The FDA Calls One of the Body’s Basic Healing Functions a “Disease”

Cool Gel Pack On A Swollen Hurting KneeWhy? To make sure Big Pharma gets a monopoly on new drugs connected to it!
 
Inflammation is the body’s complex biological response to harmful stimuli such as pathogens, irritants, or injuries. It’s a natural, protective attempt by the body to remove the stimuli and start the healing process. When this inflammation becomes too intense or chronic, the inflammatory response itself can damage tissues. Atherosclerosis, asthma, allergies, autoimmune disorders, celiac disease, rheumatoid arthritis, sarcoidosis, and even cancer are all triggered or caused by or involve inflammation.
 
Although it is a natural protective response of the human body, the FDA has decided that inflammation is, in and of itself, a disease, and that statements about the ability of a supplements to treat inflammation are “implied disease claims.” FDA issued at least ten warning letters in 2013 to companies for making alleged disease claims correlating dietary supplements to inflammation. Moreover, more than 150 companies—many in the practitioner channel—also received warnings from FDA in the early months of 2013 demanding that the companies discontinue all product claims related to inflammation. Based on these actions, the agency may consider any mention of “inflammation” to be a disease claim.
 
A source told ANH-USA that the FDA rejected a supplement company’s pre-marketing application which said that the product “supports healthy inflammatory response.” Under the landmark Dietary Supplement Health and Education Act of 1994, supplements are allowed to make claims about how a supplement may affect the structure and function of the body (“structure/function” claims), and this statement would seem to fall squarely in the structure/function category—but that’s not how the FDA is treating it.
 
Why is the FDA doing this? Because Big Pharma has some anti-inflammatory drugs in the pipeline, and they want a monopoly on its treatment. So they pressure the FDA, which receives an inordinate percentage of its operating budget from the pharmaceutical industry, and the FDA issues its warning letters. Here are just a few of the products being developed:
 

  • Five new drugs for inflammatory bowel disease, together with four new applications for existing drugs, are currently under investigation.
  • The FDA just approved Entyvio, which treats inflammation connected to Crohn’s disease.
  • Pharmaceutical company Gilead has nine drugs in various stages of clinical trials for inflammation in relation to cancer. Two of them have already been submitted to US and EU regulatory agencies for approval.
  • Evidence from clinical trials suggests that statin drugs, which claim to treat high cholesterol, are also anti-inflammatory. If statins gain new traction as anti-inflammatory drugs, drug companies may have found an additional way to further reduce competition from supplements. Of course, as our readers know, statins come with serious side effects, such as muscle pain and depletion of the vital heart nutrient CoQ10. Since the heart is a muscle and depends on CoQ10, the current rise in heart failure could well be linked to statin use.

 
Whatever the prospective merits or demerits of these drugs, inflammation is not an abnormal “disease” state of the body. It’s part of the body’s underlying maintenance system, and can be triggered by something as simple as stubbing your toe. By the FDA’s ludicrous definition, we wonder if the inflammation that results from stubbing your toe would be considered a disease too!

69 comments

  1. Inflamation is natural, and can not be conidered a disase. Don’t be rediculous.

  2. If I had my way, big pharma, the USDA and FDA would all be on trial for murder, but of course it will never happen…………..sad to say. The government will be the end of this country yet.

  3. Inflammation is not a word that is owned by anyone. It is a legitimate response to many things and can be helped by many things. It is inappropriate for the FDA to have an opinion on this. Please do not step past your professional boundaries on this issue. We must have the freedom to speak and to believe as WE understand. That is an individual decision, not to be imposed by any corporate or federal body. Thank you.

  4. I’ve seen an increasing number of customers in my health food store who say their disease is inflammation. I do my best to explain that it is a natural response to something else such as injury, allergies, or toxins but, to no avail. They have been told by their doctor that they have an inflammatory disease and that’s what they believe it is. So, they often insist on a natural anti-inflammatory supplement. Once again I’m forced to sell what I don’t believe in. Between the big pharmas and Dr. Oz. I’m fighting an uphill battle.

    1. BIngo! Try explaining to a mother that giving Tylenol to a feverish child is totall counterproductive! Try explaining that the body has a beautiful system for killing viruses and bacteria by overheating them, and that you are working against this when you medicate. You are looked at as if you are a) mad and b) dangerous. btw, I safely brought up 3 sons by respecting the healing modalities of the human body.

  5. I know which supplements “may” assist in inflammation situations. Even if the FDA makes them take everything off their label except their name, I will still know which one(s) to buy. My rule for ALL new drugs is never accept a prescription for any drug that hasn’t been on the market for a minimum of seven years. That’s long enough to (1) really see if it does any good, and (2) see if it really does any bad. So, PharMa, develop all the inflammation drugs you want, you’ll never get me to use them.

  6. I was diagnosed with MS in January of 2011. Since then, I and my husband have done a lot of research on supplements available as anti-inflammatories. I am currently using Slippery Elm Bark (which got rid of my GERD and other stomach issues) and am also using Curcumin. I have noticed a considerable difference with just these two supplements. As far as I am concerned, natural supplements are a God send! I will not go to a physician that does not believe in the use of supplements. All of my current physicians are aware of all the supplements I am taking and agree with my regimen. More physicians should learn about alternative natural supplements and recommend it to their patients; but, because of pharmaceutical companies supporting their practices, I am afraid that that will never happen!

    1. Glad to hear of your improvement, stick with it!
      Most importantly, have you tried a gluten free/dairy free way of eating – many things would improve much more rapidly! – Good luck, Sonja

  7. It’s all about the money. The FDA is in the pocket of Big Pharma. The USDA is in the pocket of industrial and corporate agriculture. It just goes on and on, and good and integrity go right out the window.

  8. Inflammation is a natural reaction to an injury. Drugs are NOT natural.

  9. FDA: Funeral Directors of America are grotesque…..I see no difference from them and every despot that has ever existed & bullied a nation. We the people should not bow down to Cesar….we are free, Can we not gather ourselves and over throw this despot of an organization. We do have God given rights of liberty & freedom…..

  10. ns they use chemicals whos remains are still there to cause reactions that are worse then most problems. In over 60 years I have found a large percentage of pharmas con jobs are pulled because of ineffectiveness or harm. That harm is seen everywhere.
    I used to work as lab tech for a group of doctors and they assigned me to talk to the drug pushers or salesmen as they are called. I dutifully took notes and reported to the docs. I never said anything but I was very unimpressed with the cost and efficacy. In many cases they are taking the afflicated fear and hope to use against them. It is an emotional reaction even on the Drs part.
    I have actually heard someone telling a patient who had a stroke (in words that in effect blamed them for their disease) that they had to take any test or any medicine because they were told to regardless of cost or pain.
    So the FDA can do more bumbling and OKing bad medicine for the “for profit” crowd but I am pulling away. That is one reason I got out of medical labs and into water chemistry. The fear factor is a tool too easily used with sick people who just too trusting.

  11. WARNING: Eating healthy, organic food and consuming beneficial supplements may be harmful to individuals with FDA-itis.

  12. This deserves a petition, if not a law suit. I should not be legal to change the definition of a common word in the dictionary. especially at the whim (and financial benefit of any corporation:
    “1. A response of body tissues to injury or irritation, characterized by pain and swelling and redness and heat”
    form the WordWeb V. 6.71 dictionary (Princeton Database, University)

  13. It seems that the FDA is a useless agency and does not have the best interest of the public. I have been using supplement for over 65 years. As a teenage when I was in sports and studying intensely in school. I know from personal experience that the supplements which I have used help me.
    Just like the food products (approved by the FDA), there is a lot of impure ingredients in cereals; breads; cookies; corn; wheat, apples; etc. Especially those GMOs; and pesticides/fertilizers used to produce large quantities(but poor quality) by the big farms. Therefore, you have to supplement for what is leeched from the mass production.
    There is a lot of information on fish oil. I have been using it for over 65 years and never saw any side effect (I never had to use aspirin or blood thinners, so be careful if you do). Due to all the recent hullabaloo, I had stopped taking fish oil on three separate occasions for one year to test what would happen. My personal experience was by the end of the second week, the pains in my joint intensify.
    So I added to my current daily fish oil, Bio-Curcumin and what a difference. I have very little to no pain. Well, a little in my back. But I am retired, kinda.. I am rebuilding an 89 New Yorker V-6 engine; finishing up the wood work on the interior of a 16 X 20 room addition, making an 8 ft X 16 ft. vegetable garden, and of course mow the lawn twice a month. Did i mention I have to paint the new room, in and out?? I should have stayed at my old job, where I was able to get an 8 hour rest 5 days a week. Really, i do not miss that job. It put me in the hospital after 7 years of frustration with management.
    Eight years ago, after leaving the hospital, the doctors gave me a long list of Rx medications. I was more sick than before. From using 9 different Rxs a day, I am down to just one and I am researching to replace with a supplement. I also use CoQ10.
    Be careful, like anything you eat or use for your health, be sure your supplements are good quality from a reputable manufacturer and pay attention to those with terrible side effects. Remember, an exercise program, no matter how limited is important.
    Tell the FDA to keep their hands off our supplements.

    1. Ask your doctor why you haven’t been told that statins leach COQ10 out of your system. Shouldn’t they be telling you this? Mine knew when I asked her about it. Why didn’t she tell me? She acted surprised, like I should have known all along without ever being told.

  14. Well, if we want to get particular – the FDA can claim that it is of vast benefit to we the people.
    We know beyond doubt they are shills and dupes for the drug pushers – and i mean the baddest, meanest, killingest buggers on the planet – not those sissy corner and gangbanger drug babies. i mean the killers of millions through the world, the cripplers of millions more, and the walking disaster of health personified.
    Technically – they could define a grape to legally be named Frederick and state that they are legally the size of volleyballs. This doesn’t change reality. To name a body function to be a disease is …. well, irritating.
    Gandhi had it right – when asked what he thought about Western Civilization, he paused, thought a bit, and stated “I think it would be a wonderful idea.”
    These clowns are not civilized, and the rich strata who issue the marching orders are the farthest from civilization – further than the street gangs i mentioned before. Civilization is a group of diverse individuals gathering for survival improvements, increased life quality, perhaps increased life span, attempted stability. The wealthy destabilize to take advantage, they destroy quality of living, they damage our physical health and thus reduce people’s lifespans.
    The wealthy and corporate directorships (and their political whores) are pretty un-civilized.

  15. Inflammation can be positive or negative. A claim that a substance increases or decreases inflammation has little value. There is insufficient research regarding the first two issues that are raised but the latter two are clear.
    Aspirin can reduce the frequency of some cancers but not others. Even the cancers that are reduced do not show whether aspirin inhibits their induction or proliferation. Not all anti-inflammatories reduce those same cancers suggesting that anti-inflammatory action is not sufficient. Aspirin manufacturers have been enjoined from making anti-cancer claims. Why should those who market other anti-inflammatories legally make those claims?
    Statins reduce deposition of atherosclerotic plaques, reduce the rate at which they become destabilized to produce thrombosis and at high doses result in some regression for some subjects. The first and third effects appear to be driven by LDL reduction with concomitant risk of insufficient steroid hormones and CoQ10. The first and second appear to be driven by anti-inflammatory action with concomitant undefined risks. Lacking possible factors such as inhibition of protein prenylation manufacturers do not claim mechanisms, only documented effects. Why should others be able to claim mechanisms?
    Subject both drugs and supplements to the same rule. Claims to promote or inhibit inflammation require context and proof of benefit.
    Although physicians are free to express opinions, drug manufacturers have been penalized for promoting off-label prescribing of drugs for conditions other than those approved by the FDA. Even without physician opinions supplement marketers do publish and advertise substances backed by scanty research that often comes only from the raw supplier.
    Even if properly diagnosed, how could a consumer judge whether a product would benefit or harm him. I would rather ban advertising, label claims and articles that merely restate manufacturer hopes than risk the Draconian remedy of banning supplements.

  16. Glad to hear about the FDA’s move on inflammation and want to know what we can do to stop this.

  17. Print This Post Print This Post
    Cool Gel Pack On A Swollen Hurting KneeWhy? To make sure Big Pharma gets a monopoly on new drugs connected to it!
    Inflammation is the body’s complex biological response to harmful stimuli such as pathogens, irritants, or injuries. It’s a natural, protective attempt by the body to remove the stimuli and start the healing process. When this inflammation becomes too intense or chronic, the inflammatory response itself can damage tissues. Atherosclerosis, asthma, allergies, autoimmune disorders, celiac disease, rheumatoid arthritis, sarcoidosis, and even cancer are all triggered or caused by or involve inflammation.
    Although it is a natural protective response of the human body, the FDA has decided that inflammation is, in and of itself, a disease, and that statements about the ability of a supplements to treat inflammation are “implied disease claims.” FDA issued at least ten warning letters in 2013 to companies for making alleged disease claims correlating dietary supplements to inflammation. Moreover, more than 150 companies—many in the practitioner channel—also received warnings from FDA in the early months of 2013 demanding that the companies discontinue all product claims related to inflammation. Based on these actions, the agency may consider any mention of “inflammation” to be a disease claim.
    A source told ANH-USA that the FDA rejected a supplement company’s pre-marketing application which said that the product “supports healthy inflammatory response.” Under the landmark Dietary Supplement Health and Education Act of 1994, supplements are allowed to make claims about how a supplement may affect the structure and function of the body (“structure/function” claims), and this statement would seem to fall squarely in the structure/function category—but that’s not how the FDA is treating it.
    Why is the FDA doing this? Because Big Pharma has some anti-inflammatory drugs in the pipeline, and they want a monopoly on its treatment. So they pressure the FDA, which receives an inordinate percentage of its operating budget from the pharmaceutical industry, and the FDA issues its warning letters. Here are just a few of the products being developed:
    Five new drugs for inflammatory bowel disease, together with four new applications for existing drugs, are currently under investigation.
    The FDA just approved Entyvio, which treats inflammation connected to Crohn’s disease.
    Pharmaceutical company Gilead…

  18. I’d rather die than take what these people make.
    I hope Obamacare does destroy the drug industry,it’s already rotting in corruption.

  19. Regardless of all these new preventative actions by the FDA, the best procedure is to
    “be your own doctor” and take the initiative to search numerous alternative health sites, check out holistic books from the library, speak with alternative health experts, chiropractors, vitamin store’s qualified, knowledgeable people — and you’ll find natural products/methods to handle 90% of your health issues. Don’t give up, don’t rely on drugs or general medical people for your only answer. Many great options if you’re up to the challenge.

  20. Dear Sir:
    It is elementary and fundamental that inflammation is a bodily response, not a disease. It is also fundamental and elementary that for capitalism to work there must be competition. No company should have protection from competition. I offer that drug companies should not have any shielding from other suppliers of health related products. They should know better than to produce products that require special shielding from competition in order to compete.
    Oreste Lombardi

  21. Why does the FDA get “an inordinate amount” from Big Pharma? Seems to me that we should be signing an Action Alert to the appropriate decision-makers in Congress to provide a proper budget, independent from Big Pharma money.

    1. If I recall correctly, some years ago (I believe during the GW Bush years) it was decided that the FDA should collect fees directly from the drug companies in order to take their funding out of the general budget and shift those tax dollars to things more popular with the politicians of the time (undoubtedly tax breaks and/or subsidies for big business). In effect, what that did is turn the FDA into an arm of Big Pharma. A wholly owned subsidiary.

  22. Hypothetically if this were in court, is there evidence that the FDA wasn’t completely objective?

  23. There is always some kind of “fashion” in medicine. Back in the 19th century it was “hysteria”, the “vapors” or some other term for a vague syndrome of one kind or another. In the 1980’s we see “fibromyalgia”; in 1990’s and 2000’s “erectile dysfunction”, “high cholesterol”, “mental depression”, and numerous other disease entities that all have to have some new kind of drug to treat them, most likely ones that are heavily promoted on TV, and have dire side effects.
    Conventional medicine makes me sick !! Literally and figuratively.
    So now we have “inflammation” as our new fashionable “disease of the year”. What’s in a name? Start by using another name for inflammation and then the FDA will not be able to call it a disease.

  24. Inflammation is a healing function of the body which is necessary to life and can sometimes go awry and cause the body to become diseased, which doesn’t mean that inflammation itself is a disease any more than a scab on a sore would be a disease in and of itself. As a nutritionist who deals with whole food supplements, I am aware of those that help a natural healing inflammatory response. We should be able to make truthful claims about the various benefits of foods and food supplements. This is obviously big drug companies trying to silence any remedies, however natural, to keep people healthy and prevent or mitigate ailments in order to sell harsh drugs with multiple side effects, which they can then sell them more drugs to cope with. It’s so sad that our government agencies are protecting corporate profits and not the public.

  25. South Africa have removed Vitamin B12 and plan to only allow Omega 3 with a doctor’s prescription.

  26. Excellent article. Inflammation is definitely an inherent mode of cellular healing. We learn about this in basic biology! I suffer with asthma so I understand when inflammation becomes a real issue. The FDA shouldn’t discontinue supplements that claim to be anti-Inflammatory. If their doing that then they might as well ban specific foods too. This isn’t a game anymore, we are playing with lives.

  27. I have zero confidence or trust in the FDA or the USDA to look after my health or interest. Both these agencies have been “taken over” by big business and have just become “Rubber stamp machines” to approve what ever crazy things the likes of Monsanto want to do. This is not only endangering the nations health , wealth but our democracy. We need to put a stop to this as soon as possible.

  28. I am tired of the pharmacutical Firms getting away with putting things on the market that can harm and kill people . I have arthritis and have had 2 spinal operations and have a great deal of pain . I took Vioxx , and celebrex only to damn near die from them and now have a real bad case of asthma from them . 1month of Vioxx was bad enough 1 month of each and I could not go outside during the summer in the heat and humidity for more than 10 minutes and 4 hours inside in air-conditioning to recover for several years . Big Pharma needs a tight reign on them and the FDA needs to stop screwing the legitimate supplement companies . The NATURAL supplements work well compared to the crap that the BIG Pharma Co’s are putting out . They are just afraid that the competition will cut into their profits .

  29. I could not agree with you more. The FDA has far too much power and authority in the United States, yet does not have the qualifications and education to act rationally for all citizens, yes, even those not associated with big pharma.
    Our overall medical system in the United States is badly broken and those responsible for making it work are so corrupt that I doubt it will ever happen. Our whole medical system needs a healthy enema.

  30. The FDA is purportedly run by former exec’s of Big Pharma which, if true and in my humble opinion, is a serious conflict of interest. And as always, when there is a conflict of interest, the consumer is the one who pays the price both in health and monetarily.

  31. I’m sorry, but if a supplement is intended to control or reduce inflammation, it is treating the inflammation in the same way a drug does. It can not be said that it is supporting a healthy inflammatory response.

    1. You have over simplified the way supplements operate in the body. You have underestimated the the way pharmaceuticals harm the body. Supplements are generally used to replenish an absence of a normally occurring substance that creates a state of equilibrium. Pharmaceuticals are substances that are not natural and may do what is intended, but cause so many other problems to arise as to create more adverse conditions than they are treating. At this point in history there are some good pharmaceuticals that do what is intended without harm. But in the recent past basically none have been created that fit the do no harm bill.

  32. I wonder if doctors, who SHOULD understand inflammation and its causes, will allow this false information to stand. I UNDERSTAND, being trained as a Paramedic and RN. Is there any action that can be taken to out this lie? I must take antiinflammitory supplements due to back issues. I don’t, I won’t take drugs if I can find quality supplements. What can be done to get Monsano out of the FDA? I want to help!

  33. I wonder if the FDA also wants to regulate Curcumin?
    The overreach of the FDA into herbs and foods is unbelievable.
    I wonder what happens if website hosting is moved offshore?

  34. I am a clinical test researcher and I have been involved with longevity testing and toxicity pattern recognition for over thirty years. Through the use of advanced electrophoresis gel technology we can provide information about your personal health continuum.
    To help me explain, I will use the use of a GPS as an example. The GPS function in your device does not tell you how to get to your destination. The GPS provides a starting point for your travel and a computer program then plots the way to your destination.
    Someone in the car says “I know a shortcut” and tells the driver to turn left at the next intersection. After traveling for several minutes you reach a bridge under construction with a massive traffic problem. For you to reach your destination using the GPS you needed to have trust in the direction it gave to you.
    For you to take control of your health you need trustworthy information.
    In the realm of pre-disease we are trying to provide the information and direction you need to reach your health goals. First we take a first sample that will define the starting point for your health baseline. After 60 days we take another sample. Our computer analysis algorithm then compares thousands of data points on the two samples to provide you accurate information about your health movement.
    I would like your help. I have tried talking to the FDA , AMA physicians, major clinical laboratories, and hundreds of supporters of alternative medicine over the last 15 years, but the status quo remains the same. They promote what is profitable or politically correct.
    The need to understand if your intervention is working for you applies to both disease intervention methods and primary prevention methods. I want to communicate my belief that “The only person who can prevent or cure disease is You”. No medical professional cares as much about your state of wellness as you. How you or your loved ones are moving on the continuum of health that begins at perfect health and ends in death you need to know. I hope I can share information that will impact your wellness choices.

  35. Dear FDA,
    Please stop your attacks on food supplements and natural cures.
    Please stop supporting pharmaceutical company’s desires to monopolize my choice of treatment.
    I must remind you the taxpayers in most part are the gentile hard working backbone of this country. We demand you leave our food supplements alone and quit harassing the manufacturers of our supplements. I drink my share of clean cherry juice and I do not want the manufacturer harassed by the FDA. Quit sending letters to supplement manufacturers. Quit wasting my tax dollars immediately.

  36. nflammation is the body’s complex biological response to harmful stimuli such as pathogens, irritants, or injuries. It is not a disease!!!

  37. You bet this is the goal of big pharma and the FDA is complicit. Like the attempts of bio-tech to patent human genes, pharma wants no bodily processes or structures to be outside of their realm of control. As someone who has worked hard over time to control auto-immune symptoms related to inflammation with the use of supplements, diet, and esp. Vit. D, I resent these efforts to deny natural functions and our own rights to learn about non-drug methods. You can bet a (unfortunately expensive) black market will thrive when access to natural products is taken away.

  38. Unbelievable! We’ve known for decades that the FDA is trying to kill us all off! This is just another step closer! They should be shut down entirely for conflict of interest. “The love of money is the root of all evil.” And the FDA is getting more and more evil. More and more they are designating everything as a “disease” in order to shut down the natural health industry and prevent people from getting the real help they need. If you can make a population sicker and dumb down their IQ, they are easier to control for the coming despots, (e.g. one incumbent U.S. president).

    1. Don’t blame the FDA, blame the lobbyists who cram money into the pocket of your representative. Blame the de-regulators who think it’s a good idea for drug companies to run their own tests and monitor themselves just as the pesticide companies do, with hundreds of chemicals going untested at all. Blame the people who let Monsanto put Roundup and now part of the Agent Orange formula into your corn seeds and then you won’t have to wonder why Roundup is showing up in breast milk. If Monsanto doesn’t want you to know what contains GMO and you vote for them because they put the glossier campaign, it’s on you. If you don’t know where your representatives get their money, and keep voting for them, that’s on you too. They would love to get rid of the FDA or make it useless and they’re slowly succeeding.

      1. No, blame the FDA as well. There’s a nice revolving door scam they have going there. Today’s FDA executive is tomorrow’s highly paid Pharmaceutical executive or FDA lobbyist

    2. Where does this kind of thinking come from. To be sure, it is unethical to tamper with some of the body processes like inflammation. There is olive oil which is a natural anti-inflammatory food. Inflammation is dealt with in the brain like so much. Think again before you fool around with some of the natural process of the human body. We are quite marvelous and not to be manipulated like the drug companies believe. Look at the whole picture and be informed.

  39. Big Pharma is at it again and the FDA is in their pockets. Inflammation is a natural process. To even hint that inflammation is a disease is, absolutely, ludicrous. We all know this is all about money. The FDA needs to be eradicated.

  40. BigPharma has been inventing diseases based on SIGNS AND SYMPTOMS of illnesses or conditions, for decades, increasing incidence over the last 10 or so years.
    Pretty blatant. And under-educated populations don’t know the difference until it’s too late. I’ve encountered numerous Docs who also fall under BigPharma’s sway.
    “Signs and Symptoms” are NOT the disease/
    “Signs and symptoms” ARE Markers to point Diagnosticians [NOT BigPharma] towards finding the right diagnosis, then treating the actual root causes.
    BigPharma doing this:
    1. Perverts real medicine and BLOCKs finding root causes of diseases and ailments;
    2. Sets medicine back to the Dark Ages, practicing weird science and bogus medicine.

  41. Maybe if these people that are bugging the FDA, started taking healthy, supplements, instead of drugs. They wouldn’t be cooking their brains on drugs, and they would see more clearly!
    Talk about controlling everything!

  42. This is just so disgusting .I don’t even want to live in this country anymore. It is so corrupt

  43. Regarding inflammation, the problem with the use of drugs to ‘treat’ this natural process is that drugs are artificially created in a lab, not by nature. Because they aren’t natural, many of the wonderful things built in by Mother Nature are missing. Something is always missing in a lab-created product – processes that are started and stimulated by a drug may not be able to be stopped and thereby cause more problems. Celebrex is an example of this that is dangerous and causing death in patients. One has only to listen to the disclaimers given for most drugs by Big Pharma to realize just how dangerous these drugs are.
    It’s patently ridiculous to state that vitamins are dangerous when the death toll from vitamins is almost non-existent. The definition of a vitamin tells the story: a vitamin is a substance without which, if totally absent, life cannot exist. There’s no such thing as a critical shortage of any drug, but vitamin deficiencies can seriously impact health and life.

    1. None of the over-the-counter drugs that are currently available need to continue to be made available over-the-counter This statement in my comment above is incorrectly stated. I meant it to read: All of the over-the-counter treatments that are currently available need to continue to be made available over-the-counter. They should not be turned over to Big Pharma because of a word “inflammatory”. Stop being greedy Big Pharma. And FDA, stop being bribed into caving to Big Pharma.

  44. The human body’s inflammation responise is not bad. What’s bad is our popular methods of attempting to prematurely halt inflammatory responses.

  45. The FDA needs some serious revamping, it has all sorts of flaws. They like to shut down any
    physicians who challenge them.

  46. Inflammation is a function of the body, NOT a disease. Classifying it as a disease is a corporate malfeasance so they can make money off of something that the body does naturally.

  47. Big Pharma wants the absolute power to have a monopoly on all drugs so they can increase their profits big time. The consequences are dangerous–to consumers. Big Pharma will make sure these drugs are priced sky high so those who are not wealthy will not be able to afford them. Anti-inflammatory over the counter medications cannot and should not be handed over to Big Pharma. None of the over-the-counter drugs that are currently available need to continue to be made available over-the-counter. FDA, stop bending to the whim and pressure of Big Pharma and protect all Americans like you are supposed to. Stop accepting their dirty bribery money and stop the corruption both on Big Pharma’s side and on you, the FDA’s side. You are both equally guilty of corruption and you know it. It is shameful and what this government and all its agencies are turning into is so disgusting and shameful. Only the wealthy have the priority interest of the government body and all the government agencies. Whoever has the most influence and money is going to get whatever they want. It is like their are a bunch of children running the government, each one of them selfishly looking out only for themselves. You need to be adults and act like it.

  48. I have used natural supplements for about 50 years, this letter as stated removes one more right from USA’S Citizens being taken away by Corporate Citizens for profit. Most disappointing to minimum my feelings of free entreprise and personal choices. As Dr. Hellen Greenblatt states as double PhD in micro-biology and immunology, ‘that the body knows best’. I do not response well too more pharmaceutials. Fortunately physicians have informed to use Dr. Hellen’s product as well as those researched by Life Extention Foundation. I have to replace prescription modalities to natural supplementations more often; than not. Too many causes me hallucinations and delusional thoughts. While I am well informed, this ruling will effect future generations from knowing what to buy when pharmaceutials are ineffective or damaging to the body.

  49. As I read the comments it seems like many blame the drug companies. While they do everything possible to influence our representatives they don’t actually make the laws. Each of you still have an opportunity call your representative. You have the option to attend local meetings and meet with your representative. You have an opportunity to vote in new people to represent you. As we lose our rights on a daily basis I can only assume that the majority of people in this country are OK with the status quo as few of those who are sent to Washington DC are sent home at the end of their term.

  50. The motivation for Big Pharma (and the government) to control all ways to improve our health is much more than just money, huge as that is. it is about power. if we cannot buy our needed supplements, then we are dependent on Big Pharma and the powers that be. If we are sick, and made sicker by Big Pharma’s chemicals, that engenders even more dependency and fear. People who are sick, dependent and afraid are easier to control. That’s power.

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