This Week in Mislabeled Products for Week Ending November 14, 2020

Wrong Package - Stuffed Foods LLC, a Wilmington, Mass., establishment is recalling approximately 1,818 pounds of snack products due to misbranding and an undeclared allergen - the product contains soy which is not declared on the product label.  The problem was discovered after the firm received a customer complaint that a “Mac & Cheese Bite” carton contained “Buffalo Style Chicken Poppers.”

https://www.fsis.usda.gov/wps/portal/fsis/topics/recalls-and-public-health-alerts/recall-case-archive/archive/2020/recall-026-2020-release
Stuffed Foods LLC Recalls Frozen Snack Products Due to Misbranding and an Undeclared Allergen
Class II Recall
026-2020
Health Risk: Low

Nov 11, 2020 

FDA Issues Warning Letters to Two Importers for Lack of FSVP

FDA issued Warning Letters to two different companies for FSVP.  Neither company had a FSVP in place.

• Italfoods, Inc., of South San Francisco, CA did not have it in place for cheese products improted from Italy including Pecorino Toscano DOP Stagionato cheese, your Pecorino Cacio Di Bosco Tartufo Stagio cheese, and your Pecorino Brillo Formaggio cheese.  One of the products had been found to have Listeria monocytogenes contamination.
• Handylee USA Corp. of Maspeth, NY did not have FVSP for imported canned corn. canned mushrooms and canned bamboo.

https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/italfoods-inc-610183-10272020
Italfoods, Inc.
MARCS-CMS 610183 — October 27, 2020 

FDA Issues Warning Letter on Supply Chain Controls for Cyclospora in Salad Items

FDA issued a Warning Letter to Fresh Express regarding their Illinois processing facility that was linked a the 2020 Cyclospora outbreak.  In this outbreak, there were a reported 701 cases in 14 states that were linked to bagged salad mixes containing iceberg lettuce, carrots, and red cabbage.  The notice points out that the facility was also involved in a 2018 outbreak that affected over 500 people.

In short, FDA states that the normal supplier controls have not been sufficient, and that the company must do more to control a difficult-to-control pathogen.  This is worth a read in how far FDA pushes the idea of Supply Chain Preventive Control.

The FDA first states this product is considered adulterated - "bagged salad mixes are also adulterated within the meaning of section 402(a)(4) [21 U.S.C § 342(a)(4)] in that they have been prepared, packed or held under insanitary conditions whereby they may have been contaminated with filth or whereby they may have been rendered injurious to health."  

In the hazard analysis, the facility did have parasites listed as a hazard with the preventive control being a Supply Chain Preventive Control where the facility will "have written procedures which describe your supplier approval of growers and harvesters and your verification of your supply-chain controls, such as food safety record reviews, GFSI third-party audits, second-party audits conducted by Fresh Express, and periodic supplier questionnaires."  The facility did do testing, but initially, just to more or less keep an eye on the situation.  At the time of the outbreak, the company started to test more product.

FDA essentially points out that product testing is not a good control because it is hard to find this contaminate because it is at such low levels.  Rather FDA states that the company needs to ensure the adequate controls by the supplier and doing surveillance of the growing area - "We recommend that you reanalyze your Food Safety Plan to determine whether your preventive controls and grower/harvester verification activities are adequate to ensure control of the hazard of Cyclospora cayetanensis, particularly focusing on potential sources and routes human fecal contamination that would allow partially and fully mature oocysts to contaminate produce in the field before and during harvest. This should include additional focus on handwashing as part of the evaluation for harvesting crew audits, as well as sanitation and cleaning practices for portable toilets, worker health and hygiene, harvest practices, and employee foot traffic through fields, all which may contribute to Cyclospora contamination in the field. In addition, you should consider seasonal environmental surveillance for Cyclospora to determine potential sources of contamination near growing regions where you source your produce."

Next, FDA states that the company needs to enhance traceability - FDA "encourage[s] Fresh Express to improve its traceability systems and processes, thus improving the speed and accuracy by which the company complies with records and information requests from the Agency in the future. Greater expediency on the part of Fresh Express in providing the requested traceback records might have aided in tracing back to potential sources of contamination sooner. Our hope is that improved traceability records on the part of industry will allow the FDA to more quickly and accurately investigate foodborne outbreaks, helping to avoid human illnesses and unnecessary, costly recalls."

https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/fresh-express-inc-609899-div-chiquita-brands
Fresh Express Inc - Div of Chiquita Brands
MARCS-CMS 609899 — October 20, 2020 

FDA Outbreak Notice of Third E. coli Outbreak Occurring This Fall

FDA issued notice that they are investigating on third E. coli outbreak.  The notice goes on to discuss the sample of Romaine lettuce contaminated with E. coli O157:H7.  The company in this case had issued a recall the day before this notice was released.

This notice is a bit confusing.  It reports that there is a third outbreak and states this:

On November 6, 2020, the Michigan Department of Agriculture and Rural Development (MDARD) reported that as a part of routine sampling, they collected a product sample of romaine lettuce for testing. The sample tested positive for E. coli O157:H7 and subsequent whole genome sequencing (WGS) analysis determined that the E. coli O157:H7 present in the samples matches the strain that has caused illnesses in this outbreak.

Then the Notice states this:

At this time, there is not enough epidemiologic and traceback evidence to determine if ill people in this outbreak were exposed to romaine lettuce from Tanimura & Antle, Inc. Additional information will be provided as it becomes available.

The notice is a little vague on the outbreak itself, but does provide the CDC information.

From the CDC

Case Counts

Total Illnesses: 12

Hospitalizations: 5

Deaths: 0

Last Illness Onset Date: October 14, 2020

States with Cases: CA (2), IL (4), MI (2), OH (1), PA (2), VA (1) 

US FDA Outbreak Investigation
https://www.fda.gov/food/outbreaks-foodborne-illness/outbreak-investigation-e-coli-o157h7-unknown-food-fall-2020
Outbreak Investigation of E. coli O157:H7: Unknown Food (Fall 2020)

FDA Issues Draft Guidance on the Voluntary Labeling of Sesame

FDA issued a voluntary Draft Guidance for the labeling of sesame to "encourage manufacturers to clearly declare sesame in the ingredient list, when it is used as a “flavoring” or “spice” or when the common or usual name (such as tahini) does not specify sesame."

Sesame is not currently included in the group of eight major allergens specified in the regulation to be declared in clear terms if included on the label.  "The FDA does not have the authority to amend the eight major food allergens established by FALCPA; however, it has the authority under the Federal Food, Drug, and Cosmetic Act to require labeling for other food allergens not covered by the requirements in FALCPA."

This is a draft, so comments can be made by stakeholders.

US FDA Constituent Updates  Center for Food Safety and Applied Nutrition
https://www.fda.gov/food/cfsan-constituent-updates/fda-issues-draft-guidance-industry-voluntary-disclosure-sesame-when-added-flavoring-or-spice
FDA Issues Draft Guidance for Industry on Voluntary Disclosure of Sesame When Added as Flavoring or Spice
Constituent Update
November 10, 2020

Romaine Lettuce Recalled After State Laboratory Finds E. coli O157:H7

Tanimura & Antle Inc. is recalling its packaged single head romaine lettuce under the Tanimura & Antle brand, labeled with a packed on date of 10/15/2020 or 10/16/2020, after the State of Michigan test and found a sample with E. Coli 0157:H7.   Product was distributed in the United States to the following states: AK, OR, CA, TX, AR, OK, IN, NE, MO, TN, WI, NM, SC, WA, NC, OH, VA, MA, PR, and IL

The statement states that this product has not been linked to reported cases of E. coli infection, which would seem to indicate that this product is not liked to the two E. coli outbreaks reported in the last few weeks.

https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/tanimura-antle-voluntary-recalls-packaged-single-head-romaine-lettuce-due-potential-e-coli-0157h7
Tanimura & Antle Voluntary Recalls Packaged Single Head Romaine Lettuce Due to Potential E. Coli 0157:H7 Contamination
Summary
Company Announcement Date:  November 06, 2020
FDA Publish Date:  November 06, 2020
Product Type:  Food & Beverages
Reason for Announcement:  Possible contamination with E. Coli 0157:H7
Company Name:  Tanimura & Antle Inc.
Brand Name:  Tanimura & Antle
Product Description:  Single head romaine lettuce

USDA Issues Warning on Meatballs Potentially Contaminated with Metal Pieces

USDA-FSIS issued a public health alert for heat treated, not fully cooked, not shelf stable, spaghetti and meatballs in marinara sauce products due to concerns that the products may be contaminated with metal pieces. USDA did not issue a recall because they believe that most product is not available to consumers any longer, however it is important for consumer to be aware. The product was from Kwik Trip of La Crosse, WI (Est 20852) and was distributed in WI, IA, and MN.

"The problem was discovered when the firm received consumer complaints reporting findings of metal embedded in meatballs in Kwik Trips, Inc., Spaghetti and Meatball in Marinara Sauce product. There have been no confirmed reports of adverse reactions due to consumption of these products."


https://www.fsis.usda.gov/wps/portal/fsis/newsroom/news-releases-statements-transcripts/news-release-archives-by-year/archive/2020/pha-11042020-01
FSIS Issues Public Health Alert for Spaghetti and Meatballs in Marinara Sauce Products Due to Possible Foreign Matter Contamination 

November 4, 2020

VA Creamery Recalls Product Packed in Returnable Glass Bottles With Potential Residual Sanitizer

A Virginia creamery is recalling various products packed in returnable glass bottles after it was discovered that here was an issue with the bottle sanitizing process. According to the notice, "Glass bottled product in question may have a strong sanitizer odor which may affect the taste and quality of the product. There is no known health risk associated with the issue at this time.....The recall was initiated after it was discovered that product smelled like cleaning agent."

Product was shipped to multiple states including Pennsylvania, New York, and Georgia.

https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/homestead-creamery-issues-voluntary-glass-bottled-product-recall
Homestead Creamery Issues Voluntary Glass Bottled Product Recall
Summary
Company Announcement Date:  October 28, 2020
FDA Publish Date:  October 30, 2020
Product Type:  Food & Beverages
Reason for Announcement:  Potential for residual chlorine from the sanitizing process
Company Name:  Homestead Creamery
Brand Name:  Homestead Creamery
Product Description:  Lemonade half gallon

Colorado Market Recall Elderberries After Notification from Supplier

Vitamin Cottage Natural Food Markets, Inc., a Lakewood, Colorado-based natural grocery retailer, is voluntarily recalling Natural Grocers Brand 4-ounce Organic Whole Elderberries after being notified by its supplier of the potential presence of Salmonella.  According to the recall notice, "After initially certifying that this product had tested negative for Salmonella and was fit for human consumption, our supplier subsequently notified the company of the potential presence of Salmonella in specific lots of organic elderberries."

https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/natural-grocers-issues-voluntary-recall-organic-elderberries-due-potential-presence-salmonella
Natural Grocers Issues Voluntary Recall on Organic Elderberries Due to Potential Presence of Salmonella
Summary
Company Announcement Date:  October 29, 2020
FDA Publish Date:  November 02, 2020
Product Type:  Food & Beverages  
Reason for Announcement:  Salmonella
Company Name:  Vitamin Cottage Natural Food Markets, Inc.
Brand Name:  Natural Grocers
Product Description:  Organic Whole Elder Berries