by Marion Nestle

Search results: pomegranate juice

Nov 18 2019

Industry-funded study of the week: Pomegranates

The study: Matthews LG, Smyser CD, Cherkerzian S, Alexopoulos D, Kenley J, Tuuli MG, et al. (2019) Maternal pomegranate juice intake and brain structure and function in infants with intrauterine growth restriction: A randomized controlled pilot study. PLoS ONE 14(8): e0219596.

The findings (my emphasis): “There were no group differences in brain injury, metrics or volumes. However, treatment subjects displayed reduced diffusivity within the anterior and posterior limbs of the internal capsule compared with placebo. Resting state functional connectivity demonstrated increased correlation and covariance within several networks in treatment subjects, with alterations most apparent in the visual network in per-protocol analyses. Direct effects on health were not found.

Conclusion: In conclusion, maternal pomegranate juice intake in pregnancies with known IUGR was associated with altered white matter organization and functional connectivity in the infant brain, suggesting differences in brain structure and function following in utero pomegranate juice exposure, warranting continued investigation.

Funding: This work was supported by National Institute of Health Grants R01 HD29190 (D. M. Nelson), K02 NS089852 (C.D. Smyser), U54 HD087011 and P30 HD062171 (T.E. Inder), The Foundation for Barnes-Jewish Hospital (D. M. Nelson) and an unrestricted gift to Washington University School of Medicine from POM Wonderful, Los Angeles, CA. The funders had no role in study design, data collection and analysis, decision to publish, or preparation of the manuscript.

Comment: This is a classic example of interpretation bias.  Studies of bias associated with industry funding find that it shows up mostly in the framing of the research question or in the interpretation, as this one demonstrates.  The study did not find anything significant but concluded that drinking pomegranate juice during pregnancy is good for the growing fetus.

Bottom line: Fruit juices (of any kind) are good for health as long as volumes are small.  Eating the fruit itself is better–less sugar, more fiber.

Apr 23 2014

POM v. Coca-Cola at the Supreme Court: The Mind Boggles

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.

Jan 17 2013

The FTC says no to POM Wonderful’s health claims

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.

POM

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.

May 24 2012

POM fights back with out-of-context ads

POM Wonderful has a full-page ad in today’s New York Times (how much do these things cost?) titled “FTC v. POM: You be the judge.”  The ad includes selected quotes from the judge’s decision (see yesterday’s post) and refers readers to its wonderfully named website, pomtruth.com, where you can see the quotes and the ads for yourself.

I couldn’t help doing some checking.

The POM ad quotes from Chief Administrative Law Judge’s decision:

Competent and reliable scientific evidence supports the conclusion that the consumption of pomegranate juice and pomegranate extract supports prostate health, including by prolonging PSA doubling time in men with rising PSA after primary treatment for prostate cancer (page 282).

I turned immediately to page 282.  The sentence before the one quoted would seem to support it:

The basic research, the Pantuck Study, and the Carducci Study, relied on by Respondents [POM Wonderful], support the conclusion that pomegranate juice has a beneficial effect on prostate health.

But what follows the quotation makes it clear that although the research claims to support the effect, it really doesn’t.  Here’s what immediately follows the quotation in the same paragraph:

However, the greater weight of the persuasive expert testimony shows that the evidence relied upon by Respondents is not adequate to substantiate claims that the POM Products treat, prevent, or reduce the risk of prostate cancer or that they are clinically proven to do do so.  Indeed, the authors of the Pantuck Study and the Carducci study each testified that their study did not conclude that POM juice treats, prevents, or reduces the risk of prostate cancer.  And, as Respondents’ expert conceded, no clinical studies, research and/or trials show definitely that the POM Products treat, prevent, or reduce the risk of prostate cancer.

I will just do one more of the quotes.  The ad says:

Competent and reliable scientific evidence shows that pomegranate juice provides a benefit to promoting erectile health and erectile function (page 198).

This is indeed on page 198 but is followed immediately by:

There is insufficient competent and reliable scientific evidence to show that pomegranate juice prevents or reduces the risk of erectile dysfunction or has been clinically proven to do so…There is insufficient competent and reliable scientific evidence to show that pomegranate juice treats erectile dysfunction in a clinical sense or has been clinically proven to do so.

Because these statements are attributed to the same expert witnesses, this must mean that while some studies show benefits, the experts do not believe that these studies (many of them sponsored by POM) are scientifically credible.

Pomegranate juice is a juice.  Fruit juices are healthy and especially delicious when fresh.  I happen to like the taste of pomegranate juice.

But does it have any special health benefits as compared to orange, grapefruit, grape, or any other fruit juice?

Would any fruit juice be likely to prevent heart disease or prostate problems on its own?

Despite POM’s out-of-context advertisement, the Administrative Law Judge did not think so, and neither do I.

Addition: I’m indebted to FoodNavigator.com for noticing some of the other ads.

The caption reads: “Natural Fruit Product with Health Promoting Characteristics–FTC Judge.”

May 23 2012

The FTC vs. POM Wonderful: the latest round

I’ve been following the legal battles between the Federal Trade Commission (FTC) and the makers of POM juice and other pomegranate juice products with avid interest, mainly because they deal with the credibility of sponsored scientific research.

This week, an administrative law judge ruled that POM violated federal law when it deceptively advertised  its products as able to “treat, prevent, or reduce the risk of heart disease, prostate cancer, and erectile dysfunction.”

The judge ruled that reasonable consumers would interpret the ads as making such claims but that the company had not produced convincing evidence to support them.

The judge’s decision makes entertaining reading for someone like me who enjoys debates about whether sponsorship of scientific studies influences results and interpretation—as evidence shows they most definitely do.

POM has invested more than $35 million in research to prove that pomegranate juice has health benefits.  It has sponsored about 100 studies at 44 different institutions.  At least 70 of these studies were published in peer-reviewed journals.

It is not difficult to design research studies to give sponsors the answers they want and to make sure they are conducted well.  POM is getting the best research that money can buy.

One such study, of the effects of drinking pomegranate juice on myocardial perfusion (MP, blood flow to the heart), was conducted by Dr. Dean Ornish, who runs a preventive medicine institute in California (the quotes come from pages 268-269 of the decision).

The Ornish MP study was originally designed to last 12 months, with measurements at baseline, 3 months, and 12 months.  [The FTC] charges that the study was cut short when the three-month data came in favorably and Dr. Ornish faced cost overruns.

Dr. [Frank] Sacks [expert witness for the FTC] opined that the shortened study period and failure to report the planned duration are inconsistent with widely accepted standards for conduct of clinical trials and undermine any confidence in the findings.

Dr. Ornish testified that the Ornish MP Study was terminated after three months only because the Resnicks did not provide the funding that they had previously committed to this study….[he said the study]constitutes credible and reliable science showing that pomegranate juice lessens the risk of cardiovascular problems.

The judge found evidence on this study and many others conflicting.  He ruled that this level of disagreement about the quality of the research means that the scientific evidence is not good enough to substantiate the claims.

I was interviewed for a story in Business Week about this decision.

This makes it clear why everyone should be suspicious of the results of sponsored studies…POM-sponsored studies produce results favorable to POM.

POM’s owners have their own spin on the decision.

It says the ALJ’s ruling affirms the scientific validity behind the general health benefits of pomegranates and “completely exonerates” POM regarding its claims in broadcast or print interviews.

Let’s be clear what’s at stake here.  According to the decision document, the owners of POM control 18,000 acres of pomegranate orchards.

From September 2002 through November 2010, sales of POM juice alone totaled nearly $248 million (the supplements and other products add more).

The owners must believe that nobody will buy pomegranate juice and supplements for any reason other than health benefits.

Health claims are about marketing, not health.

Let’s hope the FTC can make the decision stick.

May 23 2011

POM Wonderful vs. the FTC: what this is about

On May 24, an administrative law judge will deal with the matter of the Federal Trade Commission’s (FTC) complaints that health claims made for POM Wonderful pomegranate juice are unsubstantiated by science.

To review:  last September, the FTC complained that the company was advertising its juice with unsubstantiated claims like these:

  • Clinical studies prove that POM Juice and POMx prevent, reduce the risk of, and treat heart disease, including by decreasing arterial plaque, lowering blood pressure, and improving blood flow to the heart;
  • Clinical studies prove that POM Juice and POMx prevent, reduce the risk of, and treat prostate cancer, including by prolonging prostate-specific antigen doubling time;
  • Clinical studies prove that POM Juice prevents, reduces the risk of, and treats, erectile dysfunction.

The FTC argues that these claims are false because POM Wonderful’s studies do not prove what the company claims.  The FTC particularly takes exceptions to the company’s advertisements:

If you want to follow the legalities, the FTC provides a handy summary.

According to FoodNavigator.com, this company must be supporting armies of lawyers:

POM is currently embroiled in a complex web of litigation, having itself launched legal action against the FTC alleging it had exceeded its statutory authority by establishing a two-clinical trial standard to back claims.

It has also filed actions against Coca-Cola Minute Maid, PepsiCo Tropicana and Ocean Spray alleging misleading claims about the contents of their pomegranate-containing juice products.

Separately, POM is itself accused of misleading consumers in a class action lodged in a Florida state court.

Leaving this particular company’s legal strategies aside, at issue is whether food health claims need to be backed up by science.   POM says it has the science.   The FTC says it doesn’t.   I will have more to say about that issue in subsequent posts.

In the meantime, it will be interesting to see what happens at the hearing.  Stay tuned.

Mar 6 2011

The perils of food and nutrition research

I write a monthly (first Sunday) Food Matters column for the San Francisco Chronicle.  Today’s is about the difficulties of doing nutrition research.  The Chronicle headline writer titled it, “Be skeptical of food studies.”  Oops.

I’m not skeptical about Food Studies—the capitalized field of study—at all.  My NYU department started undergraduate, master’s, and doctoral programs in Food Studies in 1996 and they have flourished ever since.

The column is about small-letter food studies, meaning nutrition and food research studies:

Q: You were quoted saying that you didn’t believe newspaper reports linking diet sodas to an increased risk of stroke and heart disease. How do you decide whether research is good or bad?

A: This one was easy. I didn’t think it made sense. Mind you, I’m no fan of diet sodas. They violate my rule never to eat anything artificial. And I don’t like the taste of artificial sweeteners.

Whenever a study comes out claiming harm – or benefits – from eating a single food or ingredient, I get skeptical. That’s why I also questioned these recent study results: high-fructose corn syrup (HFCS) makes rats gain weight faster than sucrose (table sugar); zinc supplements prevent symptoms of the common cold; and pomegranate juice has greater health benefits than any other kind of fruit.

When I read about single-factor studies, I want to know three things: Is the result biologically plausible? Did the study control for other dietary, behavioral or lifestyle factors that could have influenced the result? And who sponsored it?

Plausibility: The diet soda study used a self-reported questionnaire to find out how often people reported drinking diet sodas. Nine years later, people who reported habitually drinking diet sodas had a 60 percent higher rate of stroke and heart attacks. The rate was somewhat lower when controlled for age, sex, race, smoking, exercise, alcohol, daily calories and metabolic syndrome.

Leaving aside the unreliability of self-reported dietary intake, the study raises a more important question. Was it designed to investigate the link between diet sodas and stroke or was this just an accidental finding? The questionnaire undoubtedly asked hundreds of questions about diet and other matters. Just by chance, some of them could be giving results that look meaningful. And the increase in stroke risk seems surprisingly high for something not previously known to be a stroke risk factor.

Mostly, I can’t think of a biological reason why diet sodas might lead to cardiovascular disease unless they are an indicator for some other stroke risk factor such as obesity, high blood pressure or binge drinking. It would take a study designed to test this idea specifically – and a good biological explanation – to convince me that diet sodas cause strokes.

The plausibility issue also rises in the HFCS study. Again, I’m not a fan of HFCS – we would all be healthier if we ate less sugar – but from a biochemical standpoint, HFCS and table sugar are pretty much the same. They have similar amounts of glucose and fructose, are digested as quickly and are metabolized the same way. Even the average amounts consumed are about the same. That soda companies are replacing HFCS with sucrose is strictly about marketing, not health.

Controls: The zinc-and-colds study was a comprehensive review (a “meta-analysis”) of previous studies done since the first one in 1984. Eleven studies have showed some benefit; seven have not. All of them were placebo controlled, double-blind. This meant that half the participants were given a dummy pill, and neither participants nor investigators were supposed to know who was taking what.

But in some studies, the zinc takers complained about the taste of the pills, hinting that they knew what they were.

I’ve heard this before. In the early 1970s, National Institutes of Health investigators did a study of vitamin C and the common cold. They got about 300 NIH employees to take either vitamin C or a placebo, double-blind. The tantalizing result: People taking vitamin C reported fewer colds and milder symptoms than people taking placebos.

Alas, many participants withdrew from the study before it ended. When asked why, they admitted tasting the pills. The investigators reanalyzed the results. Bingo! No matter what pill the participants actually took, those who thought they were taking vitamin C reported fewer colds and milder symptoms.

If the studies were not really blinded, the zinc results are questionable. I have no doubt that many people feel better when they take zinc supplements, but I’m not sure whether that’s because of something zinc really does or just its placebo effect.

Sponsorship: Vested interests influence the design and interpretation of studies. The best-designed studies control for factors that might influence results. Even so, their results require interpretation. Interpretation requires interpreters. Interpreters bring their own biases into the interpretation.

I mention pomegranate juice because one of its major producers sponsors studies to hype its benefits. Yes, pomegranates are delicious, but antioxidant powerhouses? So are most fruits. Pomegranates may have high antioxidant activity, but compared with what? Its maker does not say. Sponsored research is also about marketing, not health.

Nutrition research is hard to do, which makes study design and interpretation particularly challenging. Nutrition is a thinking person’s field, requiring careful analysis at every step. When you hear a result that sounds too good to be true, it usually is.

Tags:
Jan 1 2011

Predictions: national nutrition issues for 2011

My first San Francisco Chronicle “Food Matters” column for the new year deals with some predictions:

Q: Whatever you used as a crystal ball last year turned out to be a pretty good predictor of the most prominent food issues of 2010. How about trying again: What food matters will we be hearing about in 2011?

A: It doesn’t take a crystal ball to figure out what’s coming up with food issues. I’m happy to make predictions, especially since most seem fairly safe.

Dietary guidelines will be released this month. By law, they were due last year and are already late. What will they say? The 2010 guidelines advisory committee recommended eating more fruits, vegetables and whole grains, but introduced a new euphemism – SOFAs, or Solid Fats and Added Sugars – for the “eat less” advice. SOFAs really mean “cut down on fatty meat and dairy products” and “avoid sugary sodas.”

Will government agencies have the nerve to say so? Let’s hope.

The U.S. Department of Agriculture will issue a new food guide. The 2005 pyramid’s rainbow stripes proved impossible to teach and useless to anyone without a computer. I’ve heard a rumor that I will love the new design. I’m skeptical. I liked the original 1992 pyramid. It showed that bottom-of-the-pyramid foods were healthiest, making it unpopular with companies selling top-of-the-pyramid products. But it is healthier to eat some foods than others (see: dietary guidelines).

Will the USDA improve on the 1992 design? We will soon find out.

The fights over food safety will continue. At the last possible moment, Congress passed the food safety bill by a large majority. Now the fights really begin.

Funding will be most contentious, with the actual regulations not far behind. The Congressional Budget Office absurdly considered the bill’s provisions to be “budget neutral.” They are anything but.

The bill’s provisions require the Food and Drug Administration to hire more inspectors just at a time when Republican lawmakers have sworn to cut domestic spending. The FDA also must translate the bill’s requirements and exemptions for small farmers into regulations.

Rule-making is a lengthy process subject to public comment and, therefore, political maneuvering. Watch the lobbying efforts ratchet up as food producers, large and small, attempt to head off safety rules they think they won’t like.

Expect more lawsuits over the scientific basis of health claims. The Federal Trade Commission just settled a $21 million claim against Dannon for advertising that yogurt protects against the flu. The agency also has gone after scientifically unsubstantiated claims that omega-3s in kiddie supplements promote brain development and that pomegranate juice protects against prostate problems. POM Wonderful has already countersued the FTC on grounds that the First Amendment protects commercial speech. I’ll be watching this case carefully.

The FDA will issue new front-of-package label regulations. The FDA has promised to propose an at-a-glance symbol to indicate the overall nutritional value of food products. Food companies like the Guideline Daily Amount spots they are using in the upper corners of food packages because the symbols are factual but nonjudgmental. The FDA, however, is considering red, yellow and green traffic-light symbols that do convey judgments. Food companies say they will not voluntarily use a symbol that tells people to eat less of their products.

Will the FDA have the courage to make traffic lights mandatory? It will need courage. The new British government dealt with the traffic-light idea by summarily dismantling the food agency that suggested it.

Corporations will seek new ways to co-opt critics. Under the guise of corporate social responsibility, food companies have been making large donations to organizations that might otherwise criticize their products. The most recent example is the decision by Save the Children, formerly a staunch advocate of soda taxes, to drop that cause coincidentally at a time when its executives were negotiating funding from Coca-Cola.

Such strategies remind me of how the Philip Morris cigarette company distributed grants to leading arts groups. Expect food companies to use generosity to neutralize critics and buy silence.

School meals will make front-page news. Congress passed the Healthy, Hunger-Free Kids Act last month. Now the USDA must implement it by setting nutrition standards, adding fresh fruits and vegetables (some locally grown) and expanding eligibility.

President Obama has promised to restore the $4.5 billion “borrowed” from the SNAP (food stamp) program to fund this act. The scrambling over the regulations and financing should make excellent spectator sport.

Farm bill advocates will be mobilizing. You might think it too early to be worrying about the 2012 Farm Bill, but I’ve already gotten position papers analyzing commodity and food-assistance issues from groups gearing up to lobby Congress to bring agricultural policy in line with nutrition and public health policy.

I have a personal interest in such papers. I will be teaching a course on the Farm Bill at New York University next fall. Please get busy and write more of them!

Happy new year, and let’s see how my guesses play out.