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FDA sends warning letters to New York seafood importers

Mon, 01/08/2018 - 00:00

Three New York seafood importers are on notice from the Food and Drug Administration for violations of the Seafood Hazard Analysis and Critical Control Point (HACCP) regulation in addition to several federal food safety rules.

The FDA sent the warning letters to the companies in July, August and November of 2017 and posted them for public view in recent days. Companies are allowed 15 working days to respond to FDA warning letters. Failure to promptly correct violations can result in legal action without further notice, including, without limitation, seizure and injunctions.

Derby Paradise Inc., Rosedale, NY
Derby Paradise Inc. in Rosedale, NY, is on notice from the FDA because of significant deviations from the Seafood HACCP regulation for foods under the Federal Food, Drug, and Cosmetic Act (the Act). The firm imports fish and fishery products to their U.S. establishment.

Staff from the Food and Drug Administration inspected the Rosedale, NY, location of Derby Paradise Inc. on March 2 and March 17 of 2017. They discovered “serious violations” regarding the firm’s affected products, according to a July 21 warning letter.

“As an importer of fish or fishery products, you must operate in accordance with the requirements, … there must be evidence that all fish and fishery products offered for entry into the United States have been processed under conditions that comply,” according to the warning letter sent to company president, Juliana Allotey.

If upon inspection, the FDA does not find assurance that the imported fish or fishery products have been processed under conditions that are equivalent to domestic processor requirements, then the fish or fishery products will be adulterated under the Act, and will be denied entry.

“Your canned tuna fish in sunflower oil with pepper are adulterated in that it has been prepared, packed, or held under insanitary conditions whereby they may have been rendered injurious to health,” according to the warning letter.

“You must implement an affirmative step which ensures that the fish and fishery product(s) you import are processed in accordance with the seafood HACCP Regulation.”

First Choice E Trading Corp., Flushing, NY
In a Nov. 22 warning letter to First Choice E Trading Corp., staff from the FDA discussed the inspection of the firm’s Flushing, NY, establishment on June 8, 2017.

The firm is on notice from the FDA because of significant deviations from the Seafood HACCP regulation. The firm imports fish and fishery products to their United States facility.

“As an importer of fish or fishery products, you must operate in accordance with the requirements,” the warning letter states. “… there must be evidence that all fish and fishery products offered for entry into the United States have been processed under conditions that comply,” according to the warning letter sent to company president Ms. Jin Chung.

If upon inspection, the FDA does not find assurance that the imported fish or fishery products have been processed under conditions that are equivalent to domestic processor requirements, then the fish or fishery products will appear to be adulterated under the Act, and will be denied entry.

“Your frozen bigeye tuna, Thunnus obesusare adulterated in that they have been prepared, packed, or held under insanitary conditions whereby they may have been rendered injurious to health,” according to the warning letter.

FDA inspectors noted the following significant violations.

The firm failed to implement an affirmative step that ensures the fish products it imports are processed in accordance with the Seafood HACCP Regulation.

In addition, the FDA acknowledged a response from the firm, however, “We have reviewed your response to the FDA 483 issued to your firm on June 8, 2017. Your response is not adequate because the documentation submitted with your response, including the certificates, do not provide assurance that the fishery products you import are processed in accordance with the requirements of the U.S. FDA seafood HACCP regulation.”

FDA officials warned that they may pursue additional enforcement actions if the firm does not promptly correct these violations.

“For instance, we may take further action to refuse admission of your imported fish or fishery products, including placing them on ‘detention without physical examination,’ seize your products and/or enjoin your firm from further violating the Act,” the FDA warned.

KBF INC., Astoria, NY
KBF Inc. in Astoria, NY, is on notice from the FDA because of significant deviations from the Seafood HACCP regulation, under the Act. The firm imports fish and fishery products to their United States facility.

According to the Aug. 16 warning letter, the FDA discovered and documented problems during an inspection on April 3 and 4 at the company’s establishment in the United States.

“Your Kaski dried fish, Faisha Chapa dried fish, and Puthi Chapa dried fish are adulterated, in that they have been prepared, packed, or held under conditions whereby they may have been rendered injurious to health,” according to the letter.

Upon inspection, the FDA observed the following significant deviations:

  • The firm failed to perform an affirmative step for their Kaski dried fish, Faisha Chapa dried fish, and Puthi Chapa dried fish; and
  • On March 21, 2017, the FDA collected a sample of Faisha Chapa dried fish that they offered for import. FDA laboratory analysis found these products to be uneviscerated and to measure greater than five inches in length. “FDA considers uneviscerated fish that are salt-cured, dried, or smoked and that are greater than five inches in length to represent a potentially life-threatening health hazard.”

Additionally, the FDA noted a May 31, 2017, response letter from the firm, saying it was “not adequate because it did not list the specific affirmative step you are performing nor did it include documentation of your performance of an affirmative step.”

FDA officials warned that they may pursue additional enforcement actions if the firm does not promptly correct these violations.

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Food Service Workers should be Vaccinated against Hepatitis A

Sun, 01/07/2018 - 12:39

Hepatitis A is a communicable disease that often spreads from person to person. Person-to-person transmission occurs via the “fecal-oral route,” while all other exposure is generally attributable to contaminated food or water. Food-related outbreaks are usually associated with contamination of food during preparation by a hepatitis A – infected food handler. The food handler is generally not ill because the peak time of infectivity – that is, when the most virus is present in the stool of an infected individual – occurs two weeks before illness begins.  Hepatitis A symptoms may not occur for several weeks after exposure and may include abdominal discomfort, fever, malaise, muscle aches, and a yellowing of the skin called jaundice. In rare cases, hepatitis A causes liver failure and death.

In 2017 San Diego saw at least 577 illness with 20 deaths and 396 hospitalizations some of those illnesses have spread to local restaurants workers.  We also saw clusters of hepatitis A illnesses spreading to other parts of California as well as Utah, Kentucky, New York and Hawaii, and there are likely other less reported hepatitis A illnesses.  The largest outbreak that has also spread to restaurant workers is in South East Michigan where the total number is 658 illnesses with 22 deaths.

In 2006, the CDC recommended routine hepatitis A vaccination for all children ages 12-23 months, that hepatitis A vaccination be integrated into the routine childhood vaccination schedule, and that children not vaccinated by two years of age be vaccinated subsequently. The vaccine is also recommended for the following persons: Travelers to areas with increased rates of hepatitis A, Men who have sex with men, Injecting and non-injecting drug users, Persons with clotting factor disorders, Persons with chronic liver disease, Persons with occupational risk of infection, Children living in regions of the U.S. with increased rates of hepatitis A, and Household members and other close personal contacts.

The CDC has not yet recommended hepatitis A vaccinations for food service workers.  However, to Oakland County Michigan Health Department’s credit, in the last weeks it has hosted vaccination clinics for restaurant workers.  In fact, the department recognized restaurant workers as a priority target for the limited supply of the hepatitis A vaccine because they handle other people’s food and could unknowingly infect customers with the hepatitis A virus.

Other health departments – especially in areas with active hepatitis A outbreaks – should take Oakland County’s lead.  In addition, restaurants, in those areas or generally, are putting themselves and their customers at risk if they do not offer hepatitis A vaccines to their employees.

One hepatitis A positive food service worker can infect customers and cause thousands of customers to seek preventive vaccines.  Illness and vaccines can cost us all thousands if not millions of dollars, and can cost restaurants its viability either by a downturn in customers or an increase if lawsuits.

All of this is preventable by a vaccine.

Orange Cream Bars Recalled

Sat, 01/06/2018 - 00:29

Fieldbrook Foods Corporation of Dunkirk NY has issued a voluntary recall of 20 cases of the Tops brand of Orange Cream Bars and 320 cases of the Meijer Purple Cow brand Orange Cream Bars due to the possibility that the product may be contaminated with Listeria monocytogenes, an organism which can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened immune systems. Although healthy individuals may suffer only short-term symptoms such as high fever, severe headache, stiffness, nausea, abdominal pain and diarrhea, Listeria infection can cause miscarriages and stillbirths among pregnant women.

The recalled Top’s Orange Cream Bars were sold in Tops retail stores located in New York, Pennsylvania, Massachusetts, and Vermont.  The product comes in a 12 ct retail box (pictures attached).  The product has a production date of December 18, 2017 and a “best by” date of December 18, 2018.

The recalled Purple Cow Orange Cream Bars were sold in Meijer retail stores located in Michigan, Ohio, Indiana, Illinois, Kentucky, and Wisconsin. The product comes in a 12 ct retail box (pictures attached). The product has a production date of November 30, 2017 and a “best by” date of November 30, 2018.

No illnesses have been reported to date in connection with this problem.

The potential for contamination was noted after routine testing revealed the presence of Listeria monocytogenes in another production lot that has been fully contained. The recall is out of precaution for consumer health and food safety.  The company has suspended production and distribution of the product while it cooperates with the FDA to fully investigate the source of the problem.

 

Ready-to-Eat ham recalled for under processing

Sat, 01/06/2018 - 00:20

Crescent City Meats in Metairie, LA Saturday recalled approximately 430 pounds of Ready-to-Eat (RTE) Tasso Cajun Spicy Ham products because the RTE product may be underprocessed, according to the U.S. Department of Agriculture’s Food Safety and Inspection Service (FSIS).

The products were produced on Nov. 9, Dec. 18, and Dec. 20, 2017. The following products are subject to recall: [View Label (PDF only)]

  • 5-lb vacuum packs that were shipped in 10-lb. cases with the product labeled “TASSO CAJUN SPICY HAM READY TO EAT.”  The cases contain lot codes 1631317, 1635517, and 1635217 or 35217.

The products subject to recall bear the establishment number “Est. 13244” inside the USDA mark of inspection. The items were distributed for institutional use in the New Orleans metropolitan area.

The problem was discovered on Jan. 4, 2018, when another federal establishment who was further processing the product noticed that the RTE product appeared to be raw.  Upon investigation, FSIS Inspection Program Personnel verified that some of the RTE product was underprocessed and could be undercooked.

FSIS routinely conducts recall effectiveness checks to verify recalling firms notify their customers of the recall and that steps are taken to make certain that the product is no longer available to consumers. When available, the retail distribution list(s) will be posted on the FSIS website.

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Roe recalled nationwide in Canada; botulism possible

Fri, 01/05/2018 - 00:08

Imperial Caviar & Seafood has expanded its Dec. 15 warning, recalling Whitefish Roe and VIP Caviar Club brand Salmon Roe, urging consumers to not eat the fish eggs due to concerns of botulism poisoning.

The Fairfield, NJ-based company recalled some trout roe last month that had been distributed to retailers in Ontario and Quebec. This Wednesday, the company expanded the recall to include certain lots of Whitefish Roe and Salmon Roe that had been distributed across Canada in 50-gram containers.

No illnesses had been confirmed in relation to the recalled roe as of yesterday, according to the Canadian Food Inspection Agency (CFIA).

“Check to see if you have recalled products in your home. Recalled products should be thrown out or returned to the store where they were purchased,” according to the recall notice on the CFIA website.

“Food contaminated with Clostridium botulinum toxin may not look or smell spoiled but can still make you sick. Symptoms can include nausea, vomiting, fatigue, dizziness, blurred or double vision, dry mouth, respiratory failure and paralysis. In severe cases of illness, people may die.”

In foodborne botulism, symptoms generally begin 18 to 36 hours after eating a contaminated food, but they can occur as soon as six hours or as long as 10 days after exposure.

Anyone who has eaten any of the recalled fish eggs and developed symptoms of botulism poisoning should immediately seek medical attention and inform their doctors about the possible exposure.

Consumers can identify the recalled Imperial Caviar & Seafood brand Whitefish Roe and VIP Caviar Club brand Salmon Roe in the following sized containers with the specified label codes:

Brand Name Common Name Size Code(s) on Product UPC VIP Caviar Club Salmon Roe 50 g 27017-02
BB: 27-SEP-18 1 86866 90024 8 VIP Caviar Club Salmon Roe 50 g 19417-01
BB: 13-07-2018 1 86866 90024 8 Imperial Caviar and Seafood Whitefish Roe 50 g 17917-02
BB: 28-JUN-2018 1 86866 90027 9

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Hempler Family recalls pepperoni products found containing metal pieces

Fri, 01/05/2018 - 00:08

Consumer complaints about small metal pieces found in pepperoni products brought a recall announcement late on Thursday.

Ferndale, WA-based Hempler Foods Group, LLC, is recalling approximately 4,068 pounds of pepperoni sticks products that may be contaminated with extraneous material, specifically metal, according to the U.S. Department of Agriculture’s Food Safety and Inspection Service (FSIS).

The pepperoni stick items were produced on Oct. 10, 2017. The following product is subject to recall:

  • 2.25-lb. vacuum-packed packages containing “HEMPLER’S FAMILY CLASSIC PEPPERONI NATURAL SMOKE FLAVORING ADDED” with a “packed on” date of 10/10/2017 and case code 59716.

The product subject to recall bears the establishment number “EST. 6410” inside the USDA mark of inspection. These items were distributed for institutional use and shipped to retail locations in Eastern Washington State.

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.  Consumers who have purchased these products are urged not to consume them. These products should be thrown away or returned to the place of purchase.

FSIS routinely conducts recall effectiveness checks to verify recalling firms notify their customers of the recall and that steps are taken to make certain that the product is no longer available to consumers. When available, the retail distribution list(s) will be posted on the FSIS website.

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Briefly

Fri, 01/05/2018 - 00:05

Every hour of every day people around the world are living with and working to resolve food safety issues. Here is a sampling of current headlines for your consumption, brought to you today with the support of Alchemy Systems.

Shredded Coco(oh-no)nut 

Evershing International Trading Company is recalling its Coconut Tree brand frozen “Shredded Coconut” in 16-ounce plastic bags because of potential Salmonella contamination. According to the FDA, “The issue was discovered by testing performed by the State of Massachusetts.”

Although no injuries or illnesses had been reported as of the Jan. 3 recall, the recalled coconut product was sold by retailers in Ohio, Massachusetts, Washington, California, Oklahoma, Illinois, Michigan, New Jersey, New York, Pennsylvania, Oregon, Florida, and Texas.

“This recall is limited to Lot SE07A1, but the lot number is only printed on the case. Therefore, any customer that purchased this product from January 3, 2017 through January 3, 2018, should return the product to place of purchase for full refund.”

To determine if they have unused portions of the recalled coconut product in their homes, consumers check the labels of the 16-ounce plastic bags of Coconut Tree brand frozen “Shredded Coconut” for the item number: 331 223 and the UPC code: 05216-44081.

Bad News (Ice) Bars 

Triggered by a consumer complaint in Canada, the San Francisco company California Popsicle, Inc. doing business as Polly Ann Ice Cream is recalling ice bars because it may contain undeclared milk.

“People who have an allergy or severe sensitivity to milk run the risk of serious or life-threatening allergic reaction if they consume these products.”

 

From Aug. 3 to Aug. 31 of 2017 the products were distributed for retail in CA, NY, and Canada; “The products were further distributed by customers to various Chinese markets potentially nationwide.”

The recalled ice bars are packaged in cardboard boxes with four bars per box, and the UPC code can be found under the nutrition label on the side panel of each box.

Consumers can identify the following recalled ice bars, which contain an expiration date ranging from 7-01-2018 through 07/3102018:

Polly Ann Mango Ice Bar UPC#7-00730-28866-1
Polly Ann Red Bean Ice Bar UPC#7-00730-26868-7
Polly Ann Green Bean Ice Bar UPC#7-00730-26666-9

Fruit or Veggie Cup

Condies Foods of Kearns, UT is recalling over 160 cases of “Fruit Cups”, due to the concern of undeclared milk and egg allergens.

The product is supposed to be a broccoli, celery, carrot, and ranch dip called Veggie Cup 6.5oz, however, “After getting an initial complaint from a customer about the label not matching the description of the product” a voluntary recall was initiated “to ensure that our public would not get further exposure to an erroneous product.” Although there have been no illnesses reported to date, the ranch dip is a threat to people who have an allergy or severe sensitivity to milk and egg.

Consumers can identify the recalled “Fresh Fruit” product labels with the date “USE THRU 01/05/2018” on the side, and UPC number 50777222655.

The recalled product was distributed to stores in Arizona, Colorado, Idaho, Nevada, Nebraska, Utah and Wyoming.

 

“Raw milk Moms” are targets of NJ enforcement action against food clubs

Fri, 01/05/2018 - 00:04

“Raw milk Moms” in New Jersey were targeted last month with “cease and desist” orders from the state’s Public Health and Food Protection Program. The targeted individuals and the broader raw milk community are resisting the enforcement action.

New Jersey gave at least eight families five days to stop selling and distributing raw milk in the state. Raw milk advocate David Gumpert, writing on his popular Complete Patient blog on Dec. 29, quoted three Raw milk Moms” who are resisting the orders.

One said they were “false accusations” and another said her family isn’t doing anything illegal, and a third said she was “choosing to ignore” New Jersey’s order.

Since the enforcement action, Gumpert also reported that New Jersey foo clubs have taken down organizational information on public websites. State officials likely used that information to target the Moms.

Raw milk makes its way into New Jersey from Pennsylvania. “Food clubs” set up “drop sites” in private homes to distribute the product. Several of those “drop sites” did shut down after the enforcement actions began.

New Jersey is one of seven states to prohibit the sale of raw milk in any form. Delaware, Hawaii, Iowa, Louisiana, Nevada, and Rhode Island are the others. But New Jersey’s shares its entire eastern border with Pennslyvania, where raw milk sales are wide open.

The cross-border raw milk trafficking gained a boost from the U.S. Food and Drug Administration (FDA) in 2011 when the agency said transporting the product across state lines was permissible if it was for “personal consumption.”

The orders to the “Raw milk Moms” followed New Jersey’s “cease and desist” order for Udder Milk for “illegal sales of unpasteurized, raw milk” following confirmation in November that a woman who drank it was infected with antibiotic-resistant brucellosis.
“It is illegal in New Jersey to sell or distribute raw milk or products made from raw milk, such as yogurt, soft cheese, and ice cream,” State Epidemiologist Dr. Tina Tan said when taking action against Udder Milk.

Federal law prohibits the commercial sale of non-pasteurised dairy products across state lines. Most states ban the sale of unpasteurized, raw milk and products made from it because of the associated danger of contamination with bacteria, viruses, and parasites. New Jersey’s health department is working with the U.S. Department of Agriculture and the Centers for Disease Control and Prevention to find out where Udder Milk is getting the raw milk it is selling.

The Udder Milk website shows delivery locations in several states, including Connecticut, New Jersey, New York and Rhode Island. The company has been selling raw milk since 2005.

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Split decision on Idaho’s Ag-Gag Law Might Extend Beyond Agriculture

Fri, 01/05/2018 - 00:02

An appellate court Thursday restored specific provisions of Idaho’s 2012 Ag-Gag law but said audio, visual recordings of animal agricultural facilities could not be prohibited by the Gem State under the First Amendment to the U.S. Constitution.

It may be a landmark decision for being the first time a federal circuit court has found there is a constitutional right to take pictures or audio-visual recordings on private property.

The 2-to-1 ruling by the San Francisco-based U.S. Court of Appeals for the Ninth Circuit gives both Idaho Attorney General Lawrence G. Wasden and the collection of animal activists something to crow about.

In the summary of their opinion, the 3-judge appellate panel said:

“The Interference with Agricultural Production law was enacted after a disturbing secretly-filmed expose of operations at an Idaho dairy farm went live on the internet. The statute—targeted at the undercover investigation of agricultural operations—broadly criminalizes making misrepresentations to access an agricultural production facility as well as making audio and video recordings of the facility without the owner’s consent.”

The Ninth Circuit first sided with animal activists challenging the “Ag-Gag” law by finding that “Idaho’s criminalization of misrepresentations to enter a production facility…could not survive First Amendment scrutiny.”

According to the case summary, “the panel held that the subsection criminalized innocent behavior, was staggeringly overbroad, and that the purpose of the statute was, in large part, targeted at speech and investigative journalists. The panel also struck down the statute’s subsection which banned audio and video recordings of a production facility’s operations.

“The panel held that the Recordings Clause regulated speech protected by the First Amendment and was a classic example of a content-based restriction that could not survive strict scrutiny,” it continues.

The appellate judges came down on Idaho’s side when a section which criminalizes obtaining records of an agricultural production facility by misrepresentation—protected against a legally cognizable harm associated with a false statement survived constitutional scrutiny under United States v. Alvarez.

Also, the panel upheld the constitutionality of a section which criminalizes obtaining employment by misrepresentation with the intent to cause economic or other injuries.

It rejected the animal activists arguments that the statute would reach “a person who overstates her education or experience to get a job for which she otherwise would not have qualified, whether the person is an undercover investigator or not,” because in such a case, the law’s requisite intent to injure would not be satisfied.

AG Wadsen has yet commented on the Court ruling. The Animal Legal Defense Fund, which led the activist groups in the case, claimed victory mainly because the ban on audio, visual recordings was struck down.

“The Ninth Circuit’s decision sends a strong message to Idaho and other states with Ag-Gag laws that they cannot trample on civil liberties for the benefit of industry, ” said ALDF’s Stephen Wells.

ALDF was previously successful in getting Utah’s Ag-Gag law struck down in its entirety. It has is involved in challenges against Iowa and North Carolina Ag-Gag laws.

The Idaho Legislature enacted the Ag-Gag law at the behest of the Idaho Dairyman’s Association after animal abuse at a dairy farm was made public by the activist group, Mercy for Animals.

The U.S. District Court Judge B. Lynn Winmill, chief judge for the Idaho district, struck the Ag-Gag law down entirely. Wasden appealed the lower court decision to the Ninth Circuit, which heard oral arguments in Seattle last May 12.

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New patents to disinfect avocados and other Mexican produce

Thu, 01/04/2018 - 00:01

A patent registration is pending at the Mexican Institute of Industrial Property for intervention recipes that might successfully disinfect avocados, mangos, strawberries, chilis, tomatoes and coriander.

If successful, once the intervention mixes reach the market Mexico would be able to keep much of its fresh produce from landing on the Import Alert list maintained by the U.S. Food and Drug Administration.

Mexico frequently finds the food it is exporting to the United States on the Import Alert list once it crosses the international border. Mexico begins 2018 with 71 food products on the FDA Import Alert List, many for produce like cantaloupes, dried peppers and green onions.

Concern over Mexico’s large avocado crop, however, kicked started the new research by the Autonomous University of the State of Hidalgo (UAEH). Mexico growers produce 30 percent of the world’s avocados — more than 1.52 million tons per season — and most are for export.

Javier Castro Rosas and other UAEH researchers have been working on the problem for years, first studying the antimicrobial nature of the hibiscus flower to reduce strains of salmonella, typhoid and E. coli in avocados.

In later research, the UAEH team tried adding commercial solutions of colloidal silver or chlorine. That did reduce some of the bacteria, but not enough. Next they mixed recipes using acetic acids from vinegar, citric acids from lime, and other substances of natural origins that their patent claims eliminate all bacteria on avocados.

Their mixes also control bacteria on other products exported to the U.S.

An FDA Import Alerts with a Detention without Physical Examination order are costly for exporters. Food products that land on that list cannot enter the U.S. until they’ve been sampled and tested by a qualified independent laboratory.

If the independent lab finds an illegal residue or contaminant on the product, FDA will refuse to allow it into the U.S. The product must be sent on to another country or destroyed. And every shipment from exporters who make the Import Alert list must go through the same process.

If new shipments are clean the exporter’s products are allowed to enter the U.S. Getting off the list requires five clean deliveries in a row. The lab protocols are strict.

Fresh Mexican produce often makes Americans sick before an Import Alert is issued.  Last year, maradol papayas from Mexico sickened more than 250 people in four separate outbreaks, resulting in two deaths and 79 hospitalizations. About half of the U.S. states were involved in at least one of the four outbreaks.

Also in 2017, imported fresh produce from Mexico was named as the likely cause of  1,065 laboratory-confirmed cases of cyclosporiasis in the U.S.  Fresh basil, cilantro, mesclun lettuce, raspberries and snow peas transported the parasite caused past outbreaks in the U.S., but the exact cause last season was not found.

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Consumer Reports warns against eating any romaine lettuce

Thu, 01/04/2018 - 00:00

Food safety experts at Consumer Reports are advising people in the U.S. and Canada to stop eating romaine lettuce.

During the past seven weeks, 58 people in the U.S. and Canada have become ill from the strain of E. coli O157: H7. One person in each country has died. In the U.S., the infections have been confirmed in 13 states — California, Connecticut, Illinois, Indiana, Michigan, Nebraska, New Hampshire, New York, Ohio, Pennsylvania, Virginia, Vermont and Washington.

Until the cause of the current outbreak is known and the implicated food is removed from the supply chain, CR’s experts say consumers should avoid eating any romaine lettuce. It is a recommendation not yet made by either the U.S. Food and Drug Administration or the federal Centers for Disease Control and Prevention (CDC).

The source of the E. coli food poisoning is being investigated by FDA and CDC, along with public health officials in Canada. Five people in the U.S. received hospital care, and one has died, according to CDC. There has also been one death reported in Canada.

Canadian health authorities identified romaine lettuce as the source of the outbreak in their country, and since Dec. 14 have been advising people in the country’s eastern provinces to consider eating other types of salad greens until further notice. They said sick people reported eating romaine from a variety of locations, including grocery stores, restaurants and private homes.

In the U.S., government health officials are investigating the outbreaks, but have stopped short of recommending people avoid romaine lettuce or any other food.

“Even though we can’t say with 100 percent certainty that romaine lettuce is the cause of the E. coli outbreak in the U.S., a greater degree of caution is appropriate given that romaine lettuce is almost always consumed raw,” according to James Rogers, Ph.D, who is CR’s director of food safety and research.

“While anyone can get sick if they are infected with this strain of E. coli, young children, the elderly, and anyone who has a condition that weakens the immune system, such as cancer or diabetes, are at a greater risk,” Rogers added. He advises that people in these groups should be particularly vigilant about avoiding romaine lettuce.

According to the CDC, the type of E. coli making people sick genetically matches the bacteria involved in the Canadian outbreak. The U.S. investigators say that means the same food source is likely involved. Still, the CDC says it does not have enough information to recommend people in the U.S. avoid any particular food.

Jean Halloran, Director of Food Policy Initiatives at Consumers Union, the policy and mobilization division of Consumer Reports, said, “The FDA should follow the lead of the Canadian government and immediately warn the public about this risk. The available data strongly suggest that romaine lettuce is the source of the U.S. outbreak. If so, and people aren’t warned, more may get sick.”

Neither the U.S. nor Canadian health officials have provided information on where the suspect romaine lettuce was grown or processed. So for now, Consumer Reports says people should assume that any romaine lettuce, even when sold in bags and packages, might be contaminated.

Do not buy romaine lettuce and don’t use any that you may have in your refrigerator until there is more information on the source of contamination, CR says. Consumers should also check salad blends and mixes, and avoid those that contain romaine.

Consumer Reports is the world’s largest independent product-testing organization. Using its more than 60 labs, auto test center, and survey research center, the nonprofit rates thousands of products and services annually. Founded in 1936, Consumer Reports has over 7 million subscribers to its magazine, website, and other publications. Its policy and mobilization division, Consumers Union, works for health reform, food and product safety, financial reform, and other consumer issues in Washington, D.C., the states, and in the marketplace.

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Auditors critical of India’s food safety agency; FSSAI fires back

Thu, 01/04/2018 - 00:00

A report to the Parliament in New Delhi by India’s Comptroller and Auditor General is highly critical of the nation’s Food Safety and Standards Authority of India (FSSAI).

Parliament tabled the report on Dec. 19, and now FSSAI is fighting back with a response that insists India’s citizens “can trust the food they get.”

The CAG report says the nation’s food testing labs are shoddy, there are not standards of regulating some food products, the infrastructure for collecting samples is poor, licenses and clearances are often allowed to lapse, and FSSAI suffers from financial lapses as well.

Areas addressed by the audit — lack of equipment, workforce shortages and accreditation for state food laboratories — are getting attention, the agency’s response says. It says 300 staffers went through training in Good Food Lab Practices during the past year.

The federal food safety organization is also supporting 23 labs in 22 states with upgrades. Meanwhile, the number of “notified private labs” has reached 152, up from 82. FSSAI also has 62 mobile food testing laboratories and has made 19 available to the states.

The food safety agency said it “appreciates the inputs from CAG to improve the performance of food safety,” but those observations must be “seen in the context of the huge and complex task at hand…”

It also FSSAI is “an evolving organization, and it faces severe constraints of manpower and resources.”

“It would have been useful if the report had noted a lot of very useful work done by FSSAI over the years that helped raise the profile of food safety significantly in recent works,” the agency added.

Food safety is no small task in India. The subcontinent nation has more than 1.3 billion citizens spread across 29 states and seven territories. FSSAI has also launched a Food Regulatory Portal, known as “One Nation One Food Law.”

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E. coli victim dies in U.S. but feds can’t discuss investigation

Wed, 01/03/2018 - 00:01

One person in the U.S. has died and two others are gravely ill in an ongoing E. coli outbreak linked to romaine lettuce, but U.S. officials had not made that information public as of Tuesday.

A statement from U.S. Centers for Disease Control and Prevention on Dec. 28 reported that 17 people across 13 states are confirmed in the outbreak, which Canadian officials say is linked to romaine lettuce. The CDC did not report hospitalizations or the death at that time.

Of 41 confirmed victims in Canada, 17 have required hospitalization and one person has died. Canadian officials first reported the outbreak on Dec. 11. In the U.S. and Canada, the first confirmed illnesses began Nov. 16, 2017.

The Toronto Star in Canada reported Tuesday evening that the U.S. CDC had confirmed the death. Additionally, the newspaper’s Alex McKeen reported the CDC said five patients in the U.S. have required hospitalization and two have developed hemolytic uremic syndrome, a type of kidney failure.

No news is not good news
Neither government has released information about the supplier(s), distributor(s) or retailers that handled the implicated romaine lettuce — which is believed to remain in the supply chain.

Neither government has initiated a recall. However, the Canadian grocery chain Sobeys voluntarily pulled romaine lettuce this past week.

“It would certainly seem that with two deaths and 56 other illness in multiple states and Canada, there would be an announcement of where the romaine lettuce was sold and who grew it. This outbreak extends back to November and December of last year,” said Bill Marler, the Seattle food safety attorney who’s been watching foodborne illnesses since the deadly 1993 E. coli outbreak traced to Jack in the Box.

The same variety of the pathogen, O157:H7, which sickened and killed children who ate undercooked fast food hamburgers 25 years ago, is the culprit in the current outbreak in the U.S. and Canada.

Investigators at the U.S. CDC have confirmed through whole genome sequencing that the E. coli O157:H7 sickening people in Canada has the same DNA fingerprint as the pathogen infecting people in the United States. Officials in both countries say that makes it most likely that a common source food is involved.

Cooperation but little candor
The U.S. Food and Drug Administration is working with the CDC on the outbreak investigation, but a spokesman said Tuesday he could not discuss any specific details of the FDA’s ongoing investigation. The CDC’s statement on Dec. 28 cited the Canadian officials’ identification of romaine lettuce as the cause of the outbreak, but added that U.S. officials had not yet made that determination.

“The FDA is supporting the CDC and state and local authorities in an investigation of an outbreak of Shiga toxin-producing E. coli O157:H7 illnesses,” the FDA spokesman said Tuesday.

“CDC informed FDA of this illness cluster in mid-December. As with all outbreak investigations our role is to identify the source of the food(s) the CDC identifies through case interviews and other evidence to identify what was commonly eaten among the people who became ill, and determine whether it is linked to the outbreak through testing or other evidence.”

The FDA will neither confirm nor deny that is has or is testing any samples of romaine or any other foods in connection with the outbreak investigation.

Canada renews warning; says threat is ongoing
North of the border, the Canadian Food Inspection Agency (CFIA) is testing romaine lettuce samples but results are not yet available. In the mean time, the Public Health Agency of Canada (PHAC) continues its warning against consuming romaine lettuce.

“Based on the investigation findings to date, exposure to romaine lettuce has been identified as the source of the outbreak, but the cause of contamination has not been identified,” according to the PHAC update Dec. 28.

The outbreak appears to be ongoing, as illnesses linked to romaine lettuce continue to be reported to the Public Health Agency of Canada. These illnesses indicate that contaminated romaine lettuce may still be on the market  — including in restaurants, grocery stores and any establishments that serve food.”

Since Dec. 14, the Canadian health agency has been urging consumers “to consider consuming other types of lettuce, instead of romaine lettuce, until more is known about the outbreak and the cause of contamination.”

Risks for consumers
Although anyone can get develop an E. coli infection from exposure to the pathogen, pregnant women, people with weakened immune systems, young children and older adults are most at risk for developing serious complications, public health officials warn.

“This is especially true for this outbreak strain of E. coli (O157:H7), which is more likely to cause severe illness than other E. coli strains,” Public Health Agency of Canada reported.

Laboratory testing is necessary to determine whether food is contaminated with E. coli because it can’t be seen, smelled or tasted.

“Romaine lettuce can have a shelf life of up to five weeks; therefore it is possible that contaminated romaine lettuce purchased over the past few weeks may still be in your home,” Canadian officials told consumers.

Advice to consumers
Anyone who has eaten romaine lettuce and developed symptoms of E. coli infection should immediately seek medical attention. Specific lab tests are required to diagnose E. coli infection.

Symptoms can include nausea, vomiting, headache, mild fever, severe stomach cramps, and watery or bloody diarrhea. The onset of symptoms can range from 1 to 10 days after exposure.

“Some do not get sick at all, though they can still spread the infection to others. Others may feel as though they have a bad case of upset stomach. In some cases, individuals become seriously ill and must be hospitalized,” according to the health agency notice.

People who develop hemolytic uremic syndrome (HUS) need intensive medical treatment, usually including dialysis for kidney failure.

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FDA chasing after voluntary recalls, but doesn’t often take mandatory route

Wed, 01/03/2018 - 00:00

Timely and efficient food recalls would cut down on foodborne illnesses, but the U.S. Food and Drug Administration has yet to figure out to do it.

That’s the bottom line of another report on FDA food recalls by the Office of the Inspector General for the federal Health and Human Services Department. The OIG put out an “early alert” on the work last June.

Titled “FDA’s Food-Recall Process Did Not Always Ensure the Safety of the Nation’s Food Supply,” the latest OIG report was an audit of the documentation “for 30 voluntary food recalls judgmentally selected from the 1,557 food recalls reported to FDA between Oct. 1, 2012, to May 4, 2015.”

The performance audit looked at FDA’s oversight of food businesses initiating recalls, monitoring of the recalls, and maintenance of food recall data. FDA is not always timely in evaluating health hazards, or efficient in handling audit checks or their assignments. And it’s status reports are not still complete or timely nor its data accurate.

FDA Commissioner Scott Gottlieb personally responded to the report on Dec. 26, saying he takes the agency’s food recall obligations “very seriously.” He said since the “early alert,” FDA has been working to improve its recall system.

The gap between FDA recall warnings and removing unsafe products from store shelves can take up to 10 months.

“FDA generally relies on firms to protect public health by voluntarily recalling food products that present a risk of injury or gross deception or are otherwise defective,” according to the OIG. “FDA monitors and assesses the adequacy of a firm’s recall efforts. According to FDA, recalls should be evaluated on a case-by-case basis because some recalls are more challenging or complex than others.”

Since the Food Safety Modernization Act (FSMA) was signed into law seven years ago, FDA has had the power to order firms to recall food, but it has only twice used that authority. FDA has to determine there is a “reasonable probability” of food adulteration before it orders a recall.

Food recalls undertaken by a business without an FDA order are monitored by the agency’s district offices. FDA and state agencies may conduct audit checks to make sure recalled products are removed from the market. FDA uses the Recall Enterprise System (RES) to document the progress of recalls.

The OIG says its “early alert” review concerns have been “catalysts to major changes in FDA’s oversight of the process.” It says FDA has “expedited changes to improve voluntary recall oversight and strengthen its enforcement strategies, including its ability to use its mandatory recall authority.”

Six findings by the OIG conclude FDA did not always:

  • evaluate health hazards promptly (initiation).
  • issue audit check assignments at the appropriate level (monitoring).
  • complete audit checks by its procedures (monitoring).
  • collect timely and comprehensive status reports from recalling firms (monitoring).
  • track key recall date in the RES (data system), and
  • maintain accurate recall data in the RES (data system).

“FDA could not always ensure that firms initiated recalls promptly; therefore, some consumers became ill, and others were at risk of illness, or in some cases, death,” the OIG reports says. “FDA relies primarily on voluntary recalls, which makes the timeliness of the recalls largely dependent on the firm’s willingness to take action.”

The report found it took from a median of 29 days to an average of 57 days for a business to issue a recall after FDA learned that a product was potentially hazardous. The time from discovery to recall ranged from nine to 303 days for the 30 voluntary recalls reviewed.

FDA also did not correctly monitor other recalls and failed to obtain complete or accurate data for others. Timely and comprehensive status reports also weren’t kept.

“Making sure the FDA has effective recall practices in place, and that we take immediate action to address unsafe foods, are high priorities of mine,” the FDA commissioner said. “Our recall authorities – and how we deploy them – are a cornerstone of our vital, consumer protection mission.”

Since last year, FDA has used its Strategic Coordinated Oversight of Recall Execution (SCORE) to set timeframes, expedite decision-making and get recalled processed.

FDA bureaucracy could spell opportunity for others.

Michael Lucas, CEO of i3 Brands and an expert in “track and trace” technologies, says his company’s patented mobile protection platform may be a better solution for “ultimately bridging the divide between the recall process and customer safety.”

i3 Brands is beta testing “WatchOut,” which will identify any defective or recalled products held within the perimeter of a retailer’s premises.

Briefly: Wild distress — Burger recall across pond — Lab meat

Wed, 01/03/2018 - 00:00

Every hour of every day people around the world are living with and working to resolve food safety issues. Here is a sampling of current headlines for your consumption, brought to you today with the support of Alchemy Systems.

Wild Ginger restaurant outbreak update
Since last week, Seattle & King County public health officials have confirmed nine cases in a norovirus outbreak at the Wild Ginger restaurant in Bellevue, WA. Initially, five people from one party reported symptoms of nausea, vomiting, and diarrhea  after consuming food and beverage from the restaurant on Dec. 22. Four employees reported similar symptoms.

Upon inspection of the restaurant, investigators observed temperature violations related to improper hot and cold holding of foods.

Although gastroenteritis has not been confirmed, health officials associate the symptoms with norovirus. The specific food or drink that caused the illness has not been identified, however, norovirus outbreaks often involve multiple food items that could have been contaminated.

On Dec. 27, Public Health ensured proper cleaning and sanitizing with the restaurant so that all violations had been corrected. Additionally, Environmental Health investigators revisited the restaurant again on Dec. 29 to ensure that employees are maintaining a high level of hand hygiene and that no ill employees are working; ill staff is required to remain out until they are symptom-free for at least 48 hours.

British burgers linked to E. coli infections
Sainsbury’s burgers are under recall in the United Kingdom after being linked to at least a dozen cases of E. coli o157 infections by Public Health England identified the brand’s British beef products were contaminated.

Testing identified the presence of E. coli in the affected burgers, and six ill people reported eating the implicated burgers so far.

Sainsbury’s recalled batches of the “Taste the Difference 4 pack Aberdeen Angus British Beef Quarter Pounders.”

“We’ve been made aware by the Food Standards Agency of a very small number of customers who may have been unwell with E. coli after consuming this product,” according to the recall notice.

The new home on the range is a clean room
In the latest demonstration of support for so-called lab meat, an Israeli biotech and food-tech startup called SuperMeat announced Tuesday it has raised $3 million in seed funding, on top of a partnership with one of Europe’s major poultry producers (PHW).

The theme of investing in more sustainable food systems has already proved success with alternative proteins, or lab meat, such as Beyond Meat and SunFed brands. SuperMeat uses chicken cells, which are painlessly extracted from a chicken, to grow and form high-quality chicken cuts.

“This process puts an end to the industrial need to mass produce animals for slaughter, while eliminating exposure to animal waste and food-borne illnesses; the potential benefits for public health and animal welfare are therefore considerable,” according to a news release.

Additionally, a drastic reduction of carbon and ecological footprints would benefit the envirnment as “switching to clean meat will allow a reduction of up to 98 percent in greenhouse gas emissions, 99 percent in land exploitation, and up to 96 percent in water usage.”

According to Ido Savir, co-founder and CEO of the company, “Our team is comprised of a diverse group of top-tier scientists, food engineers and chefs, working together with the best production experts from the pharmaceutical industry to create a new generation of meat products that are sustainable, cost-efficient, animal-friendly, and of course — delicious.”

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FDA warns supplement makers, seafood and juice processors

Tue, 01/02/2018 - 00:59

Supplement makers from Washington, Maine and Georgia, along with seafood and juice processors from New York and Jamaica, are on notice from the Food and Drug Administration for violations of federal food safety rules.

The FDA sent warning letters to the companies in April, November and December of 2017, and posted them for public view in recent days. Companies are allowed 15 working days to respond to FDA warning letters. Failure to promptly correct violations can result in legal action without further notice, including, without limitation, seizure and injunction.

Brain Alert LLC, Lynwood, WA

In a Dec. 14, 2017, warning letter to distributing agent Jared K. Lykken, the FDA cited serious violations of the Food, Drug, and Cosmetic Act, and determined that the firm’s misbranded dietary supplement do not comply with FDA requirements.

“In addition, FDA reviewed your website at www.brainalert.com. Based on our review, we have concluded that your BrainAlert product is an unapproved new drug and misbranded drug and that, even if it were not a drug, it would be a misbranded dietary supplement.”

According to the warning letter, the firm’s products were prepared, packed, or held under conditions that do not meet Current good manufacturing practice (CGMP) requirements for dietary supplements. During the inspection, the investigator observed the following violations of the FDA’s Current Good Manufacturing Practice (CGMP) requirements for dietary supplements:

  • The firm failed to implement a system of production and process controls that covers all stages of manufacturing, packaging, labeling, and holding of the dietary supplement to ensure the quality of the dietary supplement and that the dietary supplement is packaged and labeled as specified in the master manufacturing record:

“For example, you stated that you have no knowledge of how your contract manufacturer manufactures or handles your product prior to your receipt of the finished product, or whether your contract manufacturer conducts any testing of the product.”

  • The firm failed to make and keep written procedures for the responsibilities of the quality control operations, including written procedures for conducting a material review and making a disposition decision:

“To fulfill requirements for quality control operations, quality control personnel must ensure that the manufacturing, packaging, labeling, and holding operations ensure the quality of the dietary supplement and that the dietary supplement is packaged and labeled as specified in the master manufacturing record.”

  • The firm failed to establish and follow written procedures to fulfill the requirements related to product complaints:

“You have not established written procedures for handling product complaints.”

  • The firm’s BrainAlert product is misbranded because the label fails to identify the part of the plant (e.g., root, leaves) from which each botanical dietary ingredient, i.e. Ginseng (Panax), Rhodiola rosea, Ginkgo Biloba, and Gotu Kola, in the product is derived; and
  • The firm’s BrainAlert product is misbranded in that the presentation of the nutrition information on the labeling is incorrectly listed.

Maine Natural Health Inc., Warren, ME

In an April 12, 2017, warning letter to company owner and CEO Harold J. Leighton, the FDA cited serious violations of the Food, Drug, and Cosmetic Act (the Act), and determined that the firm’s misbranded dietary supplements do not comply with FDA requirements.

“In addition, we have reviewed the labeling for your dietary supplements, including product labels and your website at www.sfh.com. Based on our review of the labeling and the website, we have concluded that your SO3 + D3 Fish Oil, Fuel Whey Protein, Strong Strength + Muscle, Pure Whey Protein, and Push Pre-Workout products are in violation of the Act and regulations implementing the food labeling requirements of the Act.”

According to the warning letter, the adulterated dietary supplements have been prepared, packed, or held under conditions that do not meet CGMP requirements for dietary supplements due to the following violations:

  • “You failed to establish specifications for points, steps, or stages in the manufacturing process where control is necessary to ensure the quality of the dietary supplement and that the dietary supplement is packaged and labeled as specified in the master manufacturing record”
  • “Your firm failed to collect representative samples of a subset of finished batches of each dietary supplement that you manufacture, which you identify through a sound statistical sampling plan (or otherwise every finished batch), before releasing for distribution to verify that the finished batch of dietary supplement meets product specifications”
  • ” When a dietary supplement failed to meet an established specification, your quality control personnel did not reject the component or dietary supplement, nor did they approve a treatment, an in-process adjustment, or reprocessing that would ensure the quality of the finished dietary supplement and that the dietary supplement was packaged and labeled as specified in your master manufacturing record (MMR)”
  • “The firm failed to prepare and follow a written master manufacturing record (MMR) for each unique formulation of dietary supplement that you manufacture, and for each batch size, to ensure uniformity in the finished batch, from batch to batch”
  • “The firm’s Strong Strength + Muscle, and Push Pre-Workout products are misbranded in that their labeling is false and misleading”
  • “The firm’s Pure Whey Protein and Fuel Whey Protein  dietary supplement products are misbranded because the labeling bears nutrient content claims, but the products do not meet the requirements to bear the claims”
  • “The firm’s Peppermint SO3 + D3 Fish Oil, Coconut Fuel Whey Protein, and Coffee Strong Strength + Muscle products are misbranded within the meaning of section 403(i)(2) of the Act [21 U.S.C. § 343 (i)(2)] in that they are fabricated from two or more ingredients, and each ingredient is not declared on the label by the common or usual name”
  • “The firm’s Peppermint SO3 + D3 Fish Oil, Coconut Fuel Whey Protein, Chocolate Pure Whey Protein, Fruit Punch Push Pre-Workout, and Coffee Strong Strength + Muscle products are misbranded because of the presentation of the nutrition information on the labels”
  • “The firm’s Coconut Fuel Whey Protein, Chocolate Pure Whey Protein, Fruit Punch Push Pre-Workout, and Coffee Strong Strength + Muscle products are misbranded because the serving sizes and servings per container are not listed in the Supplement Facts labels in the format” and
  • The firm’s product labels do not list the name of the manufacturer, packer, or distributor, and lists the net weight in total ounces, rather than pounds and ounces.

Dynamic Technical Formulas, Roswell, GA 

In a Dec. 13, 2017, warning letter to company owner and COO William T. Wotiz, the FDA cited serious violations of the Food, Drug, and Cosmetic Act (the Act), and determined that the firm’s misbranded dietary supplements do not comply with FDA requirements.

According to the warning letter,”the products were prepared, packed, or held under conditions that do not meet the CGMP regulations for dietary supplements. The inspection also revealed violations of dietary supplement labeling requirements, rendering your DTF, Gym Candy, and Biotech Underground products misbranded.”

The FDA investigator noted the following violations:

  • The firm’s quality control personnel failed to ensure that their manufacturing, packaging, labeling, and holding operations ensure the quality of the dietary supplement and that the dietary supplement is packaged and labeled as specified in the master manufacturing record
  • The firm failed to prepare and follow a written master manufacturing record (MMR) for each unique formulation of dietary supplement that they manufacture, and for each batch size, to ensure uniformity in the finished batch from batch to batch
  • The firm failed to prepare a batch production record every time they manufactured a batch of a dietary supplement
  • The firm failed to establish a specification for every point, step, or stage in the manufacturing process where control is necessary to the quality of the dietary supplement and that the dietary supplement is packaged and labeled as specified in the master manufacturing record
  • The firm failed to identify each unique lot within each unique shipment of components that they receive and any lot of components that they produce in a manner that allows them to trace the lot to the supplier, the date received, the name of the component, the status of the component; and to the dietary supplement they manufactured and distributed
  • The firm failed to collect and hold reserve samples of each lot of packaged and labeled dietary supplements that they distribute
  • The firm failed to make and keep documentation of training, including the date of the training, the type of training, and the person(s) trained and
  • The firm’s OmegaFuel product label declares fish oil, but fails to declare the major food allergen “fish”

According to the warning letter, “We reviewed the labeling of your Lift Candy, Pump Candy, Clafuel, Joint Fuel, DHEA fuel, Pump Fuel, OMEGA fuel, Night fuel, Organ fuel, Purify and Tudca products and found that these dietary supplements are misbranded in that the labels fail to identify a domestic address or domestic phone number through which the responsible person may receive a report of a serious adverse event regarding a dietary supplement.”

Gold Star Smoked Fish Corp., Brooklyn, NY 
In an Dec. 15, 2017, warning letter to company president Robert Pincow, the FDA cited serious violations of the seafood Hazard Analysis and Critical Control Point (HACCP) regulations, and determined that the firm’s ready-to-eat (RTE) seafood products are adulterated in that they were prepared, packed or held under insanitary conditions whereby they may have become contaminated with filth or rendered injurious to health.

During the inspection, the FDA collected environmental samples consisting of multiple swabs taken from various areas in the facility, “including areas that are near food during processing operations and near food contact surfaces.” According to the warning letter, FDA laboratory analysis of the environmental swabs identified the presence of Listeria monocytogenes in the facility.

The FDA’s laboratory analysis of environmental sample collected on May 12 confirmed that five environmental swabs tested positive for Listeria monocytogenes. The positive swabs were collected from surface areas in locations where Ready-To-Eat (RTE) cold and hot smoked seafood products are manufactured and packaged.

FDA laboratory analysis of the environmental sample “INV987101” collected at the firm’s facility on April 26, 2017, confirmed that 15 of one 110 environmental swabs were positive for L. monocytogenes.

Specifically, “11 of the 15 positive swabs were taken from wheels of stainless steel carts (also referred to as tanks) used to thaw, brine and transport seafood products,” indicating that the facility is not achieving “satisfactory control” against the presence of Listeria monocytogenes within their facility and implementing effective methods and controls to locate niche or harborage points of the organisms within the environment to eliminate and minimize exposure to food and food contact surface during production.

“The presence of a resident strain of L. monocytogenes in your facility is significant in that it demonstrates your sanitation efforts are inadequate to effectively control pathogens in your facility to prevent contamination of food,” FDA determined.

The FDA acknowledged a June 5 response outlining the corrective actions taken in response to the L. monocytogenes environmental sample findings. “We acknowledge that you have cleaned and sanitized your processing environment, conducted environmental sampling, and that finished product was tested for L. monocytogenes. Your response also describes intensified environmental sampling being conducted after cleaning and sanitizing and before resuming production. At this time, we cannot verify the adequacy of the methods and controls you have used to identify the potential harborage sites for L. monocytogenes in your processing environment or that the methods and controls effectively prevent L. monocytogenes from contaminating finished products you may manufacture in the future. We will verify the adequacy of your corrective actions during any future inspection.”

Naturefield Company, Kingston, Jamaica 

Naturefield Company in Kingston, Jamaica is on notice from the FDA because of significant deviations from the juice Hazard Analysis and Critical Control Point (HACCP) regulation under the Federal Food, Drug, and Cosmetic Act (the Act). The firm ships frozen 100 percent coconut water in retail packaging into the United States.

The warning letter went out after the firm’s response to the FDA’s request for a copy of HACCP documentation associated with the processing of it’s 100 percent coconut water. Staff from the FDA discovered the “serious violations” regarding the firm’s affected products, according to the Nov. 16 warning letter made public by the FDA in recent days.

“You must include in your HACCP plan control measures that will consistently produce, at a minimum, a S­ log reduction, for a period at least as long as the shelf life of the product when stored under normal and moderate abuse conditions, in the pertinent microorganism,” However, “your HACCP plan for 100% coconut water, a low-acid juice product, does not include control measures that will consistently produce a 5-log reduction of the pertinent microorganism, Clostridium botulinum,” according to the warning letter sent to company contact Patrick Powell.

FDA officials encouraged the firm to review the Act, the juice HACCP regulation, the Juice HACCP Hazards and Controls Guidance, and the Refrigerated Carrot Juice and other Refrigerated Low-Acid Juices Guidance through links in FDA’s homepage.

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Aussie baker apologizes for Salmonella outbreak, then re-opens

Tue, 01/02/2018 - 00:01

An Australian bakery owner started the New Year by making a “heartfelt apology” for causing an outbreak of Salmonella at Christmas time. He is hoping to save the 50-year-old business and the jobs of his 40 employees by getting the community’s support.

Nathan Assender, owner of Gawler South Bakery in Adelaide, Australia, has re-opened after a Salmonella outbreak during the last two weeks of December was linked to the restaurant. Chicken from the bakery’s sandwich bar is the suspected cause of 17 Salmonella illnesses. Three people required hospitalization.

The Gawler South Bakery first just stopped selling sandwiches with chicken and other fillings in cooperation with South Australian Health, but now Assender has decided his loyal customers want the business open.

He is apologetic about it. “It has come to our attention that some people have fallen ill with salmonella poisoning after consuming fresh roast chicken meals from our bakery recently,” he said. “It is with sincere compassion and genuine sorrow that we apologize to all the people and their families affected by this.”

Assender promised to continue working closely with SA Health to investigate the “source of this event.”

“We hope this apology is received to be genuine and in good faith,” he said. The outbreak investigation has not implicated any bakery or cream products from Gawler South.

Dr. Kevin Buckett, SA’s director of public health, said food businesses and those preparing meals at home need to understand food safety concerns during the busy, warm time of year.

“We urge food handlers to follow these four basic food safety tips: cook food thoroughly; clean hands and surfaces that come into contact with food; chill cooked food quickly and keep it cool until eaten; and separate raw and uncooked from cooked and ready-to-eat products,” Buckett said.

South Australia experiences about 1,500 Salmonella cases a year. Most are from ingesting the bacteria from contaminated food, water, or hands.

No one should handle food while experiencing Salmonella symptoms, which include fever, diarrhea, vomiting, headaches, stomach cramps and loss of appetite.

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Deadly outbreak tied to romaine ongoing; no recall, few details

Tue, 01/02/2018 - 00:00

Little information is available to the public in the U.S. or Canada more than six weeks into a deadly E. coli O157:H7 outbreak linked to romaine lettuce.

The risk is ongoing in both countries, officials report. Canadian officials are suggesting consumers in some provinces avoid all romaine lettuce. Government officials haven’t revealed any information about implicated suppliers, distributors or retailers in the romaine supply chain.

Almost 60 people are confirmed to have fallen ill, including one in Canada who died, since mid-November. Initially thought to be limited to certain provinces in Canada, 17 of the confirmed victims are in the U.S. They are spread across 13 states from coast to coast, according to a Dec. 28 statement from the the Centers for Disease Control and Prevention.

Whole genome sequencing shows E. coli O157:H7 samples from sick people in both countries are the same strain, which is evidence that a single source is likely, the CDC reports.

The 41 Canadian victims are from five provinces. More than 40 percent of them have been hospitalized. The health agency first reported the outbreak on Dec. 11. At that time Canadian officials identified romaine lettuce as the probable source.

Three days later those federal health officials reported the death, updated the number of confirmed cases, and said people in Eastern provinces should “consider consuming other types of lettuce, instead of romaine lettuce.”

That suggestion remained in place as of Dec. 28 when the Canadian health agency last updated its outbreak information.

“The outbreak appears to be ongoing, as illnesses linked to romaine lettuce continue to be reported to the Public Health Agency of Canada. These illnesses indicate that contaminated romaine lettuce may still be on the market, including in restaurants, grocery stores and any establishments that serve food,” the Dec. 28 update reported.

“At this time, the investigation evidence suggests that there continues to be a risk of E. coli infections associated with the consumption of romaine lettuce.

The U.S. CDC acknowledged the Canadian warning and reported it’s investigators are considering leafy greens and romaine as a possible source. But the U.S. officials stopped short of recommending any changes for consumers.

“CDC is still collecting information to determine whether there is a food item in common among sick people, including leafy greens and romaine,” according to the CDC statement.

“Because we have not identified a source of the infections, CDC is unable to recommend whether U.S. residents should avoid a particular food. This investigation is ongoing, and more information will be released as it becomes available.

The U.S. Food and Drug Administration has not posted information about the outbreak or investigations. Federal food safety officials in Canada are assisting with the investigation.

“… the Canadian Food Inspection Agency is testing romaine lettuce for the presence of E. coli,” according to Canada’s public health statement. “At this time, no source of contamination has been identified. There is no evidence to suggest that provinces in western Canada are affected by this outbreak.”

Risks for consumers
Although anyone can get develop an E. coli infection from exposure to the pathogen, pregnant women, people with weakened immune systems, young children and older adults are most at risk for developing serious complications, public health officials warn.

“This is especially true for this outbreak strain of E. coli (O157:H7), which is more likely to cause severe illness than other E. coli strains,” Public Health Agency of Canada reported.

Laboratory testing is necessary to determine whether food is contaminated with E. coli because it can’t be seen, smelled or tasted.

“Romaine lettuce can have a shelf life of up to five weeks; therefore it is possible that contaminated romaine lettuce purchased over the past few weeks may still be in your home,” Canadian officials told consumers.

Advice to consumers
Anyone who has eaten romaine lettuce and developed symptoms of E. coli infection should immediately seek medical attention. Specific lab test are required to diagnose E. coli infection.

Symptoms can include nausea, vomiting, headache, mild fever, severe stomach cramps, and watery or bloody diarrhea. The onset of symptoms can range from 1 to 10 days after exposure.

“Some do not get sick at all, though they can still spread the infection to others. Others may feel as though they have a bad case of upset stomach. In some cases, individuals become seriously ill and must be hospitalized,” according to the health agency notice.

People who develop hemolytic uremic syndrome (HUS) need intensive medical treatment, usually including dialysis for kidney failure.

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More Biscuits Recalled over Listeria

Mon, 01/01/2018 - 12:04

Food Lion is voluntarily recalling all code dates of its Food Lion brand Homestyle Buttermilk Biscuits in an abundance of caution after being notified by its manufacturer today the product may contain listeria monocytogenes.

While there have been no reports of illnesses to date, the product is being recalled as a precautionary measure after T. Marzetti Company, the manufacturer of the product, has indicated a possible contamination issue with Listeria monocytogenes at one of its plants.

T. Marzetti Company Recalls Listeria Tainted Biscuits

Sat, 12/30/2017 - 05:30

In this image from the Pasteur Institute, Listeria monocytogenes (shown in red) is in the process of infecting tissue cells.

T. Marzetti Company is voluntarily recalling all “Best By” dates of the following product that was distributed in California, United States, because it may have the potential to be contaminated with Listeria monocytogenes.

Consumers should not consume this product.  No illnesses have been reported in connection with the recalled item.

All “Best By” dates of the following products are included in this recall:

Item #
Full UPC

Description

Count per pkg

7229200025

MARSHALLS OLD FASHIONED SOUTHERN STYLE BISCUITS

12 ct

Although this product is not ready-to-eat items and has baking instructions which, if followed, will reduce consumer risk, there remains some risk that the mishandling of this product prior to or without adequate baking may cause illness.

We are working in coordination with the Food and Drug Administration (FDA) and our supplier on this recall.

All affected distributors and retail customers are being notified and the affected products are being removed from store shelves.

Affected product should be destroyed.

Listeria monocytogenes is an organism which can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened immune systems. Although healthy individuals may suffer only short-term symptoms such as high fever, severe headache, stiffness, nausea, abdominal pain and diarrhea, Listeria infection can cause miscarriages and stillbirths among pregnant women.

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