Recent modifications to FDA’s import alerts, as posted by the agency, are listed below. 

Click here to go to the FDA page with links to details on specific alerts.

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Victory Trading Company Inc.
Greenland, NH

A food firm in New Hampshire is on notice from the FDA  for serious violations of the Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Food regulation. These violations include the presence of pests in their warehouse.

In an April 17, 2023, warning letter, the FDA described a Dec. 12, 2022, to Jan. 13, 2023 inspection of Victory Trading Company’s ambient, refrigerated and frozen food warehouse in Greenland, NH.

The FDA’s inspection revealed that the firm was not in compliance with regulations and resulted in the issuance of an FDA Form 483. Some of the significant violations are as follows:

Current Good Manufacturing Practice:
1. The firm did not take effective measures to exclude pests from their holding areas and to protect against the contamination of food on the premises by pests. Specifically, rodent activity was observed throughout their warehouse facility including the following:

Rodent Activity Observed

(Redacted)

• On Dec. 12, 2022, during a bag-by-bag examination of (redacted) pallets of (redacted) White Rice, lot # “(redacted)”, stored in the (redacted) corner of their warehouse, apparent rodent excreta pellets (REPs) too numerous to count (TNTC), apparent rodent gnaw holes in the bags of rice, and yellow stains on the bags of rice which smelled like urine and fluoresced UV light. An additional (redacted) pallets of (redacted) White Rice had an odor of urine and apparent REPs.
• On Dec. 13, 2022, an apparent decomposed dead rodent in the (redacted) corner of the warehouse outside the big cooler.
• On Dec. 19, 2022, an apparent decomposed dead rodent in the (redacted) corner of the warehouse outside the freezer.
• On Dec. 15, 2022, apparent REPs TNTC on an empty pallet in pallet location (redacted) in the center of the (redacted) area of the warehouse.
• On Dec. 15, 2022, approximately 10 apparent REPs on the floor below a pallet of bagged dried chili peppers among apparent rodent gnawed material in pallet location (redacted) in the center of the (redacted) area of the warehouse.
• On Dec. 15, 2022, apparent REPs TNTC on the floor behind a pallet of dried noodles in pallet location (redacted) in the center of the (redacted) area of the warehouse.
• On Dec. 15, 2022, approximately 15 apparent REPs on a pallet of BBQ sauce, and apparent rodent urine stains and apparent nesting materials on the floor directly next to pallet in pallet location (redacted) in the center of the (redacted) side of the warehouse.
• On Dec. 15, 2022, approximately 6 apparent REPs on a pallet of plastic cups in pallet location (redacted) in the center of the (redacted) side of the warehouse. The pallet also appeared to contain apparent rodent urine stains, and boxes of cups appeared to have bird excreta on them.
• On Dec. 15, 2022, approximately 13 apparent REPs on the floor in pallet location (redacted) in the center of the (redacted) side of the warehouse.

(Redacted)

• On Dec. 14, 2022, two apparent dead rodents in a glue trap in the (redacted) corner of the warehouse.
• On Dec. 14, 2022, an apparent dead rodent in a glue trap along the (redacted) wall of the warehouse under racks of bags of powdered drink mixes and seeds in pallet location (redacted).
• On Dec. 14, 2022, an apparent dead rodent in a glue trap in the (redacted) corner of the warehouse underneath racks of bagged powdered drink mixes in pallet location (redacted).
• On Dec. 14, 2022, apparent REPs TNTC on the floor at the corner junction of the (redacted) wall of the (redacted) area of the warehouse directly next to pallet location (redacted).
• On Dec. 14, 2022, apparent REPs TNTC on the floor along the (redacted) wall of the (redacted) corner of the warehouse in pallet location (redacted).
• On Dec. 14, 2022, apparent REPs on the floor along the (redacted) wall of the (redacted) corner of the warehouse in pallet location (redacted).

(Redacted)

• On Dec. 15, 2022, an apparent decomposed dead rodent on the floor along the (redacted) wall of the warehouse where bagged rice was stored.
• On Dec. 15, 2022, apparent REPs TNTC on the floor and support beams along the back (redacted) wall where bagged rice was being stored.
• On Dec. 13, 2022, apparent REPs TNTC and apparent nesting material observed in the (redacted) section of the warehouse on the floor touching and directly next to pallets of (redacted) White Rice.
• On Dec. 14, 2022, apparent REPs on the floor in the (redacted) area of the warehouse (next to the employee bathroom) in pallet location (redacted).
• On Dec. 14, 2022, apparent REPs and apparent rodent urine stains which fluoresced under UV light along the (redacted) wall of the (redacted) area of the warehouse in pallet location (redacted).
• On Dec. 14, 2022, apparent REPs on the floor in the (redacted) corner of the (redacted) area of warehouse in pallet location (redacted).
• On Dec. 14, 2022, approximately 6 REPs on the floor directly next to a pallet of rice sticks in pallet location (redacted) in racks along the (redacted) wall of the (redacted) side of the warehouse.
• On Dec. 14, 2022, approximately 20 apparent REPs on a pallet of vinegar in pallet location (redacted) in racks along the (redacted) wall of the (redacted) side of the warehouse.
• On Dec. 14, 2022, approximately 5 apparent REPs on the floor approximately 6” from a pallet of maltose in pallet location (redacted) in racks along the (redacted) wall of the (redacted) side of the warehouse.
• On Dec. 14, 2022, apparent REPs TNTC on a pallet which contained jasmine tea in pallet location (redacted) in storage racks along the (redacted) wall in the (redacted) side of the warehouse.
• On Dec. 15, 2022, apparent REPs TNTC on a pallet of plastic take-out containers in pallet location (redacted) in storage racks along the (redacted) wall in the (redacted) side of the warehouse.
• On Dec. 14, 2022, approximately 20 apparent REPs on the floor scattered directly next to a pallet of dried seaweed in pallet location (redacted) in storage racks along the (redacted) wall in the (redacted) side of the warehouse.
• On Dec. 14, 2022, a live insect and apparent REPs TNTC on a pallet of dried spices in pallet location (redacted) in storage racks along the (redacted) wall in the (redacted) side of the warehouse.
• On Dec. 14, 2022, approximately 8 apparent REPs on a pallet of rice sticks in pallet location (redacted) in storage racks along the (redacted) wall in the (redacted) side of the warehouse.

(Redacted)

• On Dec. 18, 2022, apparent REPs TNTC on the floor and on support beams along the (redacted) wall behind coolers (redacted) and (redacted).
• On Dec. 19, 2022, approximately 10 apparent REPs on a table holding shrink wrap stored along the (redacted) wall.
• On Dec. 19, 2022, approximately 15 REPs along the (redacted) wall upstairs in the equipment storage room (redacted) main office. Additionally, the rodent station (redacted) was missing from its designated wall location.
• On Dec. 19, 2022, approximately 14 apparent REPs at the top corner of the stairs leading to the equipment storage room (redacted) main office located at the (redacted) wall of the warehouse.
• On Dec. 19, 2022, approximately 25 apparent REPs in the (redacted) corner of the equipment storage room (redacted) main office located at the (redacted) wall of the warehouse.
• On Dec. 19, 2022, approximately 15 apparent REPs along the (redacted) wall of the equipment storage room (redacted) main office located at the (redacted) wall of the warehouse.
• On Dec. 14, 2022, apparent REPs TNTC on the floor at the corner junction of the (redacted) wall and the big cooler in the (redacted) side of the warehouse where bagged sugar was being stored.
• On Dec. 19, 2022, approximately 2 apparent REPs on the floor in the walk-in freezer closest to the big cooler along the (redacted) wall in the (redacted) area of the warehouse.
• On Dec. 14, 2022, apparent REPs TNTC on the floor in the center aisle of the warehouse in pallet location (redacted) of the (redacted) area of the warehouse.
• On Dec. 14, 2022, approximately 11 apparent REPs on a pallet of (redacted) noodles and approximately 15 REPS in a center food storage rack in the (redacted) side of the warehouse in pallet location (redacted).
• On Dec. 13, 2022, apparent REPs TNTC on a rack in pallet location (redacted) and (redacted) of the central aisle storage racks in the (redacted) area of the warehouse used to hold (redacted) Brown Rice in paper bags and (redacted) Potato Starch in paper bags. Additionally, apparent rodent paw prints and tail marks were observed in spilled product on the racks.
• On Dec. 14, 2022, approximately 10 apparent REPs on the floor behind a pallet of bagged rice in pallet location (redacted) of the central aisle storage racks in the (redacted) area of the warehouse.
• On Dec. 14, 2022, apparent REPs on the floor along the (redacted) wall of the (redacted) area of the warehouse in pallet location (redacted) directly below and next to bags of palleted rice.
• On Dec. 14, 2022, apparent REPs TNTC were observed on the floor along the (redacted) wall and under a food storage rack on the left-hand sides of cooler (redacted) in the (redacted) area of the warehouse.

Samples
FDA collected several samples during the inspection. These samples included a food product sample ((redacted) White Rice) and filth samples. These samples were submitted to FDA labs for analysis. Results demonstrate that the (redacted) White Rice and sample 1209823 were contaminated with rodent excreta pellets (REPs), and sample 1209822 was contaminated with rodent excreta pellets and rodent nesting material. The filth samples further demonstrate the presence of rodents throughout the facility.

2. The firm did not maintain their plant in a clean and sanitary condition and keep their plant in repair adequate to prevent food from becoming adulterated. Specifically, insanitary conditions were observed throughout their facility demonstrating that sanitation, cleaning, and maintenance operations were inadequate. The following observations reflect potential areas for pest harborage and attractants for pests:

(Redacted)

• On Dec. 13, 2022, a 24″ x 8″ rip in the insulation liner of the (redacted) wall exposing insulation. The exposed insulation had been partially removed and apparent REPs TNTC were observed inside the insulation.
• On Dec. 13, 2022, an approximate 1/4″ hole through the wall to the outside and an approximate 12″ x 12″ rip in the insulation liner of the (redacted) wall. An empty beer bottle was observed in the hole.
• On Dec. 15, 2022, an approximate 2-3” gap along the entire length of the (redacted) wall creating a potential ingress for pests.
• On Dec. 15, 2022, an approximate 1” wide crack in the floor approximately 12” from pallet location (redacted) creating a potential ingress for pests near the (redacted) wall in the warehouse.
• On Dec. 15, 2022, an approximate ½” gap in the floor approximately 6” from pallet location (redacted) in the (redacted) area of the warehouse. There appeared to be hollow space beneath the gap.

(Redacted)

• On Dec. 13, 2022, two overhead doors on the (redacted) side of the warehouse occupied by a moving and storage company were left open for an extended period during the day creating a potential ingress for pests.

(Redacted)

• On Dec. 13, 2022, spilled unknown white powder product on a pallet of soybean oil stored in the (redacted) section of the warehouse.
• On Dec. 15, 2022, an approximate 1” gap closest to the (redacted) wall of the warehouse creating a potential ingress for pests. The area below the gap appeared to be hollow.
• On Dec. 13, 2022, two approximate 1” gaps around electrical conduits in the (redacted) wall of the warehouse creating an opening to the outside.

(Redacted)

• On Dec. 12, 2022, the plastic liner of the dividing wall in the center of the warehouse in the (redacted) side contained what appeared to be rodent gnaw holes and apparent REPs inside the insulation in the wall. Apparent rodent nesting materials were observed on the ground, and gnaw marks were observed on a wooden post of the dividing wall.
• On Dec. 14, 2022, red onions in a bag made of plastic netting stored directly on the floor within 6” from where apparent REPs were observed outside the main office in the (redacted) side of the warehouse.
• On Dec. 14, 2022, stagnant clear liquid on the floor of coolers (redacted) and (redacted) creating a potential attractant for pests and a potential harborage area for bacteria in the (redacted) area of the warehouse.
• On Dec. 19, 2022, what appeared to be apparent rodent-gnawed material, apparent REPs TNTC, and insulation used as apparent rodent nesting material in the equipment storage trailer that is permanently affixed to the outside of the (redacted) wall.

3. The firm did not maintain their facility’s grounds in a condition adequate to protect food from becoming contaminated. Specifically, on Dec. 14, 2022, an overgrowth of weeds and vegetation were observed outside on the eastern and northern sides of the warehouse, creating potential harborage areas for pests.

The full warning letter can be viewed here.

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According to the FDA, this action is occurring within the context of its ongoing commitment to enhance regulatory oversight and reflects the agency’s determination to ensure optimal conditions for producing infant formula. These letters, arising from inspections carried out over several months, cite violations of the Federal Food, Drug, and Cosmetic Act and the FDA’s Infant Formula regulations. The issuance of these warnings coincides with recalls conducted by the manufacturers in December 2022, February 2023 and March 2023 to remove potentially contaminated Cronobacter sakazakii-tainted products from the market.

Despite these actions, the FDA does not advise parents and caregivers to avoid specific infant formulas. According to the FDA, no confirmed contamination has been reported in distributed products, and the recalls have been effective in removing potentially unsafe batches from the market. Furthermore, these warning letters are not tied to ongoing recalls, and as such, they are not expected to affect the availability of infant formula.

2021-2022 Cronobacter outbreak
Between December 2021 and March 2022, the US FDA received two reports of infant deaths linked to powdered infant formula produced by Abbott Nutrition in Michigan. These reports were part of 128 complaints. While two deaths were connected to a confirmed outbreak of Cronobacter sakazakii, others were reported through the FDA’s consumer complaint system, with two mentioning Salmonella. An additional 25 incidents were categorized as life-threatening, and 80 as non-life-threatening. A variety of symptoms were reported, such as fever, vomiting, diarrhea, and blood in stool. Investigations revealed Cronobacter sakazakii in Abbott’s manufacturing environment, although genetic matches weren’t found for the strains infecting the babies. All affected infants had consumed Abbott powdered formula.

Summary of warning letters
The issuance of these letters aligns with the FDA’s customary regulatory process and aims to reinforce the significance of implementing and maintaining appropriate corrective actions in the presence of pathogens. Manufacturers are required to conduct thorough root cause investigations, subsequent cleaning and sanitation activities, and comprehensive evaluations of cleaning and sanitation practices before releasing products. Each manufacturer is allotted 15 working days to provide the FDA with an explanation of the corrective actions they are taking. The agency will review the responses and evaluate the adequacy of corrective measures during its next inspection of each facility.

ByHeart Inc.
New York, NY

An infant formula producer in New York is on notice from the FDA  for significant violations of the Infant Formula Requirements Pertaining to Current Good Manufacturing Practice, Quality Control Procedures, Quality Factors, Records and Reports, and Notifications. 

In an Aug. 30, 2023, warning letter, the FDA described a Dec. 21, 2022, through Feb. 17, 2023, inspection of ByHeart Inc.’s powdered infant formula facility in (redacted).

The FDA’s inspection revealed that the firm was not in compliance with regulations and resulted in the issuance of an FDA Form 483. Some of the significant violations are as follows:

1. The firm did not establish a system of process controls covering all stages of processing that was designed to ensure that infant formula does not become adulterated due to the presence of microorganisms in the formula or in the processing environment. Specifically:

a. On Oct. 17, 2022, the firm notified (redacted) that a batch of ByHeart Whole Nutrition Infant Formula finished product had tested positive for Cronobacter spp. and was later confirmed as Cronobacter sakazakii (“C. sakazakii”). The infant formula base, which was a component of the contaminated finished product, was manufactured during a continuous production campaign at the (redacted) facility from July 13, 2022, through Aug. 23, 2022. The infant formula base from this campaign was then blended and packaged as a finished product at one of their third-party contract manufacturer’s facilities from Sept. 15, 2022, through Oct. 7, 2022.

In response to the finished product positive, (redacted) conducted a root cause analysis. (Redacted) root cause analysis concluded that post-production sample handling by a third-party laboratory was the source of the contamination, essentially resulting in a laboratory error. However, the third-party laboratory provided an “OOS Result Investigational Report for Microbiological Testing” regarding the C. sakazakii findings in finished product, which concluded that “Laboratory error was not found or supported.” The third-party laboratory reached this conclusion after reviewing its internal protocols and testing conditions, finding no basis to attribute the sample results to laboratory error. Typically, a conclusion of lab error within an RCA is supported with confirmed evidence, such as written confirmation from the third-party laboratory attesting to the error. Here, there is no attestation; there is evidence to the contrary.

Despite the discrepancy between the third-party laboratory and the internal conclusion within (redacted) root cause analysis, neither the firm nor their subsidiary company, (redacted), took any additional efforts to evaluate other routes of contamination that may have contributed to this event. FDA’s review of their records obtained during the (redacted) inspection show that they did not work with their third-party contract manufacturer to further investigate the origins or root causes of the finished product positive findings.

In response to the C. sakazakii finished product findings, the firm directed their third-party contract manufacturer to hold and destroy the lot of product that tested positive for C. sakazakii and the first pallet of the subsequent lot in the same production campaign. However, they directed the release of all other ByHeart Whole Nutrition Infant Formula finished product manufactured as part of their third-party contract manufacturer’s continuous production campaign. Upon further evaluation of (redacted) sanitation and production records, and following discussions with FDA, their firm subsequently conducted a voluntary recall of the remaining five lots of ByHeart Whole Nutrition Infant Formula, Milk Based Powder with Iron from the same Sept. 15, 2022 – Oct. 7, 2022 campaign that they had previously released into U.S. commerce.

The full warning letter can be viewed here.

Reckitt/Mead Johnson Nutrition
Parsippany, NJ

An infant formula producer in New Jersey is on notice from the FDA for significant violations the Infant Formula Requirements Pertaining to Current Good Manufacturing Practice, Quality Control Procedures, Quality Factors, Records and Reports, and Notifications at two of their facilities.

In an Aug. 30, 2023, warning letter, the FDA described a  Feb. 7-23, 2023, inspection of Reckitt/Mead Johnson Nutrition’s Zeeland, MI, powdered infant formula manufacturing facility and a Nov. 28, 2022, through Jan. 9, 2023 inspection of their Wanamingo, MN, facility.

Both of the FDA’s inspections revealed that the firm was not in compliance with regulations and resulted in the issuance of an FDA Form 483. Some of the significant violations are as follows:

1. The firm did not establish a system of process controls covering all stages of processing that was designed to ensure that infant formula does not become adulterated due to the presence of microorganisms in the formula or in the processing environment. Specifically:

Zeeland Facility
a. On Sept. 4, 2022, a batch of the firm’s Enfamil Prosobee Simply Plant-Based Infant Formula (Prosobee) powder product, tested positive for Cronobacter sakazakii (“C. sakazakii”). The Prosobee product that tested positive was manufactured in a continuous production campaign that ran from Aug. 29, 2022, through Sept. 1, 2022, which produced three batches of the Prosobee product. The Prosobee product that tested positive for C. sakazakii was produced in the first batch of this continuous campaign. The firm’s Critical Deviation Investigation Report, which includes their root cause analysis, concluded that their third-party manufactured base powder, Prosobee Lipil Synergy, was the source of the contamination. While they identified a probable source of contamination, the FDA noted that their root cause analysis did not include further investigation of the finished product isolate or the environmental isolates recovered from the facility of their third-party supplier responsible for manufacturing their base powder.

Wanamingo Facility
d. On Oct. 15, 2022, the firm’s third-party customer notified them that a finished product, non-exempt milk-based powdered infant formula tested positive for C. sakazakii. This product was blended at the firm’s facility on thier (redacted) line between Sept. 15 – 20, 2022, and then packaged on Packaging Line #1 between Sept. 30 – Oct. 7, 2022.

Upon receiving notification of this result, the firm failed to conduct an independent root cause analysis or investigation and they did not evaluate whether other products may have been impacted by this contamination event. 

The full warning letter can be viewed here.

Perrigo Wisconsin, LLC
Eau Claire, WI

An infant formula producer in Wisconsin is on notice from the FDA  for significant violations the Infant Formula Requirements Pertaining to Current Good Manufacturing Practice, Quality Control Procedures, Quality Factors, Records and Reports, and Notifications. 

In an Aug. 30, 2023, warning letter, the FDA described a March 6 through April 26, 2023  inspection of Perrigo Wisconsin, LLC’s powdered infant formula manufacturing facility (Gateway facility) in Eau Claire, WI.

Based on the information the firm provided to FDA investigators during their inspection, Perrigo Company PLC (“Perrigo”) purchased the Gateway facility from Nestle on Nov. 1, 2022. The acquisition included the facility along with the U.S. and Canadian rights to the Good Start infant formula brands. Nestle remains responsible for Nestle’s current WIC contracts, with Perrigo supplying product through the Gateway facility for those contracts. Both Perrigo and Nestle indicated they will be working closely together in the transitional period following the purchase of the Gateway facility.

The FDA’s inspection revealed that the firm was not in compliance with regulations and resulted in the issuance of an FDA Form 483. Some of the significant violations are as follows:

1. The firm did not establish a system of process controls covering all stages of processing that was designed to ensure that infant formula does not become adulterated due to the presence of microorganisms in the formula or in the processing environment Specifically:

a. The firm identified Cronobacter spp. in the following finished products:

i. During a continuous production campaign that ran from Oct. 23, 2022, to Nov. 2, 2022, two products tested positive for Cronobacter spp. The positive products were identified as Parent’s Choice Infant Formula Milk-Based Powder with Iron, which was spray dried on Oct. 26, 2022, and packaged on Oct. 27-28, 2022, and Parent’s Choice Infant Formula Milk-Based Powder with Iron, which was spray dried on Nov. 2, 2022, and packaged on Nov. 2, 2022.

Prior to the initiation of this production campaign, on Oct. 21-23, 2022, the firm conducted a major clean-in-place (CIP)/Top Down 4-Step Cleaning. On Nov. 2, 2022, when the firm received notification of the positive Cronobacter spp., they ceased production and packaging operations, placed all products on hold, and immediately initiated cleaning and sanitation activities, which entailed a major CIP/Top Down 4-Step Cleaning. FDA investigator’s review of their sanitation records indicated that there were no intervening sanitation breaks during this production campaign.

ii. During a continuous production campaign that ran from Jan. 3, 2023, through Jan. 18, 2023, a batch of their Gerber Good Start Soothe Pro powder product tested positive for Cronobacter spp. The positive product was spray dried on Jan. 11, 2023, and packaged on Jan. 12, 2023.

Prior to the initiation of this production campaign, on Dec. 31, 2022, to Jan. 2, 2023, the firm conducted a major CIP of the dryer equipment and a Top Down 4-Step Cleaning of the packaging equipment. On Jan. 18, 2023, when they received notification of the positive Cronobacter spp., they ceased production and packaging operations, placed all products on hold, and immediately initiated cleaning and sanitation activities, which entailed a major CIP/Top Down 4-Step Cleaning. FDA investigator’s review of their sanitation records indicated that there were no intervening sanitation breaks during this production campaign.

iii. During a continuous production that ran from March 26, 2023, through April 5, 2023, a batch of the firm’s Gerber Good Start Plus Iron and Calcium Fortified Milk-Based (“Gerber Good Start Plus”) powder product tested positive for Cronobacter spp. The positive product was spray dried on March 26, 2023, and packaged on March 27, 2023.

Prior to the initiation of this production campaign, on March 22, 2023, to March 26, 2023, the firm conducted a major CIP of the dryer equipment and a Top Down 4-Step Cleaning of all tote areas and the packaging room. On April 5, 2023, when they received notification of the positive Cronobacter spp., they ceased production and packaging operations, placed all products on hold, and immediately initiated cleaning and sanitation activities, which entailed a major CIP/Top Down 4-Step Cleaning. FDA investigator’s review of their sanitation records indicated that there were no intervening sanitation breaks during this production campaign.

The full warning letter can be viewed here.

Comments from the FDA
In a written statement, Donald Prater, acting director of the FDA’s Center for Food Safety and Applied Nutrition, emphasized, “Infant formula manufacturers are responsible for ensuring they make safe products, and the agency has remained in ongoing discussions with the infant formula industry to address the agency’s concerns.” The FDA aims to proactively identify and address issues before they escalate to the level of concern that triggered the significant recalls and contributed to the infant formula shortage observed last year.

The actions represent the FDA’s continuing endeavors to reinforce the safety and robustness of the infant formula supply chain in the United States. In November 2022, the FDA outlined a prevention strategy to curb Cronobacter sakazakii illnesses associated with the consumption of powdered infant formula. This approach involves collaborating with Congress to enhance regulatory tools and funding for oversight of the infant formula industry. Additionally, the FDA has partnered with the U.S. Centers for Disease Control and Prevention to support the addition of invasive Cronobacter infections among infants under one year of age to the Nationally Notifiable Conditions List. To further strengthen regulatory oversight, the FDA has begun hiring staff to establish an Office of Critical Foods and a dedicated cadre of infant formula investigators.

Recommendations for parents
For parents and caregivers, the FDA underscores the importance of adhering to manufacturer instructions when preparing powdered infant formula. The CDC recommends using ready-to-feed liquid infant formula for babies under 2 months old, those born prematurely, or those with weakened immune systems. Alternatively, extra precautions can be taken when preparing powdered formula by heating water to at least 158 degrees F or 70 degrees C to counteract pathogens, adding powdered infant formula, mixing, and then cooling the formula to body temperature before feeding.

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Recent modifications to FDA’s import alerts, as posted by the agency, are listed below. 

Click here to go to the FDA page with links to details on specific alerts.

(To sign up for a free subscription to Food Safety News,click here)

Th e Office of Investigation, Enforcement, and Audit (OIEA) conducts detention actions for Meat, Poultry and Egg products.  During the third quarter, OIEA detentions totaled 106,520 pounds, much lower than the previous two quarters when detentions hit 281, 143, and 250,246 pounds. So far for the fiscal year, there have been 330 detentions for 637,909 pounds.

The pressure was off a  bit due to slightly reduced activity during the federal fiscal third quarter that ended the third quarter.  Still, USDA’s Food Safety and Inspection Service remained busy with enforcement actions, including those where it pursued either civil or criminal actions.  

The Office of Field Operations (OFO) is the largest FSIS unit. It issued two “prohibited activity notices” during the third period, bringing the total to seven for the year.

FSIS “prohibited activity notices” may include any of the following:

• Failure of a recalling establishment or firm to notify its consignees of a recalled product
• Failure of a consignee to notify its customers of the recalled product
• Recalling establishment, firm, or consignee found offering a recalled product for sale

When FSIS determines that an establishment or firm has not taken responsibility to remove or control adulterated, misbranded, or unsafe products in commerce or to advise its consignees of a product subject to recall, it may issue prohibited activity notices to the establishment or firm. 

“Prohibited Activity Notices” during the third quarter were issued to Abie’s Place, Abie, NE; La Autentica Foods (two notices), Hialeah, FL; Old Town European Market, Springfield, MO; Prime Food USA, Edison, NJ; Walgreen Co. Store 7718, Fayetteville, AR; and Walmart, Baden, PA.

Through 10 district offices,  OFO carries out FSIS’ food safety mission in processing and slaughter facilities across the country. OFO is also responsible for managing all certification work including export verification.

FSIS also took a variety of administrative actions against 34 businesses it regulates. And among FSIS’s  “large establishments,” only seven faced administrative action and six of those involved inhumane treatment during slaughter.

On May 24, 2023, an administrative hearing found King of Basturma LLC and its owner Abbas Sachem, both of Westland, MI, as being unfit to receive federal meat inspection services. The reason is the owner’s felony and fraud convictions. He did not appeal and the decision became final.

In a civil injunction action, Ashif Saeed entered into a Consent Decree from the U.S. District Court for Eastern New York to resolve violations of the meat and poultry acts. The owner of a Jamaica, NY business, Saeed agreed to not misbrand products or offer misbranded products for sale. The decree includes enforcement provisions.

A Consent Decree was also agreed to in the District Court for the Southern District of New York involving the owners of N and M Wholesale Supply in New York, NY.  It resolves alleged violations of the Meat and Poultry Acts. It requires the owners to get training and keep proper records. And its meat and poultry products must pass proper inspections.

Finally, a 2020 case that opted out of a jury trial appears to have settled with plea bargains that came together during the quarter. There remains an October sentencing hearing for Rhode Island Beef, but not owners Michael and Joel Quattrucci as individuals.

They were charged with defrauding customers by using an illegally obtained official mark of inspection, defrauding customers with claims that their beef was inspected and that it had passed, and falsely claiming it had met federal inspection requirements.

The owners were fined and placed on probation in exchange for plea agreements.

The probation term is 1 to 5 years, with fines of $10,000 each.  The October hearing will be limited to Rhode Island Beef as a corporate entity.

Editor’s note: A previous reversion of this story carried the wrong byline. Editor Dan Flynn wrote this story.

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Surrey Heath Borough Council prosecuted the former operator of Mogul Restaurant in Bagshot. The company was ordered to pay a fine of £25,000 ($31,400), a victim surcharge of £2,000 ($2,500) and the council’s costs of more than £14,000 ($17,600).  

The restaurant was also temporarily shut at the time of the outbreak under emergency prohibition provisions to protect the public whilst necessary improvements were made.  

In total, 18 confirmed cases were part of the Salmonella Java outbreak and four people were admitted to hospital. All of those affected ate at the restaurant between Oct. 22 and Nov. 1, 2022. 

Investigations into the specific food item responsible were inconclusive. However, Salmonella was detected in environmental samples from a fridge door handle and in chopped coriander. 

Shaun Macdonald, from Surrey Heath Borough Council, said the investigation and prosecution case was complex and thanked environmental health and legal teams for their work.

“I’d also like to take this opportunity to remind all food businesses in the borough of their food safety responsibilities. These are laid out in law and the council will not hesitate to take action against those who do not prepare food safely to the required standards. We want residents and other guests to really enjoy eating out and having special times with friends and family, without any concerns for their well-being, by ensuring the highest food hygiene standards are in place,” he said. 

Several seizures of smokies
Meanwhile, Milton Keynes City Council’s environmental health team has seized almost 270-kilograms (595 pounds) of smokies.

Smokies are made from the meat of sheep and goats with the skin still attached and cooked using a blowtorch or similar method, to minimize costs and maximize profits. Their production and sale is illegal in the UK.

The council found smokies at three premises in Milton Keynes after receiving a tip-off and confiscated the unfit meat. Condemnation orders were issued by Milton Keynes Magistrates Court.

“The illegal trade in smokies is a serious public health risk, as the meat can be infected with diseases and parasites that could be passed on to consumers. It is extremely important that meat sold to the public is fit for human consumption and we will consider prosecuting anyone found to be selling illegal meat,” said Paul Trendall, cabinet member with responsibility for environmental health.

In June, smokies were found at a shop in Gravesend after environmental health officers carried out an unannounced inspection at Moyibo Foods.

Staff initially denied having any smokies on site but a search identified some unlabeled smokie meat in a chest freezer along with prepacked and unlabeled meat, which was removed from the premises and destroyed.

Several breaches of food and health and safety legislation were identified, and the business was required to close for urgent work to be carried out. A follow-up visit the next day found the premises had been cleaned and re-organized with repairs to electrical sockets and reinstatement of the hot water system, so it was allowed to re-open.

In March, a shop in Katesgrove was fined after illegal food products were discovered by Reading Council’s environmental health team.

Officers went to Freddie’s Afro-Caribbean in Reading in February 2023 for a routine hygiene inspection. During the visit, a goat carcass and three part carcasses – known as smokies – were seized after being found wrapped in black bags on the floor of the chiller unit, for collection by a customer.

Carcasses were unskinned, spines had not been removed, and they did not have an approved health identification mark. Meat sold in the UK must carry this mark. The owner was unable to show the required paperwork when asked and there were no details about where the meat had been sourced.

At a hearing at Reading Magistrates Court, justices approved the condemnation and destruction of goods. Frederick Otoo, director of Freddie’s Afro-Caribbean, was ordered to pay £2,025 ($2,550) in costs to the council.

Karen Rowland, from the council, said a routine inspection was able to uncover something much more serious.

“The production and processing in this manner with this kind of meat has been deemed illegal in this country because we are unable to guarantee the correct steps have been taken to make the goods safe. We remain vigilant against potentially unsafe food finding its way to the UK unchecked or examined without accompanying documentation. All food businesses must be able to provide a clear audit trail of where produce has come from,” she said.

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Eco Food Distribution LLC
Schiller Park, IL

An import company in Illinois is on notice from the FDA for not developing an FSVP for the foods they import.

In a May 25 warning letter, the FDA described a Feb. 28 through March 29 Foreign Supplier Verification Program (FSVP) inspection of Eco Food Distribution LLC in Schiller Park, IL.

The FDA’s inspection revealed that the firm was not in compliance with FSVP regulations and resulted in the issuance of an FDA Form 483a. Some of the significant violations are as follows:

1. The firm did not develop, maintain, and follow an FSVP as required. Specifically, they did not develop an FSVP for the foods they import from the foreign suppliers indicated.

2. The firm did not conduct a written hazard analysis for each type of food they import to determine whether there are any hazards requiring a control. Specifically, for the chocolate-covered gingerbread apple they import from (redacted) and the carrot nectar they import from (redacted), they did not provide a written hazard analysis to identify and evaluate known or reasonably foreseeable hazards for the food they import to determine whether there are any hazards requiring a control, as required.

3. The firm did not approve their foreign suppliers based on an evaluation of the foreign supplier’s performance and the risk posed by the food, and document their approval. Specifically, for the chocolate-covered gingerbread apple they import from (redacted) and the carrot nectar they import from (redacted), they did not provide documentation that they have evaluated their foreign supplier’s performance and risk posed by the food or their approval of these suppliers.

4. The firm did not perform foreign supplier verification activities. Specifically, for the chocolate-covered gingerbread apple they import from (redacted) and the carrot nectar they import from (redacted), they did not determine and document which verification activity or activities, as well as the frequency with which the activity or activities must be conducted, are needed to provide adequate assurances that the food they obtain from the foreign supplier is produced in accordance with regulation. In addition, they did not conduct and document (or obtain documentation of) one or more of the supplier verification activities for each of these foreign suppliers before importing these foods and periodically thereafter.

The full warning letter can be viewed here.

Moises Gardea
Albuquerque, NM

An import company in New Mexico is on notice from the FDA for not having FSVPs for a number of imported food products.

In a June 12 warning letter, the FDA described a March 9-24 Foreign Supplier Verification Program (FSVP) inspection of Moises Gardea in Albuquerque, NM.

The FDA’s inspection revealed that the firm was not in compliance with FSVP regulations and resulted in the issuance of an FDA Form 483a. The significant violations are as follows:

The firm did not develop, maintain, and follow an FSVP. Specifically, they did not develop an FSVP for each of the following foods:

• Asadero Cheese, Solid imported from (redacted), located in (redacted)
• Mennonite Cheese imported from (redacted), located in (redacted)
• Asadero Cheese, Tortilla Style imported from (redacted), located in (redacted)

The full warning letter can be viewed here.

FVD Produce LLC
Pharr, TX

An import company in Texas is on notice from the FDA for not having FSVPs for a number of imported food products.

In an Aug. 15 warning letter, the FDA described a Feb. 8 and March 9 Foreign Supplier Verification Program (FSVP) inspection of FVD Produce, LLC in Pharr, TX.

The FDA’s inspection revealed that the firm was not in compliance with FSVP regulations and resulted in the issuance of an FDA Form 483a. Some of the significant violations are as follows:

The firm did not develop, maintain, and follow an FSVP. Specifically, they did not develop an FSVP for each of the following foods:

• Fresh tomatoes, husk tomatoes, carrots and various onions from (redacted), located in (redacted)
• Carrots from (redacted) located in (redacted)

The full warning letter can be viewed here.

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Canterbury Homekill Services Limited (CHK) and owners Noel Womersley and Halena Hitchcock were sentenced to multiple charges under the Animal Products Act in Christchurch District Court.

The company and its owners were fined NZ $84,500 (U.S. $49,900).

Ensuring safe meat
Vincent Arbuckle, New Zealand Food Safety deputy director-general, said the agency would take action when food businesses acted outside the rules.

“Consumers deserve and expect that the meat they buy has come from a legitimate supplier. This means any risks associated with the meat have been identified, managed, and checked to keep people safe,” he said.

New Zealand Food Safety led the prosecution because the meat had not been checked in the food safety system to ensure it was safe.

The company was allowed to process recreationally hunted animals for individuals but was not permitted to sell the meat.

Womersley had a chiller at CHK where he stored meat from hunting trips. Investigators found evidence of various other meat sales, including beef, pork, and goat, that CHK illegally supplied to customers after studying electronic records.

“The prosecution resulted from a careful investigation, begun in 2020, which found evidence the company was selling unregulated meat, including large quantities of venison, through their two retail butcher shops. A close analysis of invoice records revealed discrepancies between the venison sold and purchased, meaning unregulated meat was being sold,” said Arbuckle.

“Most food businesses invest significant effort to ensure they keep their customers safe. Health risks are associated with eating unsafe meat, particularly for vulnerable communities and those with weakened immune systems, so they must do the right thing.”

Fish poaching case
In a different case, a man who poached crayfish with a commercial value of nearly NZ $300,000 (U.S. $177,200) was jailed for more than two years.

John Nohotima was sentenced in Wairoa District Court on one charge following a prosecution by the Ministry for Primary Industries (MPI). Nohotima sold 4,664 recreationally-harvested crayfish to a group.

Other members of the poaching gang were sentenced in March to home detention and community work.

Nohotima’s sister, Anne Nohotima, was also given 100 hours of community work by Tauranga District Court for her role. She sold 210 crayfish that her brother poached.

Jodie Cole, Fisheries New Zealand regional fisheries compliance manager, said a large amount of the stolen crayfish was sold at a fraction of the legitimate market price.

“Nohotima used falsified customary permits to illegally harvest this crayfish with around 16 craypots, fishing from the waters near Mahia Peninsula. The crayfish was on-sold to the Kawerau-based ringleaders who distributed the crayfish throughout Auckland, Kawerau, Tauranga, Gisborne, Wairoa, Mahia, and Napier,” said Cole.

“If you’re offered seafood at a price that appears too good to be true – assume it was probably harvested illegally. We’d advise not to buy it, and to let us know who offered it to you.” 

Nohotima gained 72 permits between December and July 21, 2021, and sold the crayfish between September 2020 and August 2021. 

“Staff at the butcher shop in Rangiora noticed homekill meat was being brought into the shop from CHK because it was vacuum packed and unlabeled with supplier branding or packaging. They reported that offal from CHK came into the butcher shop in large tubs, still with grass, which was being cleaned and packaged for sale to the public. These meats were sold to the public through their retail butchery.” 

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Caffeinated energy drinks are beverages or mixtures that include added caffeine, often accompanied by various other ingredients like vitamins, minerals, taurine and herbal elements. These products can also contain natural caffeine sources such as guarana and yerba mate. In Canada, these drinks are allowed to have a maximum caffeine content of 180 mg per serving.

Consumers are urged to carefully review product labels to ascertain the caffeine content per serving, the number of servings in the container, and the recommended daily consumption. It is advised that CEDs should not be consumed by individuals younger than 14 years old, pregnant or breastfeeding women, or those sensitive to caffeine. Adults aged 18 and over are cautioned not to exceed a daily caffeine intake of 400 mg.

Excessive caffeine consumption can result in adverse health effects including insomnia, irritability, headaches, and nervousness. The CFIA has recently recalled certain caffeinated energy drinks because of excessive caffeine levels and improper labeling, including missing cautionary statements. Consumers are encouraged to report any consumption-related incidents to the CFIA and can also reach out to the manufacturers directly.

To ensure safety, the CFIA recommends that children, pregnant or breastfeeding individuals, and those sensitive to caffeine refrain from consuming caffeinated energy drinks. Others are advised to limit their intake and adhere to the cautionary instructions on the product labels.

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Recent modifications to FDA’s import alerts, as posted by the agency, are listed below. 

Click here to go to the FDA page with links to details on specific alerts.

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Koi CBD, LLC
Norwalk, CA

In a June 18 warning letter, the FDA described a review of Koi CBD, LLC’s website at the internet address koicbd.com from June 2023 through July 2023.

The FDA determined that the firm’s products, Koi brand “Delta 8 Gummies” and Hemp Living brand “Pot Rocks,” are adulterated because they bear or contain an unsafe food additive. Furthermore, it is a prohibited act to introduce adulterated food into interstate commerce.

The FDA has observed a proliferation of products containing the cannabinoid, Delta-8 THC, and has recently expressed serious concerns about products containing Delta-8 THC that include: 

1) Delta-8 THC products have not been evaluated or approved by FDA for safe use and may be marketed in ways that put public health at risk; 

2) FDA has received adverse event reports involving Delta-8 THC containing products; 

3) Delta-8 THC has psychoactive and intoxicating effects; 

4) FDA is concerned about the processes used to create the concentrations of Delta-8 THC claimed in the marketplace; and 

5) FDA is concerned about Delta-8 THC products that may be consumed by children, as some packaging and labeling may appeal to children. 

Adulterated Human Foods
According to the firm’s product labeling, their Koi brand “Delta 8 Gummies” and Hemp Living brand “Pot Rocks” are foods to which Delta-8 THC has been added.

There is no food additive regulation that authorizes the use of Delta-8 THC. FDA is not aware of any information to indicate that Delta-8 THC is the subject of a prior sanction. Furthermore, they are not aware of any basis to conclude that Delta-8 THC is generally recognized as safe (GRAS) for use in conventional foods. FDA’s regulations describe the criteria for eligibility for the classification of a food ingredient as GRAS. The use of a food substance may be GRAS based on either scientific procedures or, for a substance used in food before 1958, through experience based on common use in food.

The FDA knows of no basis for general recognition of safety for Delta-8 THC based either on scientific procedures or common use in food prior to Jan. 1, 1958. Based on FDA review of published, scientific literature, existing data and information do not provide an adequate basis to conclude that the use of Delta-8 THC in food meets the criteria for GRAS status. Some of the available data raise serious concerns about potential harm from Delta-8 THC. FDA review of published scientific literature identified potential for adverse effects of Delta-8 THC on the central nervous and cardiopulmonary systems. In addition, studies in animals have suggested that gestational exposure to Delta-8 THC can interfere with neurodevelopment. Therefore, based on FDA review, the use of Delta-8 THC in the products does not satisfy the criteria for GRAS status.

The full warning letter can be viewed here.

Northland Vapor Company, LLC
Fargo, ND

In a July 7 warning letter, the FDA described an inspection of the firm’s Wonky Confections, LLC facility, which manufactures ready-to-eat (RTE) human food products containing Delta-8 tetrahydrocannabinol (THC) in Nov. 8-9, 16, 28, and Dec. 7, 2022

Based on the inspection, a review of the product labels collected during the inspection, and laboratory analysis of the firm’s products, the FDA has determined the “Death by Gummy Bears” and “Wonky Weeds” gummy bear products they manufactured in their facility are adulterated because they bear or contain an unsafe food additive. Additionally, the FDA has determined that the RTE food products manufactured in their facility are adulterated, in that they were prepared, packed, or held under insanitary conditions whereby they may have become contaminated with filth, or whereby they may have been rendered injurious to health.

At the conclusion of the inspection FDA issued a Form FDA-483, Inspectional Observations, listing the deviations found at the facility. 

FDA has observed a proliferation of products containing the cannabinoid, Delta-8 THC, and has recently expressed serious concerns about products containing Delta-8 THC that include: 

1) Delta-8 THC products have not been evaluated or approved by FDA for safe use and may be marketed in ways that put the public health at risk; 

2) FDA has received adverse event reports involving Delta-8 THC containing products; 

3) Delta-8 THC has psychoactive and intoxicating effects; 

4) FDA is concerned about the processes used to create the concentrations of Delta-8 THC claimed in the marketplace; and 

5) FDA is concerned about Delta-8 THC products that may be consumed by children, as some packaging and labeling may appeal to children. 

Adulterated Human Foods
According to the firm’s product labeling, their “Death by Gummy Bears” and “Wonky Weeds” gummy bear products are foods to which Delta-8 THC has been added. In addition, the FDA confirmed through laboratory analysis that samples of these products contain Delta-8 THC.

Food additives require premarket approval based on data demonstrating safety. Any food additive that has not been approved for its intended use in food is deemed to be unsafe, and causes the food to be adulterated. Introduction of an adulterated food into interstate commerce is prohibited.

There is no food additive regulation that authorizes the use of Delta-8 THC.

Adulterated Human Foods
The firm’s RTE food products are adulterated, in that they have been prepared, packed, or held under insanitary conditions whereby the food products may have become contaminated with filth, or whereby they may have been rendered injurious to health. During FDA inspection of their establishment, FDA investigators found violations of the Current Good Manufacturing Practice regulations for human foods. The significant violations are as follows:

1. The firm did not take reasonable precautions and measures to ensure that all persons working in direct contact with food wash hands thoroughly (and sanitize if necessary to protect against contamination with undesirable microorganisms) after each absence from the workstation and at any other time when hands may have become soiled or contaminated. Specifically, on Nov. 8 and Nov. 9, 2022, (redacted) employees were observed not washing and sanitizing hands prior to donning gloves before separating by hand the RTE gummy candy products from excess sugar and hand-packing the products into finished product packaging.

2. The firm did not provide (redacted) facilities designed to ensure that an employee’s hands are not a source of contamination of food, food-contact surfaces, or food-packaging materials, by providing facilities that are adequate, convenient, and furnish running water at a suitable temperature. Specifically, their facility is equipped with only one (redacted) sink, located in the employee restroom, which is inaccessible during bathroom occupancy and shared by approximately (redacted) employees. This (redacted) sink is in a separate area that is approximately (redacted) feet away from the production area.

3. The firm did not clean food-contact surfaces in a manner that protects against allergen cross-contact and contamination. Specifically, on Nov. 9, 2022, employees were observed washing equipment and utensils used in the production of the RTE gummy candy products with detergent but not sanitizing them. Cleaned utensils are placed onto a metal drying rack; however, a measuring pitcher was observed on the drying rack not inverted and containing pooled water. The pitcher also contained residual material that they identified as THC distillate.

The full warning letter can be viewed here.

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Recent modifications to FDA’s import alerts, as posted by the agency, are listed below. 

Click here to go to the FDA page with links to details on specific alerts.

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Porfirios Italian Foods Inc.
Trenton, NJ

A food firm in New Jersey is on notice from the FDA for serious violations of the Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Food regulation.

In a June 21, 2023, warning letter, the FDA described a Jan. 13 and 17 and March 17 inspection of Porfirios Italian Foods Inc.’s pasta manufacturing facility in Trenton, NJ.

The FDA determined that the pasta products manufactured in the facility are adulterated in that they were prepared, packed or held under insanitary conditions whereby they may have become contaminated with filth or rendered injurious to health. 

At the conclusion of the inspection, FDA issued a Form FDA 483, Inspectional Observations, listing the deviations found at their facility. 

Some of the firm’s significant deviation is as follows:

Hazard Analysis and Risk-Based Preventive Controls:

1. The firm did not prepare, or have prepared and implement a food safety plan, as required. The preparation of the food safety plan must be overseen by one or more preventive controls qualified individuals (PCQIs). The firm’s food safety plan must also include the following:

    1) The written hazard analysis
    2) The written preventive controls
    3) The written supply-chain program
    4) The written recall plan
    5) The written procedures for monitoring the implementation of the preventive controls
    6) The written corrective action procedures
    7) The written verification procedures

However, the firm did not have a food safety plan with any of the required elements. For example, they did not conduct a hazard analysis to identify and evaluate known or reasonably foreseeable hazards for each type of food manufactured, processed, packed, or held at their facility to determine whether there are any hazards requiring a preventive control. Also, they did not identify and implement preventive controls to provide assurances that any hazards requiring a preventive control will be significantly minimized or prevented and the food manufactured, processed, packed, or held by their facility will not be adulterated. Preventive controls include, as appropriate to the facility and the food, process controls, food allergen controls, sanitation controls, supply-chain controls, and a recall plan. Preventive controls are subject to preventive control management components (monitoring, verification, and corrective actions) as appropriate to ensure the effectiveness of the preventive controls, taking into account the nature of the preventive control and its role in the facility’s food safety system. The firm must also validate that the preventive controls are adequate to control the hazard as appropriate to the nature of the preventive control and its role in the facility’s food safety system. Specifically:

a) The firm did not identify and evaluate allergens as a known or reasonably foreseeable hazard to determine whether allergens are a hazard requiring a preventive control. Their facility manufactures pasta products containing allergens such as wheat, milk, and egg. The facility also manufactures a seafood pasta product – ravioli containing the lobster allergen. Additionally, they use shared equipment (i.e., (redacted) and (redacted) filler, and pasta sheeter) and utensils to manufacture pasta products containing different allergen profiles. Therefore, allergens are a known or reasonably foreseeable hazard. Food allergen controls include procedures, practices, and processes employed for ensuring protection of food from allergen cross-contact, including during storage, handling and use, and for labeling to ensure that all food allergens required to be stated are included on the label.

The firm does not have appropriate controls in place for the allergen cross-contact hazard. Their sanitation of the (redacted) mixer and (redacted) filler consists of scraping manually, blowing with compressed air, and wiping with a bleach sanitizing solution. This sanitation practice does not include cleaning with detergent between pasta products containing different allergenic ingredients. For example, they manufacture cheese ravioli, which does not contain seafood such as lobster, on the same (redacted) and (redacted) filler used to manufacture lobster ravioli without cleaning with detergent between products.

b) The firm did not identify and evaluate metal as a known or reasonably foreseeable hazard to determine whether it requires a preventive control. Metal screening in the bottom of wooden-framed sifters was observed to be broken and was missing metal pieces. They do not have metal detectors and are not implementing any other programs, such as visual inspection, to control the metal hazard.

c) The firm did not identify and evaluate mycotoxins as a known or reasonably foreseeable hazard to determine whether they require a preventive control. Their facility manufactures pasta products containing wheat flour, which has been associated with mycotoxins such as deoxynivalenol (DON).
The full warning letter can be viewed here.

STC India Private Limited
Mumbai, India

A food firm in India is on notice from the FDA for serious violations of the Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Food regulation.

In a July 21, 2023, warning letter, the FDA described a Jan. 12-17 inspection of STC India Private Limited’s food manufacturing facility in Mumbai, India.

The FDA determined that the ready-to-eat (RTE) mouth fresheners (mukhwas) manufactured in the firm’s facility are adulterated because they were prepared, packed, or held under insanitary conditions whereby they may have become contaminated with filth or whereby they may have been rendered injurious to health.

At the conclusion of the inspection, FDA issued a Form FDA 483, Inspectional Observations, listing the deviations found at their facility. 

Some of the firm’s significant deviation is as follows:

Hazard Analysis and Risk-Based Preventive Controls:

1. The firm’s hazard analysis for their RTE mukhwas products dated May 10, 2022, did not identify and evaluate bacterial pathogens, such as Salmonella, as a known or reasonably foreseeable hazard to determine whether the hazard requires a preventive control, as required. Specifically, their hazard analysis indicated “(redacted)” for biological hazards at the (redacted) step. However, the facility manufactures various mukhwas products which contain ingredients including seeds such as fennel, flax, coriander, watermelon, sesame, and pumpkin, and spices such as cumin, coriander, and black pepper, which have been associated with the hazard of Salmonella. Therefore, the pathogen of Salmonella is a known or reasonably foreseeable hazard. The hazard may be controlled during processing or at suppliers.

The firm’s Feb. 2 response included a revised Food Safety Plan and Preventive Control Plan dated Jan. 19, 2023. However, their revised hazard analysis did not identify bacterial pathogens, such as Salmonella, in ingredients such as seeds and spices as requiring a preventive control. It also does not appear that a (redacted) step has been identified. Their revised food safety plan indicates that “(redacted)”, which appears to indicate this is not a (redacted) step. Further, they did not identify any process or supply-chain preventive controls to address the hazard of Salmonella in these ingredients.

Current Good Manufacturing Practice

2. The firm did not take effective measures to exclude pests from their processing, packing, and holding areas and to protect against the contamination of food on the premises by pests, as required. Specifically, rodent activity was observed throughout their facility as follows:

• On Jan. 12 the investigator observed apparent rodent excreta pellets in storage rooms where raw materials, including fennel seeds, awla, shredded coconut, and various semi-finished mukhwas, were stored and on the terrace where additional raw materials including fennel seeds, sesame seeds, amaranth seeds, pumpkin seeds and awla were stored. Specifically, the investigator observed:

    o at least (redacted) apparent rodent excreta pellets on bags of fennel seeds (coated and uncoated) stored on the shelf close to the wall in the storage rooms on the (redacted) side, and extensive spillage of semi-finished product and raw materials (including Rajwadi mukhwas, Orange mukhwas, and Softy Takada) on the shelf and on the floor
    o at least (redacted) apparent rodent excreta pellets on the floor close to the wall where they stored white plastic containers and blue drums in each storage room on the (redacted) sides.
    o jute bags containing Awla chura (Indian gooseberry powder) stored on the east side storage area with holes exposing the product; apparent rodent excreta pellets were found approximately (redacted) feet from the bags
    o a glue pad placed on the floor for pest control in the (redacted) room storage room on the (redacted) side (second floor), extensively laden with numerous apparent rodent excreta pellets and sprinkled over with raw materials and semi-finished mukhwas

• On Jan. 17, 2023, the investigator observed at least four apparent rodent excreta pellets in the attic space where Fresh Mint Mukhwas are manufactured, along with spilled coconut in that area.

3. The firm did not maintain their plant in a clean and sanitary condition and keep their plant in repair adequate to prevent food from becoming adulterated, as required. Specifically, the investigator observed conditions that may serve as an attractant to pests and may restrict inspection/cleaning activities including:

• bags and plastic drums containing raw and in-process materials including sesame seeds, amaranth, and pumpkin seeds touching the wall in the storage area of the second floor and terrace
• clutter of plastic drums, plastic containers, and bags containing raw and in-process materials on the (redacted) side of the terrace
• clutter of boxes, empty woven polystyrene bags, plastic bags, and other materials on the (redacted) side of the (redacted) roaster
• dried food residue on dirty equipment including cover of the hopper where finished muskhas are processed, ribbon blender, and fill and seal machine
• extensive food residues in the bucket elevator, near the floor

The full warning letter can be viewed here.

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The FDA’s actions regarding PHOs address artificial sources of trans fat. Still, trans fat will not be completely removed from the food supply because it occurs naturally in meat and dairy products and is present at very low levels in other edible oils.

Hydrogenated oil comes in two forms: partially or fully hydrogenated. One use of hydrogenated oil is to preserve the shelf life of food. Partially hydrogenated oil contains trans fat that can raise cholesterol and result in health complications.

The direct final rule: 

• Revises regulations to no longer include PHOs as an optional ingredient in the identity standards for peanut butter and canned tuna. 
• Revises FDA GRAS affirmation regulations to no longer include partially hydrogenated forms of menhaden and rapeseed oils.   
• Revokes the regulation for partially hydrogenated fish oil as an indirect food substance  
• Revokes pre-1958 authorization for using PHOs in margarine, shortening, bread, rolls, and buns. This authorization occurred before the enactment of the Food Additives Amendment of 1958, so these uses of PHOs could not be regulated as food additives. 

In the 2015 final determination, the FDA indicated that there were outdated references to PHOs in regulations that the FDA would address separately. With respect to removing PHOs from the food supply, the FDA established Jan. 1, 2021, as the final compliance date to allow manufacturers time to reformulate foods and ensure an orderly transition in the marketplace.

The FDA is issuing these amendments directly as a final rule because it anticipates no significant adverse comments. After all, FDA declared PHOs no longer GRAS for any human food in 2015. However, the agency is issuing a companion proposed rule in the same issue of the Federal Register in case the direct final rule is withdrawn because significant adverse comments are received, and the agency needs to move forward with a proposed rule to put these changes in place. 

The FDA is accepting comments on both the direct final and proposed rules. Comments must be submitted by 75 days after publication in the Federal Register.

Submit electronic comments at https://www.regulations.gov/. 

Submit written comments to:

Dockets Management Staff (HFA-305)
Food and Drug Administration
5630 Fishers Lane, Room 1061
Rockville, MD 20852

The direct final rule would be effective 135 days after the date of publication in the Federal Register.  

• Federal Register Notice: Direct Final Rule on Revocation of Uses of Partially Hydrogenated Oils in Foods (August 2023) 
• Federal Register Notice: Companion Proposed Rule on Revocation of Uses of Partially Hydrogenated Oils in Foods (August 2023)  
• Final Determination Regarding Partially Hydrogenated Oils (Removing Trans Fat)

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Recent modifications to FDA’s import alerts, as posted by the agency, are listed below. 

Click here to go to the FDA page with links to details on specific alerts.

(To sign up for a free subscription to Food Safety News,click here)

La Yongjia Trade Co.
Vernon, CA

An import company in California is on notice from the FDA for not having FSVPs for a number of imported food products.

In a July 19 warning letter, the FDA described a Feb. 15-23 Foreign Supplier Verification Program (FSVP) inspection of La Yongjia Trade Co. in Vernon, CA.

The inspection was initiated because of findings of Listeria monocytogenes in samples of fresh enoki mushrooms from the firm’s foreign suppliers, (redacted), located in (redacted), (redacted), located in (redacted), (redacted) and (redacted), located in (redacted), (redacted), located in (redacted), and (redacted), located in (redacted), collected and analyzed by FDA and imported by their company. The firm’s foreign suppliers, (redacted) were placed on Import Alert # 99-23, Detention Without Physical Examination of Fresh Produce Due to Contamination with Human Pathogens, on July 18, 2022, Sept. 23, 2022, June 17, 2022; Feb. 3, 2023, and Sept. 23, 2022, respectively. Fresh enoki mushrooms from their foreign supplier (redacted) were placed on Import Alert # 99-35, Detention Without Physical Examination of Fresh Produce that Appears to have been Prepared, Packed or Held under Insanitary Conditions, on June 14, 2022, respectively. The FDA also notes that fresh enoki mushrooms from their foreign suppliers (redacted) and (redacted) were placed on Import Alert #99-35 on March 13, 2023.

The FDA’s inspection revealed that the firm was not in compliance with regulations and resulted in the issuance of an FDA Form 483. The significant violations are as follows:

The firm did not develop, maintain, and follow an FSVP. Specifically, they did not develop an FSVP for each of the following foods:

• Fresh Enoki Mushrooms from foreign manufacturer and supplier (redacted), located in (redacted).
• Fresh Enoki Mushrooms from foreign manufacturer (redacted) and foreign manufacturer and supplier (redacted), located in (redacted).
• Fresh Enoki Mushrooms from foreign manufacturer (redacted) and foreign manufacturer and supplier (redacted), located in (redacted).
• Fresh Enoki Mushrooms from foreign manufacturer and supplier (redacted), located in (redacted).
•  Fresh Enoki Mushrooms from foreign manufacturer (redacted) and foreign manufacturer and supplier (redacted), located in (redacted).

The full warning letter can be viewed here.

Premier Food Supplies LLC
Troy, MI

An import company in Michigan is on notice from the FDA for not having FSVPs for a number of imported food products.

In a July 14 warning letter, the FDA described a March 14-23 Foreign Supplier Verification Program (FSVP) inspection of Premier Food Supplies LLC in Troy, MI.

The FDA’s inspection revealed that the firm was not in compliance with FSVP regulations and resulted in the issuance of an FDA Form 483a. The significant violations are as follows:

1. The firm did not develop, maintain, and follow an FSVP as required. Specifically, they did not develop an FSVP for the foods from the foreign suppliers indicated in the attached list.

2. The firm did not meet the requirement to conduct a written hazard analysis for each type of food you import to determine whether there are any hazards requiring a control, as required. Although they may meet this requirement by reviewing and assessing the hazard analysis conducted by another entity using a qualified individual, the firm must document their review and assessment of that hazard analysis, including documenting that the hazard analysis was conducted by a qualified individual. Specifically, for the firm’s Boondi Plain (Boondi Salted) and Nimbu Masala imported from Haldiram Snacks Pvt. Ltd., located in India, while they obtained the hazard analysis for each of these products from their foreign supplier, they did not document their review and assessment of the hazard analyses or that the hazard analyses were conducted by a qualified individual, as required.

3. The firm did not meet the requirement to evaluate their foreign supplier’s performance and the risk posed by the food, as required, and document their approval of their foreign suppliers based on this evaluation, as required. Specifically, for their Boondi Plain (Boondi Salted) and Nimbu Masala imported from Haldiram Snacks Pvt. Ltd. in India, and Cut Mango Pickle with Garlic imported from (redacted), located in (redacted), they did not provide documentation that they have evaluated their foreign supplier’s performance and the risk posed by the food, as required.

4. The firm did not meet the requirement to perform foreign supplier verification activities as required. Specifically, they did not document their determination of the appropriate supplier verification activity or activities, including the frequency with which the activity or activities must be conducted, for their Boondi Plain (Boondi Salted) and Nimbu Masala imported from Haldiram Snacks Pvt. Ltd. and Cut Mango Pickle with Garlic imported from (redacted), as required, nor did they conduct (and document) or obtain documentation of one or more appropriate supplier verification activities for each of these foreign suppliers before importing these foods and periodically thereafter, as required.

The full warning letter can be viewed here.

Nafta Distributors Inc.
Ontario, CA

An import company in California is on notice from the FDA for not having FSVPs for a number of imported food products.

In a July 21 warning letter, the FDA described a Feb. 7-21 Foreign Supplier Verification Program (FSVP) inspection of NAFTA Distributors Inc. in Ontario, CA.

The FDA’s inspection revealed that the firm was not in compliance with regulations and resulted in the issuance of an FDA Form 483a. The significant violations are as follows:

The firm did not develop, maintain, and follow an FSVP. Specifically, they did not develop an FSVP for each of the following foods:

• Lollipop and Candy Specialties, imported from (redacted)
• Candy, imported from (redacted)
• Blended vegetable oils, imported from (redacted)
• (Redacted) jam, jelly, preserves, marmalade, butter or candied, and candy, imported from (redacted)
• Cookies, caramel, and candy, imported from (redacted)
• (Redacted) and lollipop, imported from (redacted)
• Milk and cream, or candy bar or ieces, imported from (redacted)
• Gelatin, imported from (redacted)
• Candy specialties, chewing gum, imported from (redacted)
• Gelatin, imported from (redacted)
• (Redacted), lollipop, candy specialties, chewing gum, imported from (redacted)
• (Redacted), jam, jelly, preserves, marmalade, butter and candied, caramel candy bar, soft candy, lollipop, candy specialties, imported from (redacted)
• Candy specialties, imported from (redacted)
• Gelatin, imported from (redacted)
• Peanuts, candy bar, marshmallow candy, chocolate candy, imported from (redacted)
• Pepper sauce, imported from (redacted)
• Candy, imported from (redacted)
• Soda water, imported from (redacted)
• Salt, imported from (redacted)

The full warning letter can be viewed here.

Cheshni Foods LLC
Arlington Heights, IL

An import company in Illinois is on notice from the FDA for not having FSVPs for a number of imported food products.

In a July 14 warning letter, the FDA described a March 22 through April 28 Foreign Supplier Verification Program (FSVP) inspection of Cheshni Foods LLC in Arlington Heights, IL.

The FDA’s inspection revealed that the firm was not in compliance with regulations and resulted in the issuance of an FDA Form 483a. The significant violations are as follows:

The firm did not develop, maintain, and follow an FSVP. Specifically, they did not develop an FSVP for each of the following foods:

• Fig Jam and cookies (tea biscuits), imported from (redacted) in (redacted) located in (redacted)
• Tahini, imported from (redacted) located in (redacted)

The full warning letter can be viewed here.

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Recent modifications to FDA’s import alerts, as posted by the agency, are listed below. 

Click here to go to the FDA page with links to details on specific alerts.

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It all started in April 2022 when federal investigators checked out a meat and poultry warehouse on NYC’s Allen Street, only to discover what might’ve been the city’s best-fed rat population.

The rats consumed 43,000 pounds of meat and poultry inside the Ya Feng Trading warehouse.

Rodent droppings covered the meat containers with nesting materials, and a dead mouse was found inside a walk-in cooler. During the inspections, a rat ran up an investigator’s leg as the rodents scattered for a nearby cooler.

With the inspection, a federal lawsuit was filed with Manhattan prosecutors charging the warehouse with violating storage and inspection laws for meat and poultry products.

The civil case was settled Friday with a Consent Decree announced by Damian Williams, U.S. Attorney for the Southern District of New York. It was his office that brought the lawsuit over the rats.

Federal District Judge Valeri Caproni approved the Consent Decree.

Under the agreement, the Ya Feng company, owner Linmin Yang, and warehouse manager Kong Ping Ni accept being barred from any work or business involving meat and poultry.    

The New York Times reported that as soon as the details case were made public, it “immediately entered the pantheon of New York City rat tales.”

Those include the 2020 case when a man fell through the sidewalk in the Bronx and into a pit “teaming with rats” or when rats emerge from apartment walls or up through toilets.

“Perhaps most famous was Pizza Rat, a large brown rat that went viral after a video emerged showing it dragging a large slice of pizza down the stairs to an L line station in Manhattan in 2015, the NYT reports.

Meat Rats were shut down with chicken, pork, and other meat products. Maybe it was a victory for the city’s first rat czar.

Yang did sign a statement in 2022, admitting to the Court that the warehouse did have a “serious rodent issue.”

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The measures will be in effect from Sept. 28 to Dec. 20.

According to the CFIA, this action was taken to address the recurring outbreaks of foodborne illnesses related to E. coli O157:H7 in romaine lettuce imported from the United States. Investigations by U.S. authorities have traced the source of the outbreaks to the California Salinas Valley counties of Santa Cruz, Santa Clara, San Benito, and Monterey.

During the designated period, importers of romaine lettuce and salad mixes containing romaine lettuce from the U.S. must adhere to one of the following requirements:

• Declare that the product does not originate from the Salinas Valley counties of California mentioned above, or
• Submit an attestation form and Certificates of Analysis for each shipment, confirming that the romaine lettuce is free from detectable levels of E. coli O157:H7.

The CFIA emphasizes that these temporary SFC license conditions are in addition to existing import requirements. Importers must also comply with other Canadian legislation and fulfill specific conditions at the time of import.

To import romaine lettuce from outside the specified California counties, importers are required to provide Proof of Origin indicating the state and county where the romaine lettuce was harvested.

For romaine lettuce originating from the Salinas Valley counties, the following conditions must be met:

• An attestation, using form Importer’s Attestation for Romaine Lettuce Products from the Salinas Valley, California, United States (CFIA/ACIA 5961; 2023/06), confirming that sampling was conducted in accordance with the temporary SFC license conditions and that E. coli O157:H7 was not detected.
• Certificates of Analysis for each romaine product in the shipment, issued by an accredited laboratory, showing negative results for E. coli O157:H7.

Importers must ensure that romaine lettuce from California has been handled by a certified member of the California Leafy Greens Marketing Agreement (LGMA). Similarly, romaine lettuce from Arizona must be handled by a shipper certified by the Arizona LGMA.

The sampling and testing for E. coli O157:H7 can be performed using two options: finished-product sampling or pre-harvest sampling. In either case, the laboratory conducting the tests must be accredited by an accreditation body conforming to the requirements of ISO/IEC 17025:2017 for specific tests.

The CFIA urges importers to strictly adhere to the sampling requirements to ensure the safety of romaine lettuce shipments to Canada. Failure to comply with the temporary license conditions and import requirements may result in enforcement action taken by the CFIA.

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The deal between the Public Ministry of Minas Gerais (MPMG) and Cervejaria Três Lobos deals with compensation for sickened victims after consuming a beer produced by the company, Cervejaria Backer.

Ten people died, and dozens of others were affected with blindness and facial paralysis.

The agreement covers medical and other treatment costs, salary payments before illness, loss of earnings, food and transport costs, and money for other expenses incurred.

To be entitled to compensation, the causal link between the beer contaminated by diethylene glycol and/or mono ethylene glycol and the damage to each person’s health must be recognized and confirmed by a unit of the MPMG.

Cervejaria Três Lobos will pay R$500,000 ($105,000) to each victim and R$150,000 ($31,500) to each qualifying relative.

The factory in Belo Horizonte was shut down in January 2020. In 2022, MAPA allowed production and sales to restart. The company replaced the refrigerant fluid in its process with a hydroalcoholic solution that contained water and alcohol.

Another party, Empreendimentos Khalil, will allocate 244 lots of its property, located in Perdigão, to contribute to payments. The majority of proceeds from the sale of properties will be used to pay the victims, forming part of the fund managed by the Associação das Vítimas de Intoxicação por Dietilenoglicol.

Source of contaminated beer
Investigations by police in the state of Minas Gerais confirmed the presence of diethylene glycol, used in the beverage cooling process, in samples of the Belorizontina brand beer. The company said it never bought diethylene glycol but did use mono-ethylene glycol. A hole in a tank caused a leak that allowed the coolant liquid circulating in an external system to mix with the drink inside the container.

Fernando Ferreira Abreu, the consumer protection prosecutor of Belo Horizonte, said the agreement ends the complex civil action resulting from the traumatic event.

“Far from repairing the most intimate damage to the victims and their families, due to absolute physical impossibility, the agreement ensures . . . the right to pay compensation, the only existing means of repairing the damage,” he said.

As part of a proposed recovery plan, Cervejaria Três Lobos will maintain a fund corresponding to 5 percent of its net income as an alternative to paying victims in full. It must also pay R$ 1.5 million ($320,000) to the State Fund for Consumer Protection and Defense.

Public prosecutors filed a complaint against 11 people about the incident, and while some hearings have been held, this criminal process is ongoing.

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It continues the 15-year-old jurisdiction of the Eastern District Court over the civil matter involving the concern over RAW FARM LLC, Organic Pasture’s new legal name.

Last March, the U.S. Department of Justice raised possible civil contempt allegations against RAW FARM, Mark McAfee, and Arron McAfee. An evidentiary hearing on that issue was set for Aug. 9, 2023, but has now been canceled by the Consent Decree.

It means that the Court’s jurisdiction continues over the Defendants, and an April 2010 Order remains in effect for all the directors, officers, agents, representatives, attorneys, and others involved.

The RAW FARM defendants, after 60 months, can petition the Food and Drug Administration (FDA) for “relief  from this Decree.”  In the meantime, they must “abide by the decisions of the FDA.”

FDA gets the power of inspections without prior notice. The Decree spells out specific requirements for audits and labeling that must be followed. It includes hiring an independent “labeling expert.”

The Department of Justice reopened the 2008 litigation last March, claiming Organic Pastures, known now as RAW FARM LLC, was violating the April 2010 Permanent Injunction, which imposed restrictions from distributing in interstate commerce unapproved drugs, misbranded food, and raw milk and raw milk products for human consumption.

The production and sale of raw milk by Organic Pastures within California, where it is legal, was not impacted by the April 2010 order. It’s estimated that OP has 60,000 retail customers of raw milk in the Golden State.

In re-opening the case, DOJ said a raw cheese claiming it can cure, mitigate, treat, or prevent human disease, including heart disease, osteoporosis, and viral infections, violates the April 2010 order.  

The Court previously agreed with the DOJ that RAW FARM and the McAfee parties violated the Permanent Injunction Order issued on April 20, 2010.  Before any new testimony was taken, the Defendants agreed to the Consent Decree.

The government also takes issue with RAW FARM’s claim that its raw milk labeled as “pet food” is safe for human consumption.

“Organic Pastures and its principals, Mark and Aaron McAfee, have thus continued their pattern of distributing their products in interstate commerce with unproven claims about the ‘wonders’ of raw milk and its associated products,” said the DOJ petititon.

In that March 2023 petition, the government wanted to hold  RAW FARM/Organic Pastures and McAfee in contempt with contempt sanctions.

While the 2008 civil case was pending, Organic Pastures 15 years ago also faced similar charges in a criminal action involving similar conduct. The criminal matter concluded in settlement by plea agreement on Dec. 22, 2008, and was approved by Magistrate Judge Sandra M. Snyder on Jan. 9, 2009. 

 Pursuant to the plea agreement, Organic Pastures pleaded guilty to two counts of misdemeanor introduction and delivery for introduction into interstate commerce of misbranded food. McAfee entered into a deferred prosecution agreement whereby he agreed to the filing of a two-count information charging him and Organic Pastures with the same violations. 

In these agreements, both defendants admitted that: (1) on two separate occasions “one or more of defendant Organic Pastures’ agents or employees, with the knowledge and consent of Organic Pastures, caused [a] box of raw milk and dairy products, labeled as or otherwise represented to be ‘pet food,’ to be sent by defendant Organic Pastures” into interstate commerce, “knowing that the intended use of such foods and/or dietary supplements was for human consumption;” and (2) Organic Pastures’ raw milk and raw milk products “were foods and/or dietary supplements, and were misbranded when so introduced into or delivered for introduction into interstate commerce, in that they were falsely and misleadingly labeled as, or otherwise represented.

In the April 2010 order, Organic Pastures and McAfee acknowledged violating federal food safety law by introducing and/or distributing raw milk into interstate commerce in 2007. They also conceded that they violated the “unapproved raw drugs” provision of the FDA. 

They did oppose the order as inconsistent with the State of California’s regulation of the raw milk industry.

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Suffolk Coastal Port Health Authority (SCPHA), part of East Suffolk Council, recently discovered Salmonella mbandaka in 21,800-kilograms (48,000 pounds) of cooked chicken imported to the Port of Felixstowe. 

The agency, which inspects imported food, feed and animal-origin products, said it was highly unusual to find Salmonella in pre-cooked chicken, as the bacteria should be destroyed when heat treated. This implies chicken was not cooked properly or it was contaminated afterward. Salmonella is sometimes found in raw chicken, however there is an expectation that people will cook it before consumption.

Jose Arruga, official veterinary surgeon at SCPHA who discovered the problem, said: “Unlike raw chicken, all pre-cooked chicken must be completely devoid of Salmonella according to UK legislation, as consumers are not expected to cook it as thoroughly. We have therefore ordered the destruction of this consignment and increased our checks to root out any more instances of Salmonella mbandaka.” 

SCPHA had found Salmonella in a previous import of chicken from the same factory as part of routine checks, prompting intensified controls for all future imports.

Arruga sampled the factory’s next export to Felixstowe and the sample tested positive for Salmonella mbandaka after laboratory analysis.

“As per guidance from the Food Standards Agency (FSA), up to 30 imports of this product from the location in question must be clear of any contamination before we can resume routine checks. The cause could be something as simple as contaminated equipment at the factory or a wider issue,” he said.

Outbreak linked to chicken from Ukraine
In the UK, more than 130 people are sick with Salmonella Mbandaka after eating chicken products from Ukraine. Four patients were admitted to hospital and one person has died.

Intensified Official Controls started in April. This included a requirement that the next 10 imported consignments from the implicated establishment would be subject to extra inspections.

Because of continued breaches of food safety requirements, checks were escalated in May. These physical, documentary and testing inspections will remain in place until a minimum of 30 consecutive favorable results are achieved. An investigation by Ukrainian authorities has resulted in measures being taken at the facilities of the manufacturer.

In late 2022, the European Centre for Disease Prevention and Control (ECDC) reported that Finland had 89 cases while a few patients also lived in the Czech Republic, Estonia, France, Germany, Ireland, the Netherlands, and Israel. 

Tina Potter, head of incidents at the FSA, said: “We welcome the successful interception of the consignment of infected cooked chicken, and we commend Suffolk Coastal Port Health Authority for doing so. This case highlights the importance of high-quality import checks and inspections at ports across the country. The steps taken by dedicated officers at SCPHA has helped keep UK consumers safe.” 

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Baits and Sea Foods, S.A.
Nicaragua

A food firm in Nicaragua is on notice from the FDA for serious violations of the seafood Hazard Analysis and Critical Control Point (HACCP) regulation.

In a June 30, 2023, warning letter, the FDA described a May 8 through 11, 2023, inspection of Baits and Sea Foods, S.A. in Managua, Nicaragua.

The inspections found that the firm’s fresh and frozen histamine forming seafood products, including but not limited to mahi-mahi, are adulterated, in that they have been prepared, packed, or held under conditions whereby they may have been rendered injurious to health.

Some of the firm’s significant deviation is as follows:

1. The HACCP plan does not list the food safety hazards that are reasonably likely to occur. Specifically, the HACCP plan for histamine forming species including frozen, raw, individually vacuum-packaged, wild caught, mahi-mahi portions and fillets does not list the food safety hazard of Clostridium botulinum growth and toxin formation, and undeclared allergens as required.

2. The HACCP plan does not list one or more critical control points that are necessary for each of the identified food safety hazards. Specifically, the HACCP plan for histamine forming species including frozen, raw, individually vacuum-packaged, wild caught, mahi-mahi portions and fillets does not list as required:
  a. A critical control point (CCP) at the receiving of fresh whole gutted mahi mahi that is necessary to control the hazards of histamine formation during transit from the local ports to the processing plant.
  b. A critical control point at the fish storage between layers of ice that is necessary to control the histamine formation hazard. The fresh whole, gutted mahi mahi fish can be stored up to 48 hours between layers of ice.

3. The firm’s HACCP plan lists a critical limit that does not ensure control of one or more hazards. Specifically, their HACCP plan for histamine forming species including frozen, raw, individually vacuum-packaged, wild caught, mahi-mahi portions and fillets does not list the sensory examination critical limit to control the histamine formation hazard at the receiving critical control point as required.

4. The firm’s HACCP plan lists monitoring procedures that do not ensure compliance with the critical limit. Specifically, the HACCP plan for histamine forming species including frozen, raw, individually vacuum-packaged, wild caught, mahi-mahi portions and fillets as required:
  a. Lists the incomplete monitoring procedure of “(redacted)”. This procedure does not ensure compliance with the critical limit at the receiving CCP. The monitoring procedure does not list the number of fish to be analyzed for histamine.
  b. Lists incomplete monitoring procedures to monitor the internal temperature of the fish at the receiving CCP. The monitoring procedure does not list the minimum number of fish to be temperature checked.

5. The firm’s HACCP plan includes a corrective action plan that is not in accordance with regulation to ensure affected product is not entered into commerce and the cause of the deviation was corrected. Specifically, the HACCP plan for histamine forming species lists an inadequate corrective action procedure at the receiving CCP when the temperature measurement is above the critical limits.

The full warning letter can be viewed here.

New Manna Food
Guam

A food firm in Guam is on notice from the FDA for serious violations of the seafood Hazard Analysis and Critical Control Point (HACCP) regulation.

In a June 12, 2023, warning letter, the FDA described a Feb. 1-3, 2023, inspection of New Manna Food in Guam.

In accordance with regulation, failure of a processor of fish or fishery products to have and implement a HACCP plan that complies with this section or otherwise operates in accordance with requirements, renders the fish and fishery products adulterated. A label review was also conducted of the Guam New Manna Foods tuna salad sandwich and found violations of Food Labeling, which causes the product to be misbranded. Additionally, the inspection found the firm failed to register as required. The failure to register a facility as required is a prohibited act.

At the conclusion of the inspection, FDA issued a Form FDA 483, Inspectional Observations, listing the deviations found at their facility. 

The firm’s significant deviation is as follows:

Seafood HACCP Violations

1. The firm does not have a written HACCP plan that outlines controls for any food safety hazards that are reasonably likely to occur, as required. Specifically, the firm does not have a HACCP plan for Guam New Manna Foods tuna salad sandwich to control the hazards of histamine, pathogen growth and toxin formation, and undeclared allergens. In addition, the firm has not conducted a hazard analysis for this product. The FDA investigator observed the following lack of controls during the inspection:

a) On Feb. 1 at 11:00 a.m., the temperature of their walk-in refrigerated storage was measured at 44 degrees F using the gauge on the wall of the walk-in storage. There were ingredients used in their tuna salad sandwich stored in this cooler at the time the temperature was observed, including tuna and mayonnaise. Finished product Guam New Manna Foods tuna salad sandwich were also observed being stored in this walk-in storage. The firm stated that the sandwiches would be distributed the next morning at about 4:30 a.m.

On Feb. 2 at 9:15 a.m., the temperature of the walk-in storage was measured at 48.7 degrees F using a probe thermometer (the accuracy of which was checked using ice water). At 9:35 a.m., the temperature was 46.2 degrees F and at 11:48 a.m., the temperature was 47.3 degrees F using the same probe thermometer. At all these times, mixed tuna salad was stored in the walk-in storage awaiting assembly into Guam New Manna Foods tuna salad sandwiches. They state that the finished product Guam New Manna Foods tuna salad sandwiches would be stored in the walk-in storage until distribution the next morning at about 4:30 a.m. They stated that they do not monitor or record the temperature of their walk-in storage. There is no continuous monitoring of the temperature, and no temperature alarm system on the walk-in storage.

b) Their Guam New Manna Foods tuna salad sandwiches are not labeled with a statement of identity, an ingredient statement, or allergen statement. The product contains the allergens of milk and soy from the bread, egg from mayonnaise, and fish (tuna).

2. They are not monitoring the sanitation conditions and practices with sufficient frequency to ensure compliance with Current Good Manufacturing Practice requirements including protection from adulteration (i.e., allergen cross contact) and exclusion of pests from the food plant, as required.

Specifically,
a) On Feb. 1, an FDA investigator observed at least four flies inside their processing room. The flies were observed landing on bread used for ready-to-eat Tuna Salad Sandwiches and on other ready-to-eat products and food contact surfaces.

b) On Feb. 1, an FDA investigator observed ham and cheese sandwiches were being manufactured, and then placing the in-process sandwiches directly on a stainless-steel table. After the ham and cheese sandwich manufacturing was completed, Guam New Manna Foods wiped off using a towel that was wet with plain water and proceeded to place tuna salad sandwiches on the same table. An FDA investigator also observed the same potential cross contact issues after the manufacture of the tuna salad sandwiches where egg salad sandwiches could be potentially adulterated with fish allergens from the work surface. When allergen cross contact presents a food safety hazard, processors must implement prevention controls that effectively remove or eliminate allergens from the work surface. Wiping down food contact surfaces with water does not appear to provide the necessary safety assurance that allergens have been eliminated from that surface. FDA recommends that cleaning operations include two steps, washing the surface with soap to remove particulates and then sanitizing the cleaned surface. The processor also has the option of scheduling the products being manufactured to eliminate the potential for allergen cross contact.

Failure to Register
The FDA has determined that their facility has failed to register their facility. The failure to register a facility as required is a prohibited. FDA records indicate that, to date of this warning letter, this facility has not been registered with FDA.

The full warning letter can be viewed here.

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Irfan Hanif Patel of Ravensthorpe Road, Dewsbury, was sentenced to 120 hours of unpaid work in the community after pleading guilty to breaching the Trade Marks Act 1994 and a number of food hygiene offences. His brother, Mohammed Patel of Thornhill Street, Dewsbury, was given 100 hours of community service at Leeds Crown Court.

In December 2020, West Yorkshire Trading Standards and Kirklees Council’s environmental health team received intelligence about counterfeit Abel and Cole cranberry sauce being sold throughout the country. The sauce was also supplied near Christmas when demand was high, posing an increased risk. An investigation involved the Food Standards Agency’s National Food Crime Unit (NFCU) and other local authorities.

Fake cranberry sauce was purchased by Irfan Patel who was acting as a sole trader and was passed onto his brother Mohammed Patel, the director of Stock Up Direct Limited.

Stock Up Direct supplied more than 1,000 jars to a wholesaler who distributed them to various food companies around the country. Neither man had registered the business with the council so it had never been inspected to ensure it met the required food hygiene standards.

Lack of traceability
Officers from West Yorkshire Trading Standards and Kirklees Council visited food businesses supplied in Kirklees and obtained the jars for examination. Officials went to Irfan’s business, at the time on Bretton Park Way, Dewsbury. Irfan said stock was bought from another trader. An invoice was produced for a business which was untraceable.

Officers also visited Stock Up Direct. An interview with Mohammed Patel revealed he had never seen any stock that went through the company. It was created as a side business for his brother, and he was involved in other larger firms.

An inspection of the Bretton Park Way premises found a warehouse with large quantities of food. Irfan Patel was unable to provide documentation to demonstrate the legal provenance of the items, which were seized and later destroyed.

Kirklees Council applied to Kirklees magistrates’ court for a food condemnation order in February 2021. This was granted because of concerns on sourcing of foods from unregistered businesses, where no regulatory checks had taken place to ensure safe storage, handling or distribution. Origin was also unknown so could be linked to illegal activities such as bringing food destined for waste back into the supply chain, according to the order.

A sample of the suspected counterfeit product was found by the Public Analyst to be not genuine Abel and Cole cranberry sauce. The company confirmed the sauce had a label which was a copy of the Abel and Cole registered trademark.

David Strover, trading standards manager, and Naheed Mather, from Kirklees Council, said food that is counterfeit means the label is misleading and it can pose serious harm to consumers.

“Businesses need to ensure they are registered with the local authority 28 days before beginning to operate. They must have a traceability system in place and to only purchase stock they believe is legitimate by conducting checks. Supplying food that is counterfeit can pose serious risks to the community as it is often made in an uncontrolled environment with uncontrolled processes and ingredients,” they said.

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Recent modifications to FDA’s import alerts, as posted by the agency, are listed below. 

Click here to go to the FDA page with links to details on specific alerts.

(To sign up for a free subscription to Food Safety News,click here)

Recent modifications to FDA’s import alerts, as posted by the agency, are listed below. 

Click here to go to the FDA page with links to details on specific alerts.

Measures were taken against the trio this month. The operation involved Europol, France, Germany, Spain, and the Carabinieri NAS of Turin, and Italian Financial Police (Guardia di Finanza). It was under the umbrella of Operation Opson, an annual effort to combat counterfeit food and drink.

Law enforcement officials conducted 14 searches including private homes and commercial sites in six regions and seized more than 500,000 food and drink items as well as equipment used by the suspected criminals. Many of these items were expired and already spoiled, highlighting the potential harm to consumers, according to Europol.

The alleged criminal network collected expired or expiring food and beverages for little or no cost and replaced the shelf life dates with new ones to enable their resale. After reintroducing these items into the supply chain, gains were made at the expense of consumers. There is no involvement of food producers but intermediate suppliers or other entities working in food disposal were involved.

Investigations started in March 2022 when the Carabinieri NAS of Turin found confectionery at a retailer in the city of Novara that lacked commercial documentation and had an expiry date which was later found to be counterfeit. Further work revealed products came from another company, also located in the Novara area.

This past October, officials seized several tons of food from a warehouse in Novara, which was valued at €1 million ($1.1 million). It had already been relabeled and was ready for sale, despite items being expired.

Initial operation
The first action day in May involved Estonia, France, Germany, Lithuania, Romania, Europol, and Eurojust.

This led to the arrest of 24 people in Lithuania. About 70 searches of warehouses and other locations were carried out. Officers uncovered equipment for altering expiry dates. This included household solvents, printers and labels. More than 1 million food and beverage packages were found and prevented from entering the market.

Exploiting vulnerabilities in the supply chain initially because of the COVID-19 pandemic, suspects started acquiring expired food and beverages. They would then chemically erase the date printed on each item and reprint a new one. In other cases, a new label was forged and applied, giving the impression that food or beverages were still fresh and safe for consumption.

Active since early 2021, the organized crime group is believed to have purchased large amounts of expired food products and other perishable goods from Germany and France. They altered the dates on products and supplied them to the Lithuanian market, where they were bought by thousands of consumers.

The gang, which is also under investigation for VAT fraud, is believed to have made at least €1 million ($1.1 million) in profits from the food labelling scam. A link connecting the Lithuanian and Italian investigations was found by Europol specialists.

In June, the State Food and Veterinary Service (VMVT) in Lithuania reported that 50 inspections had been carried out and the activities of 14 food processing firms had been “restricted.” The supply of more than 220 tons of food products to the market was blocked. Seized items included sweets, non-alcoholic drinks, popcorn, crackers, waffles and lollipops which are popular among children.

VMVT also selected several products to be tested for Listeria, Salmonella and Ochratoxin A but all samples were satisfactory.

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Companies selling products containing Delta-8 tetrahydrocannabinol (THC) in California, Missouri, New Mexico, New Jersey and North Carolina are on notice by the FDA.

The FDA has determined that the companies are selling adulterated products because they bear or contain an unsafe food additive. In addition, the products are sold in forms that are appealing to children and could be deceptive.

FDA has observed a proliferation of products containing the cannabinoid, Delta-8 THC, and has recently expressed serious concerns about products containing Delta-8 THC.

In June 2022, FDA warned consumers about the accidental ingestion by children of food products containing THC. The agency received over 125 adverse event reports from Jan. 1, 2021, through May 31, 2022, related to children and adults who consumed edible products containing THC. Ten reports specifically mention the edible product as a copycat of popular foods.

The FDA is particularly concerned that the companies’ products are in forms that are appealing to children, mimic well-known snack food brands by using similar brand names, logos or pictures on the packaging, and that consumers may confuse with traditional foods. Therefore, with these products, there is a risk of unintended consumption of the Delta-8 THC ingredient by consumers.

In a series of June 29, 2023, warning letters, the FDA reviewed companies’ websites and determined that the firms sell various human products represented as containing Delta-8 THC.

1) Delta-8 THC products have not been evaluated or approved by FDA for safe use and may be marketed in ways that put public health at risk

2) FDA has received adverse event reports involving Delta-8 THC products

3) Delta-8 THC has psychoactive and intoxicating effects

4) FDA is concerned about the processes used to create the concentrations of Delta-8 THC claimed in the marketplace

 5) FDA is concerned about Delta-8 THC products that children may consume, as some packaging and labeling may appeal to children

Companies that have received warnings and products under scrutiny:

Delta Munchies LLC
Los Angeles, CA

Products are all in forms that may be attractive to children and could easily be mistaken for traditional foods that are commonly consumed by children:

• Sour Worms – 625mg Delta-8 THC
• Gummy Bears – 450mg Delta-8 THC
• Strawberry Sour Belts – 3000mg Delta-8 THC
• Peach Rings – 450mg Delta-8 THC
• Berry Blue Sour Belts – 3000mg Delta-8 THC
• Green Apple Sour Belts – 3000mg Delta-8 THC
• Watermelon Gummies – 450mg Delta-8 THC
• Sour Bites – 450mg Delta-8 THC

The full warning letter can be viewed here.

North Carolina Hemp Exchange, LLC dba NC Hemp Shoppe
Raleigh, NC

Products are all in forms that may be attractive to children and could easily be mistaken for traditional foods that are commonly consumed by children:

•  Stoner Patch Delta-8 Gummies Watermelon 500 mg, 
• Stoneo Oreo Cookies Delta-8 THC, 
• Delta-8 THC Flamin Hot Cheetos
• Stoney Patch 500mg

The full warning letter can be viewed here.

Exclusive Hemp Farms/Oshipt.com
Gilroy, CA

Products are all in forms that may be attractive to children and could easily be mistaken for traditional foods that are commonly consumed by children:

• Oreo Stoneo – Medicated 500mg 
• Cannaa Banana Delta 8 – Rope Candy 600mg – 7 Flavors 
• Pot Tarts Strawberry 1000mg – Medicated, Tropical Sour Patch – Delta-8 500mg
• Trips Ahoy Medicated – Real Chocolate Chip Cookies – 600mg Medicated 
• Trips Ahoy Medicated – Real Chocolate Chunky Cookies – 600mg Medicated
• Medicated Cheddar Snack Crackers 600mg – Medicated

The full warning letter can be viewed here.

The Haunted Vapor Room
Franklin, NJ

Products are all in forms that may be attractive to children and could easily be mistaken for traditional foods that are commonly consumed by children:

• Rope 500mg Delta 8 Nerds Candy, 
• Medicated Dope Rope Bites, Packwoods x Coned Delta-8 Edible Cones – 600mg 
• Cake 500mg Delta 8 Gummy Pack
• Candy’s D8 Chocolate Bars 500mg

The full warning letter can be viewed here.

Dr. Smoke, LLC aka Dr. S, LLC
Kansas City, MO

Products are all in forms that may be attractive to children and could easily be mistaken for traditional foods that are commonly consumed by children:

• Cheetos Crunchy Flamin’ Hot THC Infused Chips
• Doritos Nacho Cheese THC Infused Chips

The full warning letter can be viewed here.

Nikte’s Wholesale, LLC
Albuquerque, NM

Products are all in forms that may be attractive to children and could easily be mistaken for traditional foods that are commonly consumed by children:

• Delta 8 THC Gushers 
• Delta 8 THC Lemonade 500mg 
• Medicated Jolly Rancher Gummies Sour
• Delta 8 THC Hot Cheetos THC

The full warning letter can be viewed here.

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FSIS veterinarians are involved in every aspect of food safety and public health, including diagnosing and treating disease, managing surveillance programs, and inspecting animals, slaughterhouses, and food products.

The forecasts for the shortage of DMVs are expected to continue for the rest of the decade when there will still be an unmet need for 15,000 veterinarians.

This is expected to be used for both poultry and livestock. A non-veterinarian supervisor will supervise the inspection on both shifts of a single plant. An FSIS veterinarian with 26 years on the job said that without the daily presence and federal regulation enforcement, which will sometimes be available from a veterinarian, the food supply will be losing a necessary step for providing safe food for consumers.

A USDA Accredited Veterinarian has completed formal training from the National Veterinary Accreditation Program (NVAP) in the state(s) they are licensed to practice medicine in. Accreditation is state-specific and voluntary. Not all veterinarians are accredited.

This “solution” to the shortage of veterinarians in FSIS is sub-optimal, current FSIS veterinarians say; it does address the current reality of being unable to recruit and retain veterinarians in FSIS. It will reduce the overall number of available veterinary positions, but the reality is that those positions are not being filled anyway.

NAFV takes the position that both should happen, the move to create a District veterinarian position to cover more plants but also do the things necessary to attract new veterinarians into covering more plants.

With its inability to fill its veterinary openings, the FSIS policy change is no surprise. According to reports, FSIS is removing veterinarians from poultry plants under the New Poultry Inspection System. A new position known as the District Veterinary Medical Officer is being established for every four to seven plants.

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Carabinieri NAS Bari was part of a team that carried out court orders involving 18 people earlier this month. Five people were detained and six were placed under house arrest.

Measures were taken against people involved in the fish sector in the town of Bisceglie, in the province of Barletta-Andria-Trani; from a food safety consultancy company and a private laboratory in Avellino, responsible for analyzing fish products.

Investigations, coordinated by the public prosecutor’s office in Trani and launched in June 2021, followed food poisoning suffered by dozens of people, in various parts of the country, some of whom were hospitalized, after eating yellowfin tuna.

Officials believe products were defrosted and adulterated with substances such as nitrites and nitrates, to enhance their appearance and color before being placed on the market. However, such treatment and processes made items harmful to the health of consumers.

Suspects allegedly concealed unfavorable results of tests conducted on fish products and falsified certificates drawn up by other accredited labs, so as to not reveal the presence of nitrites and nitrates and to lower the values of ascorbates to mislead official agencies.

They are also accused of selling frozen salmon as fresh and expired fish products.

Broader issue
Reports of histamine or high ascorbic acid levels in tuna have been reported a dozen times in notifications on the EU Commission’s Rapid Alert System for Food and Feed (RASFF) portal so far this year. Alerts include eight people sick in Italy in July and 46 cases in Spain in May.

In late 2022, the European Commission put maximum levels on three additives in tuna to tackle food fraud. Limits apply to the use of ascorbic acid, sodium ascorbate and calcium ascorbate as antioxidants in tuna. 

The most common symptoms of histamine, also known as scombroid fish poisoning, are a tingling or burning sensation in the mouth, facial swelling, rash, hives and itchy skin, nausea, vomiting or diarrhea. They usually resolve within several hours without medical intervention. The onset of symptoms can range from minutes to several hours following ingestion of the toxin. Typically, the average incubation period before illness is one hour.

Production of histamine is related to mishandling of food because of storage at incorrect temperatures. Once produced, histamine cannot be eliminated by normal cooking or freezing temperatures.

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