FDA's Useless Consumer Complaint System

Complaint About Swollen Orange Juice Cartons Brushed Aside

"If you still wish to have one of your containers analyzed you may contact a private laboratory."

– Sheila van Twuyver, FDA Consumer Complaint Coordinator

Orange juice is a typical part of our breakfast. My husband and I like the taste and the convenience of pasteurized, pulpy, "not from concentrate" juice, and usually stock up on several cartons at a time. We're careful to rotate our stock, using up the oldest date codes first.

On Saturday, December 19th, we reached into our refrigerator for a fresh 64-ounce carton of Florida's Natural "Growers Style" Orange Juice, a product of Citrus World, Inc. To our dismay, we discovered that the first carton we grabbed was bulged. So was the second. Both of these showed a "Best if used by" date of Dec 25 09.

We had fresh grapefruit instead.

On Monday, December 21st, we decided to open a carton of juice that sported a Jan 28 10 expiry date. To our dismay, we discovered that the two Jan 28 10 cartons in our refrigerator were also showing signs of bulging.

How badly bulged were the Dec 25 09 cartons? Check this out.

And this

What does a consumer do with a rogue's gallery of swollen orange juice cartons?

We called the supermarket where we had purchased some of the juice. The store manager simply replied, "Bring back the cartons for a refund."

Next, we telephoned and sent an email message to Florida's Natural on December 19th and contacted them again by email on December 21st. Here is their reply:

"We appreciate your visit to our Florida's Natural Brand web site, notifying us of the issue you had with our Grower's Style Orange Juice. We have forwarded the date code information you provided to our Quality Assurance Department for investigation.

We will follow up with our findings, by letter, with replacement coupons included. We appreciate your purchases of our Florida's Natural Brand products and apologize for the incident."

And, of course, we put in a call to the FDA Consumer Complaint Coordinator for Vermont.

After several telephone conversations and exchanges of email messages, we received the following reply from FDA by email this morning:

Thank you again for contacting us about the bulging containers of Florida’s Natural orange juice that may be a potential threat to the health of consumers, such as yourself.

I spoke with the manufacturing facility and they advised that the containers be disposed of immediately. They may not have been held at a proper temperature somewhere between the time they were produced to the time they made it to your refrigerator. The containers never leave the facility bulging in this way. Also, there are currently no other reported illnesses or complaints related to the orange juice.

We advise you to throw away your containers and we will not need to collect them for analysis.

FDA will follow-up with Price Chopper and Hannaford Distribution Centers as well as your local Public Health Authorities in VT.

We will also be following up with the Manufacturing facility in Florida.

If you still wish to have one of your containers analyzed you may contact a private laboratory.

Thank you for your time,

Sheila van Twuyver

Sheila van Twuyver

Consumer Complaint Coordinator

New England District Office

U.S. Food and Drug Administration

The two batches of defective juice were purchased from two different supermarket chains, on two separate shopping trips, one month apart. We always use coolers with freezer packs to keep perishables cold in warm weather – and these cartons of juice were purchased during the autumn, during cooler weather. Is the manufacturer suggesting that both Hannaford and Price Chopper routinely mishandle the orange juice? Or that the juice is shipped from Florida to supermarket distribution centers in trucks that are not refrigerated? This makes no sense to me!

As a food safety microbiologist, I know that the most likely cause of these bulged containers is a yeast contamination. The probable source of the yeast is the filling line. What worries me – and what should worry both FDA and the manufacturer – is that these two bulging batches of orange juice were pasteurized and packed more than one month apart.

What does this say about the effectiveness of the processor's sanitation program?

What if there is more than one contaminant in the filling line – Salmonella, or perhaps E. coli O157:H7?

What if the problem is improper pasteurization?

FDA should have analyzed the contents of the bulged cartons to determine whether or not the product presented a health risk. The agency ought to know by now that relying on a manufacturer's assurances that there have been no complaints is not always a recipe for safety.

Readers of this blog have commented in the past about the lack of response from FDA's complaint coordinators – especially when reporting pet food issues to the agency. It's clear that this lack of response extends to human food.

When I worked for Canada's Health Protection Branch in the 1970s, we investigated every single consumer complaint. We knew from experience that some of these complaints were early warnings of significant food, cosmetic or pharmaceutical safety issues.

The Obama Administration has been promising "transparency" in government. Well, it's transparent to this consumer that FDA's Consumer Complaint Coordinator system is a farce!

Anyone for a glass of fresh-squeezed orange juice?

School Lunch Tortilla Supplier Shuts Down

March 9, 2009

Del Rey Tortilleria's soft shell tortilla plant, which has been linked to several outbreaks of gastroenteritis among school children since 2003, has been shut down by FDA under a consent decree signed by the company's president and two general managers.

According to FDA, the tortilla production facility will remain closed until Del Rey complies with a series of conditions, including:

• hiring sanitation and food processing experts to develop quality control measures
  
• inspection and certification that the company complies with cGMP and other consent decree provisions
  
• successful completion of an FDA inspection to verify compliance with the consent decree, cGMP, and the Federal Food, Drug & Cosmetic Act
  

The government court action came after years of failed efforts on the part of FDA to obtain "voluntary" compliance from the company's management.

• Ten mysterious food poisoning outbreaks among school children in Massachusetts were reported to health authorities in 2003-2004. All of illnesses had a single common thread – the victims had eaten tortillas from a single source, identified in the January 2006 CDC outbreak investigation report simply as "Manufacturer A" in Chicago, IL. An inspection of the company's facilities by FDA, Illinois, and Chicago investigators uncovered numerous health and sanitation violations.
  
• In January 2006, just two weeks after the release of the CDC report, Del Rey Tortilleria, Inc. recalled all of its flour tortillas labeled with "use by" codes of March 06, 2006 or earlier, "... because government officials have associated consumption of the flour tortillas with a series of health symptoms among individuals who complained of stomach pains, vomiting, diarrhea, nausea, and headaches."
  
• In November 2007, Del Rey issued another recall, covering tortillas sold in the United States and Canada, after the tortillas were linked to yet another series of illnesses among school children – this time, in Racine, WI.
  

In announcing the plant shut down, Michael Chappell, FDA's acting Associate Commissioner for Regulatory Affairs made this statement:

"We cannot allow a company to produce potentially contaminated products because of failing to have adequate procedures in place. This enforcement action shows the FDA will take the appropriate measures deemed necessary under the Federal Food, Drug and Cosmetic Act to protect the public's health."

It only required:

• two series of outbreaks, involving more than 389 students in 13 schools over a four year period;
  
• three product recalls, two in the United States and one in Canada;
  
• multiple inspections by FDA and other agencies; AND
  
• the intervention of the Federal Court system.
  

Just another example of Voluntary Compliance at work!

Tomato Pasting

The numbers continue to climb in the largest tomato-related Salmonella outbreak in US history. At last count – as of 9pm (EDT) last night – CDC has acknowledged 869 lab-confirmed cases of Salmonella Saintpaul infections in 36 states and the District of Columbia. At least 107 people have been hospitalized.

What's even more significant than the continuing increase in reported cases is the timing of new cases. CDC now tells us that, contrary to its previous reports, 179 of the victims – more than 20% of the lab-confirmed total – began to have symptoms of salmonellosis during the month of June. The newest patients became ill on June 20, two weeks after FDA alerted consumers, retailers and food service operators nation-wide to the outbreak.

On the subject of FDA, there has been no further substantive news on its trace-back investigations. None of the tomato samples tested so far have yielded the outbreak strain. We don't even know whether any Salmonella – outbreak strain or not – has turned up in the more than 1,700 samples FDA has examined.

Having cut my food safety teeth within a federal health agency (Canada's Health Protection Branch), I usually tend to give government investigators the benefit of the doubt. I know how complex and difficult it can be to trace the source of a microbiological contaminant. But I get the sense that FDA is floundering in its trace-back attempts.

I am especially disturbed by the latest statements out of CDC and FDA that cast doubt on their initial positive assertions as to the source of this outbreak. And I find Dr. Acheson's apparent surprise at the complexity of the raw tomato distribution system disingenuous, at best.

This is the thirteenth Salmonella outbreak that has been linked to contaminated tomatoes in the United States since 1990. Surely, FDA should know by now the details of the tomato distribution chain – or should know where to find that information pronto.

When all the dust finally settles on this enigmatic outbreak, I hope – and expect – to see a full Congressional inquiry into the handling of this investigation by FDA and CDC.

FDA: Tomatoes In, Garbage Out

I've been checking the FDA web site several times a day for progress reports on the tomato trace-back investigation. Imagine my joy when I discovered, just a few minutes ago, that the FDA site had been updated with a new pdf document, Salmonella Contamination Response as of June 27, 2008.

I immediately downloaded the file, expecting it to contain an up-to-the-minute progress report – maybe even news as to the source of the Salmonella-contaminated tomatoes. To my chagrin, it was nothing more than a PR stunt.

This touted "update" is a combination text-and-cartoon description of the FDA's response to the tomato outbreak. The final stage in the investigation response?

FDA works with industry, states, foreign governments, and academia to prevent future outbreaks.

Who does the agency think it's kidding? The nation's consumers, as well as the produce industry and state and local health agencies, are looking for substantive answers – not PR stunts like this "update" or the FDA Commissioner's weekly so-called blog, "Andy's Take".

It's time for FDA to get its priorities straight and focus on the nation's food safety problems. If it does so, FDA's image problems will solve themselves.

Complaining To – Not About – The FDA

It's very easy to find fault with FDA. And with good reason – the agency seems to be dancing with two left feet much of the time. The new FDA weekly on-line column, Andy's Take, said to be written by FDA Commissioner Andrew von Eschenbach, has not been well-received by the media, and even most Internet-savvy consumers are probably unaware of its existence.

The communications disconnect between FDA and US consumers is disturbing. The agency relies heavily on patterns of consumer complaints and illness reports to decide where and how to spend its inadequate budget. Most of the major recalls and investigations that we learn about in the media – melamine in pet food, Salmonella in tomatoes – began as consumer complaints reported to FDA or outbreak clusters identified by state health agencies and the CDC.

But, before a consumer can lodge a complaint with FDA, he or she must know who to call. Earlier this month, the agency posted two new pages on its web site to guide consumers through the complaint process.

Your Guide To Reporting Problems To FDA tells consumers how to navigate the government's regulatory system. It offers tips on how to report problems, which agency to call (if the product is not under FDA regulation), and which office within FDA handles the various products and problems. Much of the information is displayed in an easy-to-use table.

FDA 101: How to Use the Consumer Complaint System and MedWatch, as its name implies, is a primer on how to make a consumer complaint to FDA. It lists the types of problems FDA wants to learn about from consumers, talks about what happens when a complaint is received, and provides the telephone numbers for all of the FDA regional Complaint Coordinators.

I strongly urge all my US readers to bookmark these web pages – or download the pdf versions – and to use this complaint process to make FDA aware of any health or safety issue you encounter with a product that this agency regulates.

PETCO - Where The Pests Go

FDA has announced the seizure of animal food from a PETCO warehouse in Joliet, IL after finding "widespread and active rodent and bird infestation" at the company's distribution center on two inspections in a row. The seizure was carried out yesterday by U.S. Marshals acting under a District Court warrant.

The Joliet PETCO facility distributes products to the company's stores in 16 states – Alabama, Illinois, Indiana, Iowa, Kansas, Kentucky, Louisiana, Michigan, Minnesota, Missouri, Nebraska, Ohio, Oklahoma, Tennessee, Texas, and Wisconsin.

According to FDA's news release, the seized products were in permeable packages and were held under conditions that could have allowed them to become contaminated or could have affected their quality. No illnesses from these products have been reported to FDA, and the agency does not believe that products shipped from this warehouse are hazardous to animal or human health.

As a precaution, FDA recommends that people who handle any products that might have been stored or shipped from the Joliet warehouse should wash their hands carefully with soap and hot water afterwards. Surfaces that have come in contact with the products or their outer packaging also should be cleaned thoroughly with soap and hot water.

If you suspect that your pet has become ill after eating pet food that came from the PETCO Joliet facility, FDA would like to hear from you. In addition to contacting your veterinarian, please call the FDA consumer complaint coordinator for your state.

FDA Puts Its Foot Down

When USDA's Food Safety and Inspection Service is faced with a contaminated food that is a clear and present danger to consumers, and a processor that refuses to act, the agency can threaten to withdraw its inspectors, effectively shutting down the processing plant.

FDA doesn't have that luxury. FDA inspectors must coax, cajole and convince a recalcitrant food processor to issue a voluntary product recall. As the Mars Petcare story clearly shows, this is not always a satisfactory solution.

Sometimes, a processor's breaches of safe food handling practices are so egregious that FDA has no choice but to seek a court injunction and shut down production until the company corrects its unsafe practices.

FDA announced today that it has shut down the operations of Hope Food Supply Inc., of Pasadena Texas, and has ordered the company to recall all of its products. The agency was able to take this unusual action because of a consent decree that Hope Food had signed when operating under a different name. Under the consent decree, the seafood manufacturer had agreed to develop and implement a HACCP plan, as required of it under the Food, Drugs and Cosmetic Act. It did not do so.

Hope is a producer of smoked catfish and smoked seafood, and distributes its products nationwide. It is under orders to recall everything produced and shipped since 2007. FDA is advising consumers who have purchased any smoked fish or smoked seafood to contact their retailer to determine their source, and to discard anything produced by Hope Food Supply, Inc.

FDA has also obtained a signed consent decree of permanent injunction against Lifeway Foods, Inc., and its subsidiary LFI Enterprises, Inc. The decree shuts down operations at the companies' production facilities in Skokie, IL and Philadelphia, PA. Lifeway and LFI process and distribute cream cheese and seafood products, such as cream cheese and lox spreads and whitefish salad.

According to the FDA news release, both facilities have been in violation of food safety and food labeling standards repeatedly since 2004. The consent decree specifies that operations may only resume at these facilities once FDA is satisfied that the locations are in full compliance with food safety standards, including the development and implementation of an appropriate HACCP program. The decree does not extend to Lifeway's other products that contain no seafood. There has been no product recall ordered as part of this consent decree.

The FDA news releases contained the following statement from Margaret O'K. Glavin, associate commissioner for regulatory affairs:

"We simply will not allow a company to put the public's health at risk by not implementing adequate procedures and plans to produce safe food. . . The FDA will take action against companies and against their executives who violate the law and endanger public health."

While it's encouraging to learn that FDA is prepared to take court action against egregious offenders of food safety requirements, we shouldn't lose sight of the fact that the agency had to jump through a series of hoops for four years before it could obtain a consent decree against Lifeway. And the decree only covered those products that contain seafood.

Isn't it time to strengthen FDA's ability to enforce the provisions of the Food, Drug and Cosmetic Act?

Mars Petcare Dog Food Recall: Follow-up

Why FDA Needs Mandatory Recall Authority

In 2007, 70 people in 19 states became infected with Salmonella Schwarzengrund. The first confirmed cases were reported in May in Pennsylvania. One month later, infections with the outbreak strain of Salmonella had turned up in Ohio and several other states.

Based on information uncovered by Pennsylvania health authorities and the CDC, suspicion fell on dry dog food as the source of the multi-state outbreak. Hot on the scent of the common link, investigators sampled 13 dog stool samples and 22 samples of dry dog food – and found the outbreak strain of Salmonella Schwarzengrund in 5 of the stools and in 2 dog food samples.

The implicated dog food was manufactured in the Pennsylvania plant of Mars Petcare. Pennsylvania Department of Health inspectors visited the Mars production plant on July 12th and collected 144 environmental swab samples for lab analysis. One of the samples yielded the outbreak strain of Salmonella Schwarzengrund.

Mars suspended production at its Pennsylvania plant for several months (July-November 2007) for a comprehensive clean-up and disinfection of the entire production facility. And it instituted a product recall – but only of the two specific products that were proven by FDA lab tests to be contaminated with Salmonella Schwarzengrund.

Mars Petcare's Pennsylvania facility produced dry dog food under 25 different brand names. Based on patient interviews and Salmonella-positive dog stools, some of these other brands – and some other production dates – also were implicated in the outbreak. The company, however, chose not to recall any products unless FDA could prove – based on Salmonella-positive lab results from unopened bags of dog food – that the products were contaminated.

Logically – given the scope of the outbreak, the confirmed presence of the outbreak strain in the production environment, the finding of Salmonella-contaminated dog food from two different batches, and the epidemiological evidence – the entire outstanding production from this plant should have been recalled. But FDA did not have the necessary authority to insist on a more extensive recall.

A report of the outbreak investigation appeared in this week's issue of Morbidity and Mortality Weekly Report, a CDC publication. The writer's frustration shines through clearly in the discussion of the recall. The Editorial Note to the report reads, in part, as follows:

"The case-control study found an association between infections in households and use of dry dog food or dry cat food produced by manufacturer A. In addition, the outbreak strain was isolated from 1) opened bags of dry dog food (brands A and B) that were produced in plant A by manufacturer A, 2) stool specimens from dogs in case-patient households that ate dry dog food produced in plant A, 3) an environmental sample from plant A, and 4) two bags (brands E and F) of previously unopened dry dog food produced in plant A.

A voluntary recall of specific-sized bags of two brands of dry dog food issued by the manufacturer in August 2007 was based only on lot-specific testing of finished unopened bags found to be positive for Salmonella by official FDA testing. Other sizes of bags of the two brands of dry dog food, although produced at plant A, were not recalled. Other brands of dry dog or cat food produced at plant A, including brands associated epidemiologically and microbiologically with illness, also were not included in the recall.

Plant A ceased operations during July--November 2007 to allow for cleaning and disinfection. However, because dry pet food has a 1-year shelf life and all contaminated products were not recalled, contaminated dry pet food might still be found in homes and could provide the potential for causing illness. Only an estimated 3% of Salmonella infections are laboratory-confirmed and reported to surveillance systems (2); therefore, this outbreak likely was larger than the 70 laboratory-confirmed cases identified."

Mars Petcare produces such familiar brands as Royal Canin, Pedigree and Nutro, as well as a large number of store brands. It is part of Mars, Incorporated – the company that has given the world M&Ms, Mars Bars and Uncle Ben's Rice.

The Mars Petcare dry dog foods have a one-year shelf life. Some of the dog food that was produced before the July 2007 plant shutdown is still in circulation. If you have purchased any dry dog food that was manufactured at Mars Petcare's Pennsylvania plant, please discard it. If you purchased a store brand or regional brand and are unsure of where it was made, contact your retailer and ask for the name of the manufacturer. Or call Mars North America's consumer hot line toll-free at: 1-800-627-7852.

Malt-O-Meal Breakfast Cereals Causing Illness?

On April 5th, Malt-O-Meal Company of Minneapolis announced a recall of its unsweetened Puffed Rice and unsweetened Puff Wheat breakfast cereals, due to a risk of Salmonella contamination.

The Company reported that it had detected Salmonella, had identified the source, had instituted corrective measures, and was recalling almost a full year's production of the two cereals "out of an abundance of caution." The report also stated that no illnesses had been reported.

Today, however, the Maine Department of Health and Human Services announced that it is investigating three cases of salmonellosis (onset dates of January 22 to March 19) that might be linked to the Malt-O-Meal recall. According to the state's press release, the Salmonella strain detected in the three patients – two of whom needed hospitalization – is similar to the Salmonella found by Malt-O-Meal in its product.

All three of the Maine victims reported eating unsweetened puffed rice or wheat cereals, but investigators haven't yet determined whether any of the victims ate cereal from one of the recalled batches of product. The state's press release adds that other states are also investigating cases of salmonellosis with the assistance of the CDC.

There is no information posted yet on the CDC web site, nor has the Company released to the public any information on the specific strain or serotype of Salmonella it has detected.

If you experienced any symptoms of Salmonella gastroenteritis since early January and you think that you might have eaten unsweetened puffed rice or wheat cereals, please contact your family doctor and your state health department to report the illness.

Malt-O-Meal produces and packages cereals under many store brand names. If you have unsweetened Puffed Rice or unsweetened Puffed Wheat cereals in your pantry, please check its brand name and "Best Before" date against the full list of recalled products available at the Malt-O-Meal web site. Please do NOT eat these cereals or serve them to any family members – not even the family dog.

Democratic Presidential Candidates: On Food Safety

Bill Marler posted this morning Hillary Clinton's policy proposals for our food safety system. The Clinton campaign press release , issued yesterday in the aftermath of the 143 million pound meat recall, covers several aspects of food safety, including mandatory recall authority, consolidation of responsibility for food safety oversight into a single agency, and carrying out an immediate audit to find the weaknesses in our present system.

I looked for, and found, Barack Obama's statement, also released yesterday, which I have quoted in full below.

Chicago, IL - Senator Barack Obama released a statement on the Department of Agriculture's decision to recall 143 million pounds of frozen beef that came from "downed" animals. The consumption of downed cattle can pose a higher risk of contamination from E. coli, salmonella or mad cow disease.

Senator Obama released the following statement:

"Senator Barack Obama released a statement on the Department of Agriculture's decision to recall 143 million pounds of frozen beef that came from "downed" animals. The consumption of downed cattle can pose a higher risk of contamination from E. coli, salmonella or mad cow disease.

"Senator Obama said: "Although the Department of Agriculture has now recalled the tainted beef, an estimated 37 million pounds has gone to school lunch programs, and unfortunately, officials believe that most of the meat has already been consumed by schoolchildren. This incident demonstrates yet again the inadequacy of the food recall process. Far too often, tainted food is not recalled until too late.

"When I am President, it will not be business as usual when it comes to food safety. I will provide additional resources to hire more federal food inspectors. I will also call on the Department of Agriculture to examine whether federal food safety laws need to be strengthened, in particular to provide greater protections against tainted food being used in the National School Lunch Program.

"As the parent of two young daughters, there are few issues more important to me than ensuring the safety of the food that our children consume. I commend the Humane Society of the United States for bringing this important issue to the public attention and believe that the mistreatment of downed cows is unacceptable and poses a serious threat to public health."

It would be nice to know what the co-sponsorship and voting records of both Senators has been on the various food safety bills that have been presented in Congress while they have been in office.

A Look Back at January 2008

I have just returned from a month-long trip through Southeast Asia, and have been scanning through my accumulation of news archives to see what I missed. Here are a few of the things that happened in the United States and Canada while I was away.

1. New Era Canning Company announced on January 18th a recall of green beans and canned garbanzo beans packed in #10 cans (institutional size) due to a risk of botulism. Four days later, the company expanded the recall to included all cans of green beans and garbanzo beans produced during the past five years.
2. On January 21st, Kroger's recalled it's Tri-Bean Salad from stores in 14 states. The salads had been prepared using canned beans from New Era.
3. FDA announced a recall of frozen salted yellow croaker and frozen dried yellow croaker on January 23rd, due to the possibility that the fish might be contaminated with Clostridium botulinum.
4. USDA announced on January 5th a recall of more than 13,000 pounds of steak and ground beef products from Mark's Quality Meats of Detroit due to E. coli O157:H7 contamination. The meat was sold to Detroit area restaurants. No illnesses were associated with this recall.
5. Rochester Meat Company of Rochester, MN recalled 188,000 pounds of ground beef on January 12th after six illnesses – five in Wisconsin and one in California – were linked to their meat. The ground beef had been distributed to restaurants and food service establishments nation-wide.
6. On January 22nd, the Canadian Food Inspection Agency (CFIA) alerted consumers to Salmonella-contaminated organic sesame seeds. The seeds were imported from Uganda. On January 28th, Shiloh Farms of New Holland, PA announced the recall of its "Organic Unhulled Sesame Seeds", after FDA detected Salmonella in a sample of sesame seeds from one of their suppliers. Coincidence?
7. On January 27th, CFIA warned consumers in the provinces of Quebec, Ontario and the Atlantic provinces to avoid consuming chicken sandwiches produced by Les Aliments Martel of Gatineau, QC, due to the risk that the sandwiches might be contaminated with Listeria monocytogenes.
8. The Centers for Disease Control and Prevention (CDC) reported an on-going outbreak of Salmonella Paratyphi B var. Java that has been linked to pet turtles. As of January 18th, there have been 103 confirmed illnesses in 33 states. Young children are especially susceptible to becoming infected as a result of handling the contaminated turtles. FDA has posted a Consumer Update on the risks associated with Salmonella in pet turtles.
9. Finally, Washington State Department of Agriculture announced on January 29th that it had found Listeria monocytogenes in a coconut-flavored frozen dessert produced by Ca Rem #1 Ice Cream of Sea Tac, WA. The non-dairy frozen dessert was distributed mainly through Asian restaurants and markets in Western Oregon and Western Washington, and is being recalled by the manufacturer. Consumers are advised to throw away any unused product.

I'm intrigued by the sudden upsurge of major canned food recalls in the last year or two – first Castleberry's and now New Era. This sector of the food industry has been under a HACCP-style program for many decades with apparently good results. I wonder whether the chronic underfunding of FDA's food inspection activities is bearing some bitter fruit.

FDA Botulism Alert - Take Two

FDA has just released an update to the New Era Canning Company green bean botulism recall that I first reported on December 21st. The potential contamination was discovered by the FDA during a routine inspection.

The recall covers institutional-sized (6 pound, 5 ounce) cans of GFS "Fancy Blue Lake Cut Green Beans". The product was distributed to restaurants and food service operators in eleven states. In three of those states - Tennessee, Indiana, and Kentucky - the recalled product was also available at retail through GFS Marketplace stores.

Symptoms of botulism can appear as soon as 6 hours or as late as 2 weeks after eating food that contains the toxin. Please read the FDA recall notice for details on the recall and for a description of the symptoms of botulism.

Baby Turtles - The Gift That Keeps On Giving

Not food related, but.....

North Carolina's Department of Health and Human Services is reminding parents that giving a pet turtle to their kids is not a good idea.

Four children were recently confirmed to have suffered from a Salmonella infection last summer, and one of them was hospitalized due to kidney failure. But they didn't become infected from food. Baby pet turtles were the source of the infection. Veterinarians tested the turtle belonging to one of the infected children, and found the identical strain of Salmonella to the one recovered from the sick child.

Pet turtles have long been a source of occasional Salmonella illnesses in children. Health agencies warn about this over and over again. In fact, the FDA banned the sale of these turtles more than 30 years ago - in 1975. Unfortunately, some of these are still finding their way into the hands of children. And the Salmonella that they carry is finding its way from the children's hands into their bodies.

Please be warned. Pet turtles and children - especially young children - are not a good combination.

Two Recalls To Go With Your Morning Coffee

The US Food and Drug Administration has alerted consumers to avoid using "Green Paradise Fresh Italian Basil" as it may be contaminated with Salmonella. The basil, which was shipped to distributors in Southern California, Texas and Arizona, is being recalled by Top Line Specialty Produce of Los Angeles, CA. The product is packed in 1 lb. boxes. Consumers should return the basil to the store at which it was purchased for a full refund.

The FDA has also announced a recall of "Dried Roach" uneviscerated fish due to the risk of Clostridium botulinum. This product of Latvia was imported by Royal Seafood Baza Inc. and distributed through Net Cost Market stores in Philadelphia, PA and in Brooklyn and Staten Island, NY. Sale of uneviscerated fish is illegal in New York State, due to the elevated risk of Clostridium botulinum in this food.

Melamine in Pet Food - A Final Report

A tip of the hat to the University of Guelph (Canada) Laboratory Services Division. While everyone else was wondering why the melamine-laced pet food was so toxic to dogs and cats last spring, the Canadians figured it out in short order. Now their conclusion has been confirmed independently by Michigan State University toxicologists in a follow-up study.

When melamine was first detected in pet foods that had been linked to animal deaths, veterinary toxicologists were puzzled. Melamine was never thought to be toxic to companion animals at the levels found in the contaminated products. The second contaminant, cyanuric acid, also was not known to be toxic at the levels at which it was found in the food. But the combination of the two chemicals proved deadly.

On May 1st, the University of Guelph reported that they had found the likely answer to the toxicity puzzle. Their preliminary report concluded:

Although still under investigation, it now appears that the combination of melamine and cyanuric acid has been linked to the unusual outbreak of acute renal failure in cats and dogs that have eaten the suspect products.

The researchers reached this conclusion by adding both melamine and cyanuric acid to cat urine. The two chemicals, when both present in the urine, formed crystals that were identical to the crystals found in the urine of cats that had been sickened after eating the contaminated pet food. Neither melamine nor cyanuric acid alone produced these crystals.

The American Association of Veterinary Laboratory Diagnosticians commissioned Michigan State University to investigate fully the impact of the contaminated pet food and confirm the reason for its toxicity. University of Guelph and Colorado State University collaborated with MSU on the study. Their report has just been released, and the two main findings are:

1. The contaminated pet food was probably responsible for the death of more than 300 cats and dogs
2. The toxicity of the pet food likely resulted from the combination of melamine and cyanuric acid in the contaminated food.

So now we know for sure what the University of Guelph figured out more than 6 months ago. And we also know how many pets were probably lost due to the deliberate addition of melamine and cyanuric acid to wheat gluten by an off-shore manufacturer who was trying to gain an economic advantage.

Yesterday, Health and Human Services Secretary Leavitt announced that the U.S. and China had reached an agreement on food safety issues. The agreement provides for the eventual "embedding" of FDA inspectors in Chinese food processing facilities. But I don't expect this agreement to have a major impact. The FDA doesn't have nearly enough money in its budget - or trained personnel on its staff - to fulfill its domestic mandates.

Recall Alert - Listeria in Queso Fresco

The FDA has just announced a recall of Queso Fresco/Fresh Cheese produced by Peregrina Cheese Corp. of Brooklyn, NY. Production lot #3973 of this cheese was found by the New York State Dept. of Agriculture and Markets to be contaminated with Listeria monocytogenes.

L. monocytogenes is especially dangerous to persons who are immunocompromised, the very young, the elderly, and pregnant women. A pregnant woman who is infected with L. monocytogenes is at risk of miscarrying.

If you have purchased this cheese, please discard it or return it to the place of purchase. Do NOT, under any circumstances, eat cheese with this lot number. If you have discarded the packaging or cannot read the lot number on your package, please play it safe and discard the cheese.

Managing Risks - A Page from the Australian Playbook

When my husband and I were running our business and trying to ship products to Australia, we had to deal with that country’s tough meat and dairy product import regulations. Australia’s requirements seemed a bit paranoid to us at the time, but their strict import provisions stood the country in good stead. Australia has never experienced a case of mad cow disease.

Australia developed a risk-based approach to food import control that the FDA would do well to examine and learn from. Imported foods fall into one of three categories.

“Risk categorized foods” are those thought to present the greatest risk for food-borne disease. These foods are subjected to the most intensive scrutiny by Food Standards Australia. The first five shipments of each food on the high risk list from each foreign producer are inspected. After five consecutive shipments of a given food have passed muster, one in four shipments of that food from that producer are held for inspection. After 20 successful inspections, the frequency of inspection drops to one in 20 shipments. In all cases, shipments selected for inspection are held until results are known. Any unsatisfactory result causes the risk clock to reset and, of course, the unsatisfactory shipment is refused entry.

“Active surveillance foods” represent the next lower level of perceived risk. Ten percent of shipments of these foods from each and every supplying country are sampled for lab analysis. Because of the lower perceived risk, shipments of these foods are released after sampling.

“Random surveillance” covers all remaining foods not included in one of the two higher risk categories. Five percent of these shipments are sampled randomly for lab analysis.

Food Safety Australia reviews the results of these inspections periodically and, if appropriate, moves foods to a higher or lower risk category.

No system can ensure 100% safety, but basing a screening program on scientific risk assessment, and adjusting that assessment as more information become available seems a logical way to go.

Bush-League Food Protection Plan

On Tuesday, the Senate Committee on Health, Education, Labor and Pensions (HELP) held hearings on the Bush Administration's new "Food Protection Plan". This Plan, together with its companion "Import Safety Plan", was developed in response to a tsunami of food-related recalls and illness outbreaks which have taken place in the last 12-18 months.

According to news media reports, the focus of the hearing was mainly on the issues surrounding risk assessment and the concentration of FDA attention on "high-risk" products. But in zeroing in on the "high-risk" issue, Senators have apparently overlooked an even greater flaw in this Plan - the so-called "mandatory recall" provision.

For several years, Senator Tom Harkin (now Chairman of the Senate Agriculture Committee) has sponsored legislation to provide the FDA and USDA with authority to mandate recalls of foods that present a hazard to human health. Each time, the Bush Administration claimed that it had no need of such authority; the voluntary recall system was working. Now, the Administration appears to have had a change of heart. Or has it?

The mandatory recall authority proposed in the Plan reads as follows:

"This authority would be limited to foods that the Secretary has reason to believe are adulterated and present a threat of serious adverse health consequences or death. It would be imposed only if a firm refuses or unduly delays conducting a voluntary recall. An order to recall food could only be issued by the HHS Secretary, Deputy Secretary, or Commissioner of Food and Drugs, and would be accompanied by appropriate due process rights."

There are several major flaws in this proposal. The most glaring is the total exclusion of mandatory recall authority for USDA, the federal government department that regulates all meat, poultry and processed egg products in the United States (including, for example, pepperoni-topped pizza). Another loophole is the lack of definition of the terms "threat of serious adverse health consequences", "unduly delays" and "due process rights". Are vomiting or diarrhea "serious adverse health consequences", or would the new authority only cover life-threatening situations such as botulism or hemolytic uremic syndrome (HUS)? How long is an undue delay? Who decides? And what constitutes "due process rights"? Will FDA need to go to court each time it needs to exercise its mandatory recall authority?

Canada has had mandatory recall authority on its books for ten years under the Canada Food Inspection Agency Act. The law, which covers all foods, simply states:

"19. (1) Where the Minister believes on reasonable grounds that a product regulated under an Act or provision that the Agency enforces or administers by virtue of section 11 poses a risk to public, animal or plant health, the Minister may, by notice served on any person selling, marketing or distributing the product, order that the product be recalled or sent to a place designated by the Minister.”

There is no requirement, under the Canadian law, for the Canada Food Inspection Agency to demonstrate that a company has "unduly delayed" implementing a recall. The authority is the Agency's to use as needed to ensure prompt action and to protect public health.

President Theodore Roosevelt once advised that we should "Walk softly and carry a big stick." That advice should be heeded by this Administration in its dealings with the food industry, both domestic and foreign. Unfortunately, the "mandatory recall" proposal described in the Food Protection Plan will have the FDA walking on eggshells with nothing more than a small twig in hand with which to enforce its mandate.

Recall Alert - Soma Beverages

Soma Beverage has announced a recall of its mint-flavored waters, due to the presence of Bacillus cereus, a food poisoning bacterium. Please check the FDA announcement for details on lot number and products affected by this recall. As of 1:42 PM (EST), the company has not posted information on this recall on its own web site.

No illnesses have been reported so far.

The FDA..Through Rose-colored Glasses

The latest on-line FDA Consumer update contained a Q&A session with the Director of FDA's Office of Regional Operations, Deborah Ralston. In response to a question about FDA's import surveillance program, Ms. Ralston said,

"For example, we work cooperatively with U.S. Customs and Border Protection to help identify shipments containing potentially dangerous foods and prevent them from entering the country. By law, certain information must be submitted to FDA about food products before they are allowed to enter the U.S. We keep our Prior Notice Center open to receive this information 24 hours a day, 365 days a year. This means that FDA knows in advance when and where specific food shipments will enter the United States, what those shipments will contain, the countries and entities where they originate, and the facility where the food was manufactured.

So although we don't physically inspect every product, we electronically examine 100% of imported food products before they reach our borders. Based on criteria we have set up, an automated system alerts us to any concerns. Then we investigate further and, if warranted, do a physical examination of the product."

But compare this statement to the following excerpt from the recently released internal FDA report:

"Many of the FDA systems reside on technology that has been in service beyond the usual life cycle. Systems fail frequently, and even email systems are unstable — most recently during an E. coli food contamination investigation. More importantly, reports of product dangers are not rapidly compared and analyzed, inspectors’ reports are still hand written and slow to work their way through the compliance system, and the system for managing imported products cannot communicate with Customs and other government systems (and often miss significant product arrivals because the system cannot even distinguish, for example, between road salt and table salt)."

FDA is overwhelmed and underfunded, and has been for many years. The problem gets worse day by day. Yet, instead of giving us an honest appraisal of the agency's problems, its spokespeople continue to paint a rosy picture of FDA's ability to carry out its diverse mandates. Is it any wonder that the agency is struggling to deal effectively with the deluge of imported products arriving at our ports of entry?