Search results: natural label

I’m working on a new edition of What to Eat and am spending a lot of time in grocery stores seeing what’s new and different since 2006—vastly more than I thought when I signed up to do this project, which is why it is taking a long time to do.

One change is in the number of products displaying Non-GMO labels.  The Non-GMO Project says it has certified 60,000 products, and I believe it.

On the other hand, don’t expect to see labels on foods that are genetically modified even though they are required.  With much searching, I found a few on shipping boxes but not on grocery shelf labels.

So I’m interested to see what the FDA is saying about genetically modified foods.

It sent out a press release recently.

Today, the U.S. Food and Drug Administration (FDA) released new “Feed Your Mind” educational materials to provide science-based information on genetically modified organisms (GMOs). “Feed Your Mind” is an education initiative launched in 2020 to help increase consumer understanding of GMOs and was developed in partnership with the U.S. Department of Agriculture and the U.S. Environmental Protection Agency.

The new materials for consumers include:

• A factsheet about how scientists use genome editing to develop food crops that address the needs of a growing global population and adapt to a changing environment:
  • Genome Editing in Agricultural Biotechnology
• Infographics about how growing GMOs can have environmental benefits and benefit the lives of farmers and consumers:
  • GMOs and the Environment
  • GMOs Outside the U.S.: A Closer Look at Bt Eggplant
• Videos featuring how GMOs are regulated in the U.S. and experts who grow them:
  • Talk About GMOs: Experts Who Know Them and Grow Them
  • GMOs: Government Regulation and Your Safety

…Funding for the “Feed Your Mind” initiative was provided by Congress in the Consolidated Appropriations Act of 2017 to conduct “consumer outreach and education regarding agricultural biotechnology and biotechnology derived food products and animal feed, including through publication and distribution of science-based educational information on the environmental, nutritional, food safety, economic, and humanitarian impacts of such biotechnology, food products, and feed.” More funds were provided through 2018 and 2019 Appropriations bills.

For More Information

• Feed Your Mind – Agricultural Biotechnology Initiative
• Resources for Healthcare Professionals
• FDA Releases New “Feed Your Mind” Education Materials on GMOs for Consumers, Health Educators, and Health Care Providers (August 2022)
• FDA Releases New “Feed Your Mind” Consumer Education Materials (September 2020)

The last time I wrote about the FDA’s GMO initiatives, I titled the post “The FDA’s new pro GMO propaganda.”  I pointed out that the FDA’s materials stick with limited issues, and say nothing about:

• Corporate control of commodity agriculture
• Glyphosate, the herbicide used with GMOs and considered carcinogenic by international health agencies and US courts
• How pesticides used on GMO crops contaminate organic production
• The ways GMO companies harrass independent farmers by enforcing intellectual property rights
• How the Farm Bill subsidizes GMO corn and soybeans, causing them to be overproduced and corn to be used for ethanol
• The lack of labeling of the few GMO foods on the market.

No wonder sales of organic foods are booming and so many people look for Non-GMO labels on food products.

*******

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

 

If you thought yesterday’s post about blueberries as a means to reduce hypertension in menopausal women seemed far-fetched, you are missing the point.

The food industry views menopause as a marketing opportunity.

‘We need the food industry to recognise this opportunity and step up to the plate’: Campaigner urges more NPD to embrace the menopause: The menopause represents a significant untapped opportunity for food and beverage brands, FoodNavigator’s Positive Nutrition Summit hears…. Read more

The menopause hits at a life stage when many women are particularly busy and time-poor and it is, at best, an inconvenience…This audience is now demanding more from brands – they don’t want to have to struggle and search to find items that support their symptoms. GenM research shows that 78% of women would be happy to shop for products labelled as menopause-friendly, while a further 90% of menopausal women want brands to be more inclusive to menopause. We need the food industry to recognise this opportunity and step up to the plate.

And then there’s this one:

Marketing sports nutrition products for menopausal women:  A variety of products are geared toward youth and seniors, but where do women in their 50s fit?… Watch now

Alexis Collins, director of product and brand strategy, Stratum, said one ingredient stands out to her most: NEM, the company’s flagship, branded eggshell membrane. Our ingredient is natural eggshell membrane also known as NEM and NEM is a joint health ingredient that has been specifically clinically researched in postmenopausal women to show fast exercise recovery.

Eggshell membrane.  Why didn’t I think of that?

*******

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

 

Last week I did a post on the FDA’s reorganization.   I should have made one other point: the long-standing inadequacy of FDA funding.  For decades, Congress has assigned tasks to the FDA but provided inadequate funding to do those tasks adequately (hence 1% of imported foods are inspected).  Congress also assigns the funding for specific purposes.

Yes, FDA ought to be doing more, but it is not up to the agency to decide how to deploy its funds.

One more point: For long-standing historical reasons, FDA funding comes from congressional Agriculture committees, even though it is an agency of the Public Health Service.  That is one reason why USDA’s food safety programs are funded at so much higher a level than FDA’s.

With that said, the FDA has come out with some recent initiatives of interest.

I.  Front-of-Package labels.  The FDA is proposing to research a front-of-package symbol: “an easy-to-understand, standardized system that is 1) mandatory, 2) nutrient-specific, 3) includes calories, and is 4) interpretive with respect to the levels of added sugars, sodium, and saturated fat per serving.”

It is doing this in response to a petition from the Center for Science in the Public Interest.

The comments that have come in so far are here.

It is examining the use of front-of-pack symbols in other countries.

It also plans to conduct research on consumer understanding of multiple designs.  Here are the prototype packages on which the designs will be tested.

None of these is likely to be as effective as the ones used in other countries.

Here is one of the better options, in my opinion.

To file comments, go here.  It’s important to do this because the Consumer Brand Association (formerly the Grocery Manufacturers Association) and other industry groups are unlikely to accept any labeling scheme that might discourage you from buying a product.

II.  Qualified health claim: cocoa flavanols.  The FDA has approved a qualified health claim for cocoa flavanols and reduced risk of cardiovascular disease.

This was in response to a petition from the Swiss chocolate company, Barry Callebaut.

Here’s what the FDA will allow.  Yes, this is absurd (look at what the FDA has to go through to get to this), but companies must think statements like this will sell their products.

• “Cocoa flavanols in high flavanol cocoa powder may reduce the risk of cardiovascular disease, although FDA has concluded that there is very limited scientific evidence for this claim.”
• “Cocoa flavanols in high flavanol cocoa powder may reduce the risk of cardiovascular disease. FDA has concluded that there is very limited scientific evidence for this claim.”
• “Very limited scientific evidence suggests that consuming cocoa flavanols in high flavanol cocoa powder, which contains at least 4% of naturally conserved cocoa flavanols, may reduce the risk of cardiovascular disease.”
• “Very limited scientific evidence suggests that consuming cocoa flavanols in high flavanol cocoa powder, which contains at least 4% of naturally conserved cocoa flavanols, may reduce the risk of cardiovascular disease. This product contains at least 4% of naturally conserved cocoa flavanols. See nutrition information for_____ and other nutrients.”

III.  GRAS panels.  The FDA has issued final guidance on best practices for panels deciding which ingredients can be Generally Recognized as Safe.

This lays out the guidelines for

• Identifying GRAS panel members who have appropriate and balanced expertise.
• Steps to reduce the risk of bias, or the appearance of bias, that may affect the credibility of the GRAS panel’s report, including assessing potential GRAS panel members for conflict of interest and the appearance of conflict of interest.
• Limiting the data and information provided to a GRAS panel to publicly available information.

A lot of this is headache-inducing.  FDA rulemaking takes forever.  Can’t wait to see how all this turns out.

*******

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

Last week, STAT News asked if I would write something about the FDA’s definition of “Healthy” for them.  I agreed because I was planning a blog post on it anyway (posted here).

I wrote a draft and had a great time working with a STAT editor, Patrick Skerritt, to fill in some missing pieces.  Here’s how it came out (with a couple of after-the-fact embellishments).

First Opinion: FDA’s plan to define ‘healthy’ for food packaging: Better than the existing labeling anarchy, but do we really need it?   STATNews, Oct. 7, 2022

The FDA has announced the set of rules it proposes to enforce for manufacturers to claim that a food product is “healthy.” The proposed rules are a lot better than the labeling anarchy that currently exists. But here’s my bottom line: health claims are not about health. They are about selling food products.

The FDA says that a “healthy” product must meet two requirements: It must contain a meaningful amount of food, and it must not contain more than certain upper limits for saturated fat, sodium, and added sugars.

To illustrate the “healthy” claim, the FDA is also researching a symbol that food makers can use, and might be testing examples like these.

[Source: https://www.regulations.gov/document/FDA-2021-N-0336-0003]

Doing all this, the FDA says, would align “healthy” with the 2020-2025 Dietary Guidelines for Americans and with the Nutrition Facts label that is printed on food packages.

This action is the latest in the FDA’s attempts to simplify food label information so it’s easier for consumers to identify healthier food choices. It is also an attempt to head off what food companies most definitely do not want: warning labels like those used in Chile, Brazil, and several other countries. These have been shown to discourage purchases of ultra-processed “junk” foods, just as they were supposed to, a message understood even by children or adults who cannot read. No wonder food manufacturers will do anything to prevent their use.

If we must have health claims on food packages, the FDA’s proposals are pretty good. They require any product labeled “healthy” to contain some real food (as opposed to a collection of chemical ingredients or, as author Michael Pollan calls them, “food-like objects”), and for the first time they include limits on sugars.

Here’s an example given by the FDA: To qualify for the “healthy” claim, a breakfast cereal serving would need to contain at least three-quarters of an ounce of whole grains and could contain no more than one gram of saturated fat, 230 milligrams of sodium and 2.5 grams of added sugars.

These proposed rules would exclude almost all cereals marketed to children.

But do Americans really need health claims on food products? You might think that any relatively unprocessed food from a plant or animal ought to qualify as healthy without needing FDA approval, and you would be right. But health claims aren’t about health. They are meant to get people to buy food products, not real foods like fruit, vegetables, grains, nuts, meat, poultry, dairy, eggs, or fish.

Food companies love the term “healthy” because it gets people to buy food products.

 

The history of “healthy”

How did we get to where the FDA needs to require a product to contain real food to be considered “healthy”? Blame KIND bars.

In 2015, KIND (then a small private company, but now owned by Mars) advertised its bars as healthy because they contained whole foods like grains and nuts. But nuts have more fat than the FDA allowed at the time for products to be labeled as “healthy.” The FDA warned KIND that its bars violated the rules for health claims.

KIND fought back. It filed a citizens’ petition arguing that even though nuts are higher in fat than the FDA allowed, they are healthy. The FDA could hardly argue otherwise — of course nuts are healthy — and it backed off. It permitted KIND to use the term and said it would revisit its long-standing definition of “healthy.” That was good news for KIND.

At the time, the FDA’s definition of “healthy” set upper limits for fat, saturated fat, sodium, and cholesterol; required at least minimal amounts of one or more vitamins or minerals; and said nothing about sugars. So the new FDA proposals break new ground in simplifying the nutritional criteria and in putting a limit on sugars.

 

Front-of-package symbols

These, too, have a long history with the FDA. In the early 1990s, when the agency was writing the rules for Nutrition Facts labels on food products, it tested public understanding of several prototype designs. As it happened, nobody could understand any of the samples very well, so the FDA picked the one that was the least poorly understood. Soon afterward, food companies and health organizations developed symbols that would allow buyers to recognize at a glance which products were supposed to be good for them.

By 2010, more than 20 such symbols were on food packages. The FDA commissioned the Institute of Medicine to do studies of front-of-package labeling. The Institute’s first report on the subject examined the strengths and weaknesses of all of the symbols cluttering up the labels of processed foods, and recommended that the FDA develop a single symbol that would cover just calories, saturated fat, trans fat, and sodium. Why not sugars too? The Institute said calories took care of them.

But the Institute’s second report did include sugars. It recommended a front-of-package labeling system that would give food products zero, one, two, or three stars (or check marks) depending on how little they had of the undesirable nutrients.

This idea so alarmed food manufacturers that they quickly developed the Facts Up Front labeling system in use today.

This, in my view, is so obfuscating that nobody pays any attention to it. But this scheme, coupled with industry pushback, was all it took to get the FDA to drop the entire idea of a symbol that would tell people what not to eat.

Here we are a decade later with the FDA’s current proposal. This plan is strong enough to exclude huge swaths of supermarket products from self-identifying as “healthy.” Products bearing the “healthy” symbol will have to contain real food and be low in saturated fat, salt, and sugar, as called for by federal dietary guidelines.

The new rules won’t stop “healthy” products from being loaded with additives and artificial sweeteners. And the FDA won’t require warning labels for unhealthy products, which work better than other symbols. But these proposals are a marked improvement over the current situation.

And the FDA might do more. It could look into the idea of warning labels. It already promises to make a decision about the other ambiguous marketing term, “natural.” A decision on that one can’t come soon enough.

As for “healthy,” the FDA is seeking feedback on its proposals. Instructions for filing comments, which can be made until Dec. 28, 2022, are at Food Labeling: Nutrient Content Claims; Definition of Term “Healthy.”

I can’t wait to see what companies wanting to sell ultra-processed food products as “healthy” will have to say about this.

Marion Nestle is professor emerita of nutrition, food studies, and public health at New York University, author of the Food Politics blog, and author of the new memoir, “Slow Cooked: An Unexpected Life in Food Politics” (University of California Press, October 2022).

***********

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

 

 

The FDA has announced a proposed rule for a “healthy” claim on food packages.

It proposes to align “healthy” with the Dietary Guidelines for Americans, 2020-2025 and the Nutrition Facts label.

The proposal has two requirements for the “healthy” claim.  To make the claim, products must:

1. “Contain a certain meaningful amount of food from at least one of the food groups or subgroups (e.g., fruit, vegetable, dairy, etc.) recommended by the Dietary Guidelines.”
2. “Adhere to specific limits for certain nutrients, such as saturated fat, sodium and added sugars. The threshold for the limits is based on a percent of the Daily Value (DV) for the nutrient and varies depending on the food and food group. The limit for sodium is 10% of the DV per serving (230 milligrams per serving).?

Food comes first!  What a concept!  The FDA will only allow a “healthy” claim on foods, not ingredients.  It also will only allow the claim on foods that are quite low in saturated fat, salt, and sugars (with exceptions for real foods).

The press release gave an example.  To qualify,

A cereal would need to contain ¾ ounces of whole grains and contain no more than 1 gram of saturated fat, 230 milligrams of sodium and 2.5 grams of added sugars.

The FDA is also researching a symbol to illustrate the “healthy” claim.  In March, it proposed research to develop this symbol.  The proposal did not illustrate prototypes, but some examples were published by a law firm.  ConscienHealth also published them under the heading of “A new roadmap for marketing healthy-ish food”

I see several things going on here.

1.  Positive, not negative.  This says foods are healthy.  Choose this!
2.  It adds sugars to disqualifying ingredients.
3.  It heads off warning labels—“high in fat, sugar, salt”—like those in Chile, Brazil, and Israel (see, for example, a previous post).  Avoid those!
4.  It heads off ultra-processed warnings (although this will exclude most, if not all, ultra-processed products).
5.  It supersedes the FDA’s efforts in 2010 and 2011 to put zero, one, two, or three stars or check marks on products.

I love Ted Kyle’s “Healthy-ish.”  As I keep saying, health claims are not about health; they are about marketing.

Companies love health claims; they sell food products.  Everyone falls for them; it takes serious critical thinking to resist them.

The FDA’s proposal will make “healthy” claims difficult for many products currently marketed with a health aura (Antioxidants! Gluten-free! No carrageenan!).

The time for comments is now.  I can’t wait to see the ones from companies making ultra-processed foods.

Next from FDA: a definition of “Natural?”

************

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

 

 

Douglas Frantz & Catherine Collins.  Salmon Wars: The Dark Underbelly of America’s Favorite Fish.  Henry Holt, 2022.  (355 pages)

I was asked to do a blurb for this one.  Here’s what I said:

Salmon Wars is a deep dive into the damage caused by current fish-farming methods to ocean environments, wild fish and their habitats, and to the farmed fish themselves.  It is also a dismal account of the failure of governments to stop such practices.  Salmon farming needs reform.  Until it does, read this book, and you will never eat farmed salmon again.

As for what to do about the hazards of salmon farming—lice, pollution, reduction of wild salmon, escape from pens, requirement for feeder fish and the depletion of those stocks, the authors have three suggestions:

(1) Know the risks and rewards of eating farmed salmon and insist on more transparency.

(2) Take responsibility for insisting on better ways of raising farmed salmon.

And (3)

The third step is for governments to stop putting a thumb on the scale when weighing economic interests versus the public wellbeing.  Governments should take responsibility for protecting the environment and public health.  They should adopt strict curbs on the use of chemicals by salmon farmers.  They should require notification of all relevant authorities of every escape or suspected escape, and those reports should be made public.  Food labels should be thorough, accurate, and reflect how the salmon was raised…There must be similar global efforts to protect the public health and the welfare of salmon.

This is a hard-hitting book and, as you might expect, it’s gotten some pushback.

Saving Seafood, a group that “conducts media and public relations outreach on behalf of the seafood industry,” says “New ‘Salmon Wars’ Book Is Full of Fictions. Here Are the Facts.”  Here are a couple of examples:

FICTION: Farmed salmon are crammed into cages.

FACT: Salmon occupy less than 4 percent of a typical marine cage. Farmers intentionally keep stocking densities low so fish have room to swim, grow, and mimic natural schooling patterns.

Farmers take great care to ensure the well-being of their salmon. Fish are vaccinated against several diseases, and pristine marine cage conditions are ensured with proper siting, regular fallowing (leaving sites unused), underwater cameras, and diver inspections.

FICTION: Farmed salmon are doused with pesticides and antibiotics.

FACT: Antibiotic use on salmon farms is far lower than that of any other agricultural animal producing industry in the world. In the rare instances when treatment is necessary, it is prescribed and overseen by licensed veterinarians under the oversight of government regulators.

In 2012 I visited a salmon farm above the Arctic Circle in Norway’s and wrote a post about it.

That one looked pretty good.  Now?  Others?  Who knows?

My recommendation: Visit one if you can.  Short of that, read this book.  Than decide what you think are the facts.

The New York Times’ obituary for the late Utah Senator Orrin Hatch, “Orrin Hatch, Seven-Term Senator and a Republican Force, Dies at 88,” filled an entire page of the newspaper.  That’s how important he was.

I was surprised that the obituary said not one word about Senator’s Hatch’s responsibility for the Dietary Supplement Health and Education Act of 1994 (DSHEA, pronounced d’shay).  The purpose of this act was to boost the supplement industry, which is well represented in Utah, by taking it out from under the regulatory authority of the FDA.

As a reminder, DSHEA:

• Assumed that dietary supplements were safe.
• Essentially deregulated them by weakening the FDA’s regulatory power.
• Permitted structure/function health claims on supplements, (e.g., supports a healthy immune system), regardless of level of scientific substantiation.
• Labeled supplements with Supplement Facts rather than Nutrition Facts.
• Forced the FDA to take manufacturers to court if agency regulators had concerns about safety, misleading claims, or inconsistent contents.
• Caused the FDA to lose court cases on First Amendment grounds.

The results:

• The supplement industry expanded rapidly, achieving DSHEA’s purpose.
• You cannot be sure that what you are buying is actually waht the label says you are buying.
• You cannot be sure that claimed benefits have any science behind them.
• Food manufacturers demanded the right to make struture/function claims.
• Use of the First Amendment to protect commercial (rather than personal, political, or religious) speech has gotten stronger.

We have Orrin Hatch to thank for turning the supplement industry into one based on faith, not science.

Why would he do this?

The obituary suggests one possibility:

During the opioid crisis in 2015, he introduced a bill to narrow the authority of government regulators to halt the marketing of drugs by predatory pharmaceutical companies. It later emerged that he had received $2.3 million in donations from the drug industry over 25 years.

For a more direct explanation, check out this article about Senator Hatch from the New York Times in 2011, “Support Is Mutual for Senator and Utah Industry.“

“Senator Hatch — he’s our natural ally,” said Marc S. Ullman, a lawyer for several supplement companies. Mr. Hatch, who credits a daily regimen of nutritional supplements for his vigor at 77, has spent his career in Washington helping the $25-billion-a-year industry thrive….Mr. Hatch has been rewarded with hundreds of thousands of dollars in campaign contributions, political loyalty and corporate sponsorship of his favorite causes back home.  His family and friends have benefited, too, from links to the supplement industry.

Hatch’s efforts to deregulate supplements did no good for public health or trust in science.  As the obituary said,

But there were no political repercussions. The senator was re-elected in 1982, 1988, 1994, 2000, 2006 and 2012, averaging nearly 65 percent of the vote.

Requiescat in pace.

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/