This Week in Mislabeled Products for Two Weeks, Ending March 14, 2020

Incorrect Back Label - Pero Family Farms Food Company, LLC has initiated a voluntary product recall of its 11oz “Zucchini Spiral Pesto Side Dish Kit” with run number code 1196272F; Use By date of 03/20/2020 due to a product mislabeling which did not declare the allergens of egg and milk.

Someone Added Brazil Nuts Where They Shouldn't Have - Meijer is initiating a voluntary recall of 13,284 packages of mixed nuts due to the potential risk of an undeclared tree-nut allergen (Brazil nuts) sold at all Meijer stores, and is being issued to its customers in cooperation with the U.S. Food & Drug Administration. The recall was initiated after it was discovered the product contained Brazil nuts, which is not part of the product formulation or declared on package labeling. Subsequent investigation revealed an incorrect formulation was used to manufacture this product and should not have included the Brazil nuts.

Wrong Master Pack Label Used - Dole Fresh Vegetables, Inc. is initiating a limited voluntary recall of H-E-B-branded Tuscan Herb Chopped Salad due to possible undeclared allergens (peanut, wheat, soy and tree nuts) in H-E-B-branded Tuscan Herb Salad Kit, which was manufactured by Dole for H-E-B. The incorrect masterpack (kit with dressing and other toppings) was unintentionally used during the production of the salad.

Herring In Cream Sauce Mislabeled as Herring In Wine Sauce - Vita Food Products, Inc. of Chicago, Illinois is notifying the public that it is recalling up to 8,376 individual plastic jars of 32 ounce Vita Wild Herring in Wine Sauce that are potentially mislabeled because they may contain sour cream and, therefore, may contain undeclared milk. Mislabeled products that are subject to recall will be obvious to consumers because the recalled product’s white sour cream sauce can be seen through the clear plastic jar even though the label may state “Vita Wild Herring in Wine Sauce”.

Queso Product Labeled as Salsa Product Misses Milk and Soy - Stonewall Kitchen of York, Maine is voluntarily recalling 4,812 jars of its Ghost Pepper Queso with an Enjoy By date of 23MAY2021, as a small number of those were mislabeled as Ghost Pepper Salsa. Ghost Pepper Queso includes two allergens, milk and soy, that are not included in Ghost Pepper Salsa, and therefore don’t appear on the ingredient statement of the mislabeled jars. While Stonewall Kitchen believes that only a small number of jars were mislabeled out of the 4,812 which were manufactured that day, the company is recalling all of them out of an abundance of caution. Of note, the mislabeled jars should be very easy to spot: Ghost Pepper Queso product is a bright yellow-orange color, while Ghost Pepper Salsa is dark red.

Print-and-Apply Label Does Not List Milk Ingredient - Whole Foods Market is voluntarily recalling select Green Chile Chicken Tamales from stores across 24 states because they contain undeclared milk. A print-and-apply label did not have milk ingredient listed in the ingredient statement.

New Label Design Uses Incorrect Termonology Not Stating Milk - New Capstone, Inc. of Mooresville, NC is recalling their 22oz ReStructure Vanilla Protein Powder pouches, Lot 19211 Exp. 06/21 and their 27 gram individual serving pouch, Lot 19211 Exp. 06/21, because they may contain undeclared milk. The recall was initiated after it was discovered that the new product pouch design omitted the clear statement that the product contained milk but rather just stated the product contained lactose. Subsequent to this discovery New Capstone, Inc. added a milk allergen warning sticker to all remaining packages in Lot 19211.

Review - The Risk of Pathogen Spillover from Wild Birds

Wild birds can carry pathogens, such as Campylobacter and Salmonella, that can become contaminants for food. Most of our concern is in the fields with crops that will receive minimal processing, but also in instances where birds gain access into our processing facilities. A recent review of the research shows that we probably overemphasize the risk, but more research is needed in understanding transmission from birds to our food systems.

"We conclude that current data do not provide sufficient information to determine the likelihood of enteric pathogen spillover from wild birds to humans and thus preclude management solutions. The primary focus in the literature on pathogen prevalence likely overestimates the probability of enteric pathogen spillover from wild birds to humans because a pathogen must survive long enough at an infectious dose and be a strain that is able to colonize humans to cause infection."

From their paper:

"Campylobacter spp. 14.8%(64/431)of North American breeding birds had Campylobacter spp. prevalence data (1+ observations) meeting our inclusion criteria 1–9 (Data S2). The species with the most observations meeting our inclusion criteria 1–9 were rock pigeon [N= 3659from 15 studies, range 6–1800 individuals tested, 0.1–70% reported prevalence, estimated prevalence 16± 5.3%(SE)],European starling[N= 2094 from 12 studies, range 1–957 individuals tested, 0–75% reported prevalence, estimated prevalence 28 ± 6.0% (SE)],...."

"Salmonella spp. were the most studied bacteria with 33% (141/431) of North American breeding birds having prevalence data (1+ observations) meeting our inclusion criteria 1–9. The species with the most observations of data meeting inclusion criteria 1–9 were herring gull [N = 12470 from 10 studies, range 1–5324 individuals tested, 0–22% prevalence,estimated prevalence 8.2± 2.2%(SE)],house sparrow [N = 5581 from 19 studies, range 2–1124 individuals tested, 0–21% prevalence, estimated prevalence 2.5 ± 0.7% (SE)], rock pigeon [N = 5458 from 30 studies, range 4–1800 individuals tested, 0–100% prevalence, estimated prevalence 4.0 ± 0.9% (SE)..."

So birds can carry pathogens, and we need to keep them out of food processing facilities, but with field crops, further work is needed before we go to the levels of habitat destruction.

Biological Reviews
https://onlinelibrary.wiley.com/doi/full/10.1111/brv.12581
Are we overestimating risk of enteric pathogen spillover from wild birds to humans?
Olivia M. Smith  William E. Snyder  Jeb P. Owen
First published: 31 January 2020 https://doi.org/10.1111/brv.12581

Preparing Your Food Operation for a Coronavirus Situation - Updated

(4/6/20) With the risk of Coronavirus (SARS-CoV2) rising in the US, food establishments should be implementing controls to minimize risk of COVID-19 among their personnel and begin planning for an increasing risk level in the local populace. A list of recommendations based upon CDC and WHO guidance are listed below.

How Is Corona Virus Spread?

“When someone who has COVID-19 coughs or exhales they release droplets of infected fluid. Most of these droplets fall on nearby surfaces and objects - such as desks, tables or telephones. People could catch COVID-19 by touching contaminated surfaces or objects – and then touching their eyes, nose or mouth. If they are standing within six feet of a person with COVID-19 they can catch it by breathing in droplets coughed out or exhaled by them. In other words, COVID-19 spreads in a similar way to flu. Most persons infected with COVID-19 experience mild symptoms and recover. However, some go on to experience more serious illness and may require hospital care. Risk of serious illness rises with age: people over 40 seem to be more vulnerable than those under 40.” (WHO 2020)

Enhanced Sanitary Environment

• Promote regular and thorough hand-washing by employees, contractors and customers.   Provide soap and water and alcohol-based hand rubs in the workplace. Ensure that adequate supplies are maintained. Place hand rubs in multiple locations or in conference rooms to encourage hand hygiene
• Routinely clean all frequently touched surfaces in the workplace, such as workstations, counter tops, and doorknobs. Use the cleaning agents that are usually used in these areas and follow the directions on the label.
• Provide disposable wipes so that commonly used surfaces (for example, doorknobs, keyboards, remote controls, desks) can be wiped down by employees before each use.

Employee Training

• Emphasize staying home when sick, reviewing the typical symptoms (listed below).
• Instruct employees to clean their hands often with an alcohol-based hand sanitizer that contains at least 60-95% alcohol, or wash their hands with soap and water for at least 20 seconds. Soap and water should be used preferentially if hands are visibly dirty.
• Practice proper coughing and sneezing etiquette including 
• Cover your mouth and nose with a tissue when you cough or sneeze.
• Put your used tissue in a waste basket.
• If you don’t have a tissue, cough or sneeze into your upper sleeve, not your hands.
• Remember to wash your hands after coughing or sneezing.
• FDA and CDC recommend that food workers wear face coverings as a means to limit aerosols; this done in conjunction with social distancing.
• Employees who are well but have a sick family member at home with COVID-19 should notify their supervisor and refer to CDC guidance for how to conduct a risk assessment of their potential exposure.
• Emphasize the need for social distancing, as much as can be possible for a given operation. Social distancing must become standard practice.

Actively encourage sick employees to stay home

• Employees who have symptoms of acute respiratory illness are recommended to stay home and not come to work until they are free of fever (100.4° F [37.8° C] or greater using an oral thermometer), signs of a fever, and any other symptoms for at least 24 hours, without the use of fever-reducing or other symptom-altering medicines (e.g. cough suppressants). Employees should notify their supervisor and stay home if they are sick.
• Ensure that your sick-leave policies are flexible and consistent with public health guidance and that employees are aware of these policies.
• Talk with companies that provide your business with contract or temporary employees about the importance of sick employees staying home and encourage them to develop non-punitive leave policies.
• Do not require a healthcare provider’s note for employees who are sick with acute respiratory illness to validate their illness or to return to work, as healthcare provider offices and medical facilities may be extremely busy and not able to provide such documentation in a timely way.
• Employers should maintain flexible policies that permit employees to stay home to care for a sick family member. Employers should be aware that more employees may need to stay at home to care for sick children or other sick family members than is usual.

Separate sick employees

• CDC recommends that employees who appear to have acute respiratory illness symptoms (i.e. cough, shortness of breath) upon arrival to work or become sick during the day should be separated from other employees and be sent home immediately.
• Visitors and Meetings
• Try to conduct meetings with people from outside the company via conference call or on-line web viewing apps.
• Restrict meetings to only those that are essential for operations.
• Ask visitors and contractors to sign a notice that they do not have symptoms or have knowingly encounter someone who has symptoms.

Travel

• Advise employees to check themselves for symptoms of acute respiratory illness before starting travel and notify their supervisor and stay home if they are sick.
• Ensure employees who become sick while traveling or on temporary assignment understand that they should notify their supervisor and should promptly call a healthcare provider for advice if needed.
• Restrict international travel and put in appropriate controls for those that do.

Planning

• Develop a plan of what to do if someone becomes ill with suspected COVID-19 at one of your workplaces, including how to exclude or isolate them.  Contact your local health authority to support identifying who may have contacted that employee.
• Prepare for possible increased numbers of employee absences due to illness in employees and their family members, dismissals of early childhood programs and K-12 schools due to high levels of absenteeism or illness; or a quarantine imposed on employees due to contact with a sick individual.
• Employers should plan to monitor and respond to absenteeism at the workplace. 
• Implement plans to continue your essential business functions in case you experience higher than usual absenteeism.
• Cross-train personnel to perform essential functions so that the workplace can maintain operations even if key staff members are absent.
• Assess your essential functions and the reliance that others and the community have on your services or products. Be prepared to change your business practices if needed to maintain critical operations (e.g., identify alternative suppliers, prioritize customers, or temporarily suspend some of your operations if needed).
• Increase inventories of finished goods in the event of decreased capabilities or increased demand.
• Increase inventories of ingredients and materials that may come in short suppl, but do not buy more than you need.  This includes gloves and sanitary supplies.
• Consider focusing production on main-line items that can be run more efficiently.

CDC - https://www.cdc.gov/coronavirus/2019-ncov/community/guidance-business-response.html
WHO - https://www.who.int/docs/default-source/coronaviruse/getting-workplace-ready-for-covid-19.pdf?sfvrsn=359a81e7_6

FDA Guidance for Food Operations- https://www.fda.gov/emergency-preparedness-and-response/mcmissues/coronavirus-disease-2019-covid-19-frequently-asked-questions#food
Coronavirus Disease 2019 (COVID-19) Frequently Asked Questions Food Products & Food Facilities 

FDA Guidance for Food Operations
https://www.fda.gov/emergency-preparedness-and-response/mcmissues/coronavirus-disease-2019-covid-19-frequently-asked-questions#food
Coronavirus Disease 2019 (COVID-19) Frequently Asked Questions Food Products & Food Facilities 
Q: Is food imported to the United States from China and other countries affected by coronavirus disease 2019 (COVID-19), at risk of spreading COVID-19?
A: Currently, there is no evidence to support transmission of COVID-19 associated with imported goods and there are no reported cases of COVID-19 in the United States associated with imported goods.

How Long Can Coronavirus Persist in the Environment?

See updated post for COVID-19 specific information - NIH - Study Looks at Stability of COVID-19 Virus in the Environment
With the concern on Coronavirus, there have been questions regarding its stability in the environment.  An article in Medical News Today provides information gleaned from studies on other types of Coronavirus.

“Human coronaviruses can remain infectious on inanimate surfaces at room temperature for up to 9 days. At a temperature of 30°C [86°F] or more, the duration of persistence is shorter. Veterinary coronaviruses have been shown to persist even longer for 28 d[ays].”  Higher humidity and lower temperatures increases the ability of the Coronavirus to remain active

For heating and UV destruction, "were converted to be non-infectious after 90-, 60- and 30-min exposure at 56 degrees C, at 67 degrees C and at 75 degrees C, respectively. Irradiation of UV for 60 min on the virus in culture medium resulted in the destruction of viral infectivity at an undetectable level."

“Surface disinfection with 0.1% sodium hypochlorite or 62–71% ethanol significantly reduces coronavirus infectivity on surfaces within 1 min[ute] exposure time.”  CDC has provided this environmental control for healthcare operations"

• Routine cleaning and disinfection procedures (e.g., using cleaners and water to pre-clean surfaces prior to applying an EPA-registered, hospital-grade disinfectant to frequently touched surfaces or objects for appropriate contact times as indicated on the product’s label) are appropriate for COVID-19 in healthcare settings, including those patient-care areas in which aerosol-generating procedures are performed. Products with EPA-approved emerging viral pathogens claims are recommended for use against COVID-19. These products can be identified by the following claim: 
• “[Product name] has demonstrated effectiveness against viruses similar to COVID-19 on hard non-porous surfaces. Therefore, this product can be used against COVID-19 when used in accordance with the directions for use against [name of supporting virus] on hard, non-porous surfaces.”
• This claim or a similar claim, will be made only through the following communications outlets: technical literature distributed exclusively to health care facilities, physicians, nurses and public health officials, “1-800” consumer information services, social media sites and company websites (non-label related). Specific claims for “COVID-19” will not appear on the product or master label.
• See additional information about EPA-approved emerging viral pathogens claims
• external icon
• If there are no available EPA-registered products that have an approved emerging viral pathogen claim for COVID-19, products with label claims against human coronaviruses should be used according to label instructions.

FDA on Steps for the Safety of Imported Goods from China Considering Coronavirus

The US imports a lot of goods from China and of course, people are concerned about this fact regarding Coronavirus.  FDA released a statement indicating that there is no perceived issue at this time.

"Fortunately, currently, we are not seeing the impacts of this outbreak resulting in an increased public health risk for American consumers from imported products. There is no evidence to support transmission of COVID-19 associated with imported goods and there have not been any cases of COVID-19 in the United States associated with imported goods. As noted, this remains a dynamic situation and we will continue to assess, and update guidance as needed. "

 "We also continue to aggressively monitor the market for any firms marketing products with fraudulent COVID-19 prevention and treatment claims. The FDA can and will use every authority at our disposal to protect consumers from bad actors who would take advantage of a crisis to deceive the public, including pursuing warning letters, seizures, or injunctions against products on the market that are not in compliance with the law, or against firms or individuals who violate the law."

As an enveloped virus, it will not last as long as a non-enveloped virus such as Norovirus.

https://www.fda.gov/news-events/press-announcements/coronavirus-update-fda-steps-ensure-quality-foreign-products
Coronavirus Update: FDA steps to ensure quality of foreign products
For Immediate Release:
February 24, 2020

Is it Worth Wearing Masks to Prevent Coronavirus?

There has been a rush to purchase surgical masks to prevent Coronavirus.  In short, it is not going to do much and thus not worth the effort.  Surgical masks prevent the wearer from spewing out droplets, but are not overly efficient at the reverse.    So it would be recommended for someone who may have been exposed, but not for someone who is just trying to prevent illness, especially in places like the US where it is a low risk.

Healthcare workers working with potentially ill person from Coronavirus are advised to wear a heavy-duty mask called an N95 respirator.   "These respirators are designed to fit tightly around the nose and mouth, and, when worn correctly, block out at least 95% of small airborne particles, according to the CDC."  But these are not something recommended for the general public.

https://www.businessinsider.com/wuhan-coronavirus-face-masks-not-entirely-effective-2020-1
People are racing to buy face masks amid the coronavirus outbreak, but they probably won't protect you from illness
Holly Secon Feb 26, 2020, 2:45 PM

This Week in Mislabeled Product for Week Ending February 29, 2020

Wrong Formulation Adds Milk Chocolate Chips - Choice Products USA, LLC of Eau Claire, WI, is recalling 275 - 3lb tubs of Peanut Butter Cookie Dough, because it may contain undeclared milk from milk chocolate chips. Some containers of the 3lb. Peanut Butter Cookie Dough have been found to contain milk chocolate chips which were mistakenly included in the mixing process of the Peanut Butter Cookie Dough. The recall was initiated after it was discovered that product containing milk chocolate chips was distributed in packaging that did not reveal the presence of milk. Subsequent investigation indicates the problem was caused by an inadvertent adherence to the company's “production and packaging procedures."

Pasta Contains Gluten and Cannot Be Called Gluten Free- Sierra Soups of Fresno, Ca is recalling its 13 ounce packages of "Pasta e Fagioli" because the soup mix contains an individually wrapped package of pasta, which contains gluten. However outer packaging states the product is Gluten Free.   The recall was initiated after it was discovered that the gluten-containing product was distributed in packaging that did not clearly reveal the presence of gluten. Subsequent investigation indicates the problem was caused by a breakdown in the company's packaging processes.

Milk Missing from Label - Moonstruck Chocolate Co. of Portland, Oregon is recalling 1,500 / 3.1 oz. Praline Pecan & Ginger Element Bar in Dark Chocolate, because it may contain undeclared milk.   The recall was initiated after it was discovered that product containing milk was distributed in packaging that did not list the presence of milk.

Peanut and Almond Mix-up? Vitamin Cottage Natural Food Markets, Inc., a Lakewood, Colorado-based natural grocery chain, is recalling Natural Grocers brand 8 ounce Almond Clusters Dark Chocolate Non-GMO because the product contains undeclared peanut allergen and they are recalling Natural Grocers brand 8 ounce Peanut Clusters Dark Chocolate Non-GMO because the product contains undeclared almond allergen

FDA Issues Warning Letters To Two Importers for No FSVP

FDA issued Warning Letters to two importers for not having Foreign Supplier Verification Programs in place for their international suppliers.

• Banjaras Inc of Texas did not have a FSVP in place for suppliers of coriander and garlic, Rasam powders, Kesar mango pulp and Suji rusk.
• Hindy Import Inc. of Cajon, CA did not have a FSVP for suppliers of red lentils, bulgur coarse with vermicelli noodles, and vermicelli noodles, and white quinoa.

Whether a company is directly importing product or if they are using importers to bring in product, someone must be responsible for evaluating the safety of that product. While manufacturers who directly import food or ingredients can do that as part of their Preventive Controls plan, if they are using an importer, then it is critical to understand who has a program in place to evaluate and ensure the safety of that product. For food manufacturers, they often assume the broker is covering the regulatory requirements, but without delineating that on a contractual basis, one does not know for certain.

https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/banjaras-inc-589115-09252019
FDA WARNING LETTER
Banjaras Inc
MARCS-CMS 589115 — September 25, 2019

Allergen Related Recall Triggers FDA Inspection that Results in Warning Letter

FDA issued a Warning Letter to a Wisconsin ice cream facility for an inspection that was initiated  after a company-issued recall when the company packed Bourbon Honey Pecan Ice Cream into Gluten Free Cookies N Cream ice cream containers (gluten and tree nut allergens into a package with a gluten-free label and no nuts listed).

The firm was cited for not having adequate allergen controls to prevent a recall, specifically actions to prevent improper packaging with allergen declarations.  They were also cited for not implementing their sanitation controls systems including corrective action and verification.

https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/sassy-cow-creamery-llc-587954-12042019
WARNING LETTER
Sassy Cow Creamery, LLC 
MARCS-CMS 587954 — December 04, 2019