FDA Warning Letter Highlights the Requirement for Reporting Non-compliant Product to Reportable Food Registry

In December of 2022, a feed facility of Nutra Blend, LLC subsidiary of Land O’Lakes., mistakenly added drug ingredient into a non-medicated feed which resulted in deaths of multiple calves. While FDA cited the company for issues with its Preventive Controls Plan, FDA also hit on the company for failing to report the non-compliant product into the Reportable Food Registry.  And this is an important regulation that may not be well known or can be overlooked.

What is the Reportable Food Registry?

• "The Reportable Food Registry (RFR or the Registry) is an electronic portal for Industry to report when there is reasonable probability that an article of food will cause serious adverse health consequences. The Registry helps the FDA better protect the public health by tracking patterns and targeting inspections." 
• Registered Food Facilities that manufacture, process, pack, or hold food for human or animal consumption ...are required to report when there is a reasonable probability that the use of, or exposure to, an article of food will cause serious adverse health consequences or death to humans or animals.
• Must provide amended reports as necessary- for example, FDA understands that it may take more than 24 hours to perform investigation activities and obtain information such as the results of any investigation of the root cause of the adulteration (when applicable) and the disposition of the reportable food.
• Portal - https://www.safetyreporting.hhs.gov/SRP2/en/Home.aspx?sid=938fc413-86cd-4670-8fe4-64e25d253c33

In this case, the company knew there was an issue, but fumbled around trying to determine how bad the issue was rather then getting notification out.  

"Furthermore, you failed to report a reportable food to the Reportable Food Registry (RFR) within twenty-four hours of determining that it is reportable (i.e., that there is a reasonable probability that the use of, or exposure to, such animal food will cause serious adverse health consequences or death to animals).5 Failure to submit a required reportable food report is a prohibited act."

"You tried to justify not filing an RFR while you asked the lab to reanalyze and provide the actual amount of monensin present in the sample and continued to assess with your nutritionists, veterinarians, and published data if the elevated level of ionophores would result in an animal health issue. However, this feed was not formulated to contain any monensin (an ionophore) and you were already aware the animals appeared to have died of ionophore toxicity."

As for the improper mixing issues:

Your root cause investigation found the source of the monensin to be the weighed and staged (b)(4) of monensin intended for the next product, Accuration Finisher 44 R227. Your mixing operator occasionally combines (b)(4) from (b)(4) pallets onto a single pallet to minimize time spent moving the ingredients to the mixer. In this instance, you determined the operator combined (b)(4) from the (b)(4) different work orders, then removed all the barcode tags from all staged (b)(4) and placed them near the scanner so they would be accessible when he was ready to scan them. This action left all the micro-ingredients for (b)(4) products unidentified, causing the operator to erroneously add the monensin to the incorrect product. 

https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/nutra-blend-llc-subsidiary-land-olakes-651174-05222023
Nutra Blend, LLC subsidiary of Land O’Lakes
MARCS-CMS 651174 — MAY 22, 2023

Alabama Establishment Recalls RTE Chicken Products After Complaints for Being Undercooked

Wayne Farms, LLC, a Decatur, Ala. establishment, is recalling approximately 1,377 pounds of ready-to-eat (RTE) chicken breast products that may be undercooked.  The problem was discovered when the firm received a customer complaint that the RTE chicken product appeared to be undercooked.  There have been no confirmed reports of adverse reactions due to consumption of these products. Anyone concerned about an illness should contact a healthcare provider.

https://www.fsis.usda.gov/recalls-alerts/wayne-farms-llc-recalls-ready-eat-chicken-breast-products-may-be-undercooked-0
Wayne Farms, LLC, Recalls Ready-to-Eat Chicken Breast Products That May Be Undercooked

WASHINGTON, Dec. 7, 2023 – Wayne Farms, LLC, a Decatur, Ala. establishment, is recalling approximately 1,377 pounds of ready-to-eat (RTE) chicken breast products that may be undercooked, the U.S. Department of Agriculture’s Food Safety and Inspection Service (FSIS) announced today.

Missouri Company Recalls Frozen Pizza for Undeclared Wheat Allergens

Shakespeare’s Pizza of Columbia, Missouri is recalling all its frozen pizzas from grocery stores, as they contain wheat, but do not declare the presence of wheat on their labels. A routine inspection by the  government regulatory agency partners brought to light the omission of a declaration on our labeling of the presence of wheat in the pizzas.

https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/shakespeares-pizza-issues-allergy-alert-concerning-undeclared-wheat-its-frozen-pizzas
Shakespeare’s Pizza Issues an Allergy Alert Concerning Undeclared Wheat in Its Frozen Pizzas
Summary
Company Announcement Date:  December 07, 2023
FDA Publish Date:  December 08, 2023
Product Type:  Food & Beverages
Reason for Announcement:  Undeclared wheat
Company Name:  Shakespeare’s Pizza
Brand Name:  Shakespeare’s
Product Description:  Frozen pizza

Florida Man Suffers Cardiac Arrest After Consuming Highly Caffeinated Beverages

A 46 year old Florida man suffered a fatal cardiac arrest after drinking three Charged Lemonades from a local Panera this October.  Panera's Charged Lemonade is advertised as “Plant-based and Clean with as much caffeine as our Dark Roast coffee.” with 390 milligrams of caffeine.  The Food and Drug Administration says healthy adults can safely consume 400 milligrams of caffeine a day.

The man had an unspecified chromosomal deficiency disorder, a developmental delay and a mild intellectual disability as well as suffered from hypertensive disease.  The family filed a lawsuit against the company.

A UPenn student also died after drinking the beverage. She had an underlying condition, "a heart condition called long QT syndrome type 1 and avoided energy drinks based on her doctors’ recommendation"

NBC News
https://www.nbcnews.com/news/us-news/panera-breads-charged-lemonade-blamed-second-death-lawsuit-alleges-rcna128036?utm_medium=email&utm_source=rasa_io&utm_campaign=newsletter
Panera Bread’s Charged Lemonade blamed for a second death, lawsuit alleges

Dennis Brown, 46, drank three of the highly caffeinated beverages before suffering a cardiac arrest in October, according to the suit.

Dec. 4, 2023, 11:21 PM EST

By Elizabeth Chuck

Panera Bread’s highly caffeinated Charged Lemonade is now blamed for a second death, according to a lawsuit filed Monday.

TX Establishment Recalls RTE Chicken Fried Rice After Positive Listeria Test

Garland Ventures, a Garland, Texas, establishment, is recalling approximately 13,842 pounds of ready-to-eat (RTE) chicken fried rice products that may be adulterated with Listeria monocytogenes.  The problem was discovered by FSIS during review of testing results, which showed the product tested positive for L. monocytogenes.

https://www.fsis.usda.gov/recalls-alerts/garland-ventures-recalls-ready-eat-chicken-fried-rice-products-due-possible-listeria
Garland Ventures Recalls Ready-to-Eat Chicken Fried Rice Products due to Possible Listeria Contamination

FSIS Announcement

EDITOR’S NOTE: Dec. 6, 2023 - Details of this recall were updated to reflect the correct lot code for the product implicated in the recall.

WASHINGTON, Dec. 6, 2023 – Garland Ventures, a Garland, Texas, establishment, is recalling approximately 13,842 pounds of ready-to-eat (RTE) chicken fried rice products that may be adulterated with Listeria monocytogenes, the U.S. Department of Agriculture’s Food Safety and Inspection Service (FSIS) announced today.

CA Company Recalls Noodle Product for Undeclared Peanuts

New India Bazar, Milpitas, CA is recalling 2,400 packets of Maggi 2 Minute Noodles 280g and 1,200 packets Maggi 2 Minute Noodles 560g, because it may contain undeclared Peanut allergen.  The recall was initiated after it was discovered that Maggie 2-minute noodle 280 grams and 560 grams Packaging contains peanuts, which was distributed in such packaging, and the packaging didn’t reveal the presence of peanuts.

https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/allergy-alert-undeclared-peanut-maggi-2-minute-noodles
Allergy Alert for Undeclared Peanut in Maggi 2 Minute Noodles
Summary
Company Announcement Date:  December 01, 2023
FDA Publish Date:  December 04, 2023
Product Type:  Food & Beverages
Reason for Announcement:  Undeclared peanuts
Company Name:  Undeclared peanuts
Brand Name:  Maggi
Product Description:  2 Minute Noodles

Iowa Firm Recalls Cake Products Due to Undeclared Allergens

Lara’s Bakery 3 LLC of Marshalltown, IA is recalling Pan de Racho, Panque, and Pan Surtido (Concha, Cema, Polvoron, Flan, Chocoflan, Tres Leches, Tostado de Guatemala, Pan de Guatemala, Canasta, Garibaldi, Marianas, Muffin, Pan Fino, Pastel de Glass, Pan de Trigo, Puerco, Bolillo, Telera), because it contains undeclared sesame seed, coconut, soy, wheat, milk, and egg.  The recall was initiated after it was discovered that products containing sesame, coconut, soy, wheat, milk, and eggs were distributed in packaging that did not reveal the presence of these allergens. The product had already been distributed to retail stores in the state of Iowa and Wisconsin


https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/laras-bakery-3-llc-issues-allergy-alert-undeclared-sesame-seed-coconut-soy-wheat-milk-and-eggs-pan
Lara’s Bakery 3 LLC, Issues Allergy Alert on Undeclared (Sesame Seed, Coconut, Soy, Wheat, Milk and Eggs) in Pan de Racho, Panque, Tres Leches, Chocoflan and Pan Surtido
Summary
Company Announcement Date:  December 05, 2023
FDA Publish Date:  December 04, 2023
Product Type:  Food & Beverages
Reason for Announcement:  Undeclared Sesame seed, coconut, soy, wheat, milk, and egg
Company Name:  Lara’s Bakery 3, LLC.
Brand Name:  Lara’s Bakery 3
Product Description:  Pan de Racho, Panque, Tres Leches, Chocoflan, and Pan Surtido

Michigan Firm Recalls Sandwiches For Undeclared Sesame on Buns

Gaws Gourmet Foods of Marysville, MI, is recalling three varieties of 8” deli subs, and two varieties of breakfast bagel sandwiches because they may contain undeclared sesame.  The recall was initiated after it was discovered that the sesame-containing products were distributed in packaging that did not reveal the presence of sesame.  Subsequent investigation indicates the problem was caused by a breakdown in the company's labeling process.

https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/gaws-gourmet-foods-issues-allergy-alert-undeclared-sesame-sandwiches
Gaws Gourmet Foods Issues Allergy Alert on Undeclared Sesame in Sandwiches
Summary
Company Announcement Date:  November 30, 2023
FDA Publish Date:  November 30, 2023
Product Type:  Food & Beverages
Reason for Announcement:  Undeclared sesame
Company Name:  Gaws Gourmet Foods
Brand Name:  Gaws
Product Description:  Deli sub and breakfast bagel sandwiches

NJ Firm Recalls Dark Chocolate Coin Candy for Undeclared Milk Allergen Due to Mislabeling

Manischewitz, of Bayonne, NJ, is recalling Manischewitz Dark Chocolate Coins because it may contain undeclared milk.  This recall was initiated after the company was notified by their Quantity Control Department that a limited number of bags labeled as “Dark Chocolate Coins” contained Milk Chocolate Coins, which contains milk allergen that is not declared on the label. All dairy Milk Chocolate Coins are wrapped in Gold Foil within a Blue Netting and all non-dairy Dark Chocolate Coins are wrapped in Silver Foil within a Red Netting.

https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/manischewitz-issues-product-mislabeling-advisory-and-voluntary-recall-some-very-limited-units-their
Manischewitz Issues a Product Mislabeling Advisory and Voluntary Recall on Some Very Limited Units of their Dark Chocolate Coins
Summary
Company Announcement Date:  December 01, 2023
FDA Publish Date:  December 01, 2023
Product Type:  Food & Beverages
Reason for Announcement:  Undeclared milk.
Company Name:  Manischewitz
Brand Name:  Manischewitz
Product Description:  Dark Chocolate Coins