Currently browsing posts about: Mars

All of this is enough to make me want to run out and eat some M&Ms.

You can’t make this stuff up.

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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/

Candy makers, like all food producers, want to sell more of their products.  From the standpoint of Mars Wrigley Confectionary, you need to eat more candy.

By some accounts, the US doesn’t even rank in the top ten countries in per capita candy consumption.  The Census Bureau says the average American—does this mean you?—consumes 22 pounds of candy per year.

Candy sales come in peaks.

Mars—now Mars Wrigley—wants to fix that.

Its research shows that you find the candy aisle difficult to manage.

Mars Wrigley Confectionery surveyed 1,000 Americans last year to understand how Millennials and Baby Boomers experience treats as well as the role of social media in treating.

Mars Wrigley Confectionery has begun working with retailers to put these recommendations into action. The company has created a framework that unlocks the power of confectionery at the point of purchase — online and in-stores.

Its Path to Purchase strategy advises retailers to:

• Display candy in high-traffic areas
• Promote key moments with candy brands
• Maximize promotional space
• Transition to stand-up pouches (these encourage sales)
• Use micro-gifts to encourage customers to “shop, ship and secretly gift ‘boo’ packages and build their own ‘boo’ bundles.’”

At the same time,

Mars Wrigley Confectionery knows through its research that consumers view candy as a treat and continue to enjoy it as part of a balanced lifestyle, especially Millennials. In response, it’s important retailers provide consumers with a range of formats, calories and price options to drive sales.

A few examples include:

• More options for share sizes and resealable packaging.
• 100-calorie bars and packs, such as those available for Skittles, Dove, Twix and Snickers.
• Low calories gum choices such as Extra, Juicy Fruit and 5 gum.

You are not supposed to notice any of this.  Mars wants you to buy more candy.  You are a lot better off buying less.

If you find yourself buying more candy, take a close look at how and where it is displayed.

Danone North America, Mars Inc, Nestlé USA (no relation), and Unilever US have left the Grocery Manufacturers Association to form a new organization, the Sustainable Food Policy Alliance.

Its stated purpose (as explained in the press release):

• Consumer Transparency: Improving the quality and accessibility of information available to consumers about the food they purchase for themselves and their families.
• Environment: Advocating for innovative, science-based solutions to take action against the costly impacts of climate change, build more resilient communities, promote renewable energy, and further develop sustainable agriculture systems.
• Food Safety: Ensuring the quality and safety of food products and the global supply chain.
• Nutrition: Developing and advocating for policies that help people make better-informed food choices that contribute to healthy eating while supporting sustainable environmental practices.
• People and Communities: Advancing policies that promote a strong, diverse, and healthy workplace and support the supply chain, including rural economies.

The Alliance says it intends to:

• Urge policymakers to ensure the Farm Bill and other farm policies emphasize water quality and conservation issues, improved soil health, and renewable energy (particularly wind and solar).
• Explore the economics of sustainability, including financial incentives to reduce emissions and transition to low-carbon alternatives and to create value for farmers, ranchers, and others.
• Advocate on behalf of environmental policies at the state, national, and international levels, including the Paris Climate Agreement and Clean Power Plan.

Sounds good, no?

As I told the Washington Post, I would like

to see how the four companies address more inconvenient environmental and public health policies, such as limits on bottling water from national forests or mandated, front-of-package nutrition labeling. Those policies could potentially threaten their bottom lines — an issue Danone’s Lozano said his company did not face with its current efforts around sustainability.

Let’s give them credit for going after the low-hanging fruit first…But the real questions are what they will really do, and when.

Since it’s Valentine’s Day (have a happy one), we might as well talk about a candy company, in this case, Mars, Inc.

Mars, Inc., one of the defectors from the Grocery Manufacturers Association (see yesterday’s post) has also withdrawn from membership in and support of the International Life Sciences Institute (ILSI), a group that claims to be independent  but in fact is funded by hundreds of food and beverage companies (hence: front group).

ILSI’s positions on food issues are decidedly pro-industry, and so are the results of its sponsored research.  Mars couldn’t take it anymore.

Mars told Politico Pro (this may be behind a paywall):

After careful consideration, Mars will end its relationship with the International Life Sciences Institute (ILSI) by the end of 2018, and is withdrawing from ILSI’s nutrition committees immediately,” the company said in a statement to POLITICO. “Increasingly, the presentation of certain studies by ILSI has been at odds with our position and principles. Mars has a long history of engaging in external research that is evidence-based and data-driven, particularly in the area of promoting public health. We wish to thank ILSI for its partnership.

Mars announces this departure as a component of its new research and engagement policy.

The policy applies to all of Mars’ partnerships with universities, governmental and non-governmental organizations, foundations, individuals, food companies, and trade associations (like ILSI).

Here is my summary of the policy’s long list of principles:

• High scientific standards in all animal and human research
• Full disclosure of funding and potential conflicts of interest
• Appropriate standards of authorship
• Funding not linked to achievement of a specific research outcome

The Associated Press reporter Candice Choi has a special interest in industry-funded research (as I do) and has been using emails obtained through FOIA requests to document connections between funders and researchers that otherwise would not come to light.

Yesterday, she reported some follow up on the article I was surprised to see published in the Annals of Internal Medicine—the one I wrote about in my last post.

Ms. Choi came up with these delicious tidbits:

• Mars Inc., which is one of the companies that funds ILSI (the International Life Sciences Institute, which funded the study in the Annals charging that dietary guidelines for sugar are based on weak evidence), is now denouncing the study on the grounds that “the paper undermines the work of public health officials and makes all industry-funded research look bad…[and] creates more doubt for consumers rather than helping them make better choices.”
• Mars is saying this even though emails show that two Mars executives knew about the study last year.
• Mars now said it will make clear to ILSI hat it does not support such work.
• ILSI’s executive director says ILSI devised the concept for the study, but the paper originally said that the authors wrote the protocol and conducted the study independently from the funder. Oops.  When confronted with the Associated Press emails “showing the group sent the authors ‘requested revisions’ on the proposal last year,” the journal corrected that statement to make clear that ILSI “reviewed and approved” the protocol.
• One of the authors did not fully disclose her consulting and research agreements with companies that make high-sugar foods.  The AP had emails demonstrating this author’s financial ties to Coca-Cola and to ILSI for a previous grant on the same topic.  The Annals now show a more complete disclosure statement.

The point of all this is that when food companies sponsor research, they sometimes are much more involved in it than they would like to let on.

Mars is right.  These kinds of incidents make all industry-funded research look bad.  Mars should know.  It funds research to make chocolate look like a health food.

Food companies interested in doing something meaningful to prevent childhood obesity are in a bind.  Preventing obesity usually means staying active; eating real, not processed, foods; and reserving soft drinks and juice drinks for special occasions.  None of this is good for the processed food business.  At best, food and beverage companies can make their products a bit less junky and back off from marketing to children.  In return, they can use the small changes they make for marketing purposes.

Perhaps as a result of Michelle Obama’s campaign (see yesterday’s post), companies are falling all over themselves – and with much fanfare – to tweak their products.

GROCERY MANUFACTURERS ASSOCIATION (GMA):  By all reports, GMA members applauded Mrs. Obama’s remarks.  GMA says its member companies are already doing what she asked.

Parke Wilde, a professor at the Tufts School of Nutrition (and food policy blogger), gave a talk at that meeting in a session dismissingly titled,  “The New Foodism.”  His comment:

I enjoyed hearing Michelle Obama’s talk, which was well written and delivered and fairly forceful in places. In my afternoon panel, I said grocery manufacturers would find some threatening themes in books and documentaries promoting local and organic and sustainable food, but that there is also much of substance and value. Then, Susan Borra [Edelman Public Relations] and Sally Squires [Powell Tate Public Relations] in the next session said that grocery manufacturers are frequent subjects of unfair criticism and have nothing to apologize for.

Take that, you new foodists!

MARS must think it knows more than the FDA about how to label food packages.  It is developing its own version of front-of-package labels. It volunteered to put calories on the front of its candies; its multi-pack candies ay 210 calories per serving on the front.  That number, however, remains on the back of the small candy store packs.  Mars’ new labeling plans use the complex scheme used in Europe.  I’m guessing this is a bold attempt to head off what it thinks the FDA might do – traffic lights.

KRAFT announces that it is voluntarily reducing the sodium in its foods by 10% by 2012.  Kraft’s Macaroni & Cheese (SpongeBob package) has 580 mg sodium per serving and there are two servings in one of those small boxes: 1160 in total.  A 10% reduction will bring it down to 1050 mg within two years.  The upper recommended limit for an adult is 2300 mg/day.

PEPSICO announced “a voluntary policy to stop sales of full-sugar soft drinks to primary and secondary schools worldwide by 2012.”  In a press statement, the Yale Rudd Center quotes Kelly Brownell saying that “tobacco companies were notorious for counteracting declining sales in the U.S. with exploitation of markets elsewhere, particularly in developing countries:”

it will be important to monitor whether the mere presence of beverage companies in schools increases demand for sugared beverages through branding, even if full-sugar beverages themselves are unavailable…This appears to be a good faith effort from a progressive company and I hope other beverage companies follow their lead…this announcement definitely represents progress [Note: see clarification at end of post].

According to PepsiCo, this new policy brings its international actions in line with what it is already doing in the U.S.  The policy itself is voluntary, uses words like “encourage,” assures schools that the company is not telling them what to do, and won’t be fully implemented until 2010.  It keeps vending machines in schools and still allows for plenty of branded sugary drinks: Gatorade, juice drinks, and sweetened milk for example.

Could any of this have anything to do with Kelly Brownell’s forceful endorsement of soda taxes?

LOBBYING: The Center for Responsive Politics says food companies spent big money on lobbying last year, and notes an enormous increase in the amount spent by the American Beverage Association (soda taxes, anyone?).  For example:

How to view all this?  I see the company promises as useful first steps.  But how about the basic philosophical question we “new foodists” love to ask: “is a better-for-you junk food a good choice?”

OK.  We have the Public Relations.  Now let’s see what these companies really will do.

Addendum: I received a note clarifying Kelly Brownell’s role in the PepsiCo press release from Rebecca Gertsmark Oren,Communications Director,The Rudd Center for Food Policy and Obesity,Yale University:

The Rudd Center did not work with PepsiCo on their initiative to stop sales of full-sugar beverages in schools worldwide, nor did we jointly issue a press release. A statement released by Kelly Brownell in response to PepsiCo’s announcement was simply intended to commend what appears to be a step in the right direction. As Kelly’s statement also mentioned, there is still plenty of work to be done. It’s also worth noting that the Rudd Center does not take funding from industry.