Currently browsing posts about: Food-safety

Last week, the FDA announced its proposed Redesign of Human Foods Program to Enhance Coordinated Prevention and Response Activities.   You can also watch this announcement on video.

This action comes in the wake of:

• The infant formula crisis [Contaminated formula made babies sick. The FDA was warned about food safety concerns at an Abbott plant but took no action.  Abbott recalled formulas,shut down the plant.  This led to empty shelves.  Abbott is now under criminal investigation].
• The FDA’s evaluation of its performance during the crisis [this didn’t say much about accountability]
• The evaluation of the FDA by the Reagan-Udall Foundation [it called for major structural changes]
• The resignation of Frank Yiannas, deputy FDA commissioner [which made clear needed changes were not going to happen]
• Bipartisan pressure from members of Congress to enact major reforms
• Pressure from Senators DeLauro and Durbin to enact reforms
• The Washington Post editorial calling for breaking up the FDA
• Pressure from food safety lawyer Bill Marler to put food back into the FDA and to make fundamental changes

The FDA proposal comes with a vision of how the redesign would work.

The complaints and pressures argued for appointing a senior FDA official in charge of all FDA food programs and units.  Instead, the FDA proposes to create a Human Foods Program encompassing some, but not all, FDA food units.

Most prominently missing is the Center for Veterinary Medicine which deals with food for farm animals and pets.  These, however, fully participate in the food system for humans; they eat most of US corn production and loads of byproducts of human food production.  The systems for humans and animals are inextricably linked.

The organizational chart will look like this.  It splits the food units and connects them with dotted lines.  Good luck with that.  That was precisely the problem with the previous organization.

This looks better than the previous organization chart but falls far short of the authority needed to solve the nation’s food safety problem.

What’s needed?

• Unification of food safety under a central authority that unites the functions of USDA and FDA (the Government Accountability Organization has been calling for that for decades).
• Short of that, high-level FDA authority over the entire food supply under its jurisdiction.
• And much more FDA attention to its public health as well as its safety functions.  It should be taking the lead on actions to prevent diet-influenced chronic diseases.

Hey, I can dream.

In the meantime, let’s see how the FDA’s new structure goes and who it hires into that key position in charge of human foods.

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Last week, the Washington Post editorial board gave its Opinion :  For the nation’s health, break up the Food and Drug Administration.

The Food and Drug Administration last year failed repeatedly to keep the nation’s babies safe from tainted formula. The baby formula fiasco was the latest in a long line of food crises that the agency was slow to catch and handle. But the deaths of babies and the desperation of parents trying to find enough food for their newborns shocked Congress, the public and the world into realizing just how broken the U.S. food-monitoring system had become.

The editorial cited:

• Helena Bottemiller Evich’s investigation in Politico, which found the FDA’s food-safety operations to be so slow as to be “practically in its own league.”
• A 2017 inspector general report finding the food recall system to be “dangerously sluggish.“
• Reports from the Government Accountability Office which have “repeatedly called out ‘high risk’ problems, including an urgent need for a national food-safety strategy and ‘high-level sustained leadership.'”

Bottemiller Evich is now doing her own invaluable newsletter, Food Fix (subscribe here, and  follow Food Fix on Twitter and LinkedIn).

In it, she says, “The FDA is not working if…”

• it takes a years-long struggle to set even interim, voluntary limits for heavy metals and other neurotoxins in baby food.
• its public health mission is to improve nutrition, but diet-related diseases continue to worsen unabated, driving massive human and health care costs.
• it takes more than a decade to address agricultural water safety…sparking deadly outbreaks year after year.
• it routinely fails to get to the bottom of serious food poisoning incidents – like last summer, when hundreds of people were sickened and more than 130 were hospitalized after eating Daily Harvest frozen crumbles.
• it is conducting fewer and fewer food safety inspections, even as Congress has given the agency more resources over the years to do more inspections.

The FDA says it is taking all this seriously and will come up with a plan to address these failings.  I can’t wait to see it.

Other comments

• Jerold Mande in the Washington Post: Food is making us sick. The FDA can do something about it.  
• Bill Marler asks: Hey FDA, its been over a month, are you going to do anything with the Reagan-Udall Foundation reccomendations?  Note: I discussed the Reagan-Udall report here.

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The Government Accountability Office has produced a “snapshot” on Healthy Eating: Government-wide solutions for promoting healthy diets, food safety, and food security.  It’s only two pages; take a look.

As of July 2022, many of our recommendations for developing strategies on healthy eating have not yet been addressed.

1. Strategy Needed to Address Diet-Related Chronic Health Conditions
Three diet-related chronic health conditions (cardiovascular diseases, diabetes, and cancer) were among the 10 leading causes of death in 2018, according to CDC. Men, Black or African Americans, and people living in southern states had disproportionately higher mortality rates from diet related conditions. Dietary changes could have prevented some of these deaths.

Additionally, in 2018, about three in four adults in the U.S. had excess weight, which can be associated with poor diet and lead to cardiovascular diseases, diabetes, and cancer.

The GAO recommends that the federal government establish leadership for strategies:

• On diet-related efforts
• Food-safety oversight
• Nutrition assistance programs to respond to emergencies

Excellent suggestions.  If only they could be implemented.

A review article finds it nontoxic.You may recall that on June 17,  Daily Harvest issued a recall of its frozen vegan Crumbles product  after 500 or so adverse event reports, many of  severe liver damage among the 28,000 customers who ordered it.

Here’s what the front of the package looked like.

This product has lots of ingredients:

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.

As food safety lawyer Bill Marler predicted, tara flour has been identified as the ingredient at fault.

• Tara is only in Crumbles and Crumbles is the only product that made people sick.
• Tara is also in another company’s product, Revive smoothies, that made people sick.

I had never heard of tara and had to look it up.  Since then, I’ve gotten curious and did some quick research.

Tara is a legume—a bean plant—grown in Peru and other Latin American countries.

Tara is grown for several purposes:

• Pod tannins for industrial leather, keeping ships free of marine animals, and preparing textiles to accept dyes
• Cosmetics (polysaccharides isolated from the seeds)
• Food additives—protein flours and gums (from the endosperm)

The research literature on tara is remarkably extensive (Who knew?).

On the tannins:

• Anything you want to know about tara tannins (from a doctoral dissertation)
• Use of tara tannins to prevent ship fouling

On cosmetics:

• Tara is safe as used in cosmetics.

On tara as a food ingredient:

• An overview from the International Food Additive Council implies that it’s safe
• A major safety evaluation in 1993 says it’s safe.
• It’s not toxic as used in traditional Peruvian medicine
• Another review article finds it nontoxic.
• It is neither mutagenic nor genotoxic
• It may have anti-cancer properties

From everything previously reported about tara over the past 20 years, there is no reason to think it might be unsafe.

So what’s going on?  How to explain “only” hundreds of cases of severe liver injury when 28,000 Crumbles meals were shipped during the time when cases were reported.

Possibilities:

• Some toxic ingredient accidentally or deliberately got into the tara flour (similar to melamine being substituted for wheat gluten in pet food in 2006 and in infant formula in China in 2008).
• Toxic tannins from other parts of the tara plant got into the endosperm flour.
• Some people have unusual sensitivities to tara proteins or digestive products of tara proteins (similar to what happens when people with coeliac disease eat gluten from wheat or other gluten-containing grains)
• Some people have inborn errors of metabolism that cause acute reactions to tara proteins (similar to what happens when people with deficiency of the enzyme glucose-6-phosphate dehydrogenase ingest fava beans)
• Others?  Could be, but I can’t think of any.

To prevent this from happening again, it’s necessary to identify the toxin.  I hope that happens soon.

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.

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).