FDA Uses Ability to Mandate Recall for First Time, This for Contaminated Kratom

FDA issued its first mandatory recall of contaminated 'food' product (although this product is a dietary supplement which are considered food) when the agency issued one for powdered kratom product contaminated with Salmonella.  The ability to mandate a recall was granted to FDA under the FSMA regulation.  Kratom has been involved in a wide spread Salmonella outbreak.

According to the news report, "The agency asked Triangle on Friday to voluntarily recall the kratom items. When the company did not comply with the request, the FDA the next day ordered the firm to cease distribution. The company could have requested a hearing, the agency said, but it did not respond within the required time frame. The agency then issued the mandatory recall order."

Once the weapon is pulled out of the holster for the first time, it become a lot easier the second time around.

Washington Post
https://www.washingtonpost.com/news/to-your-health/wp/2018/04/03/in-a-first-fda-orders-recall-of-a-contaminated-food-kratom-with-salmonella/?utm_term=.214cd8fb6fe4
In a first, FDA orders recall of a ‘contaminated food’ — kratom with salmonella
by Laurie McGinley by Laurie McGinley Email the author
To Your HealthApril 3, 2018

FDA Issues Warning Letter To Raw Pet Food Company, Bacteriophage Use Not Accepted

FDA issued a warning letter to Arrow Reliance (Darwin's Natural Pet Products) in light of the Salmonella contamination found in the raw pet food that resulted in a dead kitten.  Two recalls (1, 2) were made after pathogens were found.  FDA had found the same strain of Salmonella in the kitten and in product.  FDA requested a response on corrective actions within 15 days.

The warning letter reveals how the facility was planning to rid product of Salmonella - through application of bacteriophage.  While bacteriophage has had some success in reducing pathogens in food applications, particularity liquids, it has not gained sufficient validation as an absolute control.  Issues with bacterial strain diversity can be a challenge if the cocktail of bacteriophage is not equally diverse (Ref).  This is a good example of why bacteriophage was not the silver bullet.

FDA Warning Letter
https://www.fda.gov/ICECI/EnforcementActions/WarningLetters/ucm603589.htm
Arrow Reliance Inc 4/2/18

US Food and Drug
Seattle District Office
22215 26th Avenue SE, Suite 210
Bothell, Washington 98021

April 2 2018

NY Cheese Plant Ordered Closed Until Proof That Product and Process is Listeria Free

In an FDA News Release, "the U.S. District Court for the Northern District of New York entered a consent decree of permanent injunction against Vulto Creamery LLC (Walton, N.Y.) and its owner and manager Johannes “Jos” H. Vulto. The defendants cannot prepare, process, manufacture, pack and/or hold FDA-regulated food products until they can ensure that L. mono is not present in their facility and their food."

The Vulto linked Listeria outbreak which occurred last year, impacted 8 people, killing 2.  "Before the company can resume operations, the consent decree requires it, among other things, to retain an independent laboratory to collect and analyze environmental and finished samples for the presence of L. mono, retain an independent expert and develop a program to control L. mono, and eliminate unsanitary conditions at its facility."

FDA News Release
https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm603372.htm
New York raw milk cheese company ordered to stop sales for food safety violations
For Immediate Release
April 2, 2018

Summary
Vulto Creamery source of outbreak that sickened eight people, killing two

This Week in Mislabeled Product - Week ending March 31, 2018

Ingredient Allergen Issue Leads to Recall - eBars LLC of Franklin, Tenn. is issuing a voluntary recall on its line of products that may contain undeclared peanut and/or almond allergens.   The expanded recall was initiated after eBars’ quality control team discovered this issue at their manufacturing facility. Subsequent investigation indicates the problem may have arisen from a supplier whose raw ingredients tested positive for amounts of undeclared peanut and/or almonds.  As part of its quality control review process, eBars discovered that MAN, WOMAN, TRIM, RUN Cocoa Raspberry, RUN Cocoa Almond, GOLF Cocoa Almond, GOLF Cocoa Raspberry, referenced above may contain undisclosed peanut allergens. Furthermore, all the LOT#’s of FOCUS Chocolate Peanut, HEAL Chocolate Peanut, FIT Organic Peanut Butter Chocolate Raspberry, may contain undisclosed almond. Additionally, the FOCUS 4 Kids Bars may contain undisclosed peanut and/or almond. [Supplier control issue]

Mixed Product on Incoming Materials Creates Confusion - First Source of Tonawanda, NY, is voluntarily recalling 9 OZ packages of Wegmans Yogurt Raisins, because the product may contain undeclared peanuts. The recall was initiated after we received a consumer complaint stating that the product contained undeclared yogurt covered peanuts. Subsequent investigation indicates the problem was most likely caused by a pallet of product received from our supplier having some yogurt peanut cases mixed in with the yogurt raisin cases which were not detected during our packaging operation due to the very similar appearance of the product, the cases, and the case labels.  [Inadequate raw material processing procedures]

Crab Allergen Detected in Salad Items - Mrs. Gerry’s Kitchen Inc. of Albert Lea, MN is issuing a voluntary recall  salads may contain undeclared traces of imitation crab meat.  [While no reason was listed, it would appear to primarily be a sanitation issue because various products may contain small amounts of fake crab meat.]

Egg Missing from Label - Nine Whole Foods Market stores in Northern California are voluntarily recalling some decorated (iced) cookies from the self-service cookie displays because the products contained egg allergen that was not listed on the product sign. [Label design / label review issue]

Crab Meat Found in Egg Salad - WI is issuing a voluntary recall of Kitchen’s Cravings Premium Egg Salad Sandwich on Oat Multigrain Bread because it may contain undeclared traces of imitation crab meat.  The recall was initiated after a Kwik Trip co-worker identified traces of imitation crab meat (containing fish or shellfish) in the egg salad product. [Process control or sanitation issues].

https://www.fda.gov/Safety/Recalls/ucm603242.htm
Health Nut Factory Recalls Organic Coconut Smiles Because Of Possible Health Risk
For Immediate Release
March 29, 2018

Retailer Recalls Items from Hawaii Store After Losing Temperature Control During Shipment

Target Corp issued a recall for close to 200 SKUs of frozen food products sold at its store in Honolulu after it was discovered that  temperatures were not properly maintained.  According to the report, "This recall was initiated after Target received notification of a temperature malfunction during shipment of the products to Hawaii. Once Target discovered the issue, Target teams were immediately dispatched to remove all of the impacted products from the store."

https://www.fda.gov/Safety/Recalls/ucm603172.htm
Target Corporation Issues a Voluntary Recall For a Variety of Frozen Products Sold at a Single Store on Oahu
For Immediate Release
March 29, 2018

Canada - Firm Recalls Raw Chicken Nuggets Linked to Salmonella Outbreak

A Canadian firm is recalling raw chicken nuggets after the product was linked to 30 cases of Salmonella in 4 different Canadian provinces.  Product had tested positive for the strain of Salmonella.

The issue with breaded products such as this may be that they appear to be fully cooked..  People may heat them but may not be diligent in getting product to the required temperature of 165ºF (74ºC) to provide sufficient lethality. 

Products like this are often par-cooked through frying in order to set the coating, but the heating time is short, and will not provide sufficient heat to get the internal temperature to a sufficient temperature to kill pathogens such as Salmonella.   Because the product is partially cooked, it can then appear to be fully cooked.  There have been numerous recalls for these types of products because of this same reason.

MarketsInsider
http://markets.businessinsider.com/news/stocks/public-health-notice-outbreak-of-salmonella-infections-linked-to-poultry-including-frozen-raw-breaded-chicken-products-1019778225
Public Health Notice - Outbreak of Salmonella infections linked to poultry, including frozen raw breaded chicken products
PRESS RELEASE PR Newswire
Mar. 28, 2018, 08:25 PM

Canned Chicken Recalled After Two Complaints on Foreign Objects - Hard Plastic

A Madelia, Minn. establishment, is recalling approximately 96,384 pounds of canned chicken products that may be contaminated with extraneous materials, specifically hard plastic.  According to the report, "The thermally processed, commercially sterile canned chunk chicken breast items were produced on Nov. 28 and Nov. 29, 2017. The problem was discovered on March 27, 2018 after the firm received two consumer complaints regarding extraneous material contamination."

https://www.fsis.usda.gov/wps/portal/fsis/topics/recalls-and-public-health-alerts/recall-case-archive/archive/2018/recall-026-2018-release
Tony Downs Food Company, Inc. Recalls Chicken Products due to Possible Foreign Matter Contamination 
Class I Recall 
026-2018 
Health Risk: High 
Mar 28, 2018 

NY Company Recalls Coconut After Notification by Distributor Regarding Potential Salmonella Contamination

Healthy Nut Factory of Bayside, NY is recalling 7 oz. Pouches of Organic Coconut Smiles because it has the potential to be contaminated with Salmonella.  The recall was initiated after we were notified by the distributor that product with expiration date 6/1/2018 purchased on 8/21/2018 might contain Salmonella. The company states that they have ceased production and distribution of the product as FDA and the company continue their investigation as to what caused the problem.  This recall is linked to the Salmonella outbreak associated with dried coconut initially posted in March.

https://www.fda.gov/Safety/Recalls/ucm603242.htm
Health Nut Factory Recalls Organic Coconut Smiles Because Of Possible Health Risk
For Immediate Release
March 29, 2018

Two Raw Pet Food Companies Recall Products.....Again

Two more raw pet food recalls were announced after both items tested positive for pathogens.  This is not the first time for either company, Darwin's,  and Blue Ridge.

• Blue Ridge Beef of Eatonton, GA, is voluntarily recalling lot#GA0131 of BRB Complete raw pet food because of the potential of contamination with Salmonella and Listeria monocytogenes.
• This recall was initiated after samples collected and tested by the FDA showed positive for Salmonella and Listeria monocytogenes. There has been no consumer or pet illnesses in association with this product.   This product is sold in 2lb chubs.
• Darwin’s Natural Pet Products of Tukwila, Wash., a manufacturer of fresh raw meals for dogs,is recalling a total of four lots of products after testing showed that some of the Chicken and Duck with Organic Vegetables Meals for Dogs may contain Salmonella, and the Turkey with Organic Vegetables Meals for Dogs sample may contain Salmonella and E. coli O128. While the company has not received any reports of illness in pets who consumed the food to date, the owner does not believe there is a low risk to pets and states there are handling instructions.  This product is sold as pillow pack.

Blue Ridge Beef Voluntarily Recalls BRB Complete Raw Pet Food Lot#GA0131 Because of Possible Contamination

For Immediate Release
March 26, 2018