FDA Warning Letter - Two Animal Feed Companies With High Levels of Medication

FDA issued two warning levels to two animal feed companies.  Both companies had shipped cattle feed with higher levels of monensin, a medication used in animal feeds.   In both cases, poor practices led to higher levels than was indicated on the label.

Bartlett Cooperative Association Bartlett Feed Mill of Bartlett, Kansas - inspection was conducted after a voluntary recall of a custom formulated cattle feed that was reported to have contributed to the death of approximately eighty-seven (87) cattle upon its consumption.

• The inspection revealed evidence of a significant violation of the Current Good Manufacturing Practice (CGMP) regulations for non-licensed medicated animal feed manufacturers, Title 21, Code of Federal Regulations, Part 225 (21 CFR Part 225). Failure to follow these requirements causes medicated feeds and non-medicated animal foods manufactured at your facility to be adulterated 
• The inspection revealed evidence that you manufactured and distributed a cattle feed that contained a super-potent concentration of the new animal drug monensin. This Type C medicated cattle feed containing the Type A medicated article of monensin is unsafe within the meaning of Section 512(a)(2)(A) of the FD&C Act [21 U.S.C. § 360b(a)(2)(A)] because it was not in conformance with the animal drug approval. As a result, the animal feed containing the new animal drug is adulterated under Section 501(a)(6) of the FD&C Act [21 U.S.C. § 351(a)(6)].
• The inspection found evidence that this custom cattle feed is also misbranded within the meaning of Section 502(a)(1) of the FD&C Act [21 U.S.C. § 352(a)(1)] because it contained monensin at a concentration above the level stated in the product labeling (feeding directions accompanying the feed), making the labeling false or misleading.

Lewiston Feed & Produce Company
Lewiston Feed and Produce Company of, Lewiston, Minnesota, was inspected in response regarding elevated levels of monensin in the customer-formula medicated feed “(b)(4),” batch code 619202. Our inspection found that you adulterated this medicated animal feed in violation of the Federal Food, Drug, and Cosmetic Act (the Act).

• based on the level of monensin in the medicated feed  manufactured, the company actually manufactured a Type B medicated feed, rather than a Type C feed. Monensin is approved for use in Type B medicated animal feed at 41 to 80,000 grams per ton2 for the intended indications. A Type B medicated feed is intended for further manufacture, 21 CFR 558.3(b)(3). The label of your medicated feed did not include any mixing instructions. Failure to label a medicated animal feed with adequate directions for use results in that product being misbranded.2

CDC and FDA Investigating Pathogenic E. coli Outbreak Linked to Spinach

The FDA and CDC are investigating illnesses in a multistate outbreak of E. coli O157:H7. 

• As of November 15, 2021, 10 people infected with the outbreak strain of E. coli O157:H7 have been reported from 7 states. 
• Illnesses started on dates ranging from October 15 to October 27, 2021.
• Five people in this outbreak report eating spinach in the week before becoming sick and one person reported Josie’s Organics brand.

https://www.fda.gov/food/outbreaks-foodborne-illness/outbreak-investigation-e-coli-o157h7-spinach-november-2021
Outbreak Investigation of E. Coli O157:H7 - Spinach (November 2021)
Spinach sample from Minnesota tests positive for E. coli, potentially linked to illnesses

Case Counts
Total Illnesses: 10
Hospitalizations: 2
Deaths: 0
Last Illness Onset: October 27, 2021
States with Cases: IA (1), IN (3), MI (1), MN (2), MO (1), OH (1), SD (1)

$53M in Drugs Seized in Cauliflower Shipment

US Customs found a tractor trailer loaded with drugs contained in a shipment of cauliflower from Mexico.    "The tractor and the trailer were referred for a canine and non-intrusive imaging system inspection, resulting in the discovery of 412 packages containing 2,611.15 pounds of alleged methamphetamine and 50 packages containing 113.31 pounds of alleged cocaine within the commodity. The narcotics combined had an estimated street value of $53.1 million."

Cauliflower shipment loaded with $53M of meth, cocaine | Produce News (theproducenews.com)

Cauliflower shipment loaded with $53M of meth, cocaine
November 16, 2021

U.S. Customs and Border Protection Office of Field Operations officers seized narcotics this weekend, that totaled over $53 million in street value.

Import Distributor Recalls Dried Apricots After NY State Lab Finds Undeclared Sulfites

ILG International Trading, Inc of Brooklyn, NY is recalling its 500 g (17 oz) packages of “Natural Delight Collection” Natural Dried Apricots because they contain undeclared sulfites.  The recall was initiated after routine sampling by the New York State Department of Agriculture and Markets Food Inspectors and subsequent analysis by Food Laboratory personnel revealed the presence of sulfites in the 500 g (17 oz) packages of “Natural Delight Collection” Natural Dried Apricots, which were not declared on the label.   Analysis of “Natural Delight Collection” Natural Dried Apricots revealed they contained 23.49 milligrams per serving.  (The consumption of 10 milligrams of sulfites per serving has been reported to elicit severe reactions in some asthmatics. Anaphylactic shock could occur in certain sulfite sensitive individuals upon ingesting 10 milligrams or more of sulfites).  The recalled “Natural Delight Collection” Natural Dried Apricots, product of Uzbekistan, were distributed nationwide in retail stores. 

https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/ilg-international-trading-inc-issues-alert-undeclared-sulfites-natural-delight-collection-natural?utm_medium=email&utm_source=govdelivery
ILG International Trading Inc. Issues Alert on Undeclared Sulfites in “Natural Delight Collection” Natural Dried Apricots
Summary
Company Announcement Date:  November 05, 2021
FDA Publish Date:  November 12, 2021
Product Type:  Food & Beverages
Reason for Announcement:  Undeclared Sulfites
Company Name:  ILG International Trading, Inc.
Brand Name:  Natural Delight Collection
Product Description:  Dried Apricots

Ariz. Establishment Recalls Ground Beef Patties After Complaint from Foodservice Regarding White Plastic Pieces

Shamrock Foods Company, doing business as Gold Canyon Meat Company, a Phoenix, Ariz., establishment, is recalling approximately 6,876 pounds of raw ground beef patties because they may be contaminated with extraneous materials, specifically pieces of hard, white plastic.  The problem was discovered after the firm received complaints from restaurant staff reporting they found hard, white plastic in the beef patty products during preparation.

There have been no confirmed reports of adverse reactions due to consumption of these products. Anyone concerned about an injury or illness should contact a healthcare provider.

https://www.fsis.usda.gov/recalls-alerts/shamrock-foods-company-dba-gold-canyon-meat-company-recalls-raw-ground-beef-products
Shamrock Foods Company DBA Gold Canyon Meat Company Recalls Raw Ground Beef Products Due To Possible Foreign Matter Contamination
SHAMROCK FOODS COMPANY
FSIS Announcement

FDA Releases Economically Motivated Adulteration (Food Fraud) Webpage

FDA released their Economically Motivated Adulteration (Food Fraud) webpage.  It is hard to estimate the degree to which food fraud occurs.  Food fraud is more than an economic issue in that it can impact food safety and nutrition.

https://www.fda.gov/food/compliance-enforcement-food/economically-motivated-adulteration-food-fraud
Economically Motivated Adulteration (Food Fraud)

Economically motivated adulteration (EMA) occurs when someone intentionally leaves out, takes out, or substitutes a valuable ingredient or part of a food. EMA also occurs when someone adds a substance to a food to make it appear better or of greater value. For example, when manufacturers add a cheaper vegetable oil to an expensive olive oil but sell the product as 100% olive oil, they are cheating their customers. We refer to this type of EMA as food fraud.

Food Banks Expanding Capacities in Light of COVID, But Face Supply Chain Issues

Food banks proved vital during the COVID pandemic, serving a greater number of people than they ever had before.  With that, many have undertaken expansion projects to build capacity to serve, whether that be in the expansion of refrigerated storage or moving into the preparation of food.   At the same time, the same supply chain issues that have driven up costs for the entire food sector are also now impacting food banks in cost, both food and transportation, and availability.

https://apnews.com/article/coronavirus-pandemic-business-health-atlanta-utah-beb8c68cfad61e8bf8dc11e315169864
Food banks embark on expansions with lessons from COVID
By SUDHIN THANAWALA
November 4, 2021

ATLANTA (AP) — Food banks across the country are pursuing major expansion projects driven in part by their experiences during the pandemic, when they faced an explosion of need.

WA Establishment Recalls Ground Chicken Burgers After Complaints for Bone Material

Innovative Solutions, Inc., a Kent, Wash. establishment, is recalling approximately 97,887 pounds of raw ground chicken patty products that may be contaminated with extraneous materials, specifically pieces of bone.  The problem was discovered after the firm received consumer complaints reporting findings of bone in the chicken burger product.

https://www.fsis.usda.gov/recalls-alerts/innovative-solutions-inc.-recalls-chicken-patty-products-due-possible-foreign-matter
Innovative Solutions, Inc. Recalls Chicken Patty Products Due To Possible Foreign Matter Contamination
INNOVATIVE SOLUTIONS, INC
FSIS Announcement

Salmonella Outbreak in Salame Update - PA Establishment Recalls Salame Sticks After October Public Health Alert

CDC reports that there are now 31 cases of salmonella infections, with 6 hospitalized, linked to Citterio brand Premium Italian-Style Salame Sticks.

Euro Foods, a Freeland, Penn. establishment, is recalling approximately 119,091 pounds of salame stick products that may be contaminated with Salmonella. Although a public health alert was issued for the salame stick products on October 29, 2021 with FSIS believing that the product was no longer in commerce, further follow-up by FSIS found product available at one retail location and two Citterio salame stick samples previously collected by the California Department of Public Health have tested positive for Salmonella.

Euro Foods Dba Citterio USA Corp. Recalls Salame Stick Products Due To Possible Salmonella Contamination | Food Safety and Inspection Service (usda.gov)

Euro Foods Dba Citterio USA Corp. Recalls Salame Stick Products Due To Possible Salmonella Contamination