FDA Warning Letter - Inadequate Controls to Prevent Allergen Mislabeling

FDA issued Ventura Foods facility in Birmingham, AL a Warning Letter following the company's recall of Garlic Parmesan Sauce that was labeled as Garlic Sauce. In this case the Garlic Sauce finished product labels did not declare major food allergens of milk and wheat. Further, we have determined that you did not follow the requirements of the Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Food regulation (CGMP & PC rule)

The firm discovered that the Garlic Parmesan Sauce labeled as Garlic Sauce was at store level after being notified by a customer. According to the documentation issued to FDA, the mislabeling occurred because an operator brought an incorrect roll of labels to the line. Although the firm identified the mislabeling issue before the product left the facility, the firm did not re-label all affected jugs of product.

In an email from the firm, the firm causes and provided corrective and preventive actions. In particular, the firm indicated that they will use an improved label management process to pre-stage labels for each line and limit label room access; update procedures for label conversions and storage of new labels; require barcode scanning of gallon jugs; update a procedure to include details on how to properly escalate and manage nonconforming product; update a procedure to outline details regarding the proper handling of relabeling tasks; and will conduct training on all updated procedures by July 1, 2020.

The Warning Letter was issued on the fact the firm had not identified and implemented food allergen controls at the labeling step adequate to prevent mislabeling of allergen containing product. And the firm did not implement effective corrective action procedures to ensure that all affected product was evaluated for safety and prevented from entering commerce as evidenced by mislabeled Garlic Parmesan Sauce that reached customers.

https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/ventura-foods-llc-609201-10282020
WARNING LETTER
Ventura Foods LLC
MARCS-CMS 609201 — October 28, 2020

FDA Issues Warning Letters to Three Food Importers for FSVP Issues

FDA issued Warning Letters to three food importers for issues involving the Foreign Supplier Verification Program (FSVP).  Two of these were remote audits.

• E & H Distributors LLC of , San Diego, CA  did not have FSVPs for soft tamarind flavored candy from one supplier and candy imported from another foreign supplier.
• World Candy Store LLC, of Brownsville, Texas 78521. did not have FSVPs for these products, Ricolino Huevito Pinto imported from foreign supplier (b)(4), and Ricolino Huevito imported from foreign supplier (b)(4). 
• WCS Trading Inc, of  Los Angeles, CA 90032 did not complete a review of the supplier's hazard analysis and did not perform verification activities for dried crushed chili, dried black fungus and dried mushrooms

https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/eh-distributors-llc-610883-11042020
E&H Distributors LLC
MARCS-CMS 610883 — November 04, 2020 

FDA Warning Letter - RTE Salad Manufacturer Cited for Not Following Food Safety Plan

FDA issued a Warning Letter to Etai's Food, Inc of Denver Colorado, a manufacturer of RTE salad, sandwich, burritos, wraps, pasta and snack items.  One of the primary themes is having items in the Food Safety Plan, but not doing them.  If it is in the Plan, then you have to do it.

Issues

• Had not completed environmental sampling as they had detailed in the Food Safety Plan.  They set a frequency, but did not have results to show to match that frequency as stated..
• Environmental samples completed showed some results as “indeterminate".  The company had no corrective action written for indeterminate results nor did they take corrective action.  FDA had "concerns based on these results (including the frequency of “indeterminate” results) and your lack of subsequent action that your procedures are not adequate to verify that your sanitation preventive controls are consistently implemented and are effectively and significantly minimizing or preventing the hazard of environmental pathogens."
• The Environmental Monitoring Program stated that the company would “Identify and Maintain a Master Site List” .  There was no list.
• Regarding the Supplier Preventive Controls - the facility did not complete all of the items as stated in the plan including collecting audits and surveys.
• GMPs - poor personnel practices that can contribute to cross contact and cross contamination (improper glove usage, water hose usage)  There were a number of items associated with allergen control including how products were stored.

https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/etais-food-inc-607977-11052020

WARNING LETTER
Etai's Food, Inc.
MARCS-CMS 607977 — November 05, 2020 

Are Outdoor Dining Areas Any Less Risky for COVID as Indoor Eating Areas?

An interesting article in Business Insider discusses the use of outdoor eating structures that many restaurants have erected to provide service during this COVID pandemic. While it does provide extra seating for the restaurant to help expand what was lost indoors when social distancing actions were put in place to separate tables, there are some drawbacks.

For one, the thought this is actually outdoor is not necessarily true. Especially as the weather cools, these structures are probably not much different than indoor structures. These areas are essentially four walls and a ceiling and thus there is no advantage providing as would be had by truly being outside.

On top of that, there may be no air circulation thus not providing an escape for potential virus. Or air circulation may not be controlled, resulting in one person's exhaust being blown onto another person.

Sitting in these outside structures may give a person a false sense of security in thinking that they are really outside, so those individuals may be less attentive to the need for social distancing or mask wearing.

Business Insider
https://www.businessinsider.com/outdoor-dining-tent-safety-risks-explained-2020-11
Restaurants are setting up tents and temporary structures to extend outdoor dining during the winter. But they come with their own hazards, and in some cases, could be riskier than eating indoors.

As the temperature drops in many parts of the US, restaurants are coming up with creative solutions to allow for outdoor dining. But in some cases, these solutions may increase diners' coronavirus risk.

Since the onset of the pandemic, outdoor dining has allowed restaurants and bars to stay open while offering customers a way to continue eating, drinking, and socializing in a low-risk environment. Outdoor dining has become so popular and lucrative that it's becoming a more permanent fixture everywhere from Milwaukee to Boston. But as we head into the winter months, restaurants will be hard-pressed to convince diners to sit outdoors, exposed to chilly temperatures, wind, and possibly even snow.

Enter: tents, enclosed patios, and even curbside cabanas.

City and state governments across the country seem somewhat split on what types of structures are safe. In Chicago, for example, the city mandates that temporary outdoor structures must have 50% of the sides open in order to ensure air flow. New York City has the same rule, but will allow fully enclosed structures — they'll just be regulated like indoor dining and capped at 25% capacity. Cities in Connecticut and Colorado have similar mandates.

Rest of article - https://www.businessinsider.com/outdoor-dining-tent-safety-risks-explained-2020-11

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