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Breaking news: The ingredient that caused the illnesses among people who consumed Daily Harvest’s French Lentil + Leek Crumbles has been identified, sort of.  As suspected, it’s the tara flour.  But what’s the toxin in the tara flour?  That, we still don’t know.

As Rachel Drori, the CEO of Daily Harvest, explains in her latest update (all are here).

At this time, we have identified tara flour as the cause of the issue. Our extensive investigation has involved many experts analyzing data from all sources. We have only used this ingredient in French Lentil + Leek Crumbles and we are no longer sourcing from this producer who does not provide any ingredients for our 140+ other items. This was the first and only time we’ve used tara flour, which has been available and used in the North American market as a plant-based source of protein prior to our use. Our investigation team will continue working with the FDA, the tara flour producer and others to help determine what specifically made people sick.

To review: Daily Harvest is a company that makes and ships preprepared vegan frozen meals, one of which, French Lentil + Leek Crumbles, has been recalled after several hundred people who ate it developed serious problems with their livers and gall bladders.

The big question: what caused these problems?

As Drori says:

The FDA is on the case.  Its most recent accounting gives these figures:

Total Adverse Illness Events: 277*
Hospitalizations: 96*
Deaths: 0
Last illness onset: July 9, 2022*
States with Adverse Illness Events: AZ, CA, CO, CT, DE, FL, GA, IL, IN, IA, MD, MA, MN, MI, MO, MT, NH, NJ, NY, NC, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VT, VA, WA, WI
Product Distribution: Nationwide
*Estimate based on Consumer Complaint and CAERs reports received by the FDA

The FDA’s previous update noted that the company shipped about 28,000 of these specific meals between April 28 and June 17.

Food safety lawyer Bill Marler, who represents many of the afflicted (and is filing lawsuits), says:

We have filed lawsuits in both state and federal court to more effectively push discovery against both Daily Harvest and the manufacturer of the product, Stone Gate. We need to know what is the likely common ingredient and who supplied it. We need to understand all food safety protocols and what went wrong. We need to know when these companies first were aware of the “Adverse Illness Events” and what was done with that information.

Marler’s latest summary is here.

ABC News reporter Melanie Woodrow (@Melanie Woodrow) spoke with some of the victims and their lawyers (not Bill Marler)  She Tweeted:

Spoke w/ two attorneys today who say #DailyHarvest has filed motions compelling their clients to arbitrate, meaning cases would play out in conference room not court. @DlyHarvest says customers agreed to terms that included an arbitration clause.

I truly do not understand why the toxin has not yet been identified.

This situation reminds me of how hard it was to identify melamine as the toxin in the massive pet food recalls of 2006.  I ended up writing a book about this case: Pet Food Politics: The Chihuahua in the Coal Mine.

While waiting for answers, let’s all wish the victims a speedy recovery.

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.

Presidential candidate Donald Trump gave a speech to the Economic Club of New York about his tax reform plan to “make America great again.”

The plan would eliminate some programs he finds annoying, the FDA’s food safety regulations among them.

The tax plan, including the FDA provisions, was posted on Trump’s website, but it is no longer there.

Fortunately, @nycsouthpaw did a screen capture and posted it on Twitter.  Among other things, Trump would like to eliminate:

Food safety lawyer Bill Marler, who begs producers of unsafe food to “put me out of business” is getting his wish and notes how well the new food safety rules are working.  He says Trump must love him: Killing the FDA is good for business:

How did “The Donald” know that my business has dropped over the last few years as the regulatory work of our governmental agencies have kicked into gear.

Who knew that food safety would be an issue in this year’s election, let alone Skittles.

The latest Salmonella outbreak comes courtesy of Pacific Coast Fruit Company, which produces Taylor Farms Organic Power Greens Kale Medley.

Alas, Salmonella do not care whether or not vegetables are USDA Certified Organic—even kale.

Coral Beach discusses the details of the investigation into this outbreak at Food Safety News this morning.

And food safety lawyer Bill Marler has some pointed questions about this outbreak.

•  Why no announcement of the Salmonella Enteritidis outbreak?
•  Why no recall of the product?
•  Given that the product was distributed nationwide, are we seeing a spike in Salmonella Enteritis cases in states other than Minnesota?
• Why was the announcement removed from Pacific Coast Fruit Website?

He also has plenty to say about what another recent outbreak (this one due to frozen vegetables contaminated with Listeria) tells us about what is and what is not working in our current food safety system.

His essay makes the point that foodborne illness outbreaks due to contaminated meat are becoming increasingly rare.  Most current outbreaks are due to contaminated vegetables.

How come?  For meat, the system is working.

• Regulation: prevention controls on meat and poultry went into effect in the mid-1990s.
• The CDC’s ability to track outbreaks is good and getting better, thanks to genetic fingerprinting.
• Government agencies are doing more testing.
• The US Attorney’s office has shown interest in “finding companies and their CEOs criminally responsible for manufacturing tainted foods.  Lawsuits and jail time have a unique ability to make companies pay attention.”
• Recalls are “both disruptive and expensive.”
• Publicity about recalls discourages the public from buying similar products.

In sum, “recall costs, slumping sales, along with civil and criminal liability, are powerful market incentives.   The FDA Food Safety Modernization Act (FSMA) should help once companies start following its regulations.

He ought to know.  When Congress was foot-dragging on passing FSMA, Marler sent every member of Congress a tee shirt with this image:

He better be careful.  If he’s right about market forces cleaning up food safety problems, he may get his wish.

But we still have a long way to go on vegetable safety, apparently.

On my 12th-floor Manhattan terrace, I grow cilantro every summer.  I like to have it handy.  And I know it’s local, organic, seasonal, and deer-free—and unlikely to be contaminated with Cyclospora.

The CDC reports 358 people to be ill with Cyclospora, most likely because they ate cilantro imported from Mexico.

It doesn’t take much web surfing to find out anything you want to know about such problems.  I like to use three sources:

The CDC

• Information about Cyclospora
• A paper on Outbreaks of Cyclosporiasis — United States, June–August 2013
• A fact sheet
• An explanation of investigations of foodborne outbreaks
• 2014 Outbreak Investigations
• 2013 Outbreak Investigations
• Advanced Molecular Detection for Cyclospora
• Time to Think About Cyclosporiasis
• A Webinar for health-care providers

The FDA

• A statement
• Advice for consumers.
• An import Alert
• An explanation of how the US is working with Mexico to make cilantro safer
  

Bill Marler

• His blog

I was interested to read Michael Taylor’s comments on the recall of Blue Bell ice cream contaminated with Listeria.  Mr. Taylor is Deputy FDA Commissioner for food safety.

This was an outbreak in which 10 people were hospitalized and three died.  The best place to begin on this is on the CDC website for the Blue Bell outbreak.  It provides excellent graphics summarizing the number of cases and where they occurred:

This outbreak was particularly awful because inspections had found severe violations of standard food safety procedures, yet the company ignored them.  The result: people died.

Mr. Taylor asks if this outbreak could have been prevented with better FDA regulation.  In 2010, Congress passed the FDA Food Safety Modernization Act (FSMA) but it’s taken time for the implementation.  Taylor says:

the preventive controls for human food rule, if finalized as proposed, would require that companies like Blue Bell have a written food safety plan, based on an analysis of likely hazards, and companies would have to show us that plan during inspections.Listeria monocytogenes is a classic example of a hazard that a company should be controlling. Under the proposed standards, companies would be required to have the right controls in place to minimize hazards and would have to verify that their controls are working.

But, he says, to implement the law, the FDA needs funding: “If we do not get the funding, we will lose momentum, and implementation will be badly disrupted.”

Congress, no doubt, will continue to keep the FDA on a short string.  No industry likes being regulated and the food industry fights regulation in every way it can.

The FDA needs to do more to ensure food safety but can’t without inspectors.

That leaves legal approaches.  For these, I go right to the websites of the Marler-Clark law firm, which specializes in food safety cases.

Here’s what Bill Marler and his colleagues have had to say about the Blue Bell case (most recent first and I may be missing some):

• June 6  Listeria found in Blue Bell ice cream from Alabama plant
• June 2: Blue Bell Agrees to Do What It Should Have Been Doing All Along
• May 31: A Blue Bell Listeria Timeline – 2010 to 2015
• May 22: So, Why Did Blue Bell Ignore FDA’s: “Guidance for Industry: Control of Listeria monocytogenes in Refrigerated or Frozen Ready-To-Eat Foods?”
• May 21: Blue Bell Missed Warning Signs to Avoid Listeria Contamination, Illnesses, Recalls, Layoffs and ?
• May 16: Bad Listeria Management Causes 2850 Blue Bell Employees Out of Work
• May 15: Kruse: “An Agonizing Decision” – But It Was Preventable
• May 15: Blue Bell Knowingly Sold Ice Cream From A Plant With Listeria
• May 14: Blue Bell Enters Consent Decree with Texas and Oklahoma (Likely Alabama Too) To Do What It Always Should Have Been Doing – Make Safe Food
• May 14: Blue Bell Ice Cream For Sale: Stupid Is As Stupid Does
• May 7: Paul Kruse, President and CEO of Blue Bell Ice Cream – My Advice, Get a Good Criminal Lawyer
• May 7: Blue Bell Ice Cream Manufacturing – An Accident Waiting to Happen
• April 20: Listeria outbreak kills three in Kansas linked to ice cream consumed from Blue Bell Creameries
• April 8 (?): Blue Bell Ice Cream Listeria Outbreak
• March 15: Marler – The Food Safety Lawyer – Update On Blue Bell Ice Cream Listeria Outbreak
• March 13: Blue Bell Creameries Listeria Outbreak Sickens 5 in Kansas Killing 3

Marler-Clark is filling a critical regulatory gap by suing companies that cause foodborne illnesses and deaths.  But this is after-the-fact.

As Bill Marler has been pleading since 2007: please put me out of business.

Prevention would be much, much better.  Hence the need for more FDA resources.

Update, June 12: The CDC concludes its investigations and the FDA releases reports

I haven’t said anything about pet food in a while, but plenty is happening with it since my pet food books came out—Pet Food Politics (2008) and Feed Your Pet Right (2010).

A few items I’ve collected over the past month or so.

• FDA regulations: The FDA finally issued its proposed rule for processing standards for all facilities engaged in manufacturing, processing, packing or holding animal feed and pet food.  These include  Good Manufacturing Processes (GMPs) and risk-based preventive controls (formerly known as HACCP), among other provisions.
• Safety tips: Food Safety News lists ten ways to make pet food safer—pay attention and follow food safety procedures diligently, for one thing.
• Double standard: Bill Marler complains that the FDA is constantly announcing recalls of Salmonella-contaminated pet foods, even though few of them result in cases of Salmonella in pets or humans, whereas foods for humans take forever to get recalled even when they cause illness.
• Pet food recalls: The FDA certainly lists plenty of pet food recalls, and even has a web page for them.
• FDA oversight: The FDA is on the job and testing.  Bravo issued recalls because of potential Listeria contamination.  It did so because the FDA says an independent lab detected the bacteria in a sample.
• Marketing wars: Pet Food Industry, the excellent publication for manufacturers, has a juicy story about the marketing claims war between Nestlé (no relation) Purina PetCare and Blue Buffalo.  Each has sued the other.  Blue Buffalo has already been called on its advertising claims, perhaps in response to a complaint from  Hill’s Pet Nutrition.
• The ongoing mystery: Pet jerky treats, mostly imported from China, linked to at least 3 human illnesses and more than 1,000 dog deaths and 4,800 dog illnesses, mostly from gastrointestinal problems, liver and kidney disease, and neurological and skin conditions.  The FDA says it still can’t figure out the cause, despite 7 years of trying. symptoms in their pets,” said FDA.

If we can’t get pet food right, there’s not much hope for human food either.

I’ve been trying to make sense of what’s happening with the latest horrible food poisoning outbreak: this time of antibiotic-resistant Salmonella Heidelberg.  Food Safety News and attorney Bill Marler have been following the events closely.

They reported that USDA—not CDC (which was on furlough)—issued the Public Health Alert.

But the outbreak is so serious that CDC recalled staff from furlough.  Now the CDC is back on the job.  It reports that as of October 7:

• 278 persons in 17 states are infected with 7 outbreak strains of Salmonella Heidelberg.
• 42% of them are hospitalized (this is unusually high), and no deaths have been reported.
• 77% of cases are in California.
• The source is Foster Farms chicken

What does Foster Farms have to say about this?

First, it blames the government:

Consumers should know that as recently as Oct. 8, USDA-FSIS publicly assured the safety of our chicken:  “Foster Farms chicken is safe to eat but, as with all raw chicken, consumers must use proper preparation, handling and cooking practices.” There is no recall in effect and FSIS continues to inspect our poultry on a daily basis, certifying it as Grade A wholesome.”

Then, Foster Farms argues that toxic, antibiotic-resistant salmonella are normal on poultry:

Raw poultry is not a ready-to-eat product. All raw poultry is subject to naturally occurring bacteria… According to the CDC, “It is not unusual for raw poultry from any producer to have Salmonella bacteria. CDC and USDA-FSIS recommend consumers follow food safety tips to prevent Salmonella infection from raw poultry produced by Foster Farms or any other brand.”

Bill Marler asks how come Foster Farms is not issuing a recall?

Good question.  Take a look at CDC’s most recent Epi curve.  Usually, these show a standard distribution pattern over time with cases rising to a peak and then declining.  This one shows no sign of decline.

OK, so what, as Bill Marler asks, will it take to close Foster Farms or force it to recall its tainted products?

For starters, how about getting the government opened again.  And insisting that FDA issue the final food safety rules and start enforcing them.

Update, October 11:  On October 7, USDA sent three letters of intended enforcement to Foster Farms:  Letter #1, Letter #2, and Letter #3.  Now, according to a report from Bill Marler, the USDA has decided not to close Foster Farms or force a recall.

And here are two useful articles from Politico:

• Salmonella outbreak shines harsh light on government meat safety policies
• Government shutdown worst-case scenario realized: Salmonella outbreak