by Marion Nestle

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Mar 21 2022

Industry-funded study of the week: Cocoa flavanols

I learned about this one from a PR tweet from @Brigham Research: “Dr. JoAnn Manson…& colleagues report the main findings of the first ever randomized trial of a cocoa flavanol supplement on cardiovascular disease endpoints.”

Its spectacular results:  Supplementation with cocoa flavanols led to a 27% reduction in deaths from cardiovascular disease among all participants taking the supplement, and a 39% reduction in those deaths when they excluded participants who did not take the pills properly.

From taking cocoa flavanol supplements?

Who paid for this?

Bingo.

The study (still in preprint): Effect of Cocoa Flavanol Supplementation for Prevention of Cardiovascular Disease Events: The COSMOS Randomized Clinical Trial.  Sesso HD, et al.  American Journal of Clinical Nutrition, nqac055, https://doi.org/10.1093/ajcn/nqac055

Conclusion: “Cocoa extract supplementation did not significantly reduce total cardiovascular events among older adults but reduced CVD death by 27%….

Funding: “The Cocoa Supplement and Multivitamin Outcomes Study (COSMOS) is supported by an investigator-initiated grant from Mars Edge, a segment of Mars dedicated to nutrition research and products, which included infrastructure support and the donation of study pills and packaging…[and other sources].

Conflicts of interest: Drs. Sesso and Manson reported receiving investigatorinitiated grants from Mars Edge, a segment of Mars Incorporated dedicated to nutrition research and products, for infrastructure support and donation of COSMOS study pills and packaging,
Pfizer Consumer Healthcare (now part of GSK Consumer Healthcare) for donation of COSMOS study pills and packaging during the conduct of the study. Dr. Sesso additionally reported receiving investigator-initiated grants from Pure Encapsulations and Pfizer Inc. and honoraria
and/or travel for lectures from the Council for Responsible Nutrition, BASF, NIH, and American Society of Nutrition during the conduct of the study. No other authors reported any conflicts of interest.

Comment: Déjà vu all over again.

Mars, as I described in detail in Unsavory Truth, has been trying to make you think that chocolate is a health food (M&Ms!) for decades. It created a special brand, CocoaVia, for this purpose.  Here is an excerpt:

In 1982, Mars established a chocolate research center in Brazil.[i]  Its scientists were particularly interested in cocoa flavanols, a category of flavonoids with antioxidant, anti-inflammatory, and other heart-healthy effects.  Through the 1980s and 1990s, Mars’ scientists produced studies suggesting such benefits.

Alas, cocoa flavanols come with complications.  They taste bitter (dark chocolate contains more of them).  They are present in such small amounts that you would have to eat a quarter to a full pound of chocolate a day to achieve cardiovascular benefits.[ii]  Worse, they are destroyed by traditional chocolate processing.[iii]  The losses may explain why a Hershey-funded clinical trial failed to find neuropsychological or cardiovascular benefits from eating dark chocolate when compared to a placebo.[iv]

But to return to CocoaVia: Mars developed a process to preserve the cocoa flavanols during processing, and combined the rescued flavanols with cholesterol-lowering plant sterols to make chocolate bars and chocolate-covered almonds.  By 2002, the company decided that it had enough research to promote CocoaVia candies as heart-healthy.[v]  As the New York Times put it, Mars was on a “corporate quest to transform chocolate into a healthy indulgence.”[vi]  Mars marketed the candy bars—two a day, no less—as a means to increase blood flow, lower blood pressure, and reduce the risk for heart disease.

The FDA takes a dim view of unproven claims like “chocolate prevents heart disease.”  In 2006, the agency sent Mars a warning letter complaining that claims like “promotes a healthy heart” and “now you can have real chocolate pleasure with real heart health benefits,” were false, misleading, and easily misinterpreted…Chocolate, the FDA pointed out, is high in saturated fat (it didn’t mention sugar).   Furthermore, the claim “Cocoa Via Chocolate Bars contain natural plant extracts that have been proven to reduce bad cholesterol (LDL) by up to 8%,” meant that Mars was advertising chocolate as a drug.  If Mars wanted to make drug claims, it would need to conduct clinical trials to prove that eating CocoaVia chocolate bars prevented heart disease.[vii]

Rather than run the financial and scientific risk of doing that, Mars gave up on candy bars and began marketing CocoaVia in pills and powder as a “daily cocoa extract supplement.”  In doing this, Mars could take advantage of the more lenient marketing claims allowed by the Dietary Supplement Health and Education Act (DSHEA) of 1994. This act permits “structure/function” claims, those proposing that a supplement is good for some structure or function of the body.  Under DSHEA, the labels of CocoaVia are allowed to say that these supplements “promote a healthy heart by supporting healthy blood flow.”

To convince people to take CocoaVia supplements, Mars funds research.  In 2015, it funded studies demonstrating that cocoa flavanols are well tolerated in healthy men and women,[viii] support healthy cognitive function in aging,[ix] can reverse cardiovascular risk in the healthy elderly,[x] and improve biomarkers of cardiovascular risk.[xi]

Lest the “eat more chocolate” implications of these studies be missed, Mars issued a press release: “Cocoa flavanols lower blood pressure and increase blood vessel function in healthy people.”[xii]  The company followed this announcement with a full-page ad in the New York Times quoting a dietitian: flavanols “support healthy blood flow…which allows oxygen and nutrients to get to your heart more easily.”  …The ad directed readers to more information on a paid ad on the Times’ Website.  You have to look hard in these ads to discover that Mars owns CocoaVia; the company’s name only appears in barely legible print as part of the trademark.[xiii]

But Mars, which already has funded “more than 150 peer-reviewed scientific papers and [has] approximately 100 patents globally in the field of cocoa flavanols”[xiv] has more ambitious research plans.  In 2014, the company announced that in partnership with the National Heart, Lung, and Blood Institute it would provide “financial infrastructure support “ for an ambitious placebo-controlled, randomized trial of the effects of cocoa flavanols alone or in combination with vitamin supplements, on heart disease and cancer risk in 18,000 men and women over the age of 60.[xv]  The five-year trial, called the Cocoa Supplement and Multivitamin Outcomes Study (COSMOS), has evolved somewhat since then.  It now lists Brigham and Women’s Hospital in Boston as the sponsor, and Mars as a “collaborator” along with the Fred Hutchinson Cancer Research Center in Seattle and Pfizer. NIH seems no longer to be involved.[xvi]

We now have the result of this trial.  Even though cocoa flavanol supplements did not reduce cardiovascular events, Mars got its money’s worth from what must have been a very expensive study.

Tomorrow: a second report from this trial, with surprising results.

References

[i] Mars, Inc.  The history of CocoaVia.  CocoaVia.com

https://www.cocoavia.com/how-we-make-it/history-of-cocoavia

[ii] Vlachojannis J, Erne P, Zimmermann B, Chrubasik-Hausmann S.  The impact of cocoa flavanols on cardiovascular health.  Phytother Res.  2016;30(10):1641-57.

[iii] Andres-LaCueva C, Monagas M, Khan N, et al.  Flavanol and flavonol contents of cocoa powder products: influence of the manufacturing process.  J Agric Food Chem. 2008;56:3111-17.

[iv] Crews WD, Harrison DW, Wright JW.  A double-blind, placebo-controlled, randomized trial of the effects of dark chocolate and cocoa on variables associated with neuropsychological functioning and cardiovascular health: clinical findings from a sample of healthy, cognitively intact older adults.  Am J Clin Nutr. 2008;87(4):872-80.

[v] Meek J.  Chocolate is good for you (or how Mars tried to sell us this as health food).  The Guardian, Dec 23, 2002.

https://www.theguardian.com/uk/2002/dec/23/research.highereducation

[vi] Barrionuevo A.  An apple a day for health?  Mars recommends two bars of chocolate.  NY Times, Oct 31, 2005.

The FDA considers candy bars to be foods labeled with Nutrition Facts panels.  Supplements are labeled with Supplement Fact panels.

[vii] FDA.  Inspections, compliance, enforcement, and criminal investigations.  Warning letter to Mr. John Helferich, Masterfoods USA.  FDA, May 31, 2006.  http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2006/ucm075927.htm

[viii] Ottaviani JI, Balz M, Kimball J, et al. Safety and efficacy of cocoa flavanol intake in healthy adults: a randomized, controlled, double-masked trial.  Am J Clin Nutr. 2015;102(6):1425-35.

[ix] Necozione S, Raffaele A, Pistacchio L, et al.  Cocoa flavanol consumption improves cognitive function, blood pressure control, and metabolic profile in elderly subjects: the Cocoa, Cognition, and Aging (CoCoA) Study—a randomized controlled trial  Am J Clin Nutr. 2015; 101:538-48.

[x] Heiss C, Sansone R, Karimi H, et al.  Impact of cocoa flavanol intake on age-dependent vascular stiffness in healthy men: a randomized, controlled, double-masked trial.  Age. 2015;37:56.

[xi] Sansone R, Rodriguez-Mateos A, Heuel J, et al.  Cocoa flavanol intake improves endothelial function and Framingham Risk Score in healthy men and women: a randomised, controlled, double-masked trial: the Flaviola Health Study.  Brit J Nutr. 2015;114(8):1246-55.

[xii] Mars Center for Cocoa Health Science.  Press release: Cocoa flavanols lower blood pressure and increase blood vessel function in healthy people.  MarsCocoaScience.com, Sep 9, 2015.  http://www.marscocoascience.com/news/cocoa-flavanols-lower-blood-pressure-and-increase-blood-vessel-function-in-healthy-people.

[xiii] CocoaVia.  Cocoa’s past and present: a new era for heart health.  NY Times, Sep 27, 2015.  http://paidpost.nytimes.com/cocoavia/cocoas-past-and-present-a-new-era-for-heart-health.html?_r=0

[xiv] Mars Symbioscience.  Explore Mars Symbioscience.  Mars.com.

http://www.mars.com/global/brands/symbioscience

[xv] Mars.  Largest nutritional intervention trial of cocoa flavanols and hearth (sic) health to be launched.  MarsCocoaScience.com, Mar 17, 2014.

http://www.marscocoascience.com/news/largest-nutritional-intervention-trial

[xvi] The trial is registered at COcoa Supplement and Multivitamin Outcomes Study (COSMOS).    ClinicalTrials.gov.

https://clinicaltrials.gov/ct2/show/NCT02422745

[xvii] ASRC (Advertising Self-Regulatory Council).  NAD recommends Mars modify certain claims for CocoaVia cocoa extract.  ASRCReviews.org, Aug 11, 2016.

http://www.asrcreviews.org/nad-recommends-mars-modify-certain-claims-for-cocoavia-cocoa-extract/

Mar 17 2022

Plant-based animal-food substitutes: an update

I haven’t done one of these in a while, so here’s my latest collection of articles on what the plant-based meat and dairy alternative industry is up to.  This seems especially appropriate for St. Patrick’s Day.

I “borrowed” the photo from this site (thanks!).

The plant-based market isn’t doing all that well?

Plenty of companies are still in this arena, domestically as well as internationally:

Plant-based ingredients are of great interest:

Some skepticism seems warranted:

Yum?

Mar 16 2022

Devastating news: Congress fails to extend school food waiver

For those of us who have long argued that it would be good for kids and for society if they were fed meals in school, no questions asked.

Nothing makes more sense to me than universal school meals.

  • All kids get fed
  • No stigmatizing of poor kids
  • No school hassles over which kids qualify
  • No lunch shaming
  • No administative costs for policing school meal eligibility

I the pandemic did any good at all, it was to make school meals universal well into the second year.

It worked.  Kids got fed.  Schools didn’t have to police.

Yes it would cost money: an estimated $11 billion.

Let’s put that in context; it’s barely a rounding error.   If I’ve done the math right, $11 billion = 0.007% of $1.5 trillion.

Our national priorities are clear from this chart.  Defense is 48%, and all agriculture and food programs together are less than 0.02%.** 

Or, to show what this looked like visually in 2019:

Politico explains the background

Under the Families First Coronavirus Response Act, passed in mid-March 2020, the Agriculture Department was first given authority to issue waivers for a slew of regulations….The authority now expires in June. School nutrition program operators have been optimistically assuming that the waivers would get extended one more school year to help them transition

back to normal, as supply chains continue to short schools of basic staples like chicken and whole grain bread, and food costs remain high and staffing is so low it’s approaching crisis levels.

You can read about the politics in the Politico article as well.

This congressional decision is nothing short of disgraceful.  Congress should be ashamed.

What to do?  Scream and shout to your congressional representatives to get this reversed.

** Added note: Several readers wrote me to say that the Vox figures above refer to discretionary spending but leave out entitlements such as Social Security and SNAP.  Others said the figures underestimate military spending because they do not include veterans benefits and other such items.  Adding in all this would make the percentage for school meals even smaller.

Mar 15 2022

The food politics of the Ukraine War

My NYU department is hosting a discussion of this issue: Feeding Resistance and Refugees of Ukraine: The Humanitarian Crisis in Eastern Europe.  March 22, 1-3 pm (EDT).  Free, but register here.

This panel brings together experts and scholars studying Eastern Europe to share their observations and reflections about food access; local, regional and global supply chains; food production and sovereignty; as well as the unfolding humanitarian crisis. Participants include Agata Bachórz (Sociology, University of Gdańsk, Poland), Eszter Kovacs (Geography, University College London), Simone Piras (Agricultural and Food Economics, The James Hutton Institute, UK), and Mihai Varga (Sociology, Freie Universität Berlin, Germany).  Moderated by Diana Mincyte (Sociology, CUNY City Tech) and Fabio Parasecoli (Nutrition and Food Studies, NYU)

And now, for the items I’ve been collecting.   Not much good news to report.

The big picture

Disruptions in global food systems

Immediate effect: rising food prices

And a small ray of sunshine

Mar 14 2022

Industry funded opinion of the week: animal protein

This is another example of my seeing the title of a paper and wondering right away who paid for it.  The paper is displayed as a research article, but reads more like an analytical opinion piece.

The paper: Nutritionism in a food policy context: the case of ‘animal protein’.  Frédéric Leroy, Ty Beal, Pablo Gregorini, Graham A. McAuliffe, and Stephan van Vliet. Animal Production Science –   Published online: 21 February 2022

The rationale: Reductionist approaches to food focus on isolated nutritional criteria, ignoring the broader physiological and societal benefits and trade-offs involved…Among our present-day array of issues is the disproportionate stigmatisation of animal-source foods as harmful for human and planetary health.

The problem: “…animal-source foods (reduced to the notion of ‘animal protein’) are represented as an intrinsically harmful food category that needs to be minimised, thereby falsely assuming that ‘proteins’ are nutritionally interchangeable.

The solution: “…we suggest referring to said foods as ‘protein-rich foods’, while acknowledging the expanded pool of non-protein nutrients that they provide and their unique capabilities to support a much broader range of bodily functions. Several essential or otherwise beneficial nutrients are generally more bioavailable in animal-source foods than in plant-source foods.

The overall solution: “A more appropriate way forward would consist of combining and integrating the best of animal and plant solutions to reconnect with wholesome and nourishing diets that are rooted in undervalued benefits such as conviviality and shared traditions, thus steering away from a nutrient-centric dogma.”

Funding: FL acknowledges financial support of the Research Council of the Vrije Universiteit Brussel, including the SRP7 and IOF3017 projects, and in particular the Interdisciplinary Research ProgramTradition and naturalness of animal products within a societal context of change’ (IRP11). GM is funded by Soil to Nutrition (S2N), Rothamsted Research’s Institute Strategic Programme supported by UK Research and Innovation (UKRI) and Biotechnology and Biological Sciences Research Council (BBSRC) (BBS/E/C/000I0320). SvV grant support by SvV reports grant support from USDA-NIFA-SARE (2020-38640-31521; 2021-67034-35118), the North Dakota beef commission, the Turner Institute of Ecoagriculture, the Dixon Foundation, and the Greenacres Foundation for projects that link agricultural production systems (including livestock and crops) to the nutritional/metabolite composition of foods and human health. PG and FL acknowledge financial support of the project ‘Grazing for environmental and human health’ funded by the New Zealand Royal Society’s Catalyst Seeding Fund.

Conflicts of interest: FL is a non-remunerated board member of various academic non-profit organisations including the Belgian Association for Meat Science and Technology (President), the Belgian Society for Food Microbiology (Secretary), and the Belgian Nutrition Society. On a non-remunerated basis, he also has a seat in the scientific committee of the Institute Danone Belgium, the Scientific Board of the World Farmers’ Organization, and the Advisory Commission for the ‘Protection of Geographical Denominations and Guaranteed Traditional Specialties for Agricultural Products and Foods’ of the Ministry of the Brussels Capital Region. PG is an Associate Editor of Animal Production Science but was blinded from the peer-review process for this paper. SvV reports financial renumeration for academic talks, but does not accept honoraria, consulting fees, or other personal income from food industry groups/companies. All authors consume omnivorous diets.

Comment: I too am an omnivore, do not disagree with much of it, and could have written a lot of this myself, particularly the concerns about nutritionism (the use of nutrients to stand for the foods that contain them) and the concluding sentence in the Abstract: “Humans do not consume isolated nutrients, they consume foods, and they do so as part of culturally complex dietary patterns that, despite their complexity, need to be carefully considered in food policy making.”

But the purpose of this piece is to defend meat as a nutritious source of protein.

Why feel the need to take this on?

That’s what made me wonder who paid for it and whether authors had ties to the meat industry, which of course they do.

Reference: For research on why and how industry sponsorship can influence opinions and study outcomes, see Unsavory Truth: How Food Companies Skew the Science of What We Eat.

Mar 10 2022

The Ukraine War and food systems: items

The tragedy of the Ukraine War is beyond comprehension.  Like everything else, it affects food systems, and not just for the people caught up in it.

I’ve been collecting items, starting with Jose Andres @chefJoseAndres and World Central Kitchen @WCKitchen who are providing hundreds of thousands of meals to people fleeing from the Ukraine.

And then this one:

Why the silence?

  • “Unlike other chains, McDonald’s owns the vast majority of its 847 restaurants in Russia. According to a page for investors, Russia accounts for 9 percent of the company’s total revenues and 3 percent of its operating income.”
  • “Last year, Russia accounted for $3.4 billion, or more than 4 percent, of PepsiCo’s $79.4 billion in revenues.”

Other items are about what this war means for agricultural trade, food prices, and specific food businesses—especially pet food.

Here are the pet food items:

Mar 8 2022

The Abbott infant formula recall: an update

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).
Mar 7 2022

Industry-funded study of the week: animal-source foods in health and sustainability

I was sent an email with this message:

Calling your attention to this newly released review article, Animal source foods in healthy, sustainable, and ethical diets – An argument against drastic limitation of livestock in the food system. It was published in the March 2022 edition of Animal and is well worth a read, as it makes a strong case for the role of animal source foods in healthy, environmentally sustainable and ethical diets. See below for “highlights” taken directly from the paper, with the full review attached.

–Animal source foods are seen by some as unhealthy, unsustainable, and unethical.

–Outcomes depend on practical specificities, not on the fact that animals are involved.

–As for any food, the challenge is to promote best practices and limit harm.

     –Well-managed animals contribute to food security, ecological function and livelihoods.

     –Heavy reduction of livestock may lead to a fragile food system and societal damage.

I happen to agree that food animals are essential components of regenerative agriculture systems but there was something about this that triggered my “who paid for this?” question.  Bingo!

Here is the paper’s financial support statement:

FL acknowledges financial support of the Research Council of the Vrije Universiteit Brussel, including the SRP7 and IOF342 projects, and in particular, the Interdisciplinary Research Program “Tradition and naturalness of animal products within a societal context of change” (IRP11). PM acknowledges financial support of the Helsinki Institute of Sustainability (HELSUS) through the project “Understanding pastoralism sustainability through an interdisciplinary lens”. PG and FL acknowledge financial support of the project “Grazing for environmental and human health” funded by the New Zealand Royal Society’s Catalyst Seeding Fund. SvV acknowledges grant support from the North Dakota Beef Association to study the health effects of red meat in relation to diet quality. SvV reports additional grant support from USDA-NIFA-SARE (2020-38640-31521; 2021-67034-35118), the Turner Institute of Ecoagriculture, the DixonFoundation, and the Greenacres Foundation for projects that link agricultural production systems (including livestock and crops) to the nutritional/metabolite composition of foods and human health.

Here are the authors’ conflict of interest declarations:

All authors follow omnivorous diets. FL is a non-remunerated board member of various academic non-profit organisations including the Belgian Association for Meat Science and Technology (president), the Belgian Society for Food Microbiology (secretary), and the Belgian Nutrition Society. On a non-remunerated basis, he also has a seat in the scientific committee of the Institute Danone Belgium, the World’s Farmers Organization, and the Advisory Commission for the “Protection of Geographical Denominations and Guaranteed Traditional Specialties for Agricultural Products and Foods” of the Ministry of the Brussels Capital Region. PM is a non-remunerated member of the Spanish Platform for Extensive Livestock and Pastoralism. SvV reports financial renumeration for academic talks, but does not accept honoraria, consulting fees, or other personal income from food industry groups/companies.

Comment: The authors say much more than is usual about their potential conflicts of interest, either via their personal diets or their professional financial links to the meat industry.  Still, those links exist, as I could predict from the paper’s title.  The role of food animals in health and sustainability is heavily disputed.  Because of its funding and the ties of some of the authors to the meat industry, this study appears less convincing than it might if funded independently and carried out by independed researchers.

Reference: For research on why and how industry sponsorship can influence study outcome, see Unsavory Truth: How Food Companies Skew the Science of What We Eat.