FDA to Continue Leniency with Co-packers Supplier Control Where Brands Have Oversight

FDA announced that they will continue to provide 'enforcement discretion' with supply chain controls for co-packers where the brand companies they are packing for have oversight over those suppliers.  In these cases, the co-packer is packing under contract for the brand company, and that brand company has chosen and then manages the suppliers who provide raw materials to the co-packer.

Certainly if the brand companies want the control over the supply chain to the co-packer, then they should be responsible for the supply chain control components and should have the procedures and documentation to support that.  This FDA announcement does not go that far, outside of providing an out for the co-packer.

From the announcement, "under certain circumstances and on a temporary basis, we do not intend to take enforcement action against a receiving facility that is a co-manufacturer, and that is not in compliance with certain supply-chain program requirements for food manufactured for the brand owner."

From the previously published guidance establishing enforcement discretion:
"Supplier Approval
FDA does not intend to take enforcement action under the following circumstances: (1) a brand owner conducts supplier approval activities, (2) the co-manufacturer describes these activities in its food safety plan, and (3) the co-manufacturer conducts any necessary supplier approval activities not conducted by the brand owner. For example, FDA does not intend to take enforcement action when a brand owner (rather than the co-manufacturer) evaluates supplier performance as part of approving a supplier, the co-manufacturer’s food safety plan states that the brand owner will consider supplier performance before a supplier is approved, and the co-manufacturer conducts any other necessary supplier approval activities (e.g., hazard analysis of the food). The co-manufacturer is always responsible for following written procedures for receiving raw materials and other ingredients, and documenting use of the procedures (21 CFR §§ 117.420 and 507.120)."

"Supplier Verification
FDA does not intend to take enforcement action under the following circumstances: (1) a brand owner determines and/or conducts supplier verification activities for its co-manufacturer, (2) the co-manufacturer describes these activities in its food safety plan, and (3) the co-manufacturer conducts any necessary supplier verification activities not conducted by the brand owner. For example, FDA does not intend to take enforcement action when an audit is determined to be the appropriate supplier verification activity but a co-manufacturer does not independently obtain a supplier audit or review the conclusions of a supplier audit obtained and reviewed by the brand owner, the co-manufacturer’s food safety plan states that the brand owner will obtain and review audits of the supplier, and the co-manufacturer conducts any other necessary supplier verification activities (e.g., sampling and testing of the raw material or other ingredient)."

FDA Constituent Update
https://www.fda.gov/regulatory-information/search-fda-guidance-documents/guidance-industry-supply-chain-program-requirements-and-co-manufacturer-supplier-approval-and
FDA Continues Enforcement Discretion Policy Relevant to Certain Co-Manufacturers under FSMA
November 6, 2019

Kansas Spice Company Recalls Taco Seasoning After Notified by Ingredient Supplier of Potential Salmonella Contamination

Williams Foods issued a recall for their taco seasoning after their cumin supplier notified them that another cumin customer had tested and found Salmonella in a lot of cumin product, the same lot sold to Williams.

"These items contain cumin spice involved in a recall initiated by our supplier, Mincing Spice Co. Mincing has issued a recall for a specific lot of cumin they produced because a sample from that lot was tested by one of Mincing's customers and was found to be potentially contaminated with Salmonella. A portion of the lot recalled by Mincing was supplied to Williams Foods, LLC".

What were the supplier verification activities and now how does the company change them to reflect the increased risk?

https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/williams-foods-llc-initiates-voluntary-recall-taco-seasoning-product-due-possible-presence
Williams Foods LLC Initiates a Voluntary Recall of Taco Seasoning Product Due to Possible Presence of Salmonella Contamination
Summary
Company Announcement Date: July 25, 2019
FDA Publish Date: July 25, 2019
Product Type:Food & Beverages
Reason for Announcement:  Due to possible presence of Salmonella contamination
Company Name: Williams Foods LLC
Brand Name:  Great Value, HEB
Product Description:  Taco Seasoning Products

Frozen Vegetables from Canadian-based Frozen Food Company Responsible for Multiple Recalls in US

Numerous US companies have issued recalls after using frozen vegetables recalled by the supplier, McCain Foods, a Canadian based company at their California facility.  The products are being recalled for Listeria and Salmonella.    According to one news report, "As McCain Foods explained in a Friday e-mail to The Miami Herald, the company “recently identified a potential health risk related to its fire roasted, caramelized or sautéed frozen vegetable and fruit products produced at its Colton facility, California. As a result, we have made the decision to voluntarily recall all products produced at this facility."

Read more here: https://www.heraldsun.com/news/state/north-carolina/article220428265.html#storylink=cpy

• Product recalled include both RTE products and products that have cooking instructions.
• Recalled product includes various store brands produced by further processing companies including Trader Joe's, Whole Foods, Marketside.
• The statement does not indicate how the potential contamination issue was there.  One would guess testing because the statement indicates, 'out of an abundance of caution.
• Another indication the recall was found by testing is that it was for both Listeria and Salmonella...so this may indicate that a screening test was done
• There have been no illnesses to date.

Recalls posted thus far:

• Hy-Vee Voluntarily Recalls Several Meat and Potato Products - Hy-Vee, Inc., based in West Des Moines, Iowa, is voluntarily recalling six of its meat and potato products across its eight-state region
• 103-2018 Bakkavor Foods USA, Inc. Recalls Meat and Poultry Products due to Possible Salmonella and Listeria Monocytogenes Contamination In Onions - Bakkavor Foods USA, Inc., a firm with establishments located in Carson, Calif., Charlotte, N.C. and Jessup, Penn., is recalling approximately 795,261 pounds of ready-to-eat meat and poultry products that contain an onion ingredient
• SK Food Group Recalls Chicken Products due to Possible Salmonella and Listeria Monocytogenes Contamination in Vegetables - WASHINGTON, Oct. 19, 2018 – SK Food Group, a Groveport, Ohio and Reno, Nev. establishment, is recalling approximately 174,207 pounds of chicken wrap products that contain vegetables
• Buddy’s Kitchen, Inc. Recalls Pork and Chicken Products due to Possible Salmonella and Listeria Monocytogenes Contamination in Vegetables - WASHINGTON, Oct. 19, 2018 – Buddy’s Kitchen, Inc., a Burnsville, Minn. establishment, is recalling approximately 212,746 pounds of ready-to-eat pork and chicken products that contain vegetables
• Envolve Foods Recalls Chicken and Beef Products due to Possible Salmonella and Listeria Monocytogenes Contamination in Vegetables - Envolve Foods, a Corona, Calif. establishment, is recalling approximately 292,764 pounds of ready-to-eat chicken and beef products that contain a vegetable 
• Caito Foods, LLC Recalls Salad And Bowl Products Made With Chicken Due To Possible Salmonella and Listeria Monocytogenes Contamination In Corn - Caito Foods, LLC, an Indianapolis, Ind. establishment, is recalling approximately 1,532 pounds of ready-to-eat salad and bowl products made with chicken that contain a corn ingredient
• Ruiz Food Products, Inc. Recalls Beef and Poultry Products due to Possible Salmonella and Listeria Monocytogenes Contamination in Onion Ingredient -  Ruiz Food Products, Inc., a Denison, Texas, establishment, is recalling approximately 2,490,593 pounds of ready-to-eat meat and poultry taquitos
• GHSW, LLC Recalls Salad Products Due To Possible Salmonella And Listeria Monocytogenes Contamination In Corn - GHSW, LLC, a Houston, Texas establishment, is recalling approximately 1,786 pounds of ready-to-eat salad with chicken products that contain a corn ingredient 
• GHSE, LLC Recalls Salads Containing Meat Products due to Possible Salmonella and Listeria Monocytogenes Contamination In Corn - GHSE, LLC, a Green Cove Springs, Florida establishment, is recalling approximately 738 pounds of ready-to-eat salad with meat products that contain a corn ingredient 
• Taylor Farms Northwest LLC Recalls Pork Carnitas Bowl Products due to Possible Salmonella and Listeria Monocytogenes Contamination In Tomatillos -  Taylor Farms Northwest LLC, a Kent, Wash. establishment, is recalling approximately 276 pounds of ready-to-eat (RTE) pork carnitas bowl products that contain tomatillos
• Mary’s Harvest Fresh Foods, Inc. Recalls Wrap and Salad Meat Products due to Possible Salmonella and Listeria Monocytogenes Contamination In Corn - Mary’s Harvest Fresh Foods, Inc., a Portland, Ore. establishment, is recalling approximately 916 pounds of ready-to-eat wrap and salad products that contain a corn ingredient 
• GH Foods CA, LLC Recalls Salads Containing Chicken Products due to Possible Salmonella and Listeria Monocytogenes Contamination In Corn  - GH Foods CA, LLC, a Sacramento, Calif. establishment, is recalling approximately 987 pounds of ready-to-eat salad with chicken products that contain a corn ingredient
• Prime Deli Corporation Recalls Salads Containing Meat Products due to Possible Salmonella and Listeria Monocytogenes Contamination in Corn -  Prime Deli Corporation, a Lewisville, Texas establishment, is recalling approximately 217 pounds of ready-to-eat salad with bacon products that contain a corn ingredient

https://www.fda.gov/Food/RecallsOutbreaksEmergencies/SafetyAlertsAdvisories/ucm623828.htm
FDA Alerts the Public Regarding Recalled Vegetable Products
October 19, 2018

FSIS Issues Warning for Whey Powder with Possible Salmonella Contamination, Impacted Chicken Wings Recalled

FSIS is issuing a public health alert due to concerns that products may be contaminated with Salmonella from whey powder that has been recalled by the producer of the ingredient. FSIS is issuing this public health alert out of the utmost of caution to ensure that consumers are aware that these products, which bear the USDA mark of inspection, should not be consumed.

The whey powder is an FDA-regulated product that is being voluntarily recalled by the producer, Associated Milk Producers, Inc. (AMPI). Additional FSIS-regulated products containing the recalled whey powder may be added to this public health alert as more information becomes available.

Pinnacle Foods, Inc. establishment in Fayetteville, Ark. is recalling HUNGRY MAN CHIPOTLE BBQ SAUCED BONELESS CHICKEN WYNGZ”

The cooking process would most probably eliminate the Salmonella.

https://www.fsis.usda.gov/wps/portal/fsis/newsroom/news-releases-statements-and-transcripts/news-release-archives-by-year/archive/2018/pha-07202018-1
FSIS Issues Public Health Alert For Products Containing FDA-Regulated Whey Powder That Has Been Recalled Due To Possible Salmonella Contamination

NY Nut and Fruit Processor Source of Listeria Related Recalls

Over the past several days, many of the listeria - nut/dried fruit recalls have been linked to a company called HVF, Inc. AKA - Hudson Valley Farms. This includes the recent hummus recall due to pine nuts from HVF as well as other recalls such as protein bars from GoMarco, granola products from New England Bakers, and Protein Bars and Bits from Bulletproof 360. It is hard to tell what the ultimate source of these recalls, but clearly HVF is a major link, if not the primary source.

Here again is what appears to be an ingredient supply issue that triggers recalls among a number of further processing facilities.  In this case, the ingredient was produced by a very small processing facility - what kind of supplier controls were in place?  How legitimate is this supplier?

One concern was that the supplier information was not readily available online.  No website was present - was it there and taken down, or was there never one to start?  Wouldn't it be better to have a supplier who is there when there is an issue and to state the nature of the issue on their website?

It was difficult to tell the scope of the operation. According to a story in the Miami Herald, HVF is a company of 10 people or less. Looking further, it appears to be part of a larger group with the parent appearing to be a company called Bedemco, an importer of nut and fruit products.  HVF may just be a packing facility for this family run company.

Pet Treats Recall Expanded to Include Private Label Products - Controlling Overseas Co-packers

United Pets is expanding their initial recall of raw hide pet treats to now include private label products including Companion, Dentley's, Enzadent or Dentahex, Essential Everyday, Exer-Hides, Good Lovin' or Petco, Hill Country Fare, and Priority Pet.  The products are being recalled because the foreign manufacturing facility sanitized the product with quaternary ammonium or Quat.  Quat is a surface sanitizer and is not made to be used directly on food for dogs (or humans).

This case points out the concerns for companies who have another company co-pack their product in facilities outside the country.  One would have expected contracted company, in this case United Pet, would have been controlling those facilities to a point where product produced was compliant with US regulations, or even generally accepted practices.  As the purchasing clients, completing a hazard analysis to take into account unexpected, unacceptable practices can be difficult to impossible without an onsite visit by a trusted, knowledgeable auditor.

FDA Recall Notice
https://www.fda.gov/Safety/Recalls/ucm563544.htm

United Pet Group Expands Voluntary Recall of Multiple Brands of Rawhide Chew Products for Dogs to Also Include Private Label Brands Due to Possible Chemical Contamination
For Immediate Release
June 16, 2017

SoyNut Co-packer, Dixie Dew, Slammed in FDA Inspection, Now Suspended

FDA suspended the food facility registration of the co-manufacturing facility of the Soy Nut Butter which was recalled for E. coli contamination.

CDC now reports that there are 29 cases of E. coli infection with 9 people developing HUS.  The majority of cases (83%) affecting people under the age of 18.

FDA inspected the facility (3/3/17 to 3/15/17)  at the same time the initial recall.  FDA issued a 483 report detailing issues in facility.
Here are some of the highlight from the 8 page report.  (For ease, a copy of this document is pasted below, this was converted from the pdf file)

• The firm leaves product in the mix kettle overnight and over the weekend.
• The mixing equipment just shuts off during processing, 1 or 2 times per day, and has had this problem for 15 years.
• They do not calibrate their thermometer used for monitor the nut butter.  
• The chart recorder also does not work.
• During production of product, a clear liquid was observed dripping intermittently form a hole in the ceiling onto the floor and splashing on the equipment.  This was supposedly coming from a leaky pipe.
• Product build-up  on floors and walls, and walking platforms. Standing water on floor.
• Poor employee traffic flow as well as forklift flow, no restriction of movement from dirty areas /waste areas to processing areas.
• Cleaning supplies not properly maintained.
• Wooden pallets sitting in standing water.
• Product piping system not disassembled since 2015, smaller pipes and filling not routinely cleaned.
• Improper employee handwashing.
• Pest control issues.

While this is clearly a co-packer issue, somebody had to approve this company.  Did the IMHealthy folks visit the facility?  Did they recognize the risk, especially considering who would be eating this product - children.  To me, they are just as responsible.

As part of the movement to small, unique brands, more and  more of these small brand companies are turning to co-packers to package their product.  This includes store brands as well.  There are risks however if these co-packers are not properly vetted and managed.  One of the key elements of FSMA, supplier preventive controls, was put in place to prevent this type of travesty.  (This is why I stick to my big brands with lots of food scientists and well developed QA/QC systems protecting that product).

FDA Safety Alerts and Advisories
https://www.fda.gov/Food/RecallsOutbreaksEmergencies/SafetyAlertsAdvisories/ucm549734.htm
FDA Suspends Food Facility Registration of Dixie Dew Products, Inc.
No food may leave the facility for sale or distribution
March 30, 2017