Two Clinical Trials for Fruit Juice? That’s What the FTC Was Demanding!

February 2, 2015

Branch with ripe pomegranateIn breaking news, the DC Appeals Court says that would be unconstitutional. But the rest of the decision in the POM Wonderful case was disappointing.
Last August, ANH-USA filed a friend-of-the-court (amicus) brief in support of POM Wonderful. The Federal Trade Commission had barred the pomegranate juice company (and, by extension, other natural product companies) from advertising any so-called disease-related claims about their product unless it is backed by two random-controlled trials (RCTs).
RCTs are immensely expensive, and many natural products companies could never afford one RCT, let alone two, for each product for which they might wish to make a disease claim. A disease claim, under federal law, is any health claim that gets specific. For example, “better heart health” would not be a disease claim. But lowering blood pressure would be. The FTC’s order basically warned food and supplement producers never to make a specific disease claim unless they were prepared to spend what could be hundreds of millions of dollars on an unpatentable product.
The pomegranate juice company has spent many millions on health research of its own in addition to relying on academic research. It fought back, appealed the ruling, and the case was being heard in the DC Court of Appeals. On January 30, the three-judge panel returned its decision: the FTC’s blanket requirement of at least two RCTs as a precondition to any disease-related claim is indeed unconstitutional under the First Amendment—just as we had maintained in our brief.
The court stated that the FTC must “demonstrate a ‘reasonable fit’ between the particular means chosen and the government interest pursued….Here the commission fails adequately to justify a categorical floor of two RCTs for any and all disease claims.” The court noted that requiring two RCTs without justification would be very costly, and could ultimately deny consumers useful and truthful information about products. This would, in the words of the ruling, “subvert rather than promote the objectives of the commercial speech doctrine.”
So far so good. But then the court’s logic got very murky. Although a requirement for two random-controlled trials would be unconstitutional, one could be OK. Huh?
This is just one case. But based on this precedent, it’s likely that a future court would require at least one RCT. Depending on the quality of the clinical trial and the type of disease claims being demonstrated, the number of RCTs required may vary.
As we have long noted, RTCs don’t even fit food and supplement research perfectly. A drug molecule can be better isolated in its effects, although interactions with other drugs are inadequately studied. Foods and supplements are just part of our diet and often depend on co-factors. For example, supplemental calcium should not be taken without supplemental K2, but isolating it for an RCT would miss that. In addition, the effect of a food or supplement will depend in the first place on whether the subject is deficient in that nutrient. No one is nutritionally deficient in a drug. Random choice of participants for a food or supplement study is therefore illogical.
The court in this case stated that any commercial speech restriction must “directly advance the governmental interest” and “[must not be] more extensive than necessary to serve [that] interest.” This is an interesting choice of words. We would have thought that we should worry about the public interest, which is not necessarily the same as the government’s interest. In any event, it seems the only reason the court struck down the two-RCT requirement is because there could be less restrictive means to the same end, such as one RCT.
Our amicus brief highlighted another important issue as well. We argued that the FTC’s RCT requirement violates the notice-and-comment rulemaking process—that the FTC is essentially making new law, and must give the American public sufficient time to make formal comments. We made the same argument in our Citizen Petition to the FTC. Unfortunately, the court disagreed, in effect saying the FTC is free to create law this way where they are not specifically altering current law.
ANH-USA will continue working to rein in the FTC as it tries to make new law on its own. The appeals court’s word is not final. We’ll keep you posted.

42 responses to “Two Clinical Trials for Fruit Juice? That’s What the FTC Was Demanding!”

  1. kevin pyne says:

    the claims made by POM and other natural food producers as a rule are the same as those in independent studies by nutrition Phd’s, md’s, chemists et al. i never drank pom until it showed up in an independent study on correcting blood pressure through a variety of means and resources. i don’t work for pom and don’t always buy their products but i have read enough material from johns hopkins, harvard and other distinguished schools to know the value and dangers of blueberry, pomegranate, strawberry and other juices as well as coconut and olive oils and just about every other food ever grown. almost every natural thing has a benefit when taken in moderation and that sirs is about the only warning one needs. as far as claims i do believe pom and others are relying on the same studies as they are rather commonplace. thank you. kd pyne

  2. well kids need the best juice , so whats wrong with that

  3. I think it’s interesting that “our” government is challenging healthy food while allowing the meat and drug companies along with Monsanto to saturate the rest of our food with molecules that our body either cannot process or overcome.

  4. wanda Koch says:

    We have to fight for our rights which are slowly being taken away. we have a right to choose and to decided for our selves as to what we want and believe

  5. madmemere says:

    The entire current “regime” has gotten totally out of hand AND out of control. Past and current evidence has proven CDC, FTC and ANY of the rest of the “unelected” bureaucrats have NO interest in the wellbeing, OR safety of US citizens. I say let companies post their own findings and conclusions, THEN let consumers “decide for themselves” what is, or is NOT good for them. We do NOT need “nanny government” deciding “for US” what we can, or cannot drink, or eat! The fed needs to “butt out” and “stay” out of the way!

  6. wanda Koch says:

    Unbelievable Our rights to choose are slowly being taken away. Yes there is plenty of information out there to check and learn Companies should have to adhere to good standards of an for creating the product and knowing what the product is the and the scientific base of it should be acceptable.. Use words such as may be beneficial ck with your doctor or naturopath if there are any questions should be enough Companies should make them self known for there product and how it is processed.and what testing their is to create the product

  7. Bonnie Duncan says:

    On the CIA website, the United States is the 47th country listed in life expectancy. 46 countries have longer life expediencies than a US citizen at birth. If you are born anywhere in the European Union or Bermuda or Israel, you have a longer life expectancy than an American.
    One of the reasons is that our government is controlled by the big money interests that control our food and medicine. Pharma has set up regulations that forbid a traditional heart remedy like pomegranate from asserting that it can help heart disease without two double-blind academic studies to support this assertion. Thousands of years of human consumption and benefit are as nothing when confronted with industry-backed US regulations. This scenario is wrong and is one of the reasons 46 other nations have longer-lived citizens than the US does.
    To change this, we must become activist citizens and petition our legislators to change the regulations that are preventing millions of Americans from the benefits of natural cures and remedies.

  8. Oreste Lombardi says:

    When did our courts change over from protecting the public interest to protecting the government interest? An RCT requirement would only advance the pharmaceutical industry which is already very profitable. Also it would restrict our freedom of choice. This case is about fundamental freedoms that America should stand for.
    Regulatory agencies should not be allowed to make laws.or abuse their power. I assert that regulatory agencies should be accountable to the tax payers and not to the government or industry.

    • Oreste Lombardi says:

      When did our courts change over from protecting the public interest to protecting the government interest? An RCT requirement would only advance the pharmaceutical industry which is already very profitable. Also it would restrict our freedom of choice. This case is about fundamental freedoms that America should stand for.
      Regulatory agencies should not be allowed to make laws.or abuse their power. I assert that regulatory agencies should be accountable to the tax payers and not to the government or industry.

  9. susan ballarini says:

    ARE YOU SERIOUS? DOES THIS HURT YOUR EARS? I thought you believed in free speech.

  10. Charlotte Braun says:

    If it isn’t from a pharmaceutical company it’s a lost cause ’cause the bottom line is Money.
    My husband’s carotid arteries are clearer because I am giving him POM juice every morning.

  11. Natasha Gubert says:

    just leave the juice people alone.

  12. Lawrence Jacksina says:

    So illogic prevents the public from understanding the restorative, healthy value of natural foods, things many of us may know through our own means. Doesn’t that strike you as nuts, and perhaps indicative of control of the FTC by the mega-food industry. Let’s EDUCATE and PROTECT, FTC.
    Please.Ffor ALL of us.

  13. Diana says:

    I disagree with you on this one. In order to make claims, it needs to be backed up by evidence!!! And that evidence needs to be research on the actual end product. Just because pomegranates have certain health benefits, once that product becomes juice and ANY processing of it needs to have valid research to back up that the end product does the same thing. This is like structure function claims……vitamin C does this, our product contains vitamin C, hence our product does this too. NOT
    The uneducated American public is being duped all the time with outrageous claims and they fall for it. No wonder people are confused and sicker than ever. This is just one of the reasons.

  14. Martha Hyde says:

    ANH-USA should take the FTC to court because they do NOT include the nutritional and toxic status of individual participants in drug trials. This might bring to head the problems with vaccines where the immune status of the patient, especially as it is affected by the presence of toxins in hypodermal (interstital) fluids is never fully investigated by a doctor before administering a vaccine. Who among them has ever had a spectral analysis of hypodermal fluid samples, at any time in life?

  15. Nancy Wardwell says:

    It is very upsetting to see how far the government will reach to monitor such ridiculous things as these
    basic and helpful claims on containers of POM or any other real fruit juice product, for that matter.
    How many sugar loaded drinks for children claiming to have a drop of real juice in them have they
    gone after? Look at the number of pharmaceutical drugs that have caused death or severe side
    effects in humans, and yet, the government looks the other way because it is a huge monitary value
    for drug companies and their investors. Shame Shame Shame! Why not spend our hard earned
    tax dollars on something of significance instead of going after something so good for us and harmless?
    Thank you Alliance for Natural Health for keeping us informed and helping to fight back against this
    insane government interference.

  16. Richard Bentley says:

    If you think you cannot do an RCT for either economic or any other reason, then do NOT make specific health claims. If you cannot back it up it is false advertising.

  17. Harv says:

    I agree with the court that one RCT should be required if making a specific disease claim unless it’s worded to make it clear the claim is not proven. Maybe you weren’t around in the ’70’s and 80’s when supplement manufacturers were making outrageous and fraudulent claims for many substances, some of which were outright dangerous and harmful. Does the literature on the container say the claims only apply to people deficient in whatever nutrient or supplement they are selling? In my experience they seldom do. I have some POM wonderful in my refrigerator now and I take some supplements, but let’s be honest-many of the manufacturers are only in it for the money. They’ll make any claim they can get away with. Remember when they did a couple of RCTs on vitamin E and after years of wonderful testimonials it turned out to cause heart disease? Don’t get me wrong-the ‘legitimate’ drug manufacturers have plenty to answer for also. And a concentrated chemical is likely to be more harmful than a natural food substance. But I do think they should both have restrictions on what they can claim.

  18. Timothy C. Shanahan says:

    I dunno; double-checking for safety sounds like a good idea.

  19. Lewis R. Lowden says:

    The RTC is right, the cost of it is wrong. Why? If you are going to make a medical health claim then you better be able to support that claim with scientific fact, otherwise it should be against the law…we have enough “Snake Oil” salesmen within the AMA, we don’t need anymore…especial within the natural product companies.
    What is needed is a low cost, government supplemented RTC department that makes it affordable for small companies to submit their claims to for prompt, scientifically controlled RTC tests to be performed such that small companies–from all businesses–can be competitive with the “Big Boys (& girls).”

  20. J Sehler says:

    Way to go ANH… HOLD THE LINE! We need to take our government back as a representative of the PEOPLE, not of and for itself. Thank you for all your do for us.
    J Sehler

  21. Sami Thompson says:

    Interesting. I could’ve sworn that only Congress was authorized to pass new laws into existence. Of course, I also thought that the purpose of the FDA and FTC was to enforce the laws that Congress had already enacted. Silly me!
    It’s enormously frustrating when governmental agencies forget WHO they’re supposed to be representing – the citizens of this country, not corporate interests or greedy politicians.

  22. Austine Wallace says:

    ” The FTC’s order basically warned food and supplement producers never to make a specific disease claim unless they were prepared to spend what could be hundreds of millions of dollars on an unpatentable product.” So not true. A laboratory result analysis of any health benefits to be verified only costs about five thousand American dollars…. so I have heard from reliable lab technician sources. Health claims should be substanciated, not lucid fireball remedy or empty snake oil claims.
    Saying it would cost “hundreds of millions of dollars” is a false claim of the cost for a verification lab analysis. It doesn’t have to be that way.

  23. K.S. Harkey says:

    This is a tricky subject, because what we certainly do not want is large food packaging companies making whatever claims they like on their labels; which may have no basis in fact. However, since foods are neither supplements nor drugs it seems a more reasonable solution would be to require specific claims to be backed up by a formal citation directly on the label, exactly as one would for a scholarly journal article. Let the FDA regulate which citation style, so that there is consistency- and the American consumer is duly informed and able to perform his or her own research on the matter.

  24. Victoria Hay says:

    I believe we should always be careful of harmful contients inwhich we consume. Allthough putting a company broke defeats that process. Yet when I buy my food I am not allowed to know what is in my food or what the effects will be.

  25. Tom Bradburn says:

    Check out today’s New York Times front page article. Looks like the supplement companies that you and I trusted with our health and our hard earned money have been lying to us about the ingredients. I hope the government really cracks down hard and protects us consumers.

  26. Irene says:

    By restricting speech about nutrition the FTC is being used to legislate advantages to those who sell toxic management of side effects due to a poisoned environment. This eugenic policy represents crime against humanity and nature and we should be arresting and trying with grand juries all over the world the CEOs and officers of the lobbying and management arm inside each world corporation.
    Get on the anon chat boards, make the connections and be ready to move when the spark starts.
    The world bank has exposed massive corruption with in, The state department is a front for the corporate take over of all functions of the once open commons. Do we really want to be bred and slaughtered by a banking elite who poisons the earth to restrict the human population ? Worse than just prooving what the banking elite has done to humanity sinse CHRIST”S day, the proof should be posted widely over the internet so everybody can know. Then the guilty will have such a proponderance of evidence against them that they will become a target for murder, just like we are.
    Go beauty trolls, gather the evidence and publish widely…. Love

  27. Dot says:

    Please keep fighting with logic, reason, and facts as you have. I have faith that “truth will prevail”, though it takes time to educate the masses.

  28. K Hass says:

    The (so called) government is no longer “for and by the people” (if indeed it ever was); one can only go on fighting the “good fight” and get the word out through articles such as these and others as to what is going on and what is REALLY good for one’s health-organic fruits and vegetables and pray that people wake up to the big pharma scam,, $ and corruption that is on-going (plus more than that!) ,,, Really do not have ANY faith or trust in government agencies and their paid off shills,

  29. Bev says:

    Great. They want to require more extensive testing than corporations give the public for everything they put in the market – simply because of claims made?!
    well, that settles it. I guess natural food companies need to hire advertisers to speak for them – because advertisers can obviously say anything in this country and get away with it!

  30. Douglas Shackelford says:

    The requirement for a placebo based, double blind type study makes no sense in the case of food and nutrition. The interaction of multiple influencers on the outcome make predicting results a logical impossibility.
    A standard such as “the preponderance of evidence” would be far more logical and applicable. Both the government agencies and the courts should agree without undue complaint.
    As is alluded to in the article, the government’s “interest” must be directly inline with that of the public.

  31. Albert Lea says:

    I very much appreciate both government and private practice review of food and consumer items.
    I would like to be able to have the opportunity to appreciate not being required to use other’s judgments and to be able to use additional research.
    Even handed reporting of protocols used and their results builds knowledge.
    Limiting experiences and knowledge of them limits our futures.

  32. Charlene Breedlove says:

    Many natural, unadulterated fruit and vegetable juices have a well-establihsed vitamin and mineral content conductive to strengthening the human immune system and fighting many disease conditions. Perhaps they should be obliged to state their proven (i.e., measured) beneficial contents and how these affect well-being, but it would be absurd to ask their owners to perform RCTs. To claim that only manufactured drugs can cure disease is no less absurd. All drugs have harmful side effects, which doctors tend to ignore. Fresh, unadulterated fruit and vegetable juices only produce negative reactions when there’s an allergy, which is easily detected.

  33. N. Sizemore says:

    This, and similar restrictive measures, will clearly become more common as increasing numbers of people switch to healthier dietary and helath care alternatives. It may be time to organizae a more comprehensive approach to congress to restrict such efforts on the part of the government, much as was done in support of DSHEA. Bringing multiple examples of attempts, successful or not, by the FDA and, now, the FTC, to restrict choices for use of long-established modalities since passage of DSHEA might suffice to convince a committee not completely in thrall to the commercial interests that some corrective action is appropriate. One would need to draft the proposed changes, and find a CAM-friendly legislator to sponsor them, but that is necessary in any event. The many alternative practitioners, especially those previously involved in supporting DSHEA, should be well prepared to offer case histories and statements in support of such action. Perhaps the most critical area needing change is in solicitation of, and review and action on, comments to proposed regulatory action, which should include review by both conventional and CAM practitioners.

  34. Chuck Bagg says:

    Maybe I should have been a lawyer instead of an electronics engineer, but I would argue this case on the basis of free speech and due process, i.e. “innocent until proven guilty”.
    If I have reason to believe that some food or nutritional supplement can prevent or cure a disease, I have a constitutional right to say so. If the medical establishment or the government thinks I’m lying, or mistaken, and therefore potentially guilty of harming the people who listen to me, they have the burden of proving my guilt in court. I do not need to prove my innocence. (Presumably, these personal protections now also apply to corporations.)
    Since when does the medical establishment (yet no other entity), get to overrule the constitution on free speech and due process? This is an outrage!
    Chuck Bagg, Chuck-full of Ideas

  35. Lori Rees says:

    In this day where we are poisoned by our air, earth, and water it is just ridiculous to be targeting health foods or drinks. We see the damage in our children and it is soley the fault of human greed.

  36. Lori Rees says:

    Go make a law that matters. One that will actually help the earth recover from decades of pillage and rape.

  37. victoria hinton says:

    The greed it takes to demand studies (that already exist other places) is beyond outrageous, it borders on evil. Because it’s evil to destroy other human beings in your climb to own all of the money in the world. The more poor people, the fewer products to choose from. It seems that it would behoove these people more to encourage growth for their own selfish reasons. That is why it seems that this attach on food products is emanating from a higher place. But, all it would take is for a few well-reasoned people in positions of authority to not bend to the will of the greedy rich ‘overlords’ and not demand studies for each product, especially when the studies already exist elsewhere.

  38. Ron says:

    It is interesting to note that the FTC decided to require two random trials, while I know of several drugs pulled from the market over the last few years due to the FDA not noticing that their trials were anything but random. They did notice that fact after a few deaths. I think that, in the case of foods and food products, the producers should be able to quote or reference any health comments made in medical journals, and claim them as valid. If anyone questions the claims, they would have to be questioning the medical community.
    Over my many decades of life, I have heard two things since childhood regularly. “An apple a day keeps the doctor away”, and chicken soup helps a cold. Both of these statements can be true, and several medical doctors have told me that. I would bet that if apple growers or soup makers put such claims in their ads, even anecdotally, either the FTC or the FDA, or both, would be all over them. Anyone with common sense should know that proper diet, exercise, etc. is better for your overall health. Unfortunately, there is little evidence that juice, without the fiber and other nutritional value of the whole fruit, is all that healthy for you.

  39. vaughn baird says:

    thank you its good to see somebody has some accountabilty

  40. Susan Photinos says:

    Thank You for the work you do in reining in the overstepping govt. machine. Bless you with wisdom, strength, and support from Almighty God in your pursuit.
    Susan

    • Susan Photinos says:

      If you have to modify my comment then maybe you don’t have the Constitution backing you in the first place. As far as I know WE STILL HAVE FREE SPEECH IN THE COUNTRY!
      AMEN!

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