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

NY Firm Recalls Raw Macadamia Nuts After Lab Test Finds Salmonella

Sunco and Frenchie LLC of Pine Brook, New Jersey is recalling Terrafina brand Macadamia in the Raw packed in 6 oz plastic containers, because it has the potential to be contaminated with Salmonella.  The potential contamination of Salmonella was discovered through the State of New York Department of Agriculture and Markets Food Laboratory through routine testing. The company is recalling this product as FDA and Sunco and Frenchie LLC continue their investigation.  The raw macadamia nuts were manufactured by SolCaribe, S.A., Costa Rica.


https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/sunco-frenchie-llc-recalls-terrafina-brand-macadamia-raw-because-possible-health-risk
Sunco & Frenchie LLC. Recalls Terrafina Brand Macadamia in the Raw Because of Possible Health Risk
Summary
Company Announcement Date:  June 28, 2024
FDA Publish Date:  June 28, 2024
Product Type:  Food & Beverages
Reason for Announcement:  Potential Salmonella contamination
Company Name:  Sunco and Frenchie LLC
Brand Name:  terrafina
Product Description:  Macadamia in the Raw

NY Firm Recalls Salad Items for Listeria After Positive NY State Lab Test

Solata Foods LLC. of Newburgh, NY, is recalling its “Fresh Spinach” listed below because they may be contaminated with Listeria monocytogenes.   The contamination was discovered after sampling by New York State Department of Agriculture and Market Food Inspectors and subsequent analysis by Food Laboratory personnel revealed the presence of L. monocytogenes in a 9-ounce package of Bogopa “Fresh Spinach.” Production of the product has been suspended

https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/solata-foods-recalls-fresh-spinach-and-spinach-products-due-possible-health-risk
Solata Foods Recalls Fresh Spinach and Spinach Products Due to Possible Health Risk
Summary
Company Announcement Date:  June 21, 2024
FDA Publish Date:  June 27, 2024
Product Type:  Food & Beverages  Vegetable Products
Reason for Announcement:  Potential Listeria monocytogenes contamination
Company Name:  Solata Foods LLC
Brand Name:  Solata, Gaia Organic, Full Circle Organic, Farmer Direct, Uncle Vinny’s, Bogopa
Product Description:  Spinach and salad mixes

Canadian Bakery's Mislabeling Issue Results in Recall for Undeclared Walnut Allergen

FGF Brands Inc of Toronto, Ontario is recalling 11830 cases of ALDI - Bakeshop Chocolate Chip Muffin 4 count, because it may contain undeclared Walnut.   The recall was initiated after it was discovered that the walnut-containing product was distributed in packaging that did not reveal the presence of walnut. Subsequent investigation indicates the problem was caused by a temporary breakdown in the company's production and packaging processes.

https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/fgf-issues-allergy-alert-undeclared-walnuts-aldi-bakeshop-chocolate-chip-muffin-4-count
FGF Issues Allergy Alert on Undeclared Walnuts in “Aldi - Bakeshop Chocolate Chip Muffin 4 Count"
Summary
Company Announcement Date:  June 26, 2024
FDA Publish Date:  June 26, 2024
Product Type:  Food & Beverages
Reason for Announcement:  Undeclared Walnut allergen
Company Name:  FGF Brands Inc.
Brand Name:  Aldi Bake Shop Bakery
Product Description:  Chocolate Chip Muffin 4 count