The Alliance For Natural Health

Readers’ Corner: The POM Wonderful “Win”

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POM-WonderfulSome of our readers wondered about contradictory major media headlines. The facts of the case follow.

Last week we reported on the court decision in favor of pomegranate maker POM Wonderful, allowing the company to tell consumers about the health benefits of its juice.

Pat writes: “Moments after reading this article claiming the ‘win’ I saw the Yahoo headline below.”

The headline reads: “Pomegranate juice claims deceptive, US rules.”

We saw that too. The New York Times and many others are also reporting the POM Wonderful decision as a loss for POM, but this is a case where the media are completely misrepresenting the story. This is either gross media bias or simple ignorance; we can’t really say which. What we can say is that it is a disgrace to report without carefully checking facts or providing context.

The judge in the case issued a 335-page decision, so there was a lot in it. He found that product claims don’t need double-blind Random Controlled Trials (RCTs) to support them, and that claims don’t need to be FDA-approved. This is hugely important win and the heart of the case.

The judge’s decision is a major roadblock to the FTC’s and FDA’s desire to create a pharmaceutical-like pre-approval system for supplements. It reaffirms existing law which forbids such pharmaceutical standards. The idea of treating supplements as if they were drugs may sound good to an uninformed public, but it would really mean the end of supplements. A natural food or supplement ingredient cannot, in general, be patented because it is a natural substance, and without patent protection it can never get an exclusive share of the market and recoup the investment of millions of dollars it takes to do those double-blind RCTs.

The judge also found that the evidence POM Wonderful presented to substantiate some of its ads—specifically, the ones allegedly claiming that POM products treat, prevent, or reduce the risk of heart disease, prostate cancer, or erectile dysfunction—was inadequate. This was not a surprise. It is very difficult under existing law for a supplement to make a disease claim or what can be interpreted as a disease claim. But for the media to trumpet this in headlines and present it as evidence that POM “lost” is completely misleading. POM won its case, and so did natural health.

Over the past couple of years, the FTC has been requiring two RCTs as part of lawsuit settlement agreements (“consent decrees”). As we have reported, this is illegal, and FTC has been attempting to circumvent the rulemaking process by creating new law this way. In fact, the reason ANH-USA filed a Petition for Rulemaking against the FTC was that we have every reason to believe FTC will continue in this practice, and as we note above, companies simply cannot afford to perform two RCTs for each claim on each product.

Note that structure/function claims are completely legal under DSHEA, so what FTC was doing here is in opposition to the law governing supplements. There is little enough information we are currently allowed access—we can’t risk even that little bit being trampled. That is why this ruling matters.

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  • Cathy

    I feel that the POM Wonderful case is a good (or bad) example of how the natural/organic food industry has come under attack. First off, most consumers are intelligent enough to figure out that eating or drinking a certain type of food will not miraculously cause good health or cure diseases. Very few products I have seen, except on infomercials, make these claims. However, I think most people are figuring out that all of the (over) processed food, some with chemicals (i.e., aspartame vs. sugar) that have used over the past several decades do have side effects. The big food manufacturers, not unlike big pharma, have a lot to lose when consumers educate themselves. Actually, any food manufacturer has a lot to lose when consumers educate themselves. Just ask Kashi.

  • CharlaStar

    Pomegranate and its juice are certainly healthful for MOST people, however, people with Chronic Myeloid Leukemia taking one of the 3 approved medications for it should think twice before using any sort of pomegranate products. Last year I began breaking out in hives and it went on for 6 months. At first I thought it was mite bites from my chickens. We dusted and cleaned and bathed and dipped, but the ‘mite bites kept getting worse.’ After 6 months I stopped taking the leukemia medication and switched to another. Same problem.

    Then I found the following information from the National CML Society http://www.nationalcmlsociety.org/living-cml/drug-food-interactions
    Food Interactions Pomegranate – is also known to interact with TKIs and should be avoided. (NOTE: INCREASES drug in blood as it inhibits the liver enzyme CYP3A4 causing 96.8% blockage of midazolam 1′-hydroxylation that breaks down the drug).

    In doing further research, I found that if a medication has warnings against using grapefruit, pomegranate poses a greater risk, as both inhibit an enzyme in the liver that causes certain medications to break down: grapefruit deactivates it 85%, pomegranate 96-97% and starfruit 100%. After I stopped taking a multi-vitamin with pomegranate extract, I gradually got better until I was finally hive-free.

    • dez

      Do a eye opening research; ‘cancer oxygen’

  • I think this is SO important. Though over here in the UK, we don’t want this rampant fear mongering by the FTC to terrorise legitimate, honest businesses supplying wholesome products that basically do you good, pretty much the way God intended, yet don’t make a fat buck for Big Pharma. Please keep up your good work, we Brits are rooting for you all the way.

    Thanks

    Dave

  • John

    “POM, whose annual sales rose from $12 million in 2003 to a current $91 million”

    And you believe that they can’t AFFORD to do clinical RCT’s on the product they are touting???

    If I believed in my product and was making 91 million a year, the research would be done. Makes you wonder why they have chose not to do it???

    • $91 million sounds like a lot, but remember that is gross sales, not net profit. We do not know what their profit margin is, but 10% would be a figure that most businesses would envy, so we can assume profit is no more than $9 million after expenses. The average cost of a single RCT is about $12 million, and the FTC wants two RCTs per product – 100% of 3+ years’ profit just to make claims about a single POM product, and another 3+ years for every other product they wished to make claims about.

      POM has indeed invested a great deal of their profits in conducting studies–$35 million in about 15 years, representing at least 25% of their annual profits for the last 15 years. They’re just not the kind of studies the FDA/FTC like. But they are sound, peer-reviewed, and published studies nonetheless.

      By contrast, Zoloft and OxyContin sales are each $3 billion per year (10% = $300 million in net profits, making 2 RCTs just 8% of one year’s profit). Lipitor sales are $10 billion per year (10% = $1 billion in net profit, making 2 RCTs less than 2.5% of one year’s profit). There’s a reason patented drugs can afford this while even the most successful natural products cannot.