Currently browsing posts about: Health-claims

In case you were wondering why food companies would bother to sponsor research, consider CocoaVia, a chocolate derivative.

At the New York Times’ Food for Tomorrow conference last week, Mars, Inc., gave out samples of CocoaVia cocoa extract.

Here’s the one with sweetened dark chocolate.

And here’s the health claim.

Mind you, “Promotes a healthy heart by supporting healthy blood flow” is not an FDA-approved health claim.  CocoaVia is being marketed as a dietary supplement, not a food.   The label says it’s a “daily cocoa extract supplement,” and has a Supplement Facts label rather than the Nutrition Facts label used for foods.

It’s interesting that Mars, Inc. originally marketed CocoaVia as chocolate bars.  The FDA considers candy bars to be foods, labeled with Nutrition Facts.

But by marketing CocoaVia as a supplement, Mars, Inc. can take advantage of the permissive marketing allowed by the Dietary Supplement Health and Education Act of 1994.  This act allows “structure/function” claims on supplements like the one used by CocoaVia.  By marketing CocoaVia flavanols as supplements, Mars, Inc. does not have to adhere to the FDA’s more restrictive requirements for health claims on food packages.

I’m surprised that Mars, Inc. is using the supplement route because the company has gone to a lot of trouble to establish a scientific basis for a health claim for its processed cocoa flavanols.

Is it possible that Mars, Inc. thinks the cocoa flavanol claim won’t hold up to FDA scrutiny.

Here again are the three studies funded by Mars, Inc. (I posted them as examples of industry-funded studies with results favorable to the sponsor’s interest).

1. 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, by Daniela Mastroiacovo, Catherine Kwik-Uribe, Davide Grassi, Stefano Necozione, Angelo Raffaele, Luana Pistacchio, Roberta Righetti, Raffaella Bocale, Maria Carmela Lechiara, Carmine Marini, Claudio Ferri, and Giovambattista Desideri.  Am J Clin Nutr 2015; 101:538-548 doi:10.3945/ajcn.114.092189.

• Conclusion: These data suggest that the habitual intake of flavanols can support healthy cognitive function with age.
• Sponsor: Mars, Inc.

2.  Impact of cocoa flavanol intake on age-dependent vascular stiffness in healthy men: a randomized, controlled, double-masked trial.  Christian Heiss & Roberto Sansone & Hakima Karimi & Moritz Krabbe & Dominik Schuler & Ana Rodriguez-Mateos & Thomas Kraemer & Miriam Margherita Cortese-Krott & Gunter G. C. Kuhnle & Jeremy P. E. Spencer & Hagen Schroeter & Marc W. Merx & Malte Kelm & for the FLAVIOLA Consortium, European Union 7th Framework Program.  AGE (2015) 37: 56 DOI 10.1007/s11357-015-9794-9

• Conclusion: CF [cocoa flavanol] intake reverses age-related burden of cardiovascular risk in healthy elderly, highlighting the potential of dietary flavanols to maintain cardiovascular health.
• Funding: …Additional funding was provided by an unrestricted grant by MARS, Inc…MARS, Inc. provided the standardized test drinks used in this investigation. HS is employed by MARS, Inc., a member of the FLAVIOLA research consortium and a company engaged in flavanol research and flavanol-related commercial activities.

3.  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.  Roberto Sansone, Ana Rodriguez-Mateos , Jan Heuel, David Falk, Dominik Schuler, Rabea Wagstaff, Gunter G. C. Kuhnle, Jeremy P. E. Spencer, Hagen Schroeter, Marc W. Merx, Malte Kelm and Christian Heiss for the Flaviola Consortium, European Union 7th Framework Program.  British Journal of Nutrition, September 9, 2015. doi:10.1017/S0007114515002822.

• Conclusion: In healthy individuals, regular CF [cocoa flavanol] intake improved accredited cardiovascular surrogates of cardiovascular risk, demonstrating that dietary flavanols have the potential to maintain cardiovascular health even in low-risk subjects.
• Funding: Additional funding was provided…through an unrestricted grant by MARS Inc. MARS Inc. also provided the standardised test drinks used in this investigation… H. S. provided test drinks on behalf of Mars Inc… H. S. is employed by MARS Inc., a member of the Flaviola research consortium and a company engaged in flavanol research and flavanol-related commercial activities. [The conflict statement also discloses that MARS employee H.S. shared responsibility for designing the study, writing the paper, and approving the final content].

To publicize this research, Mars, Inc.

• Issued a press release: “Cocoa flavanols lower blood pressure and increase blood vessel function in healthy people.”
• Placed this ad in the September 27, 2015 New York Times. 

• Gave out samples to participants at the New York Times’ conference.

My interpretation: Mars, Inc. must expect to make some serious money on this supplement—more than enough to pay for all the research and marketing.

As for whether cocoa flavanols really do support healthy blood flow, or whether this is just the standard hyperbole only to be expected from supplement marketers, I’m reserving judgment until I see the results of independently funded studies.

Jill Hobbs, Stavroula Malla, Eric Sogah, and May Yeung.  Regulating Health Foods: Policy Challenges and Consumer Conundrums.  EE Edward Elgar Publishing, 2014.

I did a blurb for this one:

Regulating Health Foods systematically organizes the widely disparate definitions, regulations, and policies used internationally to govern functional foods, supplements and nutraceuticals, and does so from the standpoint of the industry and its regulators.  Food scientists, regulators, and industry professionals will especially appreciate its detailed international perspective.

This is a book for policy wonks and students who want to find out how various countries regulate food labels, or who would llike to know such things as how Codex Alimentarius guidelines apply to health claims.  The authors, who work at Canadian Universities, have pulled together vast amounts of detailed information about label regulations by country, with commentary.  Here is an example:

Japan currently provides an interesting mix between a purely generic system and a purely product-specific one.  Although the system is decidedly more product-specific.  Standardized FOSHU [Food for Specific Health Uses] lowers the costs to individual firms seeking claims on ingredients with well-established ingredient-health effect relationships.  At the same time, there are potentially significant returns to investment for firms wishing to market a new product with health benefits.

You might think that the Supreme Court of the United States would have more important things to do than to weigh in on which of two beverage companies puts less misleading labels on its products, but apparently not.

The highest court in the land takes POM Wonderful’s accusation against Coca-Cola seriously.  Coke’s Minute Maid juice, POM says, is advertised in ways that mislead the public.

POM should know.   It’s been under fire from the Federal Trade Commission for equally absurd label claims.

Here’s the Coca-Cola product at issue.

And here’s what the label says, in case you can’t read it (with emphasis added):

Enhanced Juice/Minute Maid/100% Fruit Juice Blend

Omega-3/DHA/HELP NOURISH YOUR BRAIN

5 Nutrients to Support Brain and Body

Pomegranate  Blueberry Flavored Blend of 5 Juices

From concentrate with added ingredients and other natural flavors

Never mind the nutritional quality or the ridiculous structure/function claims on this particular product (here’s Fooducate’s analysis from 2009—it has 29 grams of sugars, among other things).

POM doesn’t want Coke getting away with selling cheap grape and apple juices as pomengranate juice and undercutting their prices.  Coke’s drink is 99% apple and grape juice; it contains less than 1% pomegranate or blueberry juice.  You would never know that from looking at the label.

Why is the court interested?  The Minute Maid label is legal by FDA standards.  Therefore, can the label be considered misleading?

Coca-Cola won in the lower court, but the Supreme Court seems sympathetic to POM (here’s the transcript of the hearing).

The New York Times account has the best quotes:

Kathleen M. Sullivan, a lawyer for Coca-Cola, said consumers were not misled.

“We don’t think that consumers are quite as unintelligent as Pom must think they are,” she said. “They know when something is a flavored blend of five juices and the nonpredominant juices are just a flavor.”

Justice Kennedy frowned. “Don’t make me feel bad,” he said, “because I thought that this was pomegranate juice.”

It also quotes from Justice Alito:

You don’t think there are a lot of people who buy pomegranate juice because they think it has health benefits, and they would be very surprised to find when they bring home this bottle that’s got a big picture of a pomegranate on it, and it says ‘pomegranate’ on it, that it is — what is it — less than one half of 1 percent pomegranate juice?”

Where is the FDA on all this?  Blame its inaction on the Dietary Supplement Health and Education Act of 1994, which allowed ridiculous health claims on food labels and forced the FDA to keep hands off.

This outcome of this case, silly as it is, will be fun to watch.

In 2012, ConAgra petitioned the FDA to approve use of a health claim on labels and advertising for its whole grain products.  Here’s what ConAgra asked for:

Scientific evidence suggests, but does not prove, that diets low in saturated fat and cholesterol that include three servings (48 grams) of whole grains per day may reduce the risk of diabetes mellitus type 2.

or

Scientific evidence suggests, but does not prove, that whole grains (three servings or 48 grams per day), as part of a low saturated fat, low cholesterol diet, may reduce the risk of diabetes mellitus type 2.

To say that the FDA was less than impressed with evidence supporting this claim is to understate the matter.  After a comprehensive review of the evidence, here’s what the FDA says ConAgra can use:

Whole grains may reduce the risk of type 2 diabetes, although the FDA has concluded that there is very limited scientific evidence for this claim.

or

Whole grains may reduce the risk of type 2 diabetes. FDA has concluded that there is very limited scientific evidence for this claim.

No, this is not a joke.

Congress insists that the FDA must approve health claims, whether supported by science or not.

According to FoodNavigator, ConAgra is happy about this decision.  The first thing anyone will read is “whole grains may reduce the risk of type 2 diabetes.”

As I keep saying, health claims are about marketing, not health.  And qualified health claims are the worst examples.  A plague on all of them!

In what will surely be good news to people with celiac disease and other problems related to gluten intolerance, the FDA has just issued a final rule for defining foods as “gluten-free.”

This, after nine years of work on this issue (see timeline below).

The rule states that companies can label their products gluten-free if they contain less than 20 ppm (parts per million) gluten.  This, says FDA,

is the lowest level that can be consistently detected in foods using valid scientific analytical tools. Also, most people with celiac disease can tolerate foods with very small amounts of gluten. This level is consistent with those set by other countries and international bodies that set food safety standards.

As for gluten intolerance: Roughly 1% of the U.S. population has diagnosable gluten intolerance.  For those who do, eating grains containing gluten (wheat and some others) triggers an abnormal immune response that damages the intestinal tract.  To prevent symptoms—of which there can be many, none of them pleasant—people with this condition must scrupulously avoid eating gluten-containing foods.

The new rule will help establish some uniformity in labeling.  Note: gluten-free does not mean sugar-free.

In reading through the FDA’s notice in the Federal Register, I am struck by the complexity of the agency’s processes for doing something like this.

Policy wonk that I am, I immediately made a timeline.  This indicates that the FDA spent nine years getting to this point. Impressive, no?

Timeline: FDA’s Gluten-Free Rule

FDA’s documents on the gluten-free rule:

• FDA: Gluten-Free Labeling
• FDA: Gluten-Free Labeling Final Rule Q&A
• Consumer Update

The Federal Trade Commission (FTC) just ruled that POM Wonderful’s claims for the health benefits of its pomegranate juices and products are indeed deceptive.

The FTC also said POM cannot claim that its products do anything special for heart disease, prostate cancer, and erectile dysfunction—unless it produces convincing evidence for these claims through two randomized, controlled clinical trials.

The dispute over POM’s health claims has gone on for more than two years.  The FTC says POM has not proved that drinking its juice will cheat death.

POM says it has spent $35 million on peer-reviewed research proving that the antioxidants in pomegranate products promote health.

Of course they do.  Antioxidants in all fruits and vegetables promote health.

Maybe POM should resort to the defense used by Coca-Cola against charges that Vitamin Water makes deceptive health claims.

As Stephen Colbert reports, Coca-Cola’s argues: “No consumer could reasonably be misled into thinking Vitaminwater was a healthy beverage.”

Once again: health claims are about marketing, not health.

Expect POM to take the FTC to court over this ruling.  Stay tuned.

I can hardly believe it but is the FDA really proposing to test consumer understanding of food industry evasions of the “Jelly Bean Rule?”

The FDA established this “rule” (a principle, actually) in 1994 to prevent food companies from adding vitamins to junk foods in order to allow them to be marketed as healthy.

The FDA said that just because a food is low in fat, cholesterol, and sodium—like a jelly bean—the manufacturer cannot make a health claim for it unless it contains at least 10% of the Daily Value of vitamin A, vitamin C, calcium, protein, fiber, or iron.

But, the FDA also said, companies could not fortify foods with these nutrients for the sole purpose of making health claims.

This is explained in the FDA’s policy on food fortification, given in 21 CFR 104.20(a).

The addition of nutrients to specific foods can be an effective way of maintaining and improving the overall nutritional quality of the food supply.

However, random fortification of foods could result in over- or underfortification in consumer diets and create nutrient imbalances in the food supply.

It could also result in deceptive or misleading claims for certain foods.

The Food and Drug Administration does not encourage indiscriminate addition of nutrients to foods, nor does it consider it appropriate to fortify fresh produce; meat, poultry, or fish products; sugars; or snack foods such as candies and carbonated beverages.

Now the FDA announces that it wants to study consumer responses to health claims on fortified snack products:

The FDA has an interest in the American public achieving and maintaining diets with optimal levels of nutritional quality, wherein healthy diets are composed of foods from a variety of nutrient sources.

The FDA does not encourage the addition of nutrients to certain food products (including sugars or snack foods such as [cookies] candies, and carbonated beverages).

FDA is interested in studying whether fortification of these foods could cause consumers to believe that substituting fortified snack foods for more nutritious foods would ensure a nutritionally sound diet.

The makers of fortified junk foods and drinks must be trembling in their boots.  Health claims sell food products.  Health claims are practically the only things that sell food products these days.

And companies will have plenty of time to lobby.

Like all FDA processes, this one is required to move at glacial speed.  It must give 60 days to allow people to comment on the proposal and get their lobbying acts together.

Then, the FDA will have to review the comments and, presumably, include them when it submits its request to do the study to the White House Office of Management and Budget.

No point in holding breath for this one.  The OMB has been sitting on FDA proposals for months.

My prediction: if the FDA ever gets to do the study, it will show that consumers interpret health claims as government guarantees that the products are healthy and, probably, have fewer calories than they actually do.

The makers of such products would prefer that the FDA not have this information confirmed.  Watch the lobbying begin!

If you want to comment, do so by October 15.  Here’s how:

• File electronic comments here for Docket No. FDA–2012–N–0871.
• Submit written comments to Division of Dockets Management (HFA–305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. Use Docket No. FDA–2012–N–0871.

I consider the results of studies showing remarkable health benefits attributed to single foods or single nutrients to be “nutrifluff”—fun, but not necessarily meaningful unless you are eating a healthy diet anyway.

Here are four recent examples:

Dark chocolate reduces heart disease risk: Everybody loves this one—an excuse to eat chocolate (but only the dark, bitter kind, alas).  This comes from a Cochrane meta-analysis of studies on the role of flavonols in blood pressure.  It concludes that chocolate eating is associated with a small reduction in blood pressure of 2 to 3 mm Hg—but only in short-term trials.  How many of the studies were sponsored by chocolate companies?  The report doesn’t say.

Apple peel extracts reduce blood pressure: Apples also have flavonols.  These were test-tube studies.  Note: Eating fruits and vegetables in general is associated with lower blood pressure.

Walnuts boost semen quality: Here’s a fun one.  Eat 75 grams of walnuts a day, and you improve your sperm vitality, motility, and morphology, at least if you are age 21 to 35 (and male).  This one was sponsored by the California Walnut Commission.  One report on this study has the best title ever: “Nuts for your nuts.”

Goji berries promote immune function in the elderly: This one, done by researchers working for Nestlé  (no relation), tested daily supplements of “lacto-wolfberry” on immune responses to influenza vaccine.  I’m assuming Nestlé must be planning to market this supplement.

What does all this tell us?  These kinds of studies confirm that eating fruits and vegetables is good for health (I think we might have known that already).

But the main (perhaps only) reason for doing such studies is for marketing purposes, which is why food companies sponsor them.