FDA: Massive Attack on Supplements

The long-awaited revision of FDA guidance rules for new supplements is finally here. It is very bad news. Highest-level Action Alert!
We normally publish our newsletter on Tuesday, but are sending out this issue today because of its urgency.
What we are dealing with here is whether the supplement industry is allowed to innovate and create new supplements. The FDA, working as usual on behalf of the drug industry, says no. We need your help to stop this right now. It will take a huge effort on all of our parts and we need to start immediately.
Over the last few years, one of the biggest issues facing the supplement industry has been the confusion over how to comply with the new dietary ingredient (NDI) provisions contained in the landmark Dietary Supplement Health and Education Act of 1994 (DSHEA), the main law governing supplements. For the layman, “new dietary ingredient” is usually just government jargon for “new supplement.”
Under DSHEA, any dietary supplement introduced to the market in the US after 1994 is considered “new” (an NDI) and the manufacturer must notify the FDA at least seventy-five days in advance of marketing the product.
In 2011, the FDA released a draft guidance setting forth the agency’s thinking on how companies should comply with DSHEA’s NDI requirements: how and when a NDI notification should be submitted, what information should be included, what is or is not considered an NDI, etc.
The 2011 draft guidance was a massive broadside aimed at crippling—if not eliminating—the supplement industry. An economic analysis at the time by an Emory University professor estimated that the FDA’s outrageous interpretation of the DSHEA-mandated NDI notification language would have meant:

  • the elimination of tens of thousands of supplements from the market;
  • an industry-wide cost of between $2 billion and $165 billion in animal and human product safety studies to comply with the FDA’s NDI notification protocols; and
  • the loss of between 55,270 and 104,475 jobs in the supplement industry.

ANH-USA and others submitted detailed comments to the FDA concerning its deeply flawed guidance document, and ANH-USA members flooded the agency with comments. After a major backlash of 146,000 pages of comments, Congressman Peter Roskam (R-IL) stepped in and said the FDA had reversed the intent of DSHEA, which was meant to expand, not restrict, consumer access to supplements.
ANH-USA and our partners were then able to persuade Congress to add language to an appropriations bill urging the FDA to go back to the drawing board, and the agency eventually agreed. We have been waiting for the agency’s updated draft ever since.
We need to keep in mind some history about this and in particular why DSHEA was passed in the first place. In 1992, the FDA published its Task Force Report on Dietary Supplements. It included the statement that dietary supplements represented a “disincentive for patented drug research.”
This report, plus the news that the clinic of Dr. Jonathan Wright had been raided at gunpoint (later referred to as “The Great B Vitamin Bust”), sent shockwaves through every integrative doctor’s office and every health food store in America.
News of this raid turned out to be the shot heard ’round the world for health freedom. Everybody got organized and started to fight back.
By 1994, over two million letters went to Congress, which led to the passage of DSHEA. Congress for the first time began to have an inkling that diet mattered greatly for health and that dietary supplements could make a great deal of difference in our diet. When President Bill Clinton signed the bill into law, he stated that it represented “common sense.”
The draft of regulations governing new dietary supplements under DSHEA, arriving twenty-two years after the passage of the legislation, and further delayed after the disastrous first draft in 2011, was finally published last Friday. It is a little better in some respects, but the biggest problems remain. It represents a dire threat to the supplement industry and, by extension, consumer access to supplements.
First, the improvements. In the original guidance, the FDA had said that all dietary ingredients contained in supplements sold before 1994, but not marketed as a standalone dietary supplement, required a NDI notification. So if a green tea supplement marketed before 1994 also contained other natural dietary ingredients, the green tea would be grandfathered and not require a NDI, but the other ingredients would—an absurd stance that has been corrected in the new guidance. Now, dietary ingredients that were marketed as or were contained in dietary supplements before 1994 are grandfathered.
The FDA’s new guidance also allows the submission of “NDI master files,” which contain specifications and other information needed to completely describe an ingredient. If a company wants to make several products with the same ingredient but at different dosages or concentrations, this could save a lot of time. These master files can also be shared with other companies to avoid excessive duplication.
There is still no authoritative list of “grandfathered” ingredients that do not need to submit NDIs, but FDA has said in the new guidance that it is willing to develop such a list based on independent and verifiable data. This appears to be just another stalling tactic after twenty-two years of stalling. We can be sure that the agency will keep the list as short as possible.
Unfortunately, that is the extent of the improvements in the new guidance versus the first draft. Most of the other problems that were in the original guidance remain in the updated draft.
The guidance imposes safety requirements on new supplements that are not even expected of drugs! The FDA describes how to determine what kind of safety studies to submit with an NDI notification. Note that safety studies in the past have been required of drugs, not of supplements. In addition the agency states that additional safety studies may be needed if the target population changes. For example, if a history of safe use has been established with adults, but a substance will be used in a dietary supplement marketed for young children, the FDA would require another NDI notification.
Are other drugs—even dangerous antipsychotics, antidepressants, and stimulants—subject to similar requirements when they are used on children? The answer is a resounding No. In the FDA’s own words, “Most drugs prescribed for children have not been tested in children.” The same is true for use with elderly people. The drugs have almost never been tested on elderly people. This makes the FDA’s new position on supplements especially hypocritical.
The section on investigational new drugs (INDs) also remains. These provisions could destroy the future availability of many supplements. The jargon used here in the guidance is confusing, probably intentionally so, but bear with us.
Remember that an IND refers to a new drug, while an NDI refers to a new supplement. Under current law, if an IND application is filed for an ingredient—that is, an ingredient is being studied for use as part of a new drug—that ingredient can no longer be produced or included in a supplement if a NDI has not previously been accepted. This has already happened to pyridoxamine, a form of vitamin B6, even though in the end it resulted in this valuable form of natural B6 being no longer available either as supplement or drug.
Apparently the FDA couldn’t care less that this form of natural B6 is no longer available in any form. Indeed it has been considering a petition to ban the only remaining natural form of B6, the most important form of all, because all B6, synthetic or natural, must be converted to it in order for our bodies to use it.
In this guidance, the FDA explicitly states that even when an IND is rescinded or does not lead to a new drug, the supplement form is still banned. Well, at least they admit what they are doing!
But just imagine the mischief this could cause when some enterprising drug company decides to corner the market on a whole list of ingredients to keep them out of the hands of supplement formulators forever more. This could very easily be done under this guidance. Remember that it is not always clear what counts as a NDI or what has been grandfathered, so drug companies can use this confusion to claim that supplements which have been around for decades have been sufficiently “altered” that they can be claimed as drugs.
The agency has also kept intact its ridiculous position that synthetic botanical ingredients are, for the most part, not dietary ingredients. This would likely remove many products from store shelves, such as vinpocetine, which is needed to keep our brains healthy. There is an exception for synthetic botanicals that are lawfully used as an ingredient in the conventional food supply, such as vanillin. What makes this even more confusing is that the FDA has already accepted NDI notifications for vinpocetine from a number of supplement producers. Note that in most cases, the FDA does not ever have to resolve the status of NDI notifications.
The FDA is also broadening the group of substances that must submit NDIs by adopting a loose definition of what it means for a supplement to be “chemically altered.” If a post-DSHEA ingredient has been present in the food supply and has not been chemically altered, it is exempted from submitting a NDI notification. The problem is that the FDA’s definition of “chemically altered” is so broad that only the most basic manufacturing methods would not “chemically alter” an ingredient. This language will stifle innovations in manufacturing and ignores the fact that new and more effective ways of producing supplements have arisen in the last twenty-two years since DSHEA passed. It appears that this is quite intentional. The aim is to destroy supplement innovation in the hope that this will eventually destroy the supplement industry.
It’s the same old story. The agency, under the guise of protecting us, is really just protecting its funder, the drug industry, and is throttling any chance of innovation and improvement in supplements. This is so corrupt that it is hard to understand how Congress can continue to turn a blind eye to it, but of course Big Pharma funds political campaigns as well.
Probiotics—the “good” bacteria which our bodies, and in particular, our immune systems, absolutely depend on—could also be on the chopping block. The agency cites risks for these supplements which are purely theoretical and have never posed a problem. Is it a coincidence that Big Pharma is now very interested in producing its own versions of this product? Having probiotics subject to prescription—or costing $100 a bottle—will be a disaster for the health of Americans.
This is pure nonsense. Why would the FDA do this? Clearly these are the actions of an agency looking to restrict the supplement market and remove as many products as possible in as many ways as possible—even thought it openly defies the intent of Congress in passing DSHEA, which was meant to expand consumer access to dietary supplements.
Over the coming weeks we will continue to dissect the guidance and strategize about the best way to overturn this guidance in order to protect consumer access to dietary supplements. But right now, we need to send messages to the FDA but especially to Congress. We need to immediately register our opposition and dismay at what the FDA is, once again, trying to do in its relentless war against dietary supplements.
By now, it should be clear that the FDA cannot provide credible oversight of the supplement industry. Another regulator is needed.
Action Alert! Write to Congress and the FDA to protest this revised guidance that threatens our access to supplements. Please send your message immediately.
Take-Action

121 comments

      1. I care more about this issue than I care about either of these two candidates.
        Hillary is worse than most people have the ability to put to words, and Trump is hanging by his puppet-strings already. Of course, a Trump Presidency would be more interesting… Seriously. It would motivate a lot of people to get invoved in politics and social issues. We need that. With Hillary you’re gonna wake up every morning wanting to put your head in the oven.

        1. Trump has a multi level company that sells health products (vitamins and minerals) It is a good company.

          3. Oh, i found it: !. it wasn’t his company; 2) the company made claims hat are quackery; pure and simple; 30 they are under investigation; and, 4)…he un-licensed his name in 2016. Yeah, Donna a “reaLgood Trump company”…more Russian-troll BS.

          4. So whats wrong with the Russians? One of the only countries not owned by central bank? Guess you hate Iceland too…..Oh you hate Russia because the TV told you to. Got it.

          5. What’s wrong with the Russians? I’ll tell you. I just heard it on the news: Russia baaaaaaaaaaaad.
            And you know what else? Putin did it.
            With those two answers in your pocket, you could be the next President!

          8. Based on the Paycheck she gets for Talking naive people into bying supplements noone needs with some added empty promises of making money in mlm

          9. Ansgar Ragentor I do not sell Trump’s products and if I did it would not be anyone’s business. Look around you 50 year old young people are dyeing like flies because the are eating fast food fried in rancid oils, and getting no nutrition . Some one needs to educate you and poor cynical Donald j cook.

          10. Donna don’t let the flea bites bother you.
            BTW what is the name of the company or the vitamin brand. Trump is also into Organic foods not the TPP as some will have you believe.

          2. Trump’s “interesting” presidency is just neocon code word for “get ready for death camps and the corporatization of everything”…including what herbs we can take…it is retrograde to 1933.

          3. Whoa. Did you really just insult Hillary Clinton’s opponent by calling him a neocon? At this level of comprehension, I’m really not surprised you’re voting for Hillary — the same Hillary Bush Jr. has referred to as his “Sister-In-Law.” The same one that cackled over the torture and murder of a renowned foreign leader. Hillary is a neocon. She will sign the TPP, and so would Donald — and if that’s not “the corporatization of everything,” then there is no such thing.
            I suppose you’re going to tell me she’s come out against it. That charade won’t last a week. If you believe her — well, then I dare say you’ll vote for her. After she ushers in the TPP, please promise me you’ll actually start to take an interest in the people that wish to lead you.

      1. No. The FDA is real. It’s statements about supporting innovation in pharmaceuticals at the expense of natural products is real. And we can change this disastrous course by influencing the FDA. This latest attack is well enough to call for some rolling heads. We can win this one.
        Codex? That’s down the road. We’re not involved in the TPP yet, although with these two clowns at the podium we are guaranteed about to be. Political action now against the FDA can win. I think most people are sick to the gills of this presidential election. Two of the most-hated people in America are running.
        Codex? Why doesn’t this boil down to simple morality? It does. My point? Pick your fights.

    1. It seemed to work for me. I got back:
      Thank you for supporting us on this issue. Please consider inviting your friends to support us.
      Your message has been sent to the following decision makers:
      US Senator Cory A. Booker
      US Senator Robert ‘Bob’ Menendez
      US Representative Scott Garrett
      Food and Drug Administration

      1. I got a similar reply, except one of my senators, James Lankford requires I use a special form (meant to screen out messages of this sort I’m sure) requiring me to copy and paste. I often have to try a couple of times before I am successful. Very irritating.

    2. I thought it didn’t work either… pushed the send button and got a blank page. But if you scroll UP on the blank page, you will find the message sent confirmation.

  4. I will believe the scum bags of the FDA when they refuse the PAYOLA from the pharmaceuticals. The FDA who approved for Payola that greases their palms poison drug that cure nothing and murder over 100,000 people each year. How come the Scum bag so called News Media scum people never cover this fact?

    3. I dont beliebe You. (IRONY ON) Maybe i would if You used the Word Scum 3 more times ( IRONY OFF )

  5. The FDA is finally showing its true colors, should have no jurisdiction over any supplements as its funding comes from the biggest, bloodiest killers on the planet – Big Pharma! 250,000 Americans die each year in the US from taking their prescriptions properly, as prescribed. Hippo-critic oath anyone?

    1. But remember in their book “Americans getting sick” is a bingo ! – more income , more hospital stays, and more drugs sold. And if the Americans unfortunately die, the Social Security admin. is clapping, as they would not collect what they have worked for all their lives. – It is up to us to protect ourselves. Agenda 2030 is upon us, and we need to wisely, like Kung Fu masters, take care and prevent the blows. May the Force by with you !

  6. The Alternative is really the answers to cutting Health care costs, if they would just open their eyes & see the supplements as a preventative instead of pharmaceutical side effects that cause more health risk. Not sure, if this not a hidden genocide toward the weak & old. Communist think that way you know!!!!

    1. The FDA has done its job in making the public aware of the dangers of supplements. This is the job of the government. If people want healthcare costs to go down; the pharmaceutical industry and the corporations that run these hospitals need to be taken to task. If we don’t lobby against these groups, there will be no savings in the healthcare system .

      1. Dangers of supplements??  Like that someone could choke on their pills?  That’s one of the few problems found, and it has nothing to do with what’s in them.  Another is not the supplement either, but heavy metals that may get in there from factories in China.  Yes, that does need to be clamped down on.  Or, a toddler gets into a bottle of something like vitamin B complex and then has a harmless niacin flush that scares the parents because they don’t know what’s happening and they take the kid to the ER.
        Supplements don’t kill.  Big Pharma however kills at least the equivalent of a 747ful of Americans every day (yes, day, not year!), and they do it with insanely profitable drugs, the top ones having markups of up to half a million percent, for something that only masks one problem while causing three more.  The argument I hear about that is that they have to pay for their R&D investment.  But I’ve seen the figures showing that the top six drug companies spend more on marketing than they do on R&D, the top one being nearly double.  Then they often spend even more than that on lobbying.
        One way to get healthcare costs down is to require healthcare to be non-profit, to get rid of those who prey on others for profit.  They’re not there for our health.  They want to subtly make us sicker and sicker, to make us repeat customers.  We’re educating ourselves though, and more and more of us won’t resort their drugs, under any circumstances.  We realize we’re on our own for true health, that it will never come from the industry.
        At the same time, industrialized farming and food processing has made it difficult to get the nutrients we need for our bodies to work the way they should, so supplements are in order.  Normal allopathic doctors know almost nothing about nutrition though.  100 years ago, Morgan, Carnegie, and Rockefeller did their best to get control of the healthcare industry and wipe out the competition.

        1. I don’t know about this. There are dangers associated with a number of supplements in health food stores, but they are not readily understood since they are not posted.

          1. You say, “I don’t know about this.” You’re far from alone.
            But many here DO know, and they weren’t born knowing. It really comes down to whether you want to trust self-defined “experts” or find out for yourself.
            The “experts” at FDA, USDA, Codex Alimentarius, WHO, etc., tell you only approved drugs and methods are good for you; the “expert” naturalists, herbalists, holists, organic food and supplement advocates, etc., say time-proven natural remedies and methods are better. The former want to outlaw the latter and deny you choices, the latter advise you to learn for yourself what works best for you, and to rule out NO possibilities.
            It comes down to whether you want to “Ask YOUR doctor,” or study up and then ask YOUR body. (Not to mention your common sense–comparing the artificial drug and medical harm record to the naturalists’ harm record would be a sensible place to start.)

        2. This continues from the post below. Yohimbe is a supplement which is useful for aiding old geezers like myself (I’m seventy-seven.) in getting a bit more lead in the pencil. My bottle said nothing about the effect on blood pressure, and I had bit of a problem once when it lowered my BP to a level which almost left me fainting.
          W./

          1. It is our responsibility to do our own research regarding the benefits and warnings on supplements. Never order nor take anything you have thoroughly researched. I, myself will continue to take supplements over RX’s . Says another old geezer 😉

        3. Quickest way to drop health care costs would be to totally allow health freedom. NOBODY has any right to turn you into their medical slave. Not the FDA w/drugs, the CDC with vaxassination, etc.
          NO STATE MEDICAL BOARDS and naturopaths allowed to practice freely in EVERY STATE… Dr Benjamin Rush of the Declaration of Independence group stated that we needed to clarify medical freedom. His fear was kind of the polar opposite of what we see.
          He feared that medicine would actually work – and that only the rich could afford any care. What we have is medicine that causes damage, being forced upon everyone except the rich.

        4. There are supplements like ginseng, that a person that has pre-existing medical conditions are very harmful. I can’t take it because I have heart issues. I watch shows like 20/20 and local news that I hear this type of information. Now if its the wrong information, I’m sure CBS,ABC and the other news stations are supposed to tell the us. I’m not saying they always do. I also think the information and news on the internet on this subject can be wrong.. Always check the source.

          1. You have heart issues because of nutritional deficiencies such as vit C, K2, D3, and magnesium, and some of the essential nutrients you are getting that your heart needs are getting depleted from the body by pharmaceuticals.  CBS, ABC, and other mainstream news outlets are controlled to a large extent by the pharmaceutical industry.

          2. You don’t know my medical history. Please don’t make general statements about people they have nutritional deficiencies. If I didn’t take my meds, I would have died five years ago.

          3. Nobody said to stop taking the drugs cold turkey. The point is that everyone is being made sick by our lousy food, and it manifests differently in different people – cancer, heart disease, neurological disorders, even mental health issues. Most drugs worsen this, because they interfere with nutrient absorption and also use up nutrients to process. Once you treat your depleted body with drugs that further deplete it, you go into a vicious cycle, one that is incredibly hard to get out of. The news isn’t going to tell you this, because they get most of their revenue from pharmaceutical ads. Pay attention to where the money comes from. If you want to improve, there are lots of things you can do. Find a local herbalist who understands the interactions with drugs and herbs, and a practitioner of functional medicine who can get to the root of your issue, etc. It’s up to you!

  8. The Funeral Directors of America should be completely gutted from the slime that is running this massive destructive totalitarian regime. Like the KGB in Russia, they are Godless and without belief in freedom, and justice for all. That spirit if you will is behind the demise of our country, in so many sectors. Money is not evil, but the love of money is…..the lust for power and control over others is mind boggling. WE all need to shine our light and pierce the darkness. The oldest story since time……Stay faithful, and stand for the truth, and love each other. We do have power and glory is ours dont ever believe differently.

  9. Because of what I have posted below, the FDA is guilty of massive fraud and collusion to cause harm, under color of law. This is serious crime. No one is dealing with this directly.

  10. These are exerts from a STAT article, when he breezed through his appointed position as head Honcho of the FDA.
    “Since President Obama nominated Califf to replace Hamburg,
    he has won the support of many medical societies, patient advocacy
    groups, academics, and even the New England Medical Journal.”
    “But he has had to appease critics who contended that his
    past reliance on pharmaceutical industry money leaves him too close to
    the pharmaceutical companies to be an effective cop on the beat.”
    “I believe the FDA must break its cozy relationship with the
    pharmaceutical industry,” said Manchin. Califf, he said, is “just not
    that person with the passion to change the culture in this important
    agency. We’ve let the sleeping giant go far too long.”
    I knew this was going to happen when he got the job. He’s got Pharma money and we’re blazin’ mad NOW!

  11. What next? Herbs? The FDA, Big Pharma and all those that collude with each other to keep us from natural supplements all have blood on their hands. Disgusting!

    1. What Next!
      Its already happening and you’ll find out when you need hospital medical care. You’ll never know what they will be putting into your system without your consent.
      The problem? We sat around too long, giving up our consent by our silence and expecting the political system to look out for us.

        2. As if it matters what you mark on the ballot – it will be counted they way they want it to be counted anyway.

    2. Actually, herbs were among the first. Try growing the number one most popular herb in America in your front yard, see what happens.

  12. The Take Action button doesn’t work. I entered all my information in twice. Nothing happened except that all my information disappeared. Twice. i don’t think I’m going to bother clicking on this stuff anymore. It’s apparently a total waste of time.

    1. If you scroll up on the blank page after you hit send, you will see that it did in fact send the message…..it’s just that, for some reason, the confirmation page is always scrolled to the bottom, which is blank.

  16. The past 50+ years or so the USDA,FDA, and other Federal/State departments have poisoned the public food supply and killed millions of unsuspecting citizens with lies of heinous conspiracy in our medical and food industries . These lies are the basis of our cultural “science”. They have in common the system of paying for the corruption of revolving door employment of modern con artists to escape all liability for their collective actions. What we are now fighting is the total takeover of the decisions concerning what we EAT and what our medical options are. We are looking at the groundwork for absolute totalitarian government. The fleecing must end. The only hope we have for the next 4 years is TRUMP and I know this is difficult to accept. He is the only one who can “trump” Hillary. She has let her agenda be known and it does not favor the average Joe. In addition to Trump we should all be armed for our own protection and that of our country. Best wishes to all and may we win this political battle. TL

  17. In the old days, the wealthy people had nutritionists as their doctors, because food actually is our medicine. At the rate the corrupt FDA is going, they’ll start trying to outlaw healthy food and they’ve already got a head start with all the chemically laden GMO foods the Monsanto Dept of Agriculture is forcing down our throats.

  18. Regarding Food, FDA betrayed deeply every American by allowing toxic, carcinogenic GMO’s, without any long term safety studies to flood the market, starting in ~1996. Public interest attorney, Steven Druker sued FDA because of that and in 2015 published a book about it: “Altered Genes, Twisted truth: How the Venture to Genetically Engineer Our Food Has Subverted Science,
    Corrupted Government, and Systematically Deceived the Public”. Regarding Drugs, FDA is not much different. The medical system works in a way, which promotes only USELESS pharmaceutical drugs, to keep people as long sick as possible, in order to drive the demand. Also not allowing the medical doctors to speak to their patients about alternative methods,
    closes the loop of keeping the circles of the sick in the dark. If people are lucky and watch some non-TV documentaries like “The Truth About Cancer”, they might save their lives. But if one stays with the average pharmaceutical industry educated MD, one might never learn, that simple food can heal the worst type of cancer out there. Patented drugs only pretend to simulate nature, but will never be able to replace it.

    1. They’re betraying with the language in this bill. They are on record stating they are fighting the supplements industry at the behest of the pharmaceutical corporations. That alone is enough for us to bring them down. I’ve never written a petition, but it’s time to write one calling for the resignation of the head of the FDA over this matter.

    2. It’s all about greed and power.
      I have been a victim of prescription drugs for over 2 years which has causing more damage to my body than help.
      Stand up and be heard. The FDA are killing people and causing unnecessary pain and suffering … look at what prescription drugs did to Elvis… Michael Jackson. .. Prince… to name very few.
      It’s sad that there are no repercussions when the FDA and oval office kill their PEOPLE and continue to portray themselves as “looking after the better interest of mankind”
      I am concerned about the entire world … so much hate…corruption. . Upheaval and totally unacceptable behaviour by government representatives who have their own personal agendas using positions of authority for personal gain.
      Two faced
      Implorable
      Unpatriotic
      Scrupulous
      Evil
      Discussing
      Behavior
      I guess we the people get screwed again … supplements being taking away so the mafia and Trump keep getting fatter..
      While the people die…
      What crap

  19. Okay, this is on the heels of the response not to reschedule cannabis….Am I surprised by this ‘dangling’ FDA bill that was introduced over 20 years ago, and another bill by Senator Hatch who tried to introduce this to kick out Utah’s supplement industry. Yes, this is about Payola, and this is about Cannabis, and Pharma retaliation against farmers….anyone else caught this?

  20. yep! Its time to fight.
    What good are elected officials if unelected officials can do what they want without anybodies approval.
    When they can allow GMO foods to be unlabeled – how dumb do we have to be, to understand that our government does not really care about peoples rights.
    What are we waiting for? Its time we all stand up and shout.

  21. Last week ANH confirmed what I had been thinking about, how government ISN’T telling us that we are really human guinea pigs for chemicals that are sprayed on our food supply is partially responsible for our being overweight!! Yes, they KNEW that these things have side effects but FAILED to tell government when they went looking for approval to tell them the things that WOULD stop them from getting what they wanted–APPROVAL!!! I am on limited income, but am allergic to quite a few of the crap the fools in BIG PHARMA want us to use to control things like cholesterol, IBS, and kidney stones!!! I have found that the only way to get these under control is to do it the proper way–eating an all organic/natural diet and using supplements to balance out my system. Some of my drs think this is wrong, but to have a cholesterol level over 500 drop to 250 after 6 months on NOTHING but 3 supplements that are in ONE gelcap,I would say that these do WORK and are far SAFER than any statin that comes with side effects that harm joints and add other side effects that we aren’t even aware of down the line!!!

    1. The worst was the decades in which the bad fats were pushed. Heck we KNOW vegetable oil fats are pretty bad – canola, corn, soy, safflower, etc. In 1964 there was a heart health study in which – being told cholesterol was bad, when it is critically essential to health – volunteers went to corn oil. Their heart attack rate increased HUGELY – i want to recall near 30% increase – in less than a year.
      Good fats – medium chain triglycerides like Coconut oil, goat’s milk, red palm oil – rebuild synapses and myelin sheathing. Coconut oil has reversed alzheimers in some, parkinsons, ALS, MS….
      Coconut oil has the highest level of MCTs – one of the four – at 50%. Goat milk has i think second highest of that MCT at 20% – but has much more and better balance of the lesser studied other 3 MCTs….

      1. 70 years of pushing the saturated fat/cholesterol/heart disease “connection” — the lipid hyposthesis — with as little evidence for it 70 years ago as there is today — in a word: “none,” should be enough for Americans to abandon pharma’s health guidelines for life. Most people just give them a free pass. Or they still believe the lipid hypothesis. It is a crime, and it’s up to us to phrase it as such so that the average uninterested American both understands and gets interested.

        1. Its very clear, they are controlling us by keeping us unhealthy. The blood supply is the key to good health & a working brain. Both are no no’s, the rulers want us to either die or be controlled like robots.
          They can not have a world that can not be controlled.

  22. Codex or not, all of this is done by people which makes for the apparent major dichotomy besides the haves n have nots. The game twixt the average person coping and the positioned, sell out lackey. The number of this latter is appalling. From monsanto employees to vaccine promoters to chemtrail enablers to local snitches over trivia etc ad infinitum.

  23. The entire focus of the article is to set up a red herring argument between “us” (Big Pharma) v “them” (Supplement Industry), and eliminate regulations and oversight. Both types of products are either dangerous or completely useless, and only generate billions of dollars in profits for these industries, while providing little or no benefit for the consumer.

    1. Lol, first of all, you have it backwards. “Us” is the supplement industry and “them” is Big Pharma. Second of all, and more importantly, with all due respect, it sounds like you have very little experience or knowledge about this topic. Wake up and notice the power and greed of Big Pharma – it’s out of control. Yes, occasionally a drug is needed, often just temporarily, to get a person through a difficult time. Drugs deplete important nutrients the body needs, which leads to side effects, which doctors then typically just prescribe more drugs for…and suddenly you’re locked into a cycle of needing ever more drugs to fix ever more side effects. Supplements, however, are not only an important part of many a healthy person’s overall health regimen (especially considering most of the poor and nutrient-depleted options we have for food these days), but they also heal and save lives, without the negative side effects, and certainly without killing anyone!!! It’s not complicated to understand – give the body what it needs to function properly and you can have amazing results. If this industry is in jeopardy, it’s something we all need to fight against, tooth and nail.

  24. The FDA sure hasn’t helped the 127,000 people who die from adverse reactions to prescribed drugs. In 10 year there were 2 or none when you go over the data, of deaths from natural supplements or foods.

  25. This is another reason it is so important Trump get elected. I used to go to meeting where Ben Carson spoke about supplements (he used to have cancer) but then Pharma got it stopped. Many people think the election has to do with this and that but there is massive amount of money and ads on tv that have to do with this. If you look at the owners of MSBC and CNN you will see that they will lose millions. It doesn’t matter than children suffer – it is the dollar.

  26. Ironic isn’t it, the stupid FDA and other agencies in this country want to control and block our usage or anything else to do with supplements, that are actual substances that can help us usually with no side effects, but they will allow us to be poisoned by GLYPHOSATE, a saturation of a multitude of pesticides and other substances in our food industry!!! They don’t do or say anything about what MONSATAN has been enabled to do for decades to our environment and food industry!! 🙁

  27. One step further. My daughter was the first in the nation to have surgeons in ICU gave her supplements and her esophagus grew back documented in eleven days in the hospital. Her stage 4 cancer also disappeared when her vitamin d level hit 38 (they say you cannot get cancer if it is 50) They accidentally cut her throat and cut an artery. This was five years ago. The items they gave her was the same ones Ben Carson taught about. This election is more about these supplements than anyone knows because they cannot talk about it on tv.

  28. SAVE THE SUPPLEMENTS!!
    LOL! This article reads like a call to revolution! But about .05% of the population even care about this. “Integrative Medicine” is just another way to say “holistic.” It’s just schlock. Meditation? Yoga?
    Go buy a science book…

  29. SCREW the FDA. Freaking Dog Azzwipes. They have no legitimate authority to do any of this….The have statutory regulations which are non-compliant with the Constitution, highest law of the land. When “laws” (rulings, acts of congress, executive orders, statutory laws, regulations, etc) are not compliant with the constitution the founding fathers who WROTE the constitution (and therefore know how to interpret it’s intent better than corporate supreme court moron-jority “justices”) state that any law not compliant w/the constitution is basically null and void.
    They call it a pretend law, and sometimes called it imaginary law. Thomas Jeffereson stated that we not only have the RIGHT to not obey such illegitimate laws and rulings, but that we have a DUTY to disobey them.

  30. Money is the medium of exchange for power. The richest parasite class (self annointed “elite” morons) control the money, the direction of society, etc. For example JD Rockefeller Sr owned the oil industry. In the 20s the farmers were powering their Model Ts with alcohol made on their own farm. Towns had their own distilleries to power the cars.
    2 switches – one on the carburetor, one in the car for the fuel tanks – and you ran on alcohol. JD (got)Rocks funded the Prohibition. When they came out of that there was zero infrastructure to make alcohol on the scale necessary to power vehicles – which no longer (magically) had dual fuel capability.

    1. Very apt phrase, very succinct definition: “Money is the medium of exchange for power.”
      When I’ve tried to tell people this they looked at me like I’d grown two heads. When I tell them the history of Prohibition–the real story, involving Big Oil–they act like I’ve grown three.
      The difficulty in educating people is that they’ve already been “educated,” hence they can’t seem to get the larger picture: that entrenched monopolies control the very wherewithal for life. Food, fuel, land and shelter, health and procreation, hygiene, currency, personal protection, social justice, water, education, communication, the means of travel, human endeavor itself (i.e., meaningful work), even death…they cannot name one basic need which is not controlled by a monopoly and/or on which they do not pay taxes.
      It’s like trying to explain the concept of water to a fish.

  31. Yes, the point is to remove the competition of natural ingredients, it is the game of creating end games all over the place, and getting things caught up in a huge bureaucracy where men are the products of an education system that slow down a natural process to see through the smoke and mirrors game that is the game of self interest, and playing god. We accept this game of scarcity. It seems we will have to learn to eat what we have been impulsed to believe are weeds out in the woods to get the necessary nutrients to support our bodies. And, to note this should be a human right because it is what supports us as life. Also, I suppose the next trolling events will be another lie by omission, where it will be said that eating weeds is unhealthy. It really is times for a basic income, a Living Invome Guarantee to realize the right to live and the need for each to choose what supports them on the ground and here, because no one knows what is best for self but self. If we decide to listen to our bodies, we can investigate and realize what is best for us, and that will not be processed foods and drugs. The way out, humpty dumpty, is to make the decision to become self responsible.

  32. More “liberty and freedom” for Americans….not. People have to ask….who benefits? Big Pharma, the Medical Industrial Complex…and the crooked government officials who take bribes(lobby money) from them

  34. We need to eliminate the FDA and all other regulation. Instead of telling anyone what they can and cannot sell, the government should prosecute the makers of any product that causes harm. That would put a lot of pharmaceutical executives in prison, but leave our supplements available. Let the free market rule! I also wonder how these money-hungry power brokers take care of their own health–do they eat organic food and take good supplements themselves? If not, perhaps they are contributing to their own destruction.

  35. A quick petition for the head of the FDA to resign!!
    How do you write one of those?…

  36. The drug cartel has PSYOPS (psychological operations – the art of brainwashing) down to a science.. Listen to one of the most oft repeated mantras on earth.. ‘Ask your doctor’. Not ‘ask A doctor’, or ‘Ask a medical professional if you see one etc”. Ask YOUR doctor. The foregone conclusion being that we all have a doctor. Like you can’t live without one. I’m here to tell you that I’ve lived my whole adult life, from age 30 to (soon to be) 60, without a doctor. As a result, I’m in perfect health and look 20 year younger. (Meds age you because they wear out your liver). It helps also that I don’t a TV and haven’t watched one for 30 years. I’m not barraged daily with drug advertising and doctor this and med that. My medical bills are non existent. The only time I go to a doctor is for diagnosis. If it hurts, I might ask someone to tell me what I’m dealing with. Then I take all my issues to my personal physician, Jesus Christ, who has healed each and every one of them, and has yet to send a bill. Yes. My son lives this way too, and his dad, and it is possible for anyone. Faith is the substance.

  40. We are American and we will stand together.Fda you have over stepped your boundaries. Just remember we vote we have a lot for our voice to be heard. We are the majority

    1. Well, hooray for us. Workers on a chain gang are in the majority. They have shackles, the overseers have guns.
      We rail against the shackles of unconstitutional laws and “deeming” rules. But…they have guns.
      We can petition and vote. They can ignore the petitions (nothing new, there), and they own the electronic voting machines (since Y2K only the uninformed still believe elections are not rigged). And they have guns.
      You see where this leaves us.

  42. Oh man, these supplement companies finally have to have data to back up their claims!?!?! They cant just put on their label “2,000 year old Chinese recipe” and call it a day?

    1. If you lack the discernment skills to evaluate the statement: “2,000 year old Chinese recipe,” versus “Vitamin C cures scurvy” and “Vitamin D prevents rickets,” “Tart cherries reduce arthritis inflammation” and “Aloe vera heals sunburn” (all true statements which are against Federal law to actually state on a label, under strict penalty of fine and imprisonment), then perhaps you’d best “Ask your doctor” what he or she thinks.

      1. Its nice to educate folks but you can not educate a fool who supports genocide of its own people. Many don’t have time to read if they could. This is why we are in the condition we are in now.
        Consent by silence or attacking others who are innocent. That’s animal instincts – not capable of common sense brain work.
        But we’re gaining as more intelligent folks are beginning to see the truth. Better late then never.

    1. It was in response to a comment that Codex Alimentarius is a future threat, not a present one. Posting directly from FDA’s website proves that Codex is absolutely a present threat.
      Case in point, due to Codex, Canada outlawed vitamin C over 100 mg – that could be US soon if awareness doesn’t grow. 30 years ago Bread & Circus [Wholefoods] had a table outside every store alerting shoppers to Codex. Not anymore. Codex is a powerful arm of globalism, the ‘New World Order’ that barely gets mentioned anymore. Omission – it’s what’s for breakfast, lunch & dinner.

      1. Point taken, Linda; I was not aware you were responding to another post. It shows up here as a separate comment to the main article. I saw that post a day or so ago (the one arguing that we should fight the Codex battle later) and wanted to say something similar to what you just said, but got distracted by other issues elsewhere.
        I do remember Bread & Circus, and have been aware of the Codex Alimentarius threat since the early 1970s, when people thought I was a wing nut for bringing it up, or for suggesting such theories as the existence of a NWO game plan (the mysterious CFR? hah hah!…an international Jewish banking cartel? hee hee!… the Fed Reserve Bank is NOT actually branch of the US government? ho ho!).
        What issues distracted me? Two, actually: A State Department diktat advising gunsmiths that much of their bread-and-butter work may now be deemed illegal; and “deeming rules” courtesy of the FDA regarding electronic cigarettes which will effectively shut down the industry and hand it over to Big Tobacco (to presumably bury in ignominious obscurity). The former (guns and those who provide and service them) have protected my life on more than one occasion; the latter (e-cigarettes) have probably saved my life, and ultimately that of millions of former smokers worldwide.
        But now our government is deeming things…ultimately with guns drawn. Not Constitutional authority, guns.
        The FDA, in their vast scientific wisdom, are effectively outlawing one of the greatest health breakthroughs of the 21st century: a proven method of quitting a habit which has destroyed countless millions of people’s health and lives for over three centuries, and which puts trillions of dollars in “health care” costs into the pockets of Big Pharma and the medical industrial complex. Next to SAD eating habits, tobacco use is probably the most expensive addiction we have going, all costs considered. Many proponents of electronic cigarettes have long thought, and said, they were fighting Big Tobacco.
        Nonsense. We’ve been fighting Big Pharma all along. I.e., their pet prize pit bull, the FDA. (Bought and paid for by the joined-at-the-hip drug and tobacco industries whose unholy symbiosis is one of the least talked about but most profitably relationships in unwritten medical history).
        Big Tobacco and Big Pharma and the Modern Medical Monopoly all in cahoots? (God, I MUSTbe a sniveling conspiracy theorist.)

  44. Agenda 21! It’s been planned in advance for many years, a slow move to global government while removing our freedoms and killing us nutritionally.

  45. I think the FDA needs to be abolished because they are doing nothing good to benefit people and are instead in bed with those who are openly out to reduce the population. (Eugenicists, Monsanto, Big Pharma…they are all tied together).

  46. President Johnson would not allow this to happen – just saying…
    Johnson/Weld 2016

  47. The FDA uh you mean the Fascist Disease Agency? Like the EPA, the BLM Bureau of Land Management should all be eliminated, These just for starters. It’s all about keeping you sick, making you sick and helping you die. Big Pharma IS A DISEASE.

  48. Simple Solution: Stop Eating meat and Sugar. Move Out of the cities poisened air. And You will Never have a Need for neither a supplement nor a pharmaceutical Industrie. As if One of the 2 was any better then the other.

    1. All meat is not bad for you as long as it was grass fed without GMO experiments. Organic Chicken, Fresh non farm raised fish and organic Lamb are still great for the necessary protein our body needs.
      Gluten is the biggie to avoid. Its in most bread & pastry products. Gluten comes from the root word “glue” – gluten damages proper digestion which clogs up cells & damages the delivery system from getting to the proper locations. And yes, honey is much better and taster then sugars. Pure sugar cane juice is also healthier for the sweet tooth.

  49. I believe you Grath people should do their own search. I clear up many disease myself just with some simple natural supplements. There is only one disease : malnutrition. Everyone has different need on nutrition, they need to find out themselves or with the help of kind-heart nutritionist.

  51. False comment. The FDA is fighting labeling standards on all GMO engineered foods while making all natural foods outlawed.
    They destroyed the natural farmers back in the 50s by giving them subsidies not to grow food while the GMO bandits took over our food supply in labs. Even Bill Gates admitted that population controls was the agenda on national TV while speaking to globalist in Detroit, Michigan. At the time he was focused on Africa but now its us.
    The facts are buried in history, and we can only ascertain history by what happened yesterday. Then our minds go blank because of the poisoned unlabeled foods that eliminate our choices to stay healthy.
    But its true, you can believe whatever you want even without the facts. Its all a big smoke screen to harvest & conquer the human brains.

  54. do not know where I would be with supplements .. they have helped me with auto immune disorders for many years ! keeping my thyroid in check and inflammation away . herbs , vitamins and supplements have been my way of life .

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