Currently browsing posts about: Food-safety

Hundreds of reports of illness from eating Lucky Charms cereal have intrigued food safety experts.

The FDA is investigating, but being really cagey about it.

Everybody seems to know that reference number 1064 refers to Lucky Charms cereal.

The FDA has received 529 reports of adverse effects.

Food safety lawyer Bill Marler has been following the situation.

Since late 2021, the crowd sourcing website iwaspoisoned.com has received 6,400 reports from people complaining of classic food poisoning symptoms of nausea, vomiting and diarrhea after eating Lucky Charms cereal. General Mills, the maker of the cereal, has said that is has investigated the situation and there is no apparent link between the reported illnesses and Lucky Charms.

The Washington Post quotes experts calling for a recall, Bill Marler among them.

Although, there has been no scientific proven link, be it chemical or an allergen, between the several thousand illnesses and Lucky Charms,” Marler said, “my advice to General Mills is to recall the product and reset its trust with the consuming public until more is known.

Is there a link?  Or is this just a matter of people getting sick, remembering they ate this cereal, and putting the two together—even though no cause-and-effect exists.

Really?  Another peanut butter Salmonella recall?  The last one was a disaster (more than 700 cases of illness and 9 deaths).  Among other things, it resulted in imprisonment for the head of the Peanut Corporation of America.

Well, here we go again.

The FDA announced the outbreak traced to Smucker’s Jif.

It also announced Smucker’s recall of those products.

And it provided links to further information.

• What is Salmonella
• Food Safety Tips for Consumers & Retailers During an Outbreak
• Who to Contact

The CDC announced its investigation results to date.

• Illnesses: 16
• Hospitalizations: 2
• Deaths: 0
• States: 12
• Recall: Yes
• Investigation status: Active

And it issued a food safety alert. Peanut butter has a long shelf life.  Discard Jif peanut butter with lot code numbers 1274425 through 2140425, with “425” at the end of the first 7 numbers.

But that’s not all.  Companies using Jif peanut butter dip with precut vegetables or in candy were also in trouble (see list at the end).

How does Salmonella get into peanut butter?  Scientific American explained how this happened the last time.

Feces from some animal is a strong possibility. A leak in the roof, for example, caused one of the early outbreaks. How salmonella got into the water that was on the roof, no one knows for sure. Maybe birds, for instance, which accumulate around peanut butter processing plants.  The roasting of peanuts is the only step that will kill the salmonella. If contamination occurs after the roasting process, the game is over and salmonella is going to survive. Studies have shown that salmonella can survive for many months in peanut butter once it’s present.

Preventive controls, anyone?

And here, thanks to Bill Marler and Food Safety News, is the current list of Jif recalls: .

• The JM Smucker Co. – US May 20, 2022
• The JM Smucker Co. – Canada May 21, 2022

The collateral damage:

• Rainbow Asset Limited – Hong Kong:May 23, 2022
• Randy Ltd. – Israel:May 23, 2022
• Albertsons Companies(11 store-prepared items) May 21, 2022
• Bix Produce Company(2 products containing Jif Creamy Peanut Butter To Go 1.5 oz. cup) May 26, 2022
• Cargill(multiple products containing peanut butter, sold at the Wilbur Chocolate Retail Store in Lititz, Pa. and online at Wilburbuds.com.) May 23, 2022
• Coblentz Chocolate Company(multiple peanut butter products) May 24, 2022
• Country Fresh(select fresh-cut fruit snack trays and fruit snack cups) May 24, 2022
• Fresh Del Monte(fresh-cut fruit and vegetable products containing ready-to-eat Jif^® peanut butter dip) May 24, 2022
• Fudgeamentals(several fudge products made with Jif Peanut Butter) May 25, 2022
• Garden Cut, LLC(Garden Cut products containing 0.750z Jif Peanut Butter Cup) May 24, 2022
• Giant(Store Brand Apples, Pretzels & Celery with Peanut Butter) May 23, 2022
• Martin’s(Store Brand Apples, Pretzels & Celery with Peanut Butter) May 23, 2022
• Mary’s Harvest Fresh Foods Inc(Mary’s Harvest Celery Peanut Butter Cup G&G and Apple Peanut Butter Cup G&G) May 24, 2022
• Price Chopper(M32 Apples, Cheese and Pretzels with Peanut Butter Tray) May 23, 2022
• Taher Inc.(“Fresh Seasons Power Packs”) May 24, 2022
• Wawa(two products containing Jif Peanut Butter) May 24, 2022
• Wegmans(Wegmans Snack with Apple, Pretzels, Cheese and Peanut Butter) May 22, 2022

The White House says it is taking steps to alleviate the nationwide shortage of infant formula.

House speaker Nancy Pelosi has written a letter to democrats demanding action.

Nationwide shortage of infant formula?

As CBS News explained,

At retailers across the U.S., 40% of the top-selling baby formula products were out of stock as of the week ending April 24…Prices of baby formula, which three-quarters of babies in the U.S. receive within their first six months, have also spiked…Supply-chain snarls related to COVID-19 are contributing to the shortage of formula around the U.S. They include manufacturers having more difficulty procuring key ingredients, packaging hangups and labor shortages…In addition, a major baby formula recall in January exacerbated shortages.

I wrote about the Abbott recall earlier, on February 22 and March 8.

Politico’s Helena Bottemiller Evich has been following this story closely in Politico.  You can find her articles here.

Her writing is getting action.

For example, Representative Rosa deLauro released a whistleblower report warning about food safety concerns months before infants died and the FDA investigated.

Food safety lawyer Bill Marler posted a link to the redacted  whistleblower report.

He says: Mr. Abbott, you are going to jail for manufacturing tainted infant formula.

The legal jargon aside, if you are a producer of food and knowingly or not manufacturer and sell adulterated food, you can (and should) face fines and jail time.  For Abbott, at least 4 kids were sickened and of those two died, from drinking infant formula.

Here is the most recent inspection report at the plant – APPLIED – FOI II – BR Abbott Nutritions- FEI# 1815692 9-2021 EIR.

In the meantime, Bottemiller Evich keeps the focus on how hard this situation is for parents of infants with special nutritional needs.  She also has a Twitter thread on this “slow-moving train wreck.”  She reproduces this graphic from @erindataviz/@datasembly:

The Seattle Times has a particularly useful guide to what to do—and what not to do—if you can’t find the formula you need.

As to what this is really about, see:

The Morning.  This New York Times column attributes this particular shortage to general shortages, monopoly concentration in the formula business, bureaucratic inflexibility, and, most of all, American gerontocracy and overall indifference to the welfare of young children.

A blogger about the politics of monopoly, Matt Stoller, expands on these themes:  baby formula monopoly, FDA collusion, and USDA’s methods for dealing with infant formula in the WIC program (this last alone is reason to read this piece).  In response, the USDA says it is granting states flexibility in apply the WIC rules.

And the Cato Institute has an informative piece on trade restrictions that prevent import of formula from other countries, including the European Union; this pieces also discusses the WIC problem (Government is major buyer; Abbott is major supplier).

Comment: This is a really bad situation that is finally starting to get attention.  Babies are completely dependent on infant formula if they are not being breastfed.  It needs to contain all the right nutrients, but it also needs to be safe.

The FDA says it is taking steps to alleviate the formulat shortage.

Why hasn’t it acted more swiftly?  Perhaps because of what Bottemiller Evich wrote about previously?  See The FDA’s Food Failure.

Basically, we are seeing the results of unregulated monopolies and captured government.  With the most vulnerable members of society—and society’s future—at risk.

Additional links

• Letter from 8 Senators headed by Cory Booker to USDA Secretary Vilsack calling for greater formula competition
• Letter from USDA Secretary Vilsack calling on Abbott to provide rebates for competitive formula
• Politico: Senator Tammy Duckworth calls on the FTC to examine lack of competition in the formula market
• Center for Science in the Public Interest urges policymakers in Washington to deploy additional tools
• Congressional subcommittee to investigate shortages
• Background Press Call by Senior Administration Officials to Address Infant Formula Shortage
• Readout of President Biden’s Virtual Meetings with Retailers and Infant Formula Manufacturers
•  Associated Press — Parents swap, sell baby formula
• The New York Times — What Parents Need to Know
• USDA’s Q and A page about options for exchanging Abbott formula for other kinds 
• USDA’s page on the Abbott recall
• USDA’s guidance for keeping infants safe in the midst of formula shortages
• FDA’s details on Abbott product recalls
• CDC’s report on its Cronobacter investigations, now closed
• Wall Street Journal: What caused the baby formula shortage?
• Bill Marler: Abbott caused the infant formula crisi, but the FDA and public health enabled it
• Abbott and FDA agree on pathway to opening Sturgis MI plant
• Abbott denies its formulas were responsible in an 11-tweet Twitter thread

Additional links that came later

• The Washington Post – Biden invokes Defense Production Act to boost baby formula supply
• WhiteHouse.gov – Letter from President Biden to Secretary Xavier Becerra and Secretary Thomas Vilsack on addressing infant formula shortage  
• Fact sheet: President Biden announces new actions to address infant formula shortage
• Memorandum on the delegation of authority under the Defense Production Act to ensure an adequate supply of infant formula

I posted about this recall on February 22.

A quick review: The FDA is advising consumers not to use certain Abbott’s powdered formula products because they might be contaminated with  Cronobacter sakazakii or Salmonella Newport.

To date, one infant is ill with Salmonella Newport, and four ill with Cronobacter sakazakii with two deaths.

This is a shocking tragedy.  Formula-fed babies are entirely dependent on those products.  They are heavily regulated, or supposed to be.

The three powdered formula brands at issue are Similac, Alimentum, or EleCare.  The FDA says not to use them if:

• the first two digits of the code are 22 through 37; and
• the code on the container contains K8, SH or Z2; and
• the expiration date is 4-1-2022 (APR 2022) or later.

Abbott’s recall announcement has more information about the specific products.

Politico’s Helena Bottemiller Evich is following this case closely.

She interviewed parents of children harmed, sometimes terribly, by consuming contaminated formula.

In an earlier report, she detailed the history of FDA’s inspections of the Abbott laboratory and the agency’s surprising delay in getting Abbott to do a “voluntary” recall.

Food safety lawyer Bill Marler also has questions about the quality of production and FDA’s surprising lack of action.

Fortunately, House Appropriations Chair Rosa DeLauro has called on the Department of Health and Human Services’ Inspector General to invesigate whether the FDA “took prompt, appropriate, and effective action” in this situation.

As for Abbott, its statement says:

The company said all of its finished products are tested for the pathogens before they’re released, and samples it retained tested negative for the infections related to the complaints.  “We value the trust parents place in us for high quality and safe nutrition and we’ll do whatever it takes to keep that trust and resolve this situation.”

I have my own question: Why isn’t there far more media attention to the formula recalls?  Babies’ lives are at stake.  Parents, understanably, are frantic.

What should they do?

• Feed liquid formula.  It, at least, is sterile.
• Scream for federal action (if enough people do, it might get some).

The FDA is advising consumers not to use Similac, Alimentum, or EleCare powdered infant formulas if:

• the first two digits of the code are 22 through 37; and
• the code on the container contains K8, SH or Z2; and
• the expiration date is 4-1-2022 (APR 2022) or later.

The FDA and CDC are investigating.

[They have received] four consumer complaints of infant illness…All of the cases are reported to have consumed powdered infant formula (IF) produced from Abbott Nutrition’s Sturgis, MI facility. These complaints include three reports of Cronobacter sakazakii infections and one report of Salmonella Newport infection in infants. All four cases related to these complaints were hospitalized and Cronobacter may have contributed to a death in one case.

Bill Marler’s Food Poison Journal has more about Cronobacter sakazakii (formerly known as Enterobacter sakazakii) in infant formula.

The FDA reports:

On 2/17/2022, Abbott Nutrition initiated a voluntary recall of certain powdered infant formulas. Products made at the Sturgis facility can be found across the United States and were likely exported to other countries as well. Canadian health officials have also issued a recall warning.

Helena Bottemiller Evich, writing in Politico, is right on top of this situation.

The FDA first received a report of a foodborne illness suspected to be linked to infant formula in September — four months before issuing a recall of three major brands this week after four babies were hospitalized and one died, according to a state agency.

The [recall]…comes after reports of illnesses came to FDA and the Centers for Disease Control and Prevention between September and January. The Minnesota Department of Health investigated a case of an infant who was sickened by Cronobacter sakazakii in September 2021, the state agency told POLITICO.

She also Tweeted:

I’ve gotten a bunch of reports that the formula recall includes these (often unsolicited) packs that formula companies send new parents. So check those, too!

Warning to parents: if you are using any Abbott formula products, check the labels.  Do not feed recalled products to your infant.

Comment: Anything wrong with infant formula is a terrible problem because that’s all infants are fed and they are completely dependent on those products.  We will have to wait and see why the FDA:

• Did not push Abbott to recall these products four months ago.
• Did not mention the gift pack of formula given to new mothers.

And Bill Marler writes: “I have some questions about the Cronobacter and Salmonella infant formula outbreak: Why are illnesses not universally reportable and why was there a two year gap in FDA inspections at plant?”

Also worrying is that the FDA still does not have the authority to demand immediate recalls of potentially harmful products.

The Food Safety Modernization Act gave the FDA recall authority, but tied its hands.

FSMA’s mandatory recall authority allows the FDA to mandate a recall when a responsible party chooses not to conduct a voluntary recall when the criteria under section 423 of the FD&C Act are met. The FDA can use its mandatory recall authority when the FDA determines that there is a reasonable probability that an article of food is adulterated under section 402 of the FD&C Act and/or misbranded under section 403(w) of the FD&C Act and where there is a reasonable probability that the use of or exposure to such food would cause SAHCODHA.

You will be amused to know that SAHCODHA stands for Serious Adverse Health Consequences or Death to Humans or Animals.

Leafy greens pose a seemingly intractable food safety problem.

• They are responsible for many harmful and deadly outbreaks of toxic E. coli (lawyer Bill Marler has a handy table listing outbreaks from 1995 to 2019).
• They are mostly eaten raw.
• They are often grown on land adjacent to dairy farms or cattle grazing or irrigated with water containing waste from animal agriculture.

The FDA is now taking on this last point.  It is is proposing standards for water use on produce for human consumption:  FDA.  Standards for the Growing, Harvesting, Packing, and Holding of Produce for Human Consumption Relating to Agricultural Water: Notice of proposed rulemaking.  The key provisions:

This proposal would replace the microbial criteria and testing requirements for pre-harvest agricultural water for covered produce (other than sprouts) with provisions for systems-based agricultural water assessments that are designed to be more feasible to implement across the wide variety of agricultural water systems, uses, and practices, while also being adaptable to future advancements in agricultural water quality science and achieving improved public health protections. Additionally, we are proposing to require
expedited mitigation for hazards related to certain activities associated with adjacent and nearby lands, in light of findings from several recent produce outbreak investigations.

Translation: Farms would have to assess where contamination of irrigation water might occur and take steps to prevent it, but will not have to test the water.

In its press release, the FDA says:

Today, the U.S. Food and Drug Administration issued a proposed rule that aims to enhance the safety of produce. It proposes to require farms to conduct comprehensive assessments that would help them identify and mitigate hazards in water used to grow produce. This is the latest step in the agency’s implementation of the FDA Food Safety Modernization Act (FSMA), and it proposes to replace some of the existing requirements for agricultural water in the Produce Safety Rule (PSR).

This updates the FDA’s previous attempts:

• Food Safety Modernization Act Proposed Rule on Agricultural Water
• Agricultural Water Assessment Fact Sheet  
• FSMA Final Rule on Produce Safety

Food safety lawyer Bill Marler asks: Is FDA creating a HACCP for Produce? Are assessment and mitigation going to create safer produce?

He notes that the FDA is focusing on “pre-harvest risk assessment of water risk as opposed to water testing for pathogens generally.”  This requires produce growers to evaluate local pathogen risks such as cattle operations and/or wild animal populations and then take measures to prevent them from contaminating water supplies.

But without having to test the water, it’s going to be hard to confirm that the assessment of risk actually reduces it.  Marler says:

So, in my view the jury is still out on 1) will eliminating water testing and increasing assessments make for a safer product? and, 2) should there not be a recognition that produce is essentially a “ready-to-eat” product grown outside with the risks inherent by what is directly around it or what may blow or flow to it, and therefore a broader environmental approach will be required to assure produce safety?

Is the FDA backing off of safety requirements?  The link explains how to file comments.  Now is the time to weigh in.

In a press release, the USDA says it is going to take action against Salmonella contamination of poultry in order to get closer to the national target of a 25% reduction in Salmonella illnesses.

Despite consistent reductions in the occurrence of Salmonella in poultry products, more than 1 million consumer illnesses due to Salmonella occur annually, and it is estimated (PDF, 1.4 MB) that over 23% of those illnesses are due to consumption of chicken and turkey…USDA intends to seek stakeholder feedback on specific Salmonella control and measurement strategies, including pilot projects, in poultry slaughter and processing establishments. A key component of this approach is encouraging preharvest controls to reduce Salmonella contamination coming into the slaughterhouse.

The North American Meat Institute says its members are happy to assist (Salmonella is a problem for poultry, not beef).

The National Chicken Council also pledged to assist with the pilot projects, but then put the onus of responsibility squarely on you.

Even with very low levels of pathogens, there is still the possibility of illness if a raw product is improperly handled or cooked. Increased consumer education about proper handling and cooking of raw meat must be part of any framework moving forward. Proper handling and cooking of poultry is the one thing that will eliminate any risk of foodborne illness. All bacteria potentially found on raw chicken, regardless of strain, are fully destroyed by handling the product properly and cooking it to an internal temperature of 165°.

The newly formed Coalition for Poultry Food Safety Reform, led by Center for Science in the Public Interest, welcomes the USDA’s announcement, but insists that USDA’s food safety oversight needs to extend from farm to fork.

Comment: The USDA’s jurisdiction starts at the slaughterhouse, but chickens coming into the plant are already contaminated with Salmonella.  This means prevention has to start on the farm, and poultry producers would have to institute procedures to keep their flocks free of Salmonella. They would much rather you cooked your chicken properly.

The latest big Salmonella outbreak is due to onions, an FDA-regulated food.

FDA’s traceback investigation is ongoing but has identified ProSource Produce, LLC (also known as ProSource Inc.) of Hailey, Idaho, and Keeler Family Farms of Deming, New Mexico, as suppliers of potentially contaminated whole, fresh onions imported from the State of Chihuahua, Mexico.

Keeler Family Farms issued a voluntary recall.   ProSource Produce LLC also issued a voluntary recall.

The CDC has the statistics:

Comment: I wrote about a previous onion recall last year.   Food safety lawyer Bill Marler asks: What did we learn – or not – from the 2020 Salmonella Outbreak linked to onions?  That investigation, as he emphasizes, identified probable causes:

• potentially contaminated sources of irrigation water;
• sheep grazing on adjacent land;
• signs of animal intrusion, including scat (fecal droppings), and large flocks of birds that may spread contamination; and
• food contact surfaces that had not been inspected, maintained, or cleaned as frequently as necessary to protect against the contamination of produce.

The FDA lists all the products that have been recalled so far.  It also displays their labels.  If you have onions from these companies, treat them like biosafety hazards.  If you can’t bear to throw them out, at least boil them and sterilize everything they could have contacted.

Xavier Naville.  The Lettuce Diaries: How a Frenchman Found Gold Growing Vegetables in China.  Earnshaw Books, 2021. 

The publicist for this quirky book sent it to me and I have to admit being charmed by it.  The French author started out in international corporate food, managing canteens in 70 countries for the Compass Group and based in Paris.

At age 27, almost on a whim, he went to Shanghai to sell salads to the Chinese (who didn’t eat salads) and oversee the production of vegetables for KFC and other fast food places.

He was, to say the least, ignorant of Chinese language and culture but learned a lot during the twenty years or so he spent there.

His book is about how his naivete and uncertainty got in the way of getting small farmers to grow lettuce and other vegetables consistently and safely, and how he slowly and painfully learned to speak and write Chinese, and learn the importance of guanxi (personal relationships essential for getting anything done in China).

He is so modest, so hard on himself, and so likable that I wanted him to succeed—which he did, and quite well.

Among other things, his company produced bagged salads for Chinese supermarkets.  Food safety maven that I am, I won’t even buy bagged salads in the U.S.  His descriptions of small-scale food production are terrifying.

He reports no outbreaks due to his products, although he talks about plenty of others, including the melamine-in-infant-formula scandal predicted by the earlier melamine-in-pet-food scandal I wrote about in Pet Food Politics.  

I liked his thoughtfulness about his experience.

All these years, I had viewed the microscopic farming plots as a barrier to the modernization of China’s agriculture.  But after a few hours with my Chinese friends, I was beginning to see things differently.  Where would all these seasonal foods come from if there were fewer farmers?  Would there still be regional differences?  If China follows the developmental path of the West, the number of farmers will shrink while operations increase in size.  Farms will focus on scale and productivity, specializing in fewer crops, breeding the most productive ones and neglecting some that have a higher nutritional content but lower returns per acre.  Is that really what Chinese consumers want?

…family farmers weren’t necessarily just an obstacle on China’s path toward modernization; they might actually be its cultural gatekeepers, protecting the local food industry and underpinning a renaissance of Chinese beliefs that will be key to the health of both the Chinese people and the safety of the foods they cherish.  (p. 246)

Quirky?  Definitely for a business book, but in a good way.  I enjoyed reading it.

[The author is now a food business consultant in Oakland, CA].