Search results: google

So many people send me these things that I can hardly keep up.  Let’s take a look at two this time.  Thanks to Hugh Joseph and Matthew Kirby for these:

I.  The impact of almonds and almond processing on gastrointestinal physiology, luminal microbiology, and gastrointestinal symptoms: a randomized controlled trial and mastication study   Alice C Creedon, Eirini Dimidi, Estella S Hung, Megan Rossi, Christopher Probert, Terri Grassby, Jesus Miguens-Blanco, Julian R Marchesi, S Mark Scott, Sarah E Berry, Kevin Whelan.  The American Journal of Clinical Nutrition, Volume 116, Issue 6, December 2022, Pages 1790–1804, https://doi.org/10.1093/ajcn/nqac265

• Conclusions: “Almond consumption has limited impact on microbiota composition but increases butyrate in adults, suggesting positive alterations to microbiota functionality. Almonds can be incorporated into the diet to increase fiber consumption without gut symptoms.”
• Funding: Supported by an Almond Board of California grant (to KW). The funders provided financial support, and the whole and ground almonds consumed by participants in the trial, but had no role in study design, conduct, analysis, interpretation, or decision to publish.
• Author disclosures: ACC was funded by a PhD studentship funded by Almond Board of California. ED has received an education grant from Alpro, research funding from the British Dietetic Association, Almond Board of California, the International Nut and Dried Fruit Council, and Nestec Ltd, and has served as a consultant for Puratos. MR and KW have received research funding from Almond Board of California, Danone, and International Dried Fruit and Nut Council, and are co-inventors of volatile organic compounds in the diagnosis and dietary management of irritable bowel syndrome. MR is also cofounder of Bio&Me, a gut health food brand. TG supervises PhD students partially funded by Mondelez and McCain Foods Ltd, and has previously received research funding from Almond Board of California. SEB has received grant funding from Almond Board of California, Malaysian Palm Oil Board, and ZOE Ltd, and receives consultancy and options from ZOE Ltd. All other authors report no conflicts of interest.
• Comment: The Almond Board is doing its job, apparently.

II. Almond intake alters the acute plasma dihydroxy-octadecenoic acid (DiHOME) response to eccentric exercise.   David C. Nieman^1*,  Ashraf M. Omar²,  Colin D. Kay³,  Deepak M. Kasote³,  Camila A. Sakaguchi¹,  Ankhbayar Lkhagva²,  Mehari Muuz Weldemariam² and  Qibin Zhang. Front. Nutr., 09 January 2023. https://doi.org/10.3389/fnut.2022.1042719

• Conclusions: “These data support some positive effects of almond intake in improving mood state, retaining strength, decreasing muscle damage, increasing the generation of gut-derived phenolic metabolites, and altering the plasma oxylipin DiHOME response to unaccustomed eccentric exercise in untrained adults. The elevated post-exercise plasma levels of 12,13-DiHOME with almond intake support positive metabolic outcomes for adults engaging in unaccustomed eccentric exercise bouts.”
• Funding: “This work was supported by Almond Board of California, Modesto, CA. The funder had no role in the study design, data collection, analysis and interpretation, the preparation of the manuscript, or in the decision to submit the article for publication.”
• Conflict of Interest: “The authors declare that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest.”
• Comment:  I disagree.  The fact that the Almond Board funded the study if nothing else gives the appearance of conflicted interests, especially because studies so clearly document the influence of funding whether recognized by recipients or not.

********

For 30% off, go to www.ucpress.edu/9780520384156.  Use code 21W2240 at checkout.

I’m indebted to Politico for this one: Federal government won’t stop buying food from meatpacker tied to bribery case.

********

For 30% off, go to www.ucpress.edu/9780520384156.  Use code 21W2240 at checkout.

The Expert Committee tasked with evaluating the FDA’s human foods program has released its report.

The Committee begins by pointing out that to do its job, the FDA needs adequate resources, sufficient authority, and a structure and culture that breeds success.

In its judgment, the FDA has none of those.  Instead, it is an agency in “constant turmoil.”

The report focuses on lack of leadership.

A leadership skill set, it says, should include:

• Expertise and knowledge in food safety and/or nutrition
• Ability to make decisions in a complex regulatory environment
• Ability to lead in a complex work environment
• Strong demonstrated management capability
• Superb communication skills
• Ability to identify and nurture talent

Instead, the FDA is risk averse, which it admits is “not surprising in a program subject to significant external criticism.”

The committee makes many (too many) recommendations:

Identify vision and mission.

Change the agency’s culture.

Give it more resources.  Food programs are under-resourced; budget and staffing have been flat for at least a decade.

Expand user fees.  [Uh oh.  Bad idea.  The committee even explains why, but ignores the hazard.]

There is also significant skepticism in the public interest community about the potential for “industry capture” of the Human Foods Program if FDA is overly reliant on industry fees.  Efforts to establish structures to secure additional industry funding, such as enhanced registration fees, may address these concerns. While the Panel acknowledges these concerns, the Panel recommends that FDA explore whether common ground can be found on this issue.

Reinstate the Food Advisory Committee.  [I was on the first one in the early 1990s, but our job was to react to decisions the agnecy had already made, not advise it about tough issues].

Reorganize the agency to give the food programs more visibility, integrate them, and give them clear lines of authority [Note: one big weakness of this project is that the committee was instructed not to include the Center for Veterinary Medicine, as if food for pets and food animals has nothing to do with the human food supply, which of course it does].

The report gives five options for reorganization, all of them complicated and undoubtedly politically difficult.  It lists their strengths and weaknesses, but does not state a preference.

• Create a separate food administration within HHS
• Create a Deputy Commissioner for Foods
• Put CFSAN in charge of human food programs
• Puts Commissioner in charge of human food programs
• Create a Deputy Commissioner for Foods

Do more about nutrition labeling, research on consumer behavior.  [Really?  That’s all?]

Comment: The committee only had a couple of months to pull this together and was required to leave out the Center for Veterinary Medicine.  Even so, the report makes it clear that the FDA is in serious trouble, so much so that the committee did not even get into what the FDA ought to be doing about about taking steps to prevent diet-influenced chronic disease.  This, of course, would require it to take on the food industry—an unlikely scenario given everything else that’s not happening.

The next step is to see what the Commissioner does with the report, if anything.  And whether Congress will appropriate more funding.

The report did not say a word about what I see as a major political handicap for the FDA; it’s funding comes from congressional agriculture committees, not health committees, even though FDA is an agency of the public health service.   That too needs to change.

What the press is saying:

• Washington Post: Scathing report recommends major changes at FDA, including possibly breaking up agency
• Bloomberg:  FDA’s Food Program Needs Strong Leader, Outside Reviewers Find
• USA Today:  Report finds FDA’s food regulatory agency lacks leadership, is in ‘constant turmoil’
• Politico:  ‘Constant turmoil’ at FDA’s food regulatory agency, report says

Anda quote from a colleague:

“While we appreciate the Panel’s thoughtful attempt to dig into complicated food issues and their recommendation to elevate nutrition/chronic food illness, creating a seperate, unfunded, nutrition center would have the opposite effect. That’s unacceptable.” Jerold Mande CEO Nourish Science

My theme for this week is meat, poultry, and their alternatives, starting today with this:

The study: Unprocessed red meat in the dietary treatment of obesity: a randomized controlled trial of beef supplementation during weight maintenance after successful weight loss.  Faidon Magkos, Sidse I Rasmussen, Mads F Hjorth, Sarah Asping, Maria I Rosenkrans, Anders M Sjödin, Arne V Astrup, Nina R W Geiker.  The American Journal of Clinical Nutrition, nqac152, https://doi.org/10.1093/ajcn/nqac152.  

Objectives: “We sought to investigate the effects of healthy diets that include small or large amounts of red meat on the maintenance of lost weight after successful weight loss….”

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.

Nostalgia: I can still remember 6-ounce glasses of freshly squeezed orange juice.

Never mind, it’s a new world.

My former student and now colleague, Lisa Young, did not want me to miss this one: Tropicana’s campaign to pour orange juice over cereal.

Tropicana has invented a special cereal for this purpose (I wonder how it tastes?).

But I’m sure Tropicana would be pleased if you poured OJ on any other cereal.

OJ is fine, but watch out for the 22 grams of sugar in 8 ounces (one orange has about 12).

Here’s a good one for my collection:

The Study: TRENDS IN ADDED SUGARS INTAKE AND SOURCES AMONG U.S. CHILDREN, ADOLESCENTS AND TEENS USING NHANES 2001-2018.  Laurie Ricciuto,Victor L. Fulgoni III, P. Courtney Gaine, Maria O. Scott, Loretta DiFrancesco. The Journal of Nutrition, Volume 152, Issue 2, February 2022, Pages 568–578, https://doi.org/10.1093/jn/nxab395 

• Background: Over the past 2 decades, there has been an increased emphasis on added sugars intake in the Dietary Guidelines for Americans (DGA), which has been accompanied by policies and interventions aimed at reducing intake, particularly among children, adolescents, and teens.
  Objectives: The present study provides a comprehensive time-trends analysis of added sugars intakes and contributing sources in the diets of US children, adolescents, and teens …focusing on variations according to sociodemographic factors.
• Methods: Data from 9 consecutive 2-year cycles of the NHANES were combined…Trends were also examined on subsamples stratified by sex, race and ethnicity…income (household poverty income ratio), food assistance, physical activity level, and body weight status.
• Results: From 2001–2018, added sugars intakes decreased significantly…mainly due to significant declines in added sugars from sweetened beverages.
• Conclusions: Declines in added sugars intakes were observed among children, adolescents, and teens…Despite these declines, intakes remain above the DGA recommendation; thus, continued monitoring is warranted.
• Support: The funding for this research was provided by The Sugar Association, Inc. The views expressed in the manuscript are those of the authors and do not necessarily reflect the position or policy of The Sugar Association, Inc. The Sugar Association, Inc. had no restrictions regarding publication.
• Author Disclosures: LR and LD as independent consultants provide nutrition and regulatory consulting to various food manufacturers, commodity groups and health organizations. VLF III as Vice President of Nutrition Impact, LLC conducts NHANES analyses for numerous members of the food, beverage and dietary supplement industry. PCG and MOS are employed by The Sugar Association, Inc.