Breaking News: Big Scientific Free Speech Win!

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POM WonderfulIn a 335-page ruling handed down today, an Administrative Law Judge with oversight of the Federal Trade Commission (FTC) has upheld the right of pomegranate juice manufacturer POM Wonderful to tell consumers about the health benefits of its juice.

Since 1996, POM has invested over $35 million to do scientific research on their pomegranate products at 44 top universities and scientific centers around the globe. Over 70 of their studies have been published in significant peer-reviewed journals, validating the health benefits of the pomegranate and pomegranate juice.

What makes this ruling significant is the fact that the judge said, “The greater weight of the persuasive expert testimony in this case leads to the conclusion that where the product is absolutely safe, like POM Products, and where the claim or advertisement does not suggest that the product be used as a substitute for conventional medical care or treatment, then it is appropriate to favor disclosure.” While we are still studying the ruling, it seems to indicate that other safe products may also be allowed to disclose scientifically validated studies about their health benefits.

The ruling also implies that Roll Global, POM Wonderful’s parent company, will not need to get FDA approval before making health claims about its food products, nor will it have to conduct the kind of double-blind, randomized, placebo-controlled studies that are required of the pharmaceutical industry, and which the FTC was illegally insisting on.

As we reported last year, the FDA allows food and supplement producers to describe the role of a nutrient or dietary ingredient as it affects normal structure or function in humans—for example, “calcium builds strong bones” or “vitamin D boosts immune system function.” However, one cannot legally cite the science showing that vitamin D prevents and treats the flu. The flu is considered a disease, so this is forbidden.

The FTC, however, has been claiming that even structure/function claims cannot be made unless two random-controlled human clinical trials, or RCTs, are performed! And that’s two RCTs for each product, not each ingredient. Even one RCT is tremendously expensive, so to require two for each product before any health claim is made is a nearly impossible undertaking.

Both FDA and the FTC regulate health claims about food (and dietary supplements are defined as a food), but the FTC covers health claims in advertising, whereas the FDA is concerned with health claims on food product labeling. The difficulty here is that through a series of lawsuit settlement agreements (“consent decrees”) taken against food companies by the FTC, the lines between the FTC and the FDA jurisdictions are blurring, particularly in regard to health claims. In its consent agreements—under threat of severe sanction if not agreed to—the FTC has forced companies to agree that no advertising claims could be made unless (a) there was prior approval by the FDA, and (b) it was supported by two double-blind, placebo-controlled studies—a pharmaceutical standard.

In 2010, POM Wonderful sued the FTC for blurring those lines. POM alleged that the FTC was trampling on their first amendment rights to make claims about pomegranates and pomegranate juice—claims that they said were supported by reliable scientific evidence. POM argued that FTC was illegally trying to create a new standard, whereas the current legal standard is that a claim does not require FDA approval and must simply be supported by competent, reliable, scientific evidence.

Constitutional lawyer Jonathan Emord put it this way:

The [FTC] cannot make unencumbered commercial speech dependent upon anything other than the requirement that the speech be non-misleading. Speech not approved by FDA may be true. Speech not supported by a set number and kind of human trials may also be true. The constitutional burden of proof is on FTC to prove falsity in each specific case based on the precise content of the claim.

As another article in this issue makes clear, the battle for free speech about science is still far from won. We are only in the early days. But the POM case is a major step forward and worth celebrating.

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  • respectfully request a complete legal citation for the administrative law judge’s opinion about which I just received notice.

    I wish to review it and share portions with my constituents.

    william, adm consultant

  • Edith

    Thank you to POM for going up against the FTC. I am glad they have enough money, and can do it. I don’t know why the FTC thinks drugs and only drugs have an effect on health.

  • Scott Kuehne

    Isn’t this the same trouble Diamond had for selling nuts and saying they were heart healthy?

  • I swear by pomegranates, it is one of my daily supplements that keep my advanced prostate cancer in check. I have been taking it for six years. The only side effect it is anti aging!

  • Debra Greenberg

    How can we make informed decisions if we don’t understand the truth?

  • Excellent news! It is a bit of a shame that anyone needs to hire lawyers to fight the ‘government’ to enable free speech. The goals of governments should be to enable our freedoms, not to restrict them. Everyone has a right to life, liberty, and the pursuit of healthiness: http://personalhealthfreedom.blogspot.ca/2012/05/universal-declaration-of-health-freedom.html
    To your health, tracy

  • Wonderful! as a senior with many health challenges, I depend on several supplements to keep going. In the name of prptecting me, these beaurocrats are trying to push supplements out of the arena. Glad their are some companies with enough financial muscle to oppose them. As the supplement industry is so fragmented, I think a trade association needs to be set up for this purpose, so that collective finance could back up a pushback against the beaurocracies.

  • The 1st Amendment does not qualify the type of speech we are allowed: “Congress shall make no law abridging the freedom of speech.” The power of congress to regulate, must be coextensive with our liberties:

    “If the Constitution in its grant of powers is to be so construed that Congress shall be able to carry into full effect the powers granted, it is equally imperative that where prohibition or limitation is placed upon the power of Congress that prohibition or limitation should be enforced in its spirit and to its entirety. It would be a strange rule of construction that language granting powers is to be liberally construed and that language of restriction is to be narrowly and technically construed.” Kansas v. Colorado, 206 U.S. 46, 91 (1907)

    Our only limitation is that we speak the truth, which might mean to tell the reader that this is an unscientific opinion based upon tradition or history, or upon testimonials, etc. The government cannot tell us what constitutes an adequate level of proof for any statement. We decide that.

    From “The LAWFUL Remedy to Tyranny,” Sec. 5.

  • The FDA is more of a hindrance to health and wellness than a protective entity. Promoting big pharma over common sense and positive results of natural solutions is common place. Just look at the war over raw milk and small farms. Pasteurized milk is poison. Google “pustashe” and you will think twice about drinking “safe milk”.

  • Michael

    A ruling that makes some sense, I appreciate that.

  • JJM

    Good – now people have a better chance of learning what goods God and mother nature have provided us with.

  • Sherri F.

    Finally a step in the right direction…The FDA has tried too many times to control people’s rights to their own choice in food & medicines…This made me really Smile!!! 😀

  • Stan Paul

    Delighted to hear this news. Lets keep on fighting for natural health and taking responsibility for our health by being informed consumers. Like I say, nature has cures for all of us. Thanks

  • Colleen Fraser

    It is fitting that the court ruled in the defence of scientific evidence accumulated by a manufacturer to validate the health value of their product; it is not appropriate that both the FDA and FTC prevent legitimate companies’ products from reaching market with legitmately proven claims.

    For too long, their role as health watch dogs for the nation has become confused with promoting Big Pharma at the expese of alternatve means that often indicate better health applications in the long term. This is an unpardonable offence, especially on the part of a government agency.

    Who oversees their processes and outcomes? Democracy only functions well when there are safeguards and balance: where are they where these agencies are concerned?

  • Choymae Huie

    Yes!!! Yes!!! Yes!!! Thank you POM for sticking your neck out for all of us and WINNING.

  • Colleen Cummings

    Nice to see them win, but I think it is interesting that drug companies can make all kinds of claims, and people can die from taking their drugs. No one ever died from pomegranate juice, not that I know of, anyway.

  • maureen

    This is a great win. I love that judge for being so smart and making the distinction between a drug and a piece of fruit. The truth about what we all eat, including the folks who work in the FTC and FDA will have the benefit of knowing more about what we all consume everyday. I’m grateful for the decision of the court. We all need to know how to help ourselves stay healthier. Maureen

  • Chris

    All I can say is Bravo!! It makes me wonder why drugs and other chemicals can make claims about their effects without fully disclosing their potential harm, or citing inconclusive or twisted evidence for their claims. I am so thankful for this ruling and hope for a changing tide and many other related victories in favor of true health choices in the USA.

  • Mack531

    Hats off to POM Wonderful. There are many foods that can help to reverse or fight disease. Even things like cancer and a variety of pathogens, like influenza and HIV-AIDS. An Italiian study published in 2006 showed conclusively that Italians as a population had a lower incidence of certain cancers precisely because they have a higher intake of allium vegetables, like Garlic or Onions. See: American Journal of Clinical Nutrition, Vol. 84, No. 5, 1027-1032, November 2006 © 2006 American Society for Nutrition. Authors were: Galeone, Pelucchi, Levi, Negri, Franceschi, Talamini, Giacosa and La Vecchia.

    More recent studies of the lauric acid in Coconut meat, milk or oil show that this substance is converted into a medium chain fatty acid called monolauren by the liver and that this MCFA has the ability to suppress the replication of viruses and other pathogens– even MRSA. It is even being examined as a cure for AIDS. Of course the pharmaceutical industry will have a cow if it can be shown that a regular diet of Coconut milk can cure AIDS (or any other viral infection.) I have successfully used these regimens to fight not only a H1N1 infection but to force a tumor into remission. I will never use chemo or radiation therapy.

    Congrats, POM Wonderful!

  • Prof.Helen McCaffrey

    Free Speech is our greatest defense against tyranny whether it’s the FDA, FTC, or one of the other alphabet tyrants. Keep resisting evil.

  • Ingrid Harris

    Horray!! Congratulations for a job well done! Awesome. Thank you very much.

  • Michele FitzGerald

    This is an excellent article! I am very pleased a new standard is not applied to POM and this court ruling may set precedence for a variety of claims coming out of the FDA in such a way that appears to control trade on behalf of the medical industry. So many battles like this appear to be based upon western medicine model, not modern science, that attempt to regulate a particular segment of the food industry like the medical industry must be regulated. It all comes to the surface because good products that promote health make money and although the claim may not be made directly….keeps people healthy. What a concept!

  • buck

    The FDA and the FTC , like all federal programs have become corrupted by and now work for the major specific drug and chemical companies to crush their competition , who ever it might be and regardless of who gets hurt .

  • If any statement might be wrong, it can be challenged by FTC. What more do they want.

  • Frank Apostol

    The only sure way to the justice deserved from these various federal agencies — FDA; FTC — and congress itself, is to get rid of the people who are in charge now. They have unashamedly prostituted the powers of their positions to the amoral executives of the corporate world.

    If everyone were to inform their congressmen that on this basis alone he will be voted out of office if at all possible, then something worthwhile may happen. Otherwise you can forget it. Because you are dealing with a very low level life form.

  • Alan L.

    It is strange that the basic problem is never addressed, or even acknowledged. Humans seek growth. Companies want “to do better next year”. Schools want “to have more and smarter students”. Athletes want “to get stronger–to vanquish more competitors–to jump farther”– and so on. The same drive applies to governmental bureaucracies. So there are more rules, more controls, more inspectors, more fiefdoms, bigger hierarchies, more power — and so on. What is really needed is a dismantling commission (which itself will need dismantling after a while). Its role would be to challenge the very “moredom” of the operating governmental bureaucracies–to challenge regulations–to ask for specific justifications for personnel needs–to insist on cost/benefit analyses not only of proposed new regulations, but of those commonly in force. To inquire if regulations are needed and to have the power to litigate in federal and state courts for their removal. Unfortunately, the entrenched bureaucracies will never let this concept come into being.

  • Lex

    Hip, hip hurrah! This a huge first step. I really didn’t expect this outcome, but I’m so happy for all the valid companies out there trying to show a better path to good health.

  • This is an outstanding victory! It will be great to read a follow up article from ANH-USA examining the extent of the victory for Free Speech about Science for ALL supplement companies who choose to validate their products with legitimate science and published research. Thank you for sharing this article, and I look forward to more like it.

  • patrica schiewe

    Congratulations to the POM company for breaking the ice and being able to let the public know that foods can be beneficial to health and if we take care to eat healthy foods our minds, body, and spirits will be strong and our medical expenses will go way, way down.

  • Mary

    My concern is that the food companies that falsely green wash their labels, making claims of being “all natural” when they know it contains GMOs will try to pull the same card of free speech. However, I am glad to see that the POM case was successful in their efforts. The FDA disgusts me.

    • Ret

      They’ve been doing that for a long time. I’m really glad that Kashi products ingredients have been exposed. I’ve found that Wikipedia will have explanations for ingredients or processing that are not on the label or misleading.

  • Christina

    Find the full text of the decision here
    http://www.ftc.gov/os/adjpro/d9344/120521pomdecision.pdf

  • brad roon

    Why don’t we just have a mandatory label: “Caution, FDA labels are proven untrustworthy and corporation biased. They have no basis in science and are unsafe when taken in moderate dosages”

  • Pat Johnson

    Moments after reading this article claiming the ‘win’ I saw the Yahoo headline below:
    http://news.yahoo.com/pomegranate-juice-claims-deceptive-us-rules-213016310.html

    • Brandon Johnson

      That is the same version of this story I heard on the Houston local news the other night. The media is deceptive and that is why I get very little news from the “old” media.

      They refer to the FTC judge as if he handed down the official ruling in the case.

    • Bu Tino

      I saw that too. Crazy.

  • It seems that there are two standards for free speech: one for foods and one for other non-digestible products. The FTC should have to prove that the ad is deceptive, the USDA should have the burden of proof that the product is harmful,and the FDA should be divested of its witch hunting roles (be dissolved) and become a tax deduction for Pharma under advertising. The FDA really believes it’s not held to the First Amendment tenet – or at least this is what it claimed in an appeal motion against in the Life Extension Foundation case.

    • Ah, you hit the nail on the head! There seems to be two standards for freedom of speech (for food and for non-digestible products). That’s the key to my idea to completely ignore the FDA’s self-appointed control over valid health claims of food supplements and products. Here is how it works:

      Food supplement companies would sell the same products, but market them as decorations (non-digestible products), so the FDA would have zero jurisdiction. You may find a bottle of “90 beautiful white capsules”, for example, with no implication that the product should be orally consumed. How does the customer know what to buy? There would be an independent third party website, maybe something like http://www.TruthfulSupplementInfo.org, that would basically serve as a catalog for all the vendors who care to list their products there. Freedom of speech would be preserved and protected on this site because nothing would be sold. The vendors could truthfully state that an aloe vera extract helps combat cancer for instance. For each product a vendor wants to list, there would be a generic product number generated and assigned so the consumer could click and be directed to the actual vendor’s website where they could buy the “decoration”. The third-party site could even have an interface to search by function, by common product name or ingredient, etc, and also have a way to print labels that could be affixed to the “decoration’s” containers once they are received. The third-party site would be well known to consumers, and of course to the FDA, but the FDA would be powerless to interfere, and supplements could be sold regardless of the FDA’s tyranny!

  • Let me stop for a minute and do a little happy dance…..okay!
    Pom has done their research (and had the resources, no small thing) and deserves the victory!
    (VT just backed off a bill to label GMOs once Monsanto threatened a lawsuit, despite a 90% support by Vermonters.)
    Thank you for the good news!

    BYW – did you mean to say ‘for each ingredient, not each product?’
    “The FTC, however, has been claiming that even structure/function claims cannot be made unless two random-controlled human clinical trials, or RCTs, are performed! And that’s two RCTs for each product, not each ingredient. Even one RCT is tremendously expensive, so to require two for each product before any health claim is made is a nearly impossible undertaking.”

  • Thank you first amendment and the system that allows judges to make make the right call and not get fired by corporate stooges. Unbiased judges are the the last firewall against total corporate fascist control, as we obviously can’t rely on our congress critters…

  • Douglas

    “The ruling also implies…nor will it have to conduct the kind of double-blind, randomized, placebo-controlled studies that are required of the pharmaceutical industry, and which the FTC was illegally insisting on.”

    This allows the consumer to be misled by the manufacturer. There is nothing better than the double blind to determine if something is worthwhile for not. It is now, it appears, possible that the studies paid for by the industry will be used with all their bias and flaws. Research shows that an inordinate number of studies favor a product when the research is done by the products manufacturer. I strongly doubt that the studies done by POM would not stand peer review nor appear in reputable journals without criticism.

    • Shanon

      I absolutely agree with Douglas! When POM spends “over 35 million to do scientific research on the benefits of pomegranate products” that is not science that is market research and bound to be biased by POM who has a financial interest in a positive review.

    • Peter

      Any research can be biased by those conducting it, including double-blind studies by pharmaceutical manufacturers testing their own products. Merck’s Vioxx is a perfect example. Meta-analysis used by pharmaceutical companies can use cherry picked data. Marketing departments spin less than favorable studies to create acceptance of a marginal drug. As for food processors/manufacturers, the line drawn by the FDA stops at claims of cure for specific diseases. POM is not touting cures. The company is promoting health benefits. As for their studies not being peer-reviewed, here is a quote from the second paragraph of the article we’re commenting on: “Over 70 of their studies have been published in significant peer-reviewed journals, validating the health benefits of the pomegranate and pomegranate juice.” The court’s ruling is sensible. More credible information about healthful alternatives is a good thing for consumers.

    • The belief thatthe FDA ovesees adequate testing on the drugs it approves is unfounded. Ongoing scandals haunt that agency and the list of drugs that it has approved and then recalled or issued post-cionsumer use is huge. You can Google “reacalled drugs by FDA” for resources on this topic. Although many FDA officials have been exposed for their financial ties to the drug manufacturers and the subsequent approaval of poorly tested compounds, the FDA remains on a pedistal it does not deserve.

      Here is a list of recalled drugs found at http://www.drugrecalls.com/
      Drug Recalls & Warnings
      Osteoporosis Drug Warning (Actonel, Boniva, & Fosamax)
      Multaq
      Darvon & Darvocet Recalled
      Meridia Recalled
      Paxil & Other Antidepressants
      Depakote
      Yaz & Yasmin
      Accutane
      Propofol
      Gadolinium MRI/MRA Contrast Agents
      Tylenol
      Reglan
      Raptiva
      Duragestic Patch
      Chantix & Zyban
      Heparin
      Fen-Phen (Redux)
      Avandia
      Fosamax
      Levaquin
      Ketek
      Singulair
      Alloderm
      Denture Cream
      Hydroxycut
      Antidepressants
      Zelnorm
      Neurontin
      Hylenex
      Celebrex
      Prempro
      Risperdal
      Rezulin
      Painkillers
      Vioxx
      Bextra
      Blood Pressure Medications
      Diet Drugs
      SimplyThick Baby Formula
      Zoloft

      As you can see these drugs, which have passed the suposed ‘gold standard’ of double blind cross-over testing’ have all caused large numbers of deaths and diseases, inlcuding the very thing they were suposed to treat.

      Frankly, the FDA is an outdated institution run by pharmeceutical companies. The more the FDA has tried to ‘protect’ us the sicker the American population has become. It has become a problem and not a solution.

      POM’s research is substantial considering that it is small company with no government contracts to suppot it. POM’s product is not a be-all-to-end-all, but it is a safe product with health promoting benefits. Let’s see the FDA support research to disprove that!

    • Maureen Adler

      The idea that ‘double blind’ studies on all nutrition products can EVER be conducted in a manner that will satisfy everyone is disingenuous at best, and the above writer KNOWS that. In the beautiful economy of nature, nutrients work together in the body, and isolating one nutrient for testing purposes will always only hint at its benefit to the body. This writer is trying to frighten you into thinking that you need Big Pharma with their holy double blind studies to prove that something is beneficial to you. Drugs, including those prescribed to save lives, kill people many times every day. Chemo therapy, hypertension, and diabetes drugs are only the tip of the iceberg with these guys, yet they attack, through surrogates like Quackwatch, and get away with it.

      Don’t let this guy scare you: seek the best nutritional supplements you can find and don’t listen to scaremongers. I am not saying that doctors should never be consulted, but you should do your own research and find what works for you. Read about alternatives and find consultants or ‘health coaches’ if necessary. The life you save may be your own. The profits lost may be those of Big Pharma, the College of Surgeons, and so forth.