FDA Investigation into Lead Contamination in Apple Cinnamon Product, Cinnamon Identified as Probably Source

The FDA investigation into the lead contamination in the apple cinnamon fruit pouches continues. The product, manufactured in Ecuador, has resulted in lead poisoning in 34 reported individuals, primarily children. The company initially issued a recall on October 30, 2023, and then expanded the recall on November 13, 2023 to include additional brands of product.

To this point in time, FDA has not found lead in non-cinnamon product, which leads them to believe that the cinnamon is the source of the lead.  The FDA has not been able to test the specific cinnamon used in the product.

The importer is responsible for the safety of product brought into the United States.  As part of FSMA, companies must have FSVP (Foreign Supplier Verification Programs) in place for each imported food item.  As part of that program, importers must conduct a hazard analysis and then develop and implement verification activities for any significant hazard identified.  Foreign manufacturers must be in compliance with Preventive Controls for Human Foods regulations.  As part of that, they must conduct a hazard analysis for their operation and utilize programs that ensure GMP standards are met.

Total Adverse Events: 34*
Report Date Ranges: October 17, 2023 – November 15, 2023
States with Adverse Illness Events: AL (1), AR (1), CA (1), CT (1), FL (1), IL (1), LA (3), MD (2), MI (1), MO (1), NC (5), NE (1), NH (1), NM (1), NY (4), OH (1), PA (1), SC (2), TN (1), TX (1), VA (1), WA (1), Unknown (1)
Product Distribution: Nationwide

https://www.fda.gov/food/outbreaks-foodborne-illness/investigation-elevated-lead-levels-cinnamon-applesauce-pouches-november-2023
Investigation of Elevated Lead Levels: Cinnamon Applesauce Pouches (November 2023)
Do not eat, sell, or serve multiple brands of recalled apple cinnamon fruit pouches. FDA’s investigation is ongoing.

Current Update
November 16, 2023

FDA, along with CDC and state and local partners, is investigating reports of elevated blood lead levels in individuals with reported exposure to Apple Cinnamon Fruit Puree pouches manufactured in Ecuador and sold under WanaBana, Weis, and Schnucks brands.

MD Firm Recalls Cooked Chicken Dish for Mislabeling and Allergen Due to Sesame Oil

JX Restaurant, Inc., a Maryland Heights, Mo. establishment, is recalling approximately 621 pounds of fully-cooked chicken product (General Tso's Chicken) due to misbranding and undeclared allergens, the product contains sesame oil, a known allergen, which is not declared on the product label.  The problem was discovered by FSIS inspection personnel during a verification task where they discovered that sesame oil was not included on the label.

Now we know that if oils are highly refined, like soybean oil, then allergenic proteins will be absent and then soybean, in this case, does not have to be declared.  However, this is not the case with sesame oil according to FARE - Food Allergy Research and Education.

On their website, they state "*Studies show that most people with specific food protein allergies can safely eat highly refined oils made from those foods (examples include highly refined peanut and soybean oil). However, sesame oil is not highly refined and should be avoided by people who are allergic to sesame."

https://www.fsis.usda.gov/recalls-alerts/jx-restaurant-inc--recalls-chicken-products-due-misbranding-and-undeclared-allergens
JX Restaurant, Inc. Recalls Chicken Products Due to Misbranding and Undeclared Allergens
FSIS Announcement

Nov. 11, 2023, Editor’s Note: Details of this recall release were updated to reflect the change in the name of the recalling firm to their corporate name, JX Restaurants, Inc.

Recall Cancelled for Granola Product After Third Party Laboratory Error Falsely Identified Coconut

Grandy Organics of Hiram Maine cancelled their recall posted on October 5, 2023, after due determining the third-party laboratory provided faulty testing and false results. Grandy Organics Honey Oat Granola deemed safe for consumption.

From the report,

"Grandy Organics provided repacked samples of the product to the potential distributor who in turn had it tested at their labs for their own Quality Assurance records. Friday November 3rd the distributor informed Grandy Organics that traces of coconut were discovered at 6 parts per million in the Gluten Free Honey Oat sample they were given. Because coconut is a dangerous allergen, Grandy moved quickly.

“I immediately contacted the FDA for guidance, visited our facility to prepare for further testing- both in house and at a certified lab and quickly prepared to notify any sales customers who had received the affected product. We issued a press release, recalled the affected cases, and informed our Direct customers immediately. The thought that Grandy’s products, which we make with such pride, could harm anyone left me sleepless for days,” said Grandy’s owner and Chief Granola Officer, Aaron Anker.

Concurrently, Grandy sent two additional batches of product out for testing to confirm there was no further contamination. What they learned from the third-party lab was incredible: There are known cross-reactivity events with certain ingredients that can cause a false positive when testing for the coconut allergen. Lab technicians are, in fact, trained to use a different testing procedure when these ingredients are present. Once the correct procedures were run, Grandy was notified that all products sent for testing were, in fact, free of allergens, as is stated on Grandy’s packaging."

https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/grandy-organics-cancels-recall-gluten-free-honey-oat-granola-third-party-laboratory-error-resulted

Grandy Organics Cancels Recall of Gluten Free Honey Oat Granola. Third Party Laboratory Error Resulted in Falsley Identifying Presence of Coconut
Summary
Company Announcement Date: November 09, 2023
FDA Publish Date: November 09, 2023
Product Type: Food & Beverages
Reason for Announcement: CORRECTION
Company Name: Grandy Organics
Brand Name: Grandy Organics
Product Description: Gluten Free Honey Oat Granola

Improper Chip Filling Leads to Recall for Undeclared Allergens

Frito-Lay today issued a voluntary recall of 16,100 bags of 6 ¼ oz. Off The Eaten Path Chickpea Veggie Crisps that may contain undeclared milk ingredients due to the unintended presence of caramel seasoned crisps. The recall is the result of an investigation following a consumer complaint. 

So this appears to be a product filling/labeling issue where caramel chips went into the Chickpea Veggie Chip bag.  Not a first for Frito Lay (1, 2, 3, 4, 5, etc).  FDA issued the company a Warning Letter in 2020 for allergen mislabeling issues.

https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/frito-lay-issues-allergy-alert-undeclared-milk-eaten-path-chickpea-veggie-crisps
Frito-Lay Issues Allergy Alert on Undeclared Milk in Off The Eaten Path Chickpea Veggie Crisps
Summary
Company Announcement Date: November 09, 2023
FDA Publish Date:  November 09, 2023
Product Type:  Food & Beverages
Reason for Announcement:  Undeclared milk
Company Name: Frito-Lay
Brand Name:  Off the Eaten Path
Product Description:  Chickpea Veggie Crisps

Arizona Company Recalls Cantaloupe After Canadian Food Inspection Agency Testing Finds Salmonella

SOFIA PRODUCE, LLC, of Nogales, Arizona which does business under the name “Trufresh” (“Trufresh”) is recalling all sizes of fresh cantaloupes packaged in cardboard containers labeled with the “Malichita” label, sold under the following sales order numbers between October 16, 2023 and October 23, 2023 because they have the potential to be contaminated with Salmonella. The Cantaloupes were distributed directly to the following States in the United States: Arizona, California. Maryland, New Jersey, Tennessee, Illinois, Michigan, Wisconsin, Texas, Florida and Canada.

Trufresh is performing this recall after the Canadian Food Inspection Agency announced a similar recall of cantaloupes packaged with the same Malichita label and bearing the same PLU due to possible salmonella contamination for cantaloupes sold to Fruits et Légumes Gaétan Bono. That recall was triggered by Canadian Food Inspection Agency test results. investigation has revealed that the above-listed order numbers may have been associated with the cantaloupes sold to Fruits et Légumes Gaétan Bono.

https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/sofia-produce-llc-dba-trufresh-recalls-fresh-cantaloupe-because-possible-health-risk-due-salmonella
Sofia Produce, LLC DBA Trufresh Recalls Fresh Cantaloupe Because of Possible Health Risk Due to Salmonella
Summary
Company Announcement Date:  November 08, 2023
FDA Publish Date:  November 09, 2023
Product Type:  Food & Beverages
Reason for Announcement:  Potential to be contaminated with Salmonella
Company Name:  Sofia Produce, LLC dba Trufresh
Brand Name:  Malichita
Product Description:  Fresh Cantaloupe

TX Firm Expands Recall of Pet Food After Additional Product Tests Positive for Salmonella

Mid America Pet Food, Mount Pleasant, Texas, is expanding its October 30, 2023, voluntary recall to include additional pet food products, with Best By Dates before 10/31/24, made at its Mount Pleasant facility, due to the products’ potential to be contaminated with Salmonella.  This expanded voluntary recall is being issued due to some of the product lots testing positive for Salmonella through random and targeted sampling of finished product, including by the firm and the South Carolina Department of Agriculture. As of November 1, 2023, seven people reported Salmonella infections.

The recall was initially posted on October 30, 2023, just over a week ago.  And as predicted at that time, 
(https://pennstatefoodsafety.blogspot.com/2023/10/tx-firm-recalls-dog-food-after-testing.html), the recall was expanded as investigators found additional products positive for Salmonella.  Clearly, proper control was not in place, and in this case, most likely post-process contamination. 

https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/mid-america-pet-food-expands-voluntary-recall-include-additional-dog-and-cat-food-products-due
Mid America Pet Food Expands Voluntary Recall to Include Additional Dog and Cat Food Products Due to Possible Salmonella Health Risk
Summary
Company Announcement Date:  November 09, 2023
FDA Publish Date:  November 09, 2023
Product Type:  Animal & Veterinary  Food & Beverages    Pet Food
Reason for Announcement:  Potential to be contaminated with Salmonella.
Company Name:  Mid America Pet Food
Brand Name:  Multiple brand names
Product Description:  Dog and Cat Food

Expansion of Fruit Puree Pouches Due to Elevated Lead Levels, Now 22 Reported Cases

FDA provided an investigation update on November 13, 2023 where they stated "As of November 13, 2023, there have been 22 reports of illness potentially linked to recalled product submitted to FDA."

CDC reports "As of November 7, 2023, there are 22 cases, in states including Alabama, Arkansas, Louisiana, Maryland, Missouri, New Mexico, New York, North Carolina, Ohio, Pennsylvania, South Carolina, Tennessee, Texas, and Washington, ages 1 to 3 years, with BLLs ranging from 4 to 29 micrograms per deciliter (µg/dL). Cases experienced signs and symptoms including headache, nausea, vomiting, diarrhea, change in activity level, and anemia."

While any levels of lead in the blood is bad,  CDC uses a blood lead reference value (BLRV) of 3.5 µg/dL to identify children with BLLs that are higher than most children’s levels.

WanaBana USA is expanding its recall to include all lots of WanaBana Apple Cinnamon Fruit Purée pouches due to reports of elevated levels of lead found in certain units of the product.

WanaBana trade channels include 

• Dollar Tree and Amazon. WanaBana USA is working to investigate the source of the contamination and is collaborating with the FDA in updating consumers with information related to this product recall.
• The product is also distributed independently in the US as private label brands under the names of Schnucks Apple Sauce 90g pouches with cinnamon. The affected Schnucks lots subject of the product recall were identified as 05023:19, 09023:22 and 09023:24. To date, there have been no injuries reported related to Schnucks products. Photos of the Schnuck product is attached.
• In addition, Weis Cinnamon Apple Sauce 90g, reported an affected lot number 05023:28, which is also included in the product recall. To date, there have been no injuries reported related to Weis products. Photos of the Weis brand is attached.

https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/wanabana-recalls-wanabana-weis-and-schnucks-apple-cinnamon-fruit-puree-pouches-cinnamon-apple-sauce

WanaBana Recalls WanaBana, Weis, and Schnucks Apple Cinnamon Fruit Purée Pouches & Cinnamon Apple Sauce Due to Elevated Lead Levels
Summary
Company Announcement Date:  November 09, 2023
FDA Publish Date:  November 09, 2023
Product Type:  Food & Beverages
Reason for Announcement:  Elevated levels of lead
Company Name:  Wanabana LLC
Brand Name:  Wanabana, Schnucks, Weis
Product Description:  Apple Cinnamon Fruit Puree/Cinnamon Apple Sauce

Snake Pizza - Considerations for the Hazard Analysis

An news article on CNN discusses how Pizza Hut is teaming up with a century-old Hong Kong restaurant to put a modern spin on a traditional dishes, in this case, snake on a pizza.  "The new offering combines shredded snake meat, black mushrooms and Chinese dried ham – all indispensable ingredients of an authentic snake stew and part of the Hong Kong franchise’s marketing plot to generate buzz online."  "The company is also introducing a pizza made with Chinese preserved sausages featured in a claypot rice dish".

"It is not the first time Asian franchises of the original American brand have adopted a more adventurous gastronomical approach to celebrate local food culture.  In the past, Pizza Hut in Taiwan introduced pizzas made with durian, pig blood curds, and preserved eggs – ingredients that play a big role in the local culinary culture.  Meanwhile, Pizza Hut in Japan created a pizza topped with Tonkotsu ramen (pork bone soup ramen)."

As food companies look to integrate local flavors to build excitement in those markets, they will use ingredients where there may be less knowledge regarding hazards.  This can be a big challenge to food safety experts - determining risks of unique ingredients where there may be limited formal study.  Then, making sure sufficient controls are in place for hazards.

Hong Kong's Pizza Hut is partnering up with a local century-old restaurant to introduce a new snake-soup pizza.
Source - https://www.cnn.com/2023/11/08/travel/snake-pizza-in-hong-kong-intl-hnk/index.html

CNN
Pizza Hut selling snake pizza in Hong Kong
https://www.cnn.com/2023/11/08/travel/snake-pizza-in-hong-kong-intl-hnk/index.html
By Chris Lau, CNN
Updated 3:18 AM EST, Wed November 8, 2023

Investigation of 2020 Salmonella Outbreak in Restaurant Finds Drain Contamination as Likely Source for Ongoing Issues

An investigative report in the Journal of Food Protection provides the approach and findings related to a 2020 Salmonella outbreak which "identified a total of 67 cases between January 1, 2020, and August 13, 2021, 66% of which were directly linked to a restaurant in the area".   Regulatory officials conducted a intensive investigation, looking at many angles, but in the end, they believe the endemic contamination was linked to the kitchen drainage system.

"Explanatory hypothesis adopted. The most plausible explanation for the origin of this outbreak remains the contamination of the drains in Restaurant A. Indeed, most of the environmental samples positive for Salmonella were found in sinks or near them (sink sprayers, drains). The presence of contaminated biofilm (Mair-Jenkins et al., 2017) in the restaurant’s kitchen drainage system may have had a role to play in the extended duration of this outbreak."

A few takeaways:

• The importance of periodic drain cleaning. This occurs in food operations, but not really discussed to any degree for foodservice operations. Depending on the location of the drain relative to operational areas and the potential for the drains backing up, the risk of contamination from drains can vary. However, a periodic cleaning regiment can reduce this risk.
• During investigations,  much focus is placed on a given food item.  In this case, an environmental niche may have been the source to many food items via contaminated equipment or hands.  These out-of-site niche areas can foster resident or endemic contamination that can be difficult to identify if only looking at given food items.

Journal of Food Protection
https://www.sciencedirect.com/science/article/pii/S0362028X23068151?via%3Dihub
Research Paper
Investigation of a Salmonella Montevideo Outbreak Related to the Environmental Contamination of a Restaurant Kitchen Drainage System, Québec, Canada, 2020–2021