Here is the latest from the FDA:

Case Counts

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

Thank you to our 252 clients who have reached out to the FDA to report their “Adverse Illness Events,” also known as acute liver failure, with hospitalizations, blood draws, multiple other procedures, including CTs and MRIs, liver biopsies (about a dozen) and gall baller removals (nearly 25). Thank you also providing leftover product to both the lab we are using and the FDA as we search for the common contaminate that is causing these common symptoms.

To date there a no confirming tests. We hope to have updates soon as we know clients. patients and physicians are frustrated with the lack of knowledge.

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.

More to come.

Over a decade ago, the mom of two clients who both developed acute kidney failure after consuming E. coli O157:H7-tainted spinach sent me an unexpected present. The outbreak sickened over 205 people, killing five, sending hundreds to the hospital, many with life-altering complications. The gift was a bobble-head that bore a similarity to a younger version on me. On the base it said: “Colonel Colon and his League of Fecal Fighters.” It sits on my desk today.

I have always thought of doing something with the gift, and with the talent of my incredible niece, Janae Dueck, and borrowing from the work of the good food people at the FDA and FSIS, and idea is brewing of a way to help educate us all to be Fecal Fighters.

Over the next year we will be working on comic book, a cartoon video about the adventures of these superheroes, and a food safety jingle (thanks to my friend Vincent).

So, let me introduce you to the League.

Colonel Colon is the leader of four fecal fighters: Clean, Separate, Cook and Chill.  Each is a superhero, but Clean, Separate, Cook and Chill have unique superpowers.

Here are the details.

Clean: 

  • Wash your hands and surfaces often.
  • Germs that cause food poisoning can survive in many places and spread around your kitchen.
  • Wash hands for 20 seconds with soap and water before, during, and after preparing food and before eating.
  • Wash your utensils, cutting boards, and countertops with hot, soapy water.
  • Rinse fresh fruits and vegetables under running water.

Separate:

  • Raw meat, poultry, seafood, and eggs can spread germs to ready-to-eat foods—unless you keep them separate.
  • Use separate cutting boards and plates for raw meat, poultry, and seafood.
  • When grocery shopping, keep raw meat, poultry, seafood, and their juices away from other foods.
  • Keep raw meat, poultry, seafood, and eggs separate from all other foods in the refrigerator.

Cook:

  • Food is safely cooked when the internal temperature gets high enough to kill germs that can make you sick. The only way to tell if food is safely cooked is to use a food thermometer. You can’t tell if food is safely cooked by checking its color and texture.
  • Use a food thermometer to ensure foods are cooked to a safe internal temperature. Check this chart for a detailed list of temperatures and foods, including shellfish and precooked ham.
  • Whole cuts of beef, veal, lamb, and pork, including fresh ham (raw): 145°F (then allow the meat to rest for 3 minutes before carving or eating)
  • Fish with fins: 145°F or cook until flesh is opaque
  • Ground meats, such as beef and pork: 160°F
  • All poultry, including ground chicken and turkey: 165°F
  • Leftovers and casseroles: 165°F

Chill:

  • Bacteria can multiply rapidly if left at room temperature or in the “Danger Zone” between 40°F and 140°F. Never leave perishable food out for more than 2 hours (or 1 hour if exposed to temperatures above 90°F).
  • Keep your refrigerator at 40°F or below and know when to throw food out.
  • Refrigerate perishable food within 2 hours. If the food is exposed to temperatures above 90°F (like a hot car or picnic), refrigerate it within 1 hour.
  • Thaw frozen food safely in the refrigerator, in cold water, or in the microwave. Never thaw foods on the counter because bacteria multiply quickly in the parts of the food that reach room temperature.

From a FDACS press statement:

While the Florida Department of Agriculture & Consumer Services (FDACS) is still awaiting results from product sampling (which we hope to have in the coming days), we do have results from our environmental sampling at the Big Olaf processing facility. Of the 100 environmental samples collected, nine have come back positive for Listeria monocytogenes (I will note that there is one outstanding environmental sample that is taking longer to develop). With these results (attached), FDACS has issued a stop use order of the processing equipment where the Listeria monocytogenes was found. This will effectively shut down all operations at this processing facility, which had already been done voluntarily by the company.

Here are the test results:

https://www.marlerblog.com/files/2022/07/Big-Olaf-Creamery-Environmental-Results-2.pdf

Since mid-June, we have been contacted by nearly 250 people – primarily, otherwise healthy women between the ages of 25 to 55 – but, also including children, men, and even the family of a breast-fed infant.  Most have eaten the French Lentil & Leek Crumbles; however, other Daily Harvest products have been reported to have been consumed.  All report similar complaints of severe abdominal or back pain.  Nearly all report elevated liver tests showing acute liver failure. Many have been hospitalized (some repeatedly). There have been reports of a dozen liver biopsies and at least 25 gall bladder removals.  A large number report ongoing symptoms that require ongoing liver function testing.  To date, no one has a diagnosis of what specific, toxin, chemical or other contaminate in the Daily Harvest product is causing these remarkably consistent symptoms.

We have asked all to contact the FDA, and many have offered leftover product (opened and unopened) to test.  Where the FDA has not offered to test, we are testing.  We will provide those test results to the FDA and Daily Harvest. We have also offered to share both self-reported symptoms and lab tests in an effort to determine to cause of these illnesses.

Note: We are also investigating people with similar symptoms listed above linked to Revive Smoothies. Interesting, the smoothies and the French Lentil & Leek Crumbles share a common ingredient – Tara.

FDA, time to update your chart. As of last week, according to the FDA:

Total Adverse Illness Events: 133

Hospitalizations: 42

Deaths: 0

Last illness onset: June 21, 2022

States with Adverse Illness Events: CA, CO, CT, FL, GA, IL, IA, IN, MA, MD, MI, MO, MT, NH, NJ, NY, NC, OH, OR, PA, RI, TN, TX, VA, WA, WI

Product Distribution: Nationwide

According to the FDA, 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. In response to Consumer Adverse Event Reports (CAERS) and Consumer Complaints submitted to the FDA, the FDA has initiated an investigation, including an inspection and sample collection to determine the cause of illnesses. As of June 28, the FDA has received 133 CAERS reports, and Consumer Complaints related to this product.

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 [SOME] 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.

FDA’s investigation is ongoing, and more information will be provided as it becomes available.

Product was sold through online sales and in two retail locations; the Daily Harvest store in Chicago, IL, and a “pop-up” store in Los Angeles, CA. French Lentil + Leek Crumbles is a frozen product packaged in a 12oz white pouch with the words “Daily Harvest” at the top, a large “CRUMBLES” immediately below the top and the words “French Lentil + Leek” in bold, as shown below. All lot codes of the French Lentil + Leek Crumbles are affected.

After 23 people were sickened with 1 adult and 1 fetal death, and with 22 hospitalized, one would think that Big Olaf’s would have stopped selling ice cream, and that the Sarasota Department of Health and the Florida Department of Health would have forced the issue, after the link between the ice cream and the illnesses became apparent last Friday?

But, until today, apparently not. Here is the latest. And, it is not entirely clear that Big Olaf’s has in fact stopped selling the ice cream.

As of June 29, 2022, a total of 23 people infected with the outbreak strain of Listeria monocytogenes have been reported from 10 states. Of the 22 people with information, 20 sick people reported living in or traveling to Florida in the month before they got sick, although the significance of this is still under investigation. Illnesses started on dates ranging from January 24, 2021, through June 12, 2022.

The CDC reported that sick people range in age from less than 1 to 92 years, with a median age of 72, and 52% are male. Twenty-two people (96%) have been hospitalized. Five people got sick during their pregnancy, and one illness resulted in a fetal loss. One death has been reported from Illinois.

The Florida Department of Health, CDC, public health and regulatory officials in several other states, and the U.S. Food and Drug Administration (FDA) are collecting different types of data to investigate a multistate outbreak of Listeria monocytogenes infections. As a result of this investigation, Big Olaf Creamery in Sarasota, FL, is voluntarily contacting retail locations to recommend against selling their ice cream products. Consumers who have Big Olaf Creamery brand ice cream at home should throw away any remaining product.

Public health officials continue to interview people about the foods they ate in the month before they got sick. Of the 17 people interviewed, 14 (82%) reported eating ice cream. Among 13 people who remembered details about the type of ice cream they ate, six reported eating Big Olaf Creamery brand ice cream or eating ice cream at locations that might have been supplied by Big Olaf Creamery.

On July 1, 2022, Big Olaf Creamery in Sarasota, FL, voluntarily began contacting retail locations to recommend against selling their ice cream products. Consumers who have Big Olaf Creamery brand ice cream at home should throw away any remaining product.

Public health officials continue to interview people about the foods they ate in the month before they got sick. Of the 17 people interviewed, 14 (82%) reported eating ice cream. Among 13 people who remembered details about the type of ice cream they ate, six reported eating Big Olaf Creamery brand ice cream or eating ice cream at locations that might have been supplied by Big Olaf Creamery.

Now, over the two weeks, I have spoken to, and been retained by, over 230 people linked to the consumption of Daily Harvest products – specifically (but not exclusively), the French Lentil + Leek Crumbles and four people linked to the consumption of Revive Smoothies. We are presently testing about 40 samples and have offered samples to the FDA, and have offered to share our test results with the FDA and with Daily Harvest and Revive. We have asked all clients to report their illnesses to the FDA hotline.

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). We have also learned, and are still investigating, that the manufacturer of Daily Harvest products is located in Minnesota – more on that soon.

This is a very interesting and tragic outbreak that has hit, mostly women between the ages of 25 and 45 (otherwise healthy) who consumed the French Lentil + Leek Crumbles in May and June 2022 (product appears to have hit the market in very late April or early May and was pulled in mid June). 

They nearly all have identical acute symptoms – abnormal liver enzymes and bilirubin, many with gallbladder involvement.  Many have had multiple blood tests, MRIs, CTs, ultrasounds, liver biopsies (several) and gall bladder removals (over 25).  No positive clinical (human) test for a causative agent has yet to be determined.

According to Daily Harvest, they had received 470 complaints as of last week and the FDA has reported 133.

Question to the CDC and FDA, I can give you access to 234 people, medical records and leftover Daily Harvest Crumbles and Revive Smoothies – if you have an interest, you know where to find me.

On July 4, I posted “Are Revive Super Smoothies linked to acute Liver Failure too?”

I did that after being contacted by people who had consumed the Revive Pineapple and Mago Smoothie.

As I said then:  If you follow this Reddit thread – https://www.reddit.com/r/revivesuperfoods/comments/voglbs/revive_superfoods_smoothies_liver_issues_sickness/ it certainly seems that the numbers of ill coming forward are growing of people with nearly identical acute symptoms – abnormal liver enzymes and bilirubin, many with gallbladder involvement.  Many have had multiple blood tests, MRIs, CTs, ultrasounds, with likely liver biopsies and gall bladder removals.

These are essentially the same symptoms and outcomes that have surfaced after being retained by and speaking to the over 175 people linked to the consumption of Daily Harvest products – specifically (but not exclusively), the French Lentil + Leek Crumbles. See also this Reddit thread – https://www.reddit.com/r/DailyHarvest/comments/vcqwxe/extreme_stomach_painsickness_from_lentilleek/

I noted that the common ingredient between the Revive Pineapple and Mago Smoothie and the Daily Harvest French Lentil + Leek Crumbles was a product called Tara.

On July 5, I posted “Revive Superfoods no longer has Tara as a listed ingredient – what happened in the last 24 hours?” 

The on July 7 Tara was back on as an ingredient: “Tara is back on ingredient list at Revive?”

Now, the Revive Pineapple and Mango Smoothie is simple gone – Tara and all.

Here is an earlier screenshot showing the Revive Pineapple and Mango Smoothie.

Big Olaf's

Listeria monocytogenes is a deadly bacteria that hospitalizes over 95% of those with confirmed cultures and kills at least 25%. The most vulnerable are women who are pregnant, the elderly and people with compromised immune systems. The incubation period (between ingestion and symptom onset) is 3 to 70 days.

Why a company that knows it is under scrutiny for a deadly Listeria monocytogenes outbreak would ignore the science and put customers at risk is really beyond comprehension, immoral and likely criminal.

We filed the first lawsuit on behalf of the family of a woman who died after eating Big Olaf’s ice cream in January 2022.

Why the Sarasota and Florida Departments of Public Health have not stopped production and sales and ordered a full recall is a failure to protect the public.

According to Ryan Ballogg of the Bradenton Herald, the Florida Department of Health is leading the epidemiological investigation of the Listeria outbreak. On Wednesday, spokesman Jeremy Redfern told the Bradenton Herald that consumers should continue to avoid Big Olaf products. 

“The Department of Health advised Big Olaf to suspend sales and production until further notice. They informed us that they’d be contacting those that serve their product to recommend that they stop serving.

“It appears that they aren’t necessarily taking our advice,” Redfern said in an email. 

In a public statement on Saturday, Big Olaf Creamery posted on Facebook that the investigation is “only speculation” and it was unclear why the company was being “targeted” after six of 23 patients had mentioned eating their ice cream. “Our brand has not been confirmed to be linked to these cases…” a post on the Big Olaf Company Facebook page reads.

“We have been cooperating with the Florida Department of Health, FDACS and the FDA as soon as we were informed about the situation,” the post continues. “We have been transparent and have answered all their questions and provided them with all the information requested from us, as the health and well-being of the public is our first priority.”

The facts:

As of June 29, 2022, a total of 23 people infected with the outbreak strain of Listeria monocytogenes have been reported from 10 states. Of the 22 people with information, 20 sick people reported living in or traveling to Florida in the month before they got sick, although the significance of this is still under investigation. Illnesses started on dates ranging from January 24, 2021, through June 12, 2022.

The CDC reported that sick people range in age from less than 1 to 92 years, with a median age of 72, and 52% are male. Twenty-two people (96%) have been hospitalized. Five people got sick during their pregnancy, and one illness resulted in a fetal loss. One death has been reported from Illinois.

The Florida Department of Health, CDC, public health and regulatory officials in several other states, and the U.S. Food and Drug Administration (FDA) are collecting different types of data to investigate a multistate outbreak of Listeria monocytogenes infections. As a result of this investigation, Big Olaf Creamery in Sarasota, FL, is voluntarily contacting retail locations to recommend against selling their ice cream products. Consumers who have Big Olaf Creamery brand ice cream at home should throw away any remaining product.

Public health officials continue to interview people about the foods they ate in the month before they got sick. Of the 17 people interviewed, 14 (82%) reported eating ice cream. Among 13 people who remembered details about the type of ice cream they ate, six reported eating Big Olaf Creamery brand ice cream or eating ice cream at locations that might have been supplied by Big Olaf Creamery.

On July 1, 2022, Big Olaf Creamery in Sarasota, FL, voluntarily began contacting retail locations to recommend against selling their ice cream products. Consumers who have Big Olaf Creamery brand ice cream at home should throw away any remaining product.

Public health officials continue to interview people about the foods they ate in the month before they got sick. Of the 17 people interviewed, 14 (82%) reported eating ice cream. Among 13 people who remembered details about the type of ice cream they ate, six reported eating Big Olaf Creamery brand ice cream or eating ice cream at locations that might have been supplied by Big Olaf Creamery.

So says the website after being gone for a few days?

Here is my post from Wednesday regarding the missing ingredient.

I suggest folks to follow this Reddit thread – https://www.reddit.com/r/revivesuperfoods/comments/voglbs/revive_superfoods_smoothies_liver_issues_sickness/ it certainly seems that the numbers of ill coming forward are growing of people with nearly identical acute symptoms – abnormal liver enzymes and bilirubin, many with gallbladder involvement.  Many have had multiple blood tests, MRIs, CTs, ultrasounds, with likely liver biopsies and gall bladder removals.

As I said Wednesday, the common ingredient in Daily Harvest outbreak is Tara. The above symptoms lined to Revive Smoothies are essentially the same symptoms and outcomes that have surfaced after being retained by and speaking to the nearly 200 people linked to the consumption of Daily Harvest products – specifically (but not exclusively), the French Lentil + Leek Crumbles. See also this Reddit thread – https://www.reddit.com/r/DailyHarvest/comments/vcqwxe/extreme_stomach_painsickness_from_lentilleek/

Yesterday I posted “Are Revive Superfood Smoothies linked to acute Liver Failure too?” with the below picture of the ingredients – which included Tara Protein.

Today, however, the Tara Protein is gone – what’s up? Pea Protein?

I suggest folks to follow this Reddit thread – https://www.reddit.com/r/revivesuperfoods/comments/voglbs/revive_superfoods_smoothies_liver_issues_sickness/ it certainly seems that the numbers of ill coming forward are growing of people with nearly identical acute symptoms – abnormal liver enzymes and bilirubin, many with gallbladder involvement.  Many have had multiple blood tests, MRIs, CTs, ultrasounds, with likely liver biopsies and gall bladder removals.

As I said yesterday, the common ingredient in Daily Harvest outbreak is Tara. The above symptoms lined to Revive Smoothies are essentially the same symptoms and outcomes that have surfaced after being retained by and speaking to the nearly 200 people linked to the consumption of Daily Harvest products – specifically (but not exclusively), the French Lentil + Leek Crumbles. See also this Reddit thread – https://www.reddit.com/r/DailyHarvest/comments/vcqwxe/extreme_stomach_painsickness_from_lentilleek/