Currently browsing posts about: Food-safety

Everyone is worried about the FDA (or should be) and I’ve been collecting suggestions for how to fix it.  I have three so far.

I.  Move food safety out of FDA and into a new Food Safety Administration. 

This would be housed (as FDA is) in the Department of Health and Human Services (HHS).

Senators Durbin, Blumenthal, and DeLauro have proposed legislation to do this.  The bill text is here and a fact sheet here.

• “In recent years, FDA has been plagued by one failure after another—from a failure to properly recognize the dangers of prescription opioids, to a failure to protect children from e-cigarette products, to a failure to properly ensure the safety of our nation’s food supply,” said Durbin. “The sad reality is that FDA seems unwilling or unable to use their authority to protect Americans from preventable illness and death.
• “Americans deserve to know the food on their plates is safe to eat,” said Blumenthal. “By protecting consumers from foodborne illnesses and acting swiftly to respond to recalls, the Food Safety Administration will improve the safety of our nation’s vital food supply.”
• “Food safety is currently a second-class citizen at the Food and Drug Administration,” said DeLauro. “Right now, there are no food policy experts in charge of food safety at the FDA.”

II.  Move all food functions out of FDA into a separate agency.

This is proposed by several public action groups:  Consumer Reports, STOP Foodborne illness, the Environmental Working Group, and Healthy Babies Bright Futures.

[The] groups discussed the need for congressional action to separate the food portion of the Food and Drug Administration into a separate agency under the Depart of Health and Human Services. The agency would be solely devoted to the food side of the FDA, which oversees 80 percent of the nation’s food supply.

These groups have not developed specific details about how this might work.

III.  Move FDA’s food functions into USDA.

This proposal comes from Jerry Mande, former FDA and USDA official:  “A Farm to Fork approach to Fixing FDA’s food program.”

USDA is best positioned to succeed due to its history and mission. Created by President Abraham Lincoln to be the “people’s department,” USDA has the comprehensive resources and authorities needed to succeed. These include its 15 nutrition assistance programs and their $175 billion budget, its farm executive directors in every state and its transformative extension agents in literally every county, and the nation’s leading food and nutrition research programs.

Specifically, we propose that the FDA’s Center for Food Safety and Nutrition (CFSAN) merge with USDA’s Food and Nutrition Service (FNS) and Food Safety and Inspection Service (FSIS) under one Food, Nutrition and Health mission area at the USDA.

The Government Accountability Office has been calling for a separate food safety agency since at least 1990.  Its idea would be to combine the food safety functions of FDA (generally, plant foods and food products), USDA (generally, animal foods), and other federal agencies.  From a food safety perspective, that makes sense.

But what about FDA’s other food functions, such as oversight of  food ingredients, labels, and health claims?

And what about food advertising (FTC), health risks (CDC), etc?

What’s good about this is that doing something to strengthen food regulation is on the agenda.

How best to do it?

Ultimately, it’s up to Congress.

Daily Harvest is a company that makes vegan meals, mostly organic, and freezes them for home delivery.

By mid-June, it had received 470 complaints from customers who ate a new product, French Lentil + Leek Crumbles, but developed severe liver and gall bladder problems.  On June 23,  Daily Harvest issued a recall of the product “due to potential health risk” (also see After 470 reports of illnesses, Daily Harvest recalls French Lentil + Leek Crumbles).

I was especially interested in this event for two reasons: Daily Harvest twice sent me meals to sample (before it introduced this one) and I knew they had to be cooked before eating, which would kill harmful microbes, and I could not imagine what could possibly cause reactions this toxic (as I explained to the New York Times).

This product’s ingredient list seems benign:

organic butternut squash, organic hemp seeds, organic cauliflower rice, organic extra virgin olive oil, organic french lentils, organic red lentils, organic tri-colored quinoa, organic cremini mushrooms, organic tara flour, organic leeks, organic parsley, water, organic cassava root flour, organic flax seeds, organic sacha inchi powder, chia seeds, organic porcini powder, himalayan sea salt, organic apple cider vinegar, organic onion powder, nutritional yeast, organic garlic powder, organic tomato powder, organic white pepper, organic coriander seeds, organic mustard powder, organic thyme.

More than that, on June 25, food safety lawyer Bill Marler was asking the same question: What is it in Daily Harvest’s French Lentil and Leek Crumbles that is causing liver failure?  He was sending samples out to his own labs.

On June 28, Daily Harvest responds to customers sickened, hospitalized from 1 of its products.

On June 30, the FDA published its Investigation of Adverse Event Reports: French Lentil & Leek Crumbles

On June 17, 2022, in response to consumer complaints submitted to the company, Daily Harvest voluntarily initiated a recall of their French Lentil & Leek Crumbles…From April 28 to June 17, 2022, approximately 28,000 units of the recalled product were distributed to consumers in the continental United States through online sales and direct delivery, as well as through retail sales at the Daily Harvest store in Chicago, IL, and a “pop-up” store in Los Angeles, CA. Samples were also provided to a small number of consumers. Daily Harvest emailed consumers who were shipped the affected product, and other consumers for whom the company had contact information and consumers were issued a credit for the recalled product. Consumers who may still have the recalled product in their freezers should immediately dispose of it.

On July 1, the FDA announced the recall and issued an advisory for these events.

Also on July 1,  Daily Harvest issued UPDATES ON OUR VOLUNTARY RECALL OF FRENCH LENTIL + LEEK CRUMBLES

Rachel here – I want to give you another update on the French Lentil + Leek Crumbles recall. As you know, we’ve been conducting exhaustive testing over the course of the last two weeks. Despite this, we still have not identified a possible cause. I am sorry that it’s taking as long as it is to pinpoint exactly what may have made people sick. We are deeply committed to finding answers for those impacted. We’re working with top doctors, microbiologists, toxicologists as well as 3 independent labs.   While additional testing is underway, results to date rule out the following:

• Hepatitis A

• Norovirus

• A range of mycotoxins, including aflatoxins

• Food-borne pathogens including Listeria, E.Coli, Salmonella, Staphylococcus Aureus (Staph), B.Cereus, and Clostridium Species

• Major allergens including egg, soy, milk, and gluten

I assure you, we will not stop until we get to the bottom of this. We’re continuing to work in close cooperation with the FDA, CDC and other health agencies. The FDA released an update on their investigation yesterday, which can be found here on their website.

I’m baffled.  I can’t understand why toxin testing hasn’t come up with anything.  The illnesses are real and all traced to this product.

The FDA’s recommendation: “Consumers should not eat, sell, or serve recalled products. Consumers who may still have the recalled product in their freezers should throw it away.”

Bill Marler agrees with don’t eat it, but he wants the product saved as evidence.  He has questions and suggestions:

• When did Daily Harvest first learn that its French Lentil + Leek Crumbles were causing Liver Failure?
• What to do if you have been or are sick after eating French Leek and Lentil Crumble  

His hypothesis: the Tara ingredient.

• Revive Superfoods no longer has Tara as a listed ingredient – what happened in the last 24 hours?
• Are Revive Superfood Smoothies linked to acute Liver Failure too?
• Is Reddit the new FDA? Is it the Tara?
• Hey, CDC, I have 175 people you should talk to

We believe that the illnesses may well be linked to a common ingredient called Tara that comes exclusively from Peru (this due because it is a unique ingredient to the French Lentil + Leek Crumbles AND to certain Revive Smoothies where people are reporting identical symptoms).

Here’s what Wikipedia says about Tara:

Tara gum…is produced by separating and grinding the endosperm of T. spinosa seeds…The major component of the gum is a galactomannan polymer similar to the main components of guar and locust bean gums that are used widely in the food industry….Tara gum has been deemed safe for human consumption as a food additive… Medicinal uses in Peru include gargling infusions of the pods for inflamed tonsils or washing wounds; it is also used for fevers, colds, and stomach aches. Water from boiled, dried pods is also used to kill fleas and other insects.

Bill Marler is on the case.  He has 175 clients so far.

• Marler Clark files first of hundreds of lawsuits against Daily Harvest
• Daily Harvest customer had gallbladder removed after eating frozen item: suit.
• Daily Harvest hit with lawsuit by woman who blames company for gallbladder removal
• Daily Harvest Faces Lawsuits Over Claims of Mystery Illness Causing Severe Pain and Gallbladder Failure

I’ve heard privately from people who experienced sickness after eating this product.  I’ve read about others like this one:

• Daily Harvest customer tried to warn CEO symptoms much worse than ‘gastrointestinal discomfort’

I wish everyone a speedy recovery, and hope the toxin gets identified soon.  Stay tuned.

Food prices are rising.  The American Farm Bureau keeps score.

Every year, the American Farm Bureau, with the help of volunteer shoppers around the country, calculates the average cost for a July 4^th cookout. This year, it will cost about $70 to feed ten people. That’s a 17% increase compared to a year ago. Inflation, ongoing supply chain disruptions, and the war in Ukraine are all contributing to the substantial increase in food prices.

And stay safe!  (Food Safety News has the details on how to avoid food poisonings).

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.