FDA Issues Warning Letters to Five Importers for Not Developing FSVP

FDA issued Warning Letters to five food imports for not developing, maintaining, and implementing an FSVP as required by section 805 of the FD&C Act and 21 CFR 1.502(a).   FSVP is required for food importers to ensure that their foreign producers are meeting same standards required in the US.

Lempira Distribution LLC of. Miami, FL did not develop FSVPs for the imported food products including, but not limited to:
Banana Soft Drink, imported from (b)(4), located in (b)(4).
Sweet Bread, imported from (b)(4), located in (b)(4).
Plantain Chips, imported from (b)(4).
https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/lempira-distribution-llc-616514-11032021

LECS USA, Inc. of Los Angeles, CA did not develop an FSVP for any of their imported foods including Green Tea

https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/lecs-usa-inc-623164-03282022

Fres Co, LLC of Bronx, NY did not develop an FSVP for any of the their imported foods including the following:
Fresh plantains from (b)(4)
Fresh mangoes from (b)(4)
Tomatoes from (b)(4)
https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/fres-co-llc-627216-04182022

El Dorado Imports Inc of Spring, Texas. did not develop an FSVP for any of their imported food products  including:
Coconut candy imported from (b)(4)
Sugar baked flour tortillas imported from (b)(4)
Sweet bread with pineapple imported from (b)(4)
https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/el-dorado-imports-inc-626870-04262022

Triple J Fresh, LLC of McAllen, Texas did not develop an FSVP for any of their imported foods including:

Fresh broccoli and fresh coriander imported from (b)(4), located in (b)(4), and 

Fresh Persian limes imported from (b)(4), located in (b)(4).
https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/triple-j-fresh-llc-627680-04252022

FDA Provides Conditions for Troubled Infant Formula Facility to Reopen

FDA has agreed to allow Abbott Laboratories to resume operations if Abbott meets conditions outlined on consent decree.  The plant could be operating within a few weeks although it will take a few months before product will be back on the retail shelves.  The loss of this facility's production has created a supply shortage in overall infant formula market.

Regulatory officials have not found a direct link of illnesses to the facility, different strains of the organism Cronobacter sakazakii were found in the facility.

Company Press Release
https://abbott.mediaroom.com/2022-05-16-Abbott-Enters-into-Consent-Decree-with-U-S-Food-and-Drug-Administration-for-its-Sturgis,-Mich-,-Plant-Agreement-Creates-Pathway-to-Reopen-Facility
ABBOTT ENTERS INTO CONSENT DECREE WITH U.S. FOOD AND DRUG ADMINISTRATION FOR ITS STURGIS, MICH., PLANT; AGREEMENT CREATES PATHWAY TO REOPEN FACILITY

• After FDA approval, Abbott could restart the site within two weeks; from the time of restart it would take six to eight weeks before product is available on shelves
• Abbott will continue to import formula from FDA-registered facility in Ireland to help alleviate near-term supply shortage
• CDC concluded its investigation with no findings of a link between Abbott formulas and infant illnesses

What's In Your Fast Food Milkshake? Hopefully Not Tinkle

A manager at an Arby's restaurant in Vancouver WA , already under investigation for pedophilia, was found through videos on his phone to have urinated in milkshake mix that was then served to customers.  While completely disgusting, it should pose no health risk.

The Guardian
https://www.theguardian.com/us-news/2022/may/16/arbys-washington-urinating-milkshake
Arby’s manager accused of urinating in milkshake mix
Washington police uncovered the video as they executed a search warrant on his phone as part of child abuse image investigation

A manager at an Arby’s fast-food restaurant in Washington state has been accused of urinating into a milkshake mix that might then have been served to dozens of people.

Health Alert Issued For Ground Meat Sold by Whole Foods Due to Complaints of Plastic Pieces in Product

The U.S. Department of Agriculture’s Food Safety and Inspection Service (FSIS) is issuing a public health alert for raw ground beef products due to concerns that the ground beef may contain hard plastic. A recall was not requested because the products are no longer available for purchase. The problem was discovered after the firm received complaints from consumers reporting they found hard, rigid plastic in the ground beef products. The firm then notified FSIS of the issue. The product, sold through Whole Foods, was produced by NPC Processing Inc. of Shelburne VT.

https://www.fsis.usda.gov/recalls-alerts/fsis-issues-public-health-alert-raw-ground-beef-products-due-foreign-material
FSIS Issues Public Health Alert for Raw Ground Beef Products Due to Foreign Material Contamination
NPC PROCESSING INC.
FSIS Announcement

Ohio Company Recalls Bacon Jam Product After Label Misses Soy Allergen Declaration

Mrs Miller’s Homemade Jams in Fredericksburg OH is voluntarily recalling its Smokey BBQ Bacon Jam and Spicy Chili Bacon Jam, packaged in 9 oz glass jars. The recall is due to an undeclared soy allergen found in the Worchestire Sauce and Hickory Smoke ingredients used in these jams. This recall has been initiated due to the ingredient label not stating a soy allergen.

Here is an example of where the label design process needs to include allergen control procedures.

https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/mrs-millers-homemade-jams-issues-voluntary-recall-due-undeclared-soy-allergen
Mrs Miller’s Homemade Jams Issues Voluntary Recall Due to an Undeclared Soy Allergen
Summary
Company Announcement Date:  May 09, 2022
FDA Publish Date:  May 13, 2022
Product Type:  Food & Beverages
Reason for Announcement:  Undeclared soy
Company Name:  Mrs Millers Homemade Jams
Brand Name:  Mrs Millers Homemade Jams
Product Description:  Smokey BBQ Bacon Jam and Spicy Chili Bacon Jam

Gummy Candies Recalled After Complaints of Metal Strands in Product

Mars Wrigley Confectionery US, LLC is recalling specific varieties of SKITTLES® Gummies, STARBURST® Gummies, and LIFE SAVERS® Gummies due to the potential presence of a very thin metal strand embedded in the gummies or loose in the bag.  This comes after the company received reports from consumers.

https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/mars-wrigley-confectionery-us-llc-issues-voluntary-recall-specific-varieties-skittlesr-gummies
Mars Wrigley Confectionery US, LLC Issues Voluntary Recall of Specific Varieties of SKITTLES® Gummies, STARBURST® Gummies, and LIFE SAVERS® Gummies Due to Potential Presence of Thin Metal Strand Embedded in Gummies or Loose in the Bag
Summary
Company Announcement Date:  May 13, 2022
FDA Publish Date:  May 13, 2022
Product Type:  Food & Beverages  Candy/Gum (without chocolate)
Reason for Announcement: Possible presence of metal fragments.
Company Name:  Mars Wrigley Confectionary US, LLC
Brand Name:  Skittles, Starburst, Life Savers
Product Description:  Gummies

Non-Dairy Frozen Dessert Recalled for Allergens After Chocolate Peanut Butter Swirl Packaged in Chocolate Chip Cookie Dough Containers

Lynnfield, MA, is recalling 4,481 cases of Planet Oat Chocolate Chip Cookie Dough and Planet Oat Chocolate Peanut Butter Swirl Non-Dairy Frozen Dessert with a Best By date of 12/17/22, because it may contain undeclared peanuts.  The recall was initiated after it was discovered that some Chocolate Peanut Butter Swirl product, which contains peanuts, was packaged in a Chocolate Chip Cookie Dough container, which does not contain the peanut allergen statement. The issue was discovered by a retail customer, which contacted Hood.

https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/hp-hood-llc-issues-allergy-alert-undeclared-peanuts-planet-oat-non-dairy-frozen-dessert-updated
HP Hood LLC Issues Allergy Alert on Undeclared Peanuts in Planet Oat Non-Dairy Frozen Dessert (Updated: Additional Locations)
Summary
Company Announcement Date: May 12, 2022
FDA Publish Date: May 12, 2022
Product Type: Food & Beverages
Reason for Announcement: Undeclared peanuts
Company Name: HP Hood LLC
Brand Name: Planet Oat
Product Description: Planet Oat Chocolate Chip Cookie Dough and Plant Oat Chocolate Peanut Butter Swirl frozen dessert

Non-Dairy Frozen Dessert Product Recalled After Consumer Experiences Nut Allergic Response

Van Leeuwen Ice Cream of Brooklyn, NY is voluntarily recalling 2,185 frozen 14 oz pints of its non-dairy frozen dessert product "Oat Milk Brown Sugar Chunk” because it may contain undeclared specific trace of allergens (tree nuts – cashews and pistachios).  The recall was voluntarily initiated after it was discovered due to a customer complaint, who experienced a reaction, that the lot contains the undeclared tree nuts and was distributed in packaging that did not reveal the presence of the allergen. The cause of the contamination is being investigated.


https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/van-leeuwen-issues-voluntary-recall-undeclared-tree-nuts-cashew-and-pistachio-frozen-dessert-product
Van Leeuwen Issues Voluntary Recall on Undeclared Tree Nuts (Cashew and Pistachio) in Frozen Dessert Product
Summary
Company Announcement Date:  May 10, 2022
FDA Publish Date:  May 10, 2022
Product Type:  Food & Beverages
Reason for Announcement:  Undeclared tree nuts (cashew & pistachio)
Company Name:  Van Leeuwen Ice Cream
Brand Name:  Van Leeuwen
Product Description:  Oat Milk Brown Sugar Chunk non-dairy frozen dessert

Lucky Charms Not Yet Recalled Despite High Number of Reports

Updated on 5/4/22, the FDA Core Response Table has a case count 529 total cases associated with Lucky Charms.  The website iwaspoisoned.com has already received over 7,300 cases.  The company has not recalled the product.  

Forbes
Over 7,300 Lucky Charms Cereal Illness Complaints On Iwaspoisoned.com, FDA Investigating (forbes.com)
Over 7,300 Lucky Charms Cereal Illness Complaints On Iwaspoisoned.com, FDA Investigating
Bruce Y. LeeSenior Contributor