Currently browsing posts about: Health-claims

The terms “healthy” and “natural” help to sell food products.  They are about marketing, not health.

This makes life difficult for the FDA, which has the unenviable job of defining what the terms mean on food labels.

In a victory for the maker of KIND bars, the FDA has just said that the bars can be advertised as healthy—and that the agency will be revisiting its long-standing definition of the term.  This is what that definition says now:

You may use the term “healthy” or related terms as an implied nutrient content claim on the label or in labeling of a food that is useful in creating a diet that is consistent with dietary recommendations if the food meets the conditions for total fat, saturated fat, cholesterol, and other nutrients…In addition, the food must comply with definitions and declaration requirements for any specific NCCs [Nutrient Content Claims].

The chronology :

• March 2015: FDA issues a warning letter to KIND stating that product labels make nutrient content claims without meeting the requirements for making such claims.
• December 1, 2015: KIND files citizen petition asking FDA to permit use of “healthy” because nuts, even though higher in fat than FDA permits, are healthy.
• April 20, 2016: FDA says KIND products now meet labeling requirements
• May 10, 2016: KIND announces that the FDA has reversed its stance and will allow it to use “healthy.”

As reported by Food-Navigator-USA (in a remarkably thorough account of these events),

Dr. Susan Mayne, Director of the Center for Food Safety and Applied Nutrition at the FDA, said: We do not object to the specific statement that you would like to place on your bar wrappers, on the condition that there will be no other nutrition-related statement, such as express or implied nutrient content claims, on the same panel of the label…We agree with you that our regulations concerning nutrient content claims are due for a reevaluation in light of evolving nutrition research.”

What this sounds like is that FDA will be soliciting comments on the meaning of “healthy.”   It also sounds like the FDA agrees that fat is not an appropriate criterion.  But will the FDA set a limit on sugars?  KIND bars are sweetened.

This looks like the FDA will request comments as the start of its interminable rulemaking process.

In the meantime, here’s the Wall Street Journal’s video explanation of the absurdity of the current rules.

Natural

The FDA is further along in that process for “Natural.“  The comment period closed and Politico Pro Morning Agriculture reports that more than 5000 came in.  These have not yet been posted, but Morning Ag has some.  It says opinions vary.  Widely.

• FDA should prohibit using the term.
• Acceptable post-harvest processing and production methods [including GMOs]
• No chemicals, no additives, and no kitchen chemistry
• Some forms of processing can be used – and indeed may be necessary.
• ‘Natural’ means that this product contains no artificial or synthetic ingredients.

I’ve commented many times in the past on the ongoing debates about “natural.”

I repeat: When it comes to food labels, “healthy” and “natural” are marketing terms.  Their purpose is to sell food products.

Caveat emptor.

Health and wellness and terms like natural and organic help food manufacturers sell products.  Food-Navigator-USA.com offers this collection of its articles addressing the question, “What does health & wellness mean to consumers today? We ask what Americans now expect of the food industry, and which innovative firms are best placed to meet their evolving needs.”

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.