ill people have been hospitalized. Five people developed hemolytic uremic syndrome, a type of kidney failure, and no deaths have been reported.

Fourteen of the 16 ill people in this outbreak are younger than 18 years old.

ucm545298Illnesses reported in Connecticut, New Your and Vermont – and possibly other States – at least one and perhaps two deaths.  See, Vulto Creamery Cheese Listeria Lawsuit

Vulto Creamery, Walton, New York, is recalling all lots of Ouleout, Miranda, Heinennellie, and Willowemoc soft wash-rind raw milk cheeses  out of an abundance of caution due to testing result from the US Food & Drug Administration (FDA), which found Ouleout lot # 617 positive for Listeria monocytogenes and New York Department of Agriculture and Markets finding the possible contamination of Ouleout lot #623.

Product photos of all four cheese items being recalled along with a brief description are shown.  If you have any of this soft, wash-rind raw-milk cheese, please do not consume it.  The soft raw milk cheeses were distributed nationwide, with most being sold at retail locations in the Northeastern and Mid-Atlantic States, California, Chicago, Portland and Washington, DC.

Consumers that have any of these soft raw milk cheeses from Vulto Creamery should return the cheese to the purchase location for a refund.  Food and cheese wholesalers and retailers with any of the Vulto Creamery soft, wash-rind raw milk cheeses on hand should immediately remove these products from common storage coolers and quarantine these cheeses in a secured area of a cooler.  Any wholesaler or distributor that has any of the four cheeses should contact Vulto Creamery to receive instructions on what to do with the cheese.   The production of the product has been suspended while FDA and the company  continue to investigate the source of the problem.

15892120388_d11e1ac418_o-1488640033-2461Today the SoyNut Butter Co. released the following:

Please note that the SoyNut Butter Co. has expanded our voluntary recall to include ALL I.M. Healthy SoyNut Butters and I.M. Granola effective immediately. Regardless of Best Buy date or variety, we recommend that you do not consume I.M. Healthy SoyNut Butter or I.M. Healthy Granola and return it to the store full a full refund.

For over 20 years, the SoyNut Butter Co. has tried to make nut free products that help those with allergies eat like everyone else. Likewise, we chose our contract manufacturer because of their integrity and knowledge of food safety and quality. Unfortunately, we feel that is better to be cautious regarding public safety and urge our customers to heed the expanded recall. We have enjoyed serving you and will do everything we can possibly do to assist the FDA in this outbreak.

With 16 people with E. coli O157:H7, mostly children, many with life-threatening hemolytic uremic syndrome, a broad and expanded recall was warranted.  However, what struck me most was the bolded and italicized sentence above.  My guess is that most, if not all, customers purchasing these SoyNut Butter products thought it was not being “contract manufacture[d].”

So, who is the “real” manufacturer?