Wednesday, July 3, 2024

Salmonella Outbreak Linked to Cucumbers - Outbreak Strain Found in Grower's Canal Water

Bedner Growers, Inc. in Florida has been identified as the source of Salmonella contaminated cucumbers that have caused 449 reported cases of illness.  FDA found the outbreak Salmonella strains in the canal water.
"FDA collected samples at the grower in Florida and identified Salmonella Braenderup in untreated canal water. WGS determined that the Salmonella found in the water is the same strain of Salmonella Braenderup that made people in this outbreak sick. Additional soil and water samples collected at Bedner Growers, Inc. were positive for other strains of Salmonella. CDC and FDA are looking to see if these strains have caused illness in people."
Of the 449 reported cases, 125 people have been hospitalized.
"As of July 2, a total of 449 people infected with one of the outbreak strains of Salmonella Africana and Salmonella Braenderup have been reported from 31 states and the District of Columbia (see map). Of these illnesses, 215 people were infected with the newly added Salmonella Braenderup strain. Illnesses started on dates ranging from March 11, 2024, to June 4, 2024 (see timeline). Of 360 people with information available, 125 have been hospitalized and no deaths have been reported."

CDC
https://www.cdc.gov/salmonella/africana-06-24/index.html
Salmonella Outbreak Linked to Cucumbers
Posted July 2, 2024

Fast Facts
Illnesses: 449 (38 new Africana, 215 Braenderup new)
Hospitalizations: 125 (11 new Africana, 50 Braenderup new)
Deaths: 0
States: 31 states and the District of Columbia (1 new Africana, 26 Braenderup)
Recall: Yes
Investigation status: Active (first posted on June 5, 2024)

Outbreak Investigation Summary
Epidemiologic, traceback, and laboratory data show that cucumbers were contaminated with Salmonella and made people sick. Testing identified the Salmonella Braenderup strain in untreated canal water used by a grower in Florida. Cucumbers from this grower are no longer in season and any sold previously are no longer on shelves.

NC Facility Recalls Raw Pet Food After Inspection Samples Positive for Listeria

Viva Raw LLC, Hillsborough, NC is voluntarily recalling dog and cat foods, including the Viva Turkey for Dogs Ground, Viva Turkey for Dogs Chunked, Viva Turkey for Cats, Viva Pure Turkey, and Viva Beef & Turkey for Puppies all manufactured under Lot 21244 because this lot, which includes these five products are contaminated with Listeria monocytogenes and is a potential health risk to people and pets.

The issue was discovered during a facility inspection conducted by the U.S. Food and Drug Administration (FDA) and The North Carolina Department of Agriculture (NCDA). The FDA tested samples of Viva Turkey for Dogs and found samples from Lot 21244 were positive for Listeria monocytogenes. All products produced in Lot 21244 were slated for destruction. However, we have since learned some of the product from this lot was inadvertently released from the warehouse.
No illnesses related to this lot have been reported to date.

A few items to point out....1) If one lot is positive for Listeria, it is likely other lots are positive for Listeria unless tight controls were in place for those other lots and not this lot, and 2) Allowing suspect product to be shipped indicates a lack of tight food safety related SOPs

https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/viva-raw-issues-voluntary-recall-dog-and-cat-food-including-select-viva-turkey-recipes-lot-21244-due
Viva Raw Issues Voluntary Recall of Dog and Cat Food Including Select Viva Turkey Recipes (Lot 21244) Due to Potential Listeria Monocytogenes Health Risk to People and Pets
Summary
Company Announcement Date:  July 01, 2024
FDA Publish Date:  July 01, 2024
Product Type:  Animal & Veterinary  Food & Beverages  Animal Feed
Reason for Announcement:  Listeria monocytogenes
Company Name:  Viva Raw, LLC
Brand Name:  Viva
Product Description:  Raw dog and cat food

Tuesday, July 2, 2024

Ongoing Salmonella Outbreak Associated with Backyard Chickens

CDC is reporting on an ongoing Salmonella outbreak associated with backyard chickens.  "As of June 20, 2024, 195 people infected with one of the outbreak strains of Salmonella have been reported from 38 states (see map). Illnesses started on dates ranging from February 18, 2024, to May 30, 2024 (see timeline). Of 136 people with information available, 50 (37%) have been hospitalized. No deaths have been reported."

"Of 45 people with information available, 36 (80%) reported purchasing or obtaining poultry before their illness started. People reported purchasing poultry from multiple retail stores or directly from a hatchery. Multiple hatcheries supplied birds to the retail stores. A common poultry supplier has not been identified across all outbreaks."

Investigators in Minnesota, Ohio, and Utah collected samples from inside the boxes used to ship poultry from hatcheries to retail stores, including the box liner and bedding. WGS showed that the Salmonella Altona, Cerro, and Mbandaka found in these samples are the same strains as the ones found in sick people.

https://www.cdc.gov/salmonella/backyardpoultry-05-24/index.html
Salmonella Outbreaks Linked to Backyard Poultry
Posted June 27, 2024

Fast Facts
Illnesses: 195 (86 new)
Hospitalizations: 50 (17 new)
Deaths: 0
States: 38 (9 new)
Investigation status: Active (first posted on May 23, 2024)

Monday, July 1, 2024

Lancaster Country (PA) Bakery Issued Warning Letter

FDA issued a Warning Letter to McClure’s Lancaster Old Fashioned, LLC, a processor of ready-to-eat (RTE) bakery products located in Bowmansville, PA, 17507.  McClure's is a self-described Amish bakery.  (Located in the heart of Amish Country, McClures Bakery has been bringing delicious Amish baked goods to our customers for more than 50 years. The bakers at our family-owned and operated bakery specialize in making shoofly pies, cakes, bread, and other traditional recipes using the finest ingredients.)
  • Did not have a hazard analysis completed for all products.
  • Did not identify Salmonella as a hazard requiring a preventive control.
  • Did not identify and evaluate recontamination with environmental pathogens (e.g., Salmonella and L. monocytogenes) as a known or reasonably foreseeable hazard
  • did not identify and evaluate allergens as a known or reasonably foreseeable hazard to determine whether allergens are a hazard requiring a preventive control
  • Duct tape is not a sanitary fix - Investigator observed production of Country Maid Creme Filled Doughnuts with Lot Code: 263 and noted duct tape at the joints of the grey PVC pipe which appeared uncleanable and was located directly above exposed creme inside the doughnut filler-hopper.
  • Added allergen to Contains statement although not used in formulation - "labeling is false or misleading because “peanut” is declared in the “Contains” statements; however, “peanut” is not an ingredient in the formulations of these products. You stated that this was done as a mitigation strategy for the identified reasonably foreseeable hazard of “Allergen cross contamination.” However, FDA expects food manufacturers to follow the CGMP and PC rule to prevent the unintentional incorporation of allergens into foods which are not formulated to contain them. Labeling is not a substitute for adherence to the CGMP and PC rule. Instead, firms must comply with the applicable CGMP and PC requirements to address allergen cross-contact."
  • A number of labeling-related issues.

https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/mcclures-lancaster-old-fashioned-llc-670611-05162024
McClure’s Lancaster Old Fashioned, LLC
MARCS-CMS 670611 — MAY 16, 2024

Recipient:
Mr. Thomas Keenan
Owner & President
McClure’s Lancaster Old Fashioned, LLC
1212 Reading Road
Bowmansville, PA 17507
United States

FDA Issue Warning Letter to Dollar Tree for Failure to Remove Lead-contaminated Apple Sauce from Shelves

FDA issued a Warning Letter to Dollar Tree retailer for failing to stop selling the lead-contaminated cinnamon apple sauce after the recall was announced by WanaBana.  As you may recall, this was the imported apple sauce that used cinnamon adulterated with lead chromate.

From the Warning Letter, "On October 29, 2023, Wanabana USA initiated a voluntary recall of all WanaBana Apple Cinnamon Fruit Puree pouches. As a consignee of the recalled products, Dollar Tree Inc. (Dollar Tree or you) was notified in writing, on October 29, 2023, of Wanabana USA’s voluntary recall of Apple Cinnamon Fruit Puree pouches. Subsequent recall audit checks of your Dollar Tree and Family Dollar/Dollar Tree combination stores (collectively referred to as your “Dollar Tree stores”) revealed that you continued to offer the recalled WanaBana Apple Cinnamon Fruit Puree pouches on store shelves well after the recall was initiated, despite FDA’s numerous attempts to bring this serious issue to your attention."

Basically, lead-contaminated product was left available to be sold for more than a month.  Here is a management team that needs to be held responsible.  Guess what, this Dollar Tree also owns Family Dollar....that same one with the rat infestation issue.


https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/dollar-tree-inc-674301-06112024
WARNING LETTER
Dollar Tree Inc.

MARCS-CMS 674301 — JUNE 11, 2024

FDA Issue Warning Letter to Bakery for Bad Labeling Decisions

FDA issued a Warning Letter to a PA bakery operation.  The primary issue was putting allergens in the Contains statement, but not including those items in it the formulation.

The "bread loaf products are misbranded within the meaning of section 403(a)(1) of the Act [21 U.S.C. § 343(a)(1)] in that the product labels are false or misleading because they include sesame seeds in the ingredient and “Contains” statements; however, sesame seed is not an ingredient in the product formulations. The Brownberry brand Whole Grains 12 Grains and Seeds RTE bread loaf product is misbranded for a similar reason; the product label includes walnuts, almonds, and hazelnuts in the ingredient and “Contains” statements; however, these nuts are not ingredients in the formulation of the product. FDA expects food manufacturers to follow good manufacturing practices and implement preventive controls to prevent the unintentional incorporation of allergens into foods which are not formulated to contain them. Labeling is not a substitute for adherence to good manufacturing practices or implementation of preventive controls."

The company also tried to say brown sugar was a natural flavor.  "Flavor were not declared on the label, and you stated that the Brown Sugar Powder and the (b)(4) ingredients meet the definition of “Natural Flavors” and are considered to be included as that on the label. According to 21 CFR § 101.22(a)(3), the term “natural flavor” means “the essential oil, oleoresin, essence or extractive, protein hydrolysate, distillate, or any product of roasting, heating or enzymolysis, which contains the flavoring constituents derived from a spice, fruit or fruit juice, vegetable or vegetable juice, edible yeast, herb, bark, bud, root, leaf or similar plant material, meat, seafood, poultry, eggs, dairy products, or fermentation products thereof, whose significant function in food is flavoring rather than nutritional.” Natural flavors include the natural essence or extractives obtained from plants listed in 21 CFR §§ 182.10, 182.20, 182.40, and 182.50 and Part 184, and the substances listed in 21 CFR § 172.510. If these ingredients do not meet the definition of natural flavor contained in 21 CFR § 101.22(a)(3), they may not be declared as such on the label."


https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/bimbo-bakeries-usa-inc-672140-06172024
WARNING LETTER

Bimbo Bakeries USA, Inc.

MARCS-CMS 672140 — JUNE 17, 2024

FDA Study Confirms Milk Pasteurization Will Inactivate Highly Pathogenic H5N1 Avian Influenza

FDA along with USDA announced that they completed a study that confirms pasteurization is effective at inactivating Highly Pathogenic H5N1 Avian Influenza (H5N1 HPAI) virus in fluid milk and other dairy products made from pasteurized milk.  "The study – the only one to date designed to simulate commercial milk processing – found that the most commonly used pasteurization time and temperature requirements were effective at inactivating the H5N1 HPAI virus in milk. These results complement the FDA’s initial retail sampling study in which all 297 samples of dairy products collected at retail locations were found to be negative for viable H5N1 HPAI virus."

https://www.fda.gov/food/alerts-advisories-safety-information/updates-highly-pathogenic-avian-influenza-hpai
Updates on Highly Pathogenic Avian Influenza (HPAI)

June 28, 2024

The FDA, along with our federal partners at the U.S. Department of Agriculture, is announcing results from a first-of-its-kind study using the process typically used by commercial milk processors. The intention of this study was to further confirm that pasteurization is effective at inactivating Highly Pathogenic H5N1 Avian Influenza (H5N1 HPAI) virus in fluid milk and other dairy products made from pasteurized milk.

Minnesota Establishment Recalls Egg Products for Undeclared Milk Due to Mis-packaging Issue

M.G. Waldbaum dba Michael Foods Inc., a Gaylord, Minn. establishment, is recalling approximately 4,620 pounds of liquid egg products due to misbranding and undeclared allergens...the product contains dairy (milk) which is not declared on the label.  The problem was discovered during a routine carton inventory evaluation. The establishment notified FSIS when it discovered that a limited amount of Whole Egg with Citric Acid cartons was unaccounted for, and there was a corresponding excess of Breakfast Blend Scrambled Egg carton in inventory. The establishment investigated and determined that the unaccounted Whole Egg with Citric Acid cartons were inadvertently utilized during a single short Breakfast Blend Scrambled Egg production run. The Breakfast Blend formulation contains an allergen, a dairy ingredient (milk), which is not declared on the Whole Egg with Citric Acid label.

USDA does not have the same allergen preventive control requirements as FDA, however, this is an example where those types of controls could prevent this type of issue.  However, it was an inventory check that informed the company that something was wrong.

https://www.fsis.usda.gov/recalls-alerts/michael-foods-inc--recalls-fair-meadow-foundations-liquid-egg-products-due
Michael Foods Inc. Recalls Fair Meadow Foundations Liquid Egg Products Due to Misbranding and Undeclared Allergens

WASHINGTON, June 30, 2024 – M.G. Waldbaum dba Michael Foods Inc., a Gaylord, Minn. establishment, is recalling approximately 4,620 pounds of liquid egg products due to misbranding and undeclared allergens, the U.S. Department of Agriculture’s Food Safety and Inspection Service (FSIS) announced today. The product contains dairy (milk), a known allergen, which is not declared on the product label.

CA Company Recalls Products with Mushroom Bioactive Compounds

Prophet Premium Blends of Santa Ana, California is recalling Diamond Shruumz Infused Cones, Chocolate Bars, and Gummies (Micro- and Mega/Extreme-Dose), because such products contain Muscimol, a chemical found in mushrooms of the genus Amanita; Muscimol could be a potential cause of symptoms consistent with those observed in persons who became ill after eating Diamond Shruumz products. Reported symptoms have included those linked to seizures, agitation, involuntary muscle contractions, loss of consciousness, confusion, sleepiness, nausea and vomiting, abnormal heart rates, and hyper/hypotension.

At this time, there are 39 illnesses that have been reported to date. States with cases include: AL, AZ, CA, CO, GA, IN, IA, KY, MD, MN, MO, MT NV, NJ, NY, NC, OH, PA, SC, TN. Reported symptoms have included those linked to central nervous system excitation (e.g., seizures, agitation, and involuntary muscle contractions), central nervous system depression (e.g., loss of consciousness, confusion, and sleepiness), gastrointestinal symptoms (e.g., nausea and vomiting), and cardiovascular involvement (e.g., abnormal heart rates and hyper/hypotension).

As posted earlier this month, FDA issued a health warning on this product.  The recall was not initally issued.  As stated in this posting, "To date, Prophet Premium Blends received two (2) complaints (on May 27, 2024), regarding consumers becoming ill after consuming the entire chocolate bar. Upon receiving the complaints, we reviewed the products’ Certificates of Analysis (COAs) which showed higher than normal amounts of Muscimol. Prophet Premium Blends initiated this Recall and has ceased the production and distribution of the Diamond Shruumz product line as the FDA and Prophet Premium Blends continues their investigation as to what is the cause of the serious adverse effects."

On Muscimol from Wikipedia, "Muscimol, a psychoactive compound derived from the ibotenic acid found in certain mushrooms, particularly Amanita muscaria, has garnered significant interest due to its unique effects on the nervous system. Muscimol binds to GABA receptors in the brain, resulting in its sedative and hallucinogenic properties.[39] Muscimol-based products are currently being investigated for their potential therapeutic applications, especially in the treatment of anxiety, insomnia, and other neurological disorders.[40][41] The psychoactive nature of muscimol necessitates stringent regulation and cautious usage to ensure safety.[42] However, ongoing research aims to harness its medicinal benefits in a controlled context, highlighting the broader scientific interest in natural compounds as potential sources for novel medical treatments.[43][44]"

https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/prophet-premium-blends-recalls-diamond-shruumz-products-because-possible-health-risk
Prophet Premium Blends Recalls Diamond Shruumz Products Because of Possible Health Risk
Summary
Company Announcement Date:  June 27, 2024
FDA Publish Date:  June 28, 2024
Product Type:  Food & Beverages
Reason for Announcement:  Toxic levels of muscimol
Company Name:  Prophet Premium Blends
Brand Name:  Diamond Shruumz
Product Description:  Infused Cones, Chocolate Bars, and Gummies