FDA Issues Final Guidance for FSVP for Imported Foods

FDA issued the Final Guidance for FSVP, the Foreign Supplier Verification Program.  This document "provide guidance for industry on the requirements for a foreign supplier verification program (FSVP) in 21 CFR part 1, subpart L, that importers of human or animal food must establish and follow to ensure that each food they import into the United States meets applicable U.S. requirements and is not adulterated or (for human food) misbranded with respect to allergen labeling."

When introduced in 2017, this established the requirements for food importers to ensure that significant hazards are identified in foods they import and that the importer was verifying that controls are in place.   However, many food importers are still being found to be out of compliance.  Many of them seem to be unaware that the rule is in place as evidenced by Warning Letters issued by FDA.

The Guidance is lengthy, but should provide answers to most questions posed on the Rule.
Guidance for Industry: Foreign Supplier Verification Programs for Importers of Food for Humans and Animals (fda.gov)

https://cacmap.fda.gov/index.php/food/cfsan-constituent-updates/fda-issues-foreign-supplier-verification-programs-importers-food-humans-and-animals-final-guidance
FDA Issues the Foreign Supplier Verification Programs for Importers of Food for Humans and Animals Final Guidance
Constituent Update
January 10, 2023

CA Company Recalls Popcorn Snack Products for Undeclared Allergens

Daiso California LLC of La Mirada, CA is recalling the various popcorn snacks, under the brand Tohato and Kashiwado, due of undeclared allergen ingredients.

Daiso had also issued a recall in October of 2022 for cookies that had undeclared almonds and hazelnuts.

https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/daiso-issues-alergy-alert-tohato-and-kashiwado-snacks
Daiso Issues Alergy Alert Tohato and Kashiwado Snacks
Summary
Company Announcement Date:  January 10, 2023
FDA Publish Date:  January 10, 2023
Product Type:  Food & Beverages
Reason for Announcement:  Undeclared almonds, peanuts, soybeans, milk, and shellfish
Company Name:  Daiso California, LLC
Brand Name:  TOHATO and KASHIWADO
Product Description:  Popcorn and other snacks

FDA Issues Warning Letter to Florida Rice Operation for Heavy Pest Activity

FDA issued a Warning Letter to Florida Gold Foods of Kissimmee FL, a firm that handles dried rice, after FDA inspectors found numerous GMP issues including rodent, insect, and animal activity.  (Animal activity -  investigators observed four (4) or more live cats in the northern end of the building and apparent cat feces and urine throughout the warehouse, and they observed a cat running from building (b)(4) with a rodent in its mouth.  Cats are not pest control for food facilities)

FDA also analyzed several samples for filth.  "Results from the Florida Gold brand 2-lb bags of rice demonstrate that this product was adulterated with various species of insects at larval, pupae and adult stages including multi-stage dead beetles, sawtoothed grain beetles, and red flour beetles. Further, the samples collected from within your facility resulted in numerous filth findings including the presence of rodent excreta pellets of a size implicating a rat, fecal material with internal cat/dog hairs, rat/mouse hairs, two (2) feathers identified as songbird feathers, multi-stage beetles (adult and larvae), and insects including but not limited to, flies and moths."

Of course, there were plenty of GMP issues for cleanliness.

https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/florida-gold-foods-llc-637153-11222022
WARNING LETTER

Florida Gold Foods LLC
MARCS-CMS 637153 — NOVEMBER 22, 2022

CFP Releases Best Practice Guidance Document for Direct-to-Consumer Delivered Foods

A guidance document was recently released for food delivery business. The regulations covering such operations can be viewed as nebulous since they ship product directly to consumers via a delivery service. This document, written by the Conference for Food Protection (CFP) Direct-to-Consumer Delivery Committee, provides food safety best practices for direct-to-consumer and third-party food delivery services that meet Food Code requirements.

That document can be found at this link: http://www.foodprotect.org/media/guide/guidance-document-for-direct-to-consumer-and-third-party-delivery.pdf

Also included below is the USDA's document, Mail Order Food Safety, which is also a nice reference for those shipping food to consumers.

Food Safety Magazine
https://www.food-safety.com/articles/8233-guidance-on-food-safety-best-practices-for-food-delivery-businesses
Guidance on Food Safety Best Practices for Food Delivery Businesses

The U.S. Food and Drug Administration recently highlighted a voluntary guidance document on food safety best practices for direct-to-consumer and third-party food delivery services.

The guidance features several updates from the original draft, such as recommended practices for transportation directly to a consumer of perishable products, to include proper packaging; temperature control during shipping, receiving, and storage; return of compromised and abused products; and other food safety related topics.

FDA Issues More Warning Letters to Importers for Lack of FSVP - December 2022

In December of 2022, FDA issued close to a dozen food importers, all lacking a FSVP for the products they import.

Ruth Special Food Store LLC. of Belleville, NJ 07109 have not developed FSVPs for any of the foods imported including: Organic shine skin pumpkin kernels, Shine skin pumpkin kernels, and Dry roasted edamame
https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/ruth-special-food-store-llc-644551-12092022

Bagged Popcorn with Various Allergens Recalled Due to No Allergen Label

Avery’s Savory Popcorn LLC of Dallas, Texas is recalling Gourmet Popcorn, ALL Flavors because it may contain undeclared specific type of allergen. People who have an allergy or severe sensitivity to specific type of allergen (e.g., milk, soy, peanuts, tree nuts {almonds, walnuts, pecans, cashews}, and sulfites) run the risk of serious or life-threatening allergic reaction if they consume these products.

According to the FDA release, "The recall was initiated after it was discovered that product containing (the allergen) was distributed in packaging that did not reveal the presence of the allergen (soy, milk, peanuts, tree nuts). Subsequent investigation indicates the problem was caused by a temporary breakdown in the company's production and packaging processes."  From the posted picture, there was either no statement, or someone forgot to stick a label with the allergens on the pre-labeled bag (containing no information about ingredients or nutrition.)

https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/averys-savory-popcorn-llc-issues-allergy-alert-undeclared-allergens-gourmet-popcorn
Avery’s Savory Popcorn LLC Issues Allergy Alert on Undeclared Allergens in Gourmet Popcorn
Summary
Company Announcement Date:  December 30, 2022
FDA Publish Date:  January 03, 2023
Product Type:  Food & Beverages
Reason for Announcement:  Undeclared milk, soy, peanuts, tree nuts, and sulfites
Company Name:  Avery’s Savory Popcorn LLC
Brand Name:  Avery’s
Product Description:  Gourmet Popcorn, All Flavors

FDA Issue Warning Letter to FL Ice Cream Company, Source of July 2022 Listeria Outbreak

FDA issued a Warning Letter to Big Olaf Creamery, an operation that was responsible for a July 2022 Listeria outbreak with 28 cases ("Among 28 ill people with available information, 27 (96%) were hospitalized, and seven illnesses were in pregnant people or their newborns. One death and one fetal loss attributable to listeriosis have been reported.")

In short summary, the company did not have a food safety plan in place, and along with that, apparently no controls for potential hazards.  The company had not identified Listeria as a concern, and testing was only completed after it was the determined that the company as the source of the Listeria outbreak.  

"After the product recall and in response to FDACS’s positive L. monocytogenes environmental and finished product samples and FDACS’s stop sale order ceasing all sale of ice cream products, your firm contracted with a third-party laboratory to conduct environmental swabbing (b)(4). Multiple pieces of equipment used to manufacture RTE ice cream products were reported positive for L. monocytogenes by your contract laboratory, including (b)(4). Additionally, four swabs of finished product ice cream buckets ((b)(4)) were reported positive for L. monocytogenes."

https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/big-olaf-creamery-llc-dba-big-olaf-642758-12092022
Big Olaf Creamery LLC dba Big Olaf
MARCS-CMS 642758 — DECEMBER 09, 2022

CT Firm Recalls Granola Product After Product Determined to Contain Undeclared Almonds

Garden of Light (dba Bakery On Main) of  East Hartford, Connecticut December is recalling one lot of Organic Oat and Honey Granola for possible Tree nut (Almond)contamination.  The company manufactured 14,304 pounds of product which was distributed by Total Granola in Topco and SEG retail stores throughout the United States. The product recall was voluntarily initiated after it was discovered that product potentially containing Almonds was distributed in packaging that did not reveal the presence of Almonds. No illnesses or injuries have been reported to date.

https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/garden-light-dba-bakery-main-voluntarily-recalls-oat-honey-organic-granola-due-potential-almond
Garden of Light (dba Bakery On Main) Voluntarily Recalls Oat & Honey Organic Granola Due to Potential Almond Contamination
Summary
Company Announcement Date: December 30, 2022
FDA Publish Date:  December 30, 2022
Product Type:  Food & Beverages
Reason for Announcement:  Undeclared almonds
Company Name:  Garden of Light dba Bakery on Main
Brand Name:  Full Circle Market & Naturally Better
Product Description:  Oat & Honey Organic Granola

Imported Potato Ring Snack Recalled for Lack of Milk Allergen Labeling

Daiso California LLC of La Mirada, CA is recalling Tohato Nagewa Snack, an imported crisp potato ring product, because it contains an undeclared milk derivative ingredient. The recall was initiated after it was discovered that the product was distributed in packaging that did not correctly warn for the presence of a milk allergen. Subsequent investigation indicates the problem was caused by a temporary breakdown in the company’s production and packaging process.


https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/daiso-issues-allergy-alert-undeclared-milk-tohato-nagewa-snack
Daiso Issues Allergy Alert on Undeclared Milk in Tohato Nagewa Snack
Summary
Company Announcement Date:  December 30, 2022
FDA Publish Date:  December 30, 2022
Product Type:  Food & Beverages  Snack Food Item 
Reason for Announcement:  Undeclared milk
Company Name:  Daiso California LLC
Brand Name:  Tohato
Product Description:  Nagewa Snack