Will FDA Censor the Cranberry?

FDA’s treatment of fruit illustrates what scientific censorship looks like. Action Alert! 
The FDA is currently considering a petition from Ocean Spray, the juice company, to allow a qualified health claim that cranberries can reduce the risk of recurrent urinary tract infections (UTIs) in healthy women. Given the way the FDA protects Big Pharma’s monopoly over medicine and elbows out cheap, safe, and effective natural medicines—especially in gagging free speech about the health benefits of these products—consumers must speak up so that justice—and health—are served.
Ocean Spray’s petition points to several randomized clinical trials (RCTs)—what the FDA considers the “gold standard” of scientific evidence—that support their claim that cranberry products can help with UTIs. Recall that the FTC—most likely at the behest of the FDA—tried to stop POM Wonderful from making claims about its pomegranate juice unless it had two RCTs to back them up. Ocean Spray’s petition indicates three RCTs that support their claim.
A qualified health claim is a claim that communicates a relationship between a substance and a disease or health condition. These claims must be accompanied by a disclaimer or qualifying language to accurately covey to the consumer the level of scientific evidence supporting the claim. By definition, qualified health claims do not need to meet the same scientific standard as traditional health claims, which require “significant scientific agreement” that the claim is truthful and not misleading. The bar for a qualified health claim is lower to reflect that the science is not as conclusive as full-scale drug trials (which themselves are often far from conclusive). A notable example is the qualified health claim for folate supplements and their role in preventing neural tube defects in infants, as well as omega-3 fatty acids reducing the risk of heart disease.
With not one, not two, but three RCTs behind their claim, one would think that Ocean Spray would have no trouble meeting the evidentiary bar for a qualified health claim.
Yet we’ve seen how this scenario can play out. The FDA previously blocked walnut and cherry growers from telling consumers about the health benefits of those foods, because only FDA-approved drugs can claim to “prevent, treat, cure, or mitigate a disease.” Diamond Foods, a walnut company, listed some of the health benefits of walnuts on their site, backed up by scientific studies—yet the FDA ignored the science and sent them a warning letter charging that this information turned walnuts into unapproved drugs.
The FDA also swooped in on cherry growers even though no health claims were being made—cherry companies dared to link to some of the scientifically-supported health benefits of these foods from their websites. For example, when cherry companies linked to peer-reviewed research that showed tart cherries may help with gout, arthritis, and inflammation, the FDA sent warning letters threatening regulatory action if they did not remove the link from their websites. Telling the truth about the benefits of tart cherries and walnuts, in the FDA’s twisted thinking, turned those foods into misbranded, and therefore illegal, drugs subject to raids, seizures, and criminal prosecution. Some companies were even forced to sign consent decrees, violation of which came with stiff financial penalties–$1,000 per violation per day, in addition to paying the cost of FDA inspections, including gas mileage and nearly $100 an hour for each FDA employee involved.
Qualified health claims were established by the landmark decision of Pearson v. Shalala, of which ANH was a co-plaintiff. Qualified health claims are critical in communicating important health benefits of natural foods and dietary supplements otherwise forbidden by the FDA. Unfortunately, the FDA has consistently limited the information available to consumers about the real health benefits of food and supplements and routinely rejects qualified health claims: what qualified health claims do exist have been won largely through legal challenges to the FDA on the part of ANH-USA and allies in the natural health community. In fact, qualified health claims for folate/neural tube defects, B-vitamins/vascular disease, omega-3’s/heart disease, vitamin C/gastric cancer, vitamin E/bladder cancer, and selenium/prostate, colon, bladder, and thyroid cancer, were all the result of court victories over the FDA of which ANH-USA was a plaintiff.
Even if there is some disagreement about the evidence supporting Ocean Spray’s claim, the very nature of a qualified health claim is that it is “qualified” to communicate to consumers that the product is not a drug, but that there is strong evidence that it can help with a particular condition. Denying consumers this knowledge serves no one but the drug industry. We must not let the FDA once again prevent free speech about the benefits of natural foods.
Denying legal qualified health claims is yet another way that the federal government protects Big Pharma’s monopoly over medicine and reduces access to cheap, safe, and effective natural medicines. If consumers aren’t allowed to learn of the benefits of healthy foods and supplements, these products cannot compete with pharmaceutical drugs—which is just the way the FDA wants it. We can’t let them get away with it.
Action Alert! Write to the FDA and tell them to grant Ocean Spray’s petition for a qualified health claim on cranberry juice. Please send your message immediately.

33 comments

  1. That companies need to substantiate claims is not a free speech restriction issue, it’s a consumer protection issue. Before a claim can be made, there must be evidence. If this is an issue of proof required by derived drugs and those required by foods, they should be the same and if they are not, then there is a big problem that must be dealt with. If not, the solution is not to relax evidence of foods.

    1. Yeah, and the “evidence” they want would bankrupt supplement manufacturers. If you do your homework, you’ll find that research has been done on many supplements — but not by the FDA. To justify their existence, the FDA should do the research. Of course, it wouldn’t be honest research as they are beholden to giant pharmaceutical companies. How is it they approve crap that really is life threatening, but want to restrict our access to healthful supplements? More people now die of prescription drugs than die of illegal drugs!
      Salt and water are vital to life, but both can kill you. Try swallowing a cup of salt. I remember reading of a man who learned that drinking lots of water was a good.thing and he drowned! Drink enough water and all your tissues become saturated and finally the excess water has nowhere to go but your lungs.
      I read of another man who decided that carrots were good for him. He ate so many carrots that he caused kidney and liver damage and his skin turned orange.
      Even the FDA can’t prevent stupidity.
      Who said that “all governments are criminal enterprises”? And the bigger the government the more restrictive and criminal it becomes. We have a huge government.

      1. Perhaps the research should be sponsored by NIH – specifically by the National Center for Complementary and Integrative Health, a whole institue whose mission is to research non-conventional medical practices.

        1. Sounds like you trust government agencies. I think the NIH also recommends vaccines that contain mercury. Amazingly, they think there is no natural cancer cure. ‘Guess they haven’t heard that baking soda, molasses, and water cure cancer. Watch: https://www.youtube.com/watch?v=Yl8Y8I_TsjI&t=325s
          Also, Dr. Simoncini of Italy thought that cancer looked like fungus and began to cure cancer with injections of baking soda.

          1. Bureaucrats are not inherently evil. They are like everyone else – selfish human beings who will respond to the incentives they are given. FDA is currently operating under a set of perverse incentives that cause it to behave in ways contrary to the public interest. Congress should fix that. But there are a lot of things Congress should do that are not getting done.
            NIH is rather decentralized, with each institute operating in its own silo and pursuing its own mandate. The whole reason for the existence of NCCIH is to investigate alternative medical practices of the sort that FDA wants to squelch. NCCIH has an incentive to find and validate alternative and complementary medical practices – that’s what it was created to do, and that is how its success is measured. In short, it was founded to sponsor the sorts of research that other government agencies, centers, and institutes were not interested in. It is often criticized by the medical establishment.

          2. I’d prefer that bureaucrats were honest and honorable. They have cushy jobs in hugely bloated agencies with too much power. If half the people who work for government agencies were suddenly fired, nothing would change. A private company, who needs to make a profit to survive, could not hire way more people than he actually needs. But, the government takes your money to pay a bunch of unnecessary employees.

          3. We live in a fallen world. While there are always some people who are honest and honorable, such people are rarely in the majority in any milieu.
            As you point out, private companies have very different incentives than bureaucrats. Even though businessmen are no more honest than bureaucrats, they usually behave better because they have to answer to customers and shareholders if they want to keep their jobs. It is harder to hold bureaucrats accountable. (Bureaucracy was the subject of my doctoral dissertation, so I could go on a long time about this.)

          4. Here’s bureaucracy at work for you. The US built a gas station in Afghanistan. What should have cost about $500,000 cost taxpayers $43,000,000! Some people got very rich on this thievery. Why is no one ever held to account? What about the people responsible for buying (or selling) $37 screws, $7,622 coffee makers, $640 toilet seats? Why is no one ever jailed?

          5. Some of those stories are grossly exaggerated. The $640 “toilet seat”, for example, was a cover for an entire lavatory assembly on a military plane. It was designed to be lightweight, seamless, and corrosion resistant and was made of polycarbonate. Basically, it had to ensure that a military pilot in a combat situation would not have to worry about feces flying around the cockpit.
            But, more to the point, those price tags did not come from government bureaucracy. They came from government contractors. To the extent they are outrageous, they are examples of crony capitalism, not bureaucratic corruption.

          6. Yes, those are the prices the contractors charged, but some crooked bureaucrat agreed to the larcenous prices so he’d get a kickback. How about shopping around for prices you’d pay in a chain store or order directly from the manufacturers. And don’t tell me that the manufacturers are not approved government contractors. What a crock!
            Doesn’t anyone check what we pay for stuff? And please don’t tell me that a $7,622 coffee maker had to be made from platinum.

          7. If you need a toilet that will fit into a small military jet without adding significantly to its weight and perform adequately during zero-G maneuvers, you won’t be able to find it on the shelf at a chain store – any more than you could find the jet itself. These high-tech products are produced exclusively for the US military. As for kickbacks, they are illegal in this country and almost unheard of in the federal civil service. (That’s not to say there is no corruption, but the corruption is mostly political, not financial.)
            Corruption begins in Congress. Congress creates the laws under which all of these entities operate and approves their budgets. If Congress wanted these contracts policed better, it would allocate more funds to contract enforcement. But every contractor is located in some Congressman’s district, and therefore has a protector on the inside.

  2. The real solution is to dismantle the FDA – get them out of food – let them deal with pharma only.

      1. They know the difference. This is just a blatant power grab. You’ll get arrested and thrown in the slammer when you are reduced to buying vitamin C on the black market. They want you to get an Rx from your doctor for vitamin C (and every other supplement). This will cost you waiting room time, $100 for the doctor’s time, and you can then fill your prescription for Vitamin C at your local pharmacy for an inflated price.
        The FDA thugs raided Daniel Smith in the middle of the night and put him in prison for TEN years. His crime? Daniel was selling MMS, a simple, inexpensive cure for almost anything, including most cancers. Tiny infants in Africa that were near death from malaria were saved with MMS. MMS also saved the lives of HIV/AIDS victims in Africa. Worldwide, MMS has cured hundreds of thousands of people from nearly any disease you can imagine.
        So, you tell me if the FDA is really interested in your health or simply lust for more power and to retain their incestuous relationship with the pharmaceutical companies.
        Actually, they are more like jack-booted Nazis.

    2. Godd luck with that! The FDA ia an enormous bureaucracy with way too much power. They approve dangerous Rx drugs with horrifying side effects but want to destroy our access to supplements. Isn’t it obvious that Big Pharma’s obscene profits are threatened by vitamin C and other beneficial supplements whose side effects are better health and well being.

      1. Didn’t say it would be easy. People never thought Trump would be president. Stuff can happen.

        1. Yeah, stuff can happen, but disempowering the FDA is a pipe dream. Tell me who or what is going to do that. Certainly there is no consensus in any group of elected officials in D.C. In fact, they have likely never even given it a second of thought. It is simply not on any agenda. Besides, those people in the house and senate probably rely on their doctors for their FDA approved blood pressure meds and chemotherapy and don’t understand the dangers of either. Their supplements probably consist of a bottle of multi-vitamin/mineral pills. Unfortunately, most people rely on doctors and their Rx meds rather than learning about cheap and natural cures.

  3. There is really only one job now that the law has been changed. They are protecting the Drug, Food and medical device companies. They are the MOB of Washington DC.

  4. I guess I am opposed to allowing these claims. It will become like the claims for eggs from “cage free hens”. And we will need another bureaucracy to decide what a “legal, qualified health claim” is
    If people are interested in medical alternatives they will find out how to treat their UTI’s with cranberries. But they might also find out they can use D-Mannose and avoid the sugar, or take c’berry capsules and avoid the sugar. And they will learn more about the processof healing if they take the time to do so.

  5. All claims of health benefits regarding any product should be backed up by solid, unbiased, independent testing. This should include all food products and drugs. The FDA should be able to ensure that the testing was done properly and not by the maker or producer of the product in question. Unfortunately, this will remove most if not all manufactured drugs, as the FDA relies on the results of manufacturers’ testing in order to approve the product for sale. Once the independent testing is done and approved, the FDA should not be able to limit any advertising or claims that specifically report the results of the tests.

    1. Who is going to do the testing? Most supplement manufacturers don’t have the facilities or a few million dollars for the research. Some universities and others have tested lots of things. Do some of your own research and you’ll find professional research and studies done on many supplements. However, your government DOES have the $$$ but I guess they’re not interested. Besides, I sure wouldn’t want the FDA to do this research.
      If any government agency was interested in our health they would never have allowed Monsanto’s Roundup with its GMOs and glyphosates. This crap is poison! Find out more here: What is Glyphosate? (Roundup)
      https://www.youtube.com/watch?v=LdDyMe9ohnM
      This is Big Brother trying to kill you.

      1. As you stated in your comment, the testing is already being done on many of these non-pharmaceutical products. What is not being done is independent studies of pharmaceutical products. Cranberries are not being targeted because of unsubstantiated claims, but claims not recognized by the FDA.

        1. Ron, Don’t you own a TV? I read that about 70% of TV commercials are for prescription drugs. You must have seen them. Each ad gives you a long list of possible side effects — none of them good, and some of them deadly!
          These ads always tell you to ask your doctor. What amazes me is that anyone would want to ingest one of these poisons. but apparently they do. The pharmaceutical companies wouldn’t keep running these expensive commercials unless they paid off.

          1. I own a TV, and even watch it about two hours a week. I have seen the drug commercials and, having friends and family in the medical industry, know full well the side effects of these drugs. This does not negate my original statement of wanting independent testing of all products before the producer or seller can make claims about them. This should be done for all drugs as well as food products before the claims can be made. Of course profits trump all other considerations. Any intelligent person knows that no industry in the U.S. can police itself, and that is why we need an independent and non-biased agency that can confirm all claims of efficacy and safety. At present, we do not have that.

          3. A product which tests to simply bear out its claims provides the consumer with no information as to its safety… and that’s what the ‘protection’ issue is really about. It’s easy to show that an artificial sweetener sweetens like sugar; knowing that it acts as neurotoxin is of greater importance to the consumer than knowing it tastes like sugar. The sole vital issue is, and always has been, consumer safety – at which all governmental regulatory agencies have failed miserably. Self-responsibility works wonders at mitigating such product information blackouts. This is the information age – seek it and ye shall find it rather easily.

    2. Hey Ron, Turpentine has been used for thousands of years as a remedy for lots of ailments –including candida. Kids got runny noses? Guve ’em a dose of turpentine.
      Why spend millions of dollars testing turpentine in some lab when it has been “tested” by millions of people throughout history.? Do a little turpentine research –it may save you and your family expensive doctor visits.
      I taught my friends and family to make their own liposomal vitamin C when I got tired of being their supplier. Homemade liposomal C is not as potent as the expensive brand you can buy from LypoSpheric Labs. Either way, it’s a life saver.
      Check out the YouTube video of the New Zealand farmer with a deadly Swine flu (https://www.youtube.com/watch?v=VrhkoFcOMII) The doctors wanted to pull the plug, but his family gave him liposomal C and saved his life.
      You’ll need some equipment to make your own liposomal C but worth the outlay. You can learn how to make liposomal C on line. One caveat, though: All the instructional YouTube videos use soybean lecithin granules. There’s no such thing as a good soybean so please use sunflower lecithin.

      1. Re the turpentine – one must be certain it is simply unadulterated turpentine. Most turpentine sold today has harmful additives (to undermine its use as a home treatment?).

        1. You can buy Pure Gum Spirits of Turpentine at Home Depot and likely at most hardware stores. This ain’t rocket science. If you’re considering taking turpentine, then do your homework.

  6. It’s time to stop begging for permission to do the things that rightfully should be done. Just do it. We should all become non-compliant with ridiculous ‘authorities’; the era of ‘governance’ has become quite stale.

  7. THE FDA has to go! All underhanded depts right now. I say get them out of food & only have them over pharma.

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