"FDA is Violating Federal Law"—Emord

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Bolstered by a massive outpouring of support from you, we are asking the agency to withdraw its New Dietary Ingredient (NDI) draft guidance completely!

The period for comments to the FDA on the draft guidance on NDI notifications closed on December 2. Along with the hundreds of thousands of messages you sent and the 20,000 phone calls you made to FDA and Congress, ANH-USA also submitted formal comments.

The problem with the FDA’s draft guidance on New Dietary Ingredients is that it allows FDA to arbitrarily deny the sale of any supplement created (or modified) in the past seventeen years. If you’re a supplement manufacturer or distributor or possibly even a health food store, and you don’t file a NDI “notification” (actually a request for approval) for each ingredient in each product developed since 1994 in just the way prescribed by the FDA, and the court later decides the FDA is right, then you are guilty of product “adulteration,” which is punishable by prison. With your favorite supplements off the market, it also would allow the drug industry to adapt and patent them, and sell them back to you—by doctor’s prescription only—for 10 or 100 (or even more) times what you’re paying now.

Our comments, drafted by acclaimed attorney Jonathan Emord on our behalf, show that the FDA is engaged in substantive new rulemaking, in violation of the federal Administrative Procedure Act (APA). “The APA says if an agency’s action is legislative in nature, that’s rulemaking,” explained Emord. “The guidance distorts the plain language of the laws that govern supplements. FDA needs to comply with the APA’s formal rulemaking requirements, not issue unilateral guidance as a deceptive means of creating new rules.”

We argue that the FDA is acting illegally. The FDA circumvented the regulatory process by issuing a guidance, which gives them cover and flexibility, instead of going through the rulemaking process, which is required when creating a new law—and we believe the guidance in fact does create new law. As a result, FDA’s actions leave interested parties little recourse within the regulatory system.

In technical terms, a guidance is supposed to be legally non-binding. It is meant to simply present the FDA’s interpretation of the rule. However, the NDI guidance goes well beyond an interpretation, and we believe it is in fact a legislative rule with legal implications:

  • The NDI guidance is a departure from the FDA’s previous standards for NDI notifications. It alters and broadens the meaning of what qualifies as an NDI, and creates new—and very expensive—requirements to comply with the NDI notification process (creating what we would call a de facto pre-approval system), counter to what is outlined in Dietary Supplement Health and Education Act (DSHEA).
  • Not fulfilling the NDI notification requirements outlined in the guidance ensures that the supplement will be considered adulterated and therefore illegal. This indicates there’s a clear, legally binding impact to the NDI guidance.
  • Supplements that are considered illegal can be confiscated, and under the Food Safety Modernization Act, as we noted lasted week, can now be subject to administrative detention as well.

You may recall that Joanna M. Shepherd Bailey, PhD, professor of law and economics at Emory University, demonstrated that FDA grossly underestimated the economic cost of the NDI guidance. Her report found that:

  • Up to 29,000 nutritional supplements would likely be removed from the market;
  • The nutritional supplement market could shrink by between 28% and 52.5%, producing an annual loss for the industry of between $7.84 billion to $14.7 billion; and
  • Between 55,720 and 104,475 jobs in the supplement industry could be lost.

FDA’s analysis did not take into consideration the costs of the expanded reach and requirements of the NDI guidance. The agency therefore misled the Office of Management and Budget, in violation of the Paperwork Reduction Act of 1996.

FDA has arbitrarily determined that supplement companies need to show at least “25 years of widespread use” in order it to meet the “history of safety” standard in NDI notification. In other words, only supplements on the market before October 1986 could be considered “safe.” This is patently ridiculous, since the cutoff date for grandfathered ingredients assumed to be safe, according to DSHEA, is October 1994.

The NDI notification system was intended to ensure safety. The very reason pre-DSHEA supplements were grandfathered is because they had proven themselves safe through years of use by hundreds of thousands of consumers! If safety is of utmost concern to FDA, why does the guidance document burden the supplement industry with regulatory requirements that have nothing to do with proving the safety of the supplements? It appears FDA is acting out of spite—and not in the public’s best interest. Moreover, many of the provisions in the guidance are totally unrelated to safety and serve only to limit consumers’ access to nutritional supplements.

We believe FDA will be unable incorporate enough changes to their draft guidance to bring it in line with existing law, preserve supplement access for customers, and remove needless regulatory hurdles for industry. Because of this, we asked FDA in our formal comments to withdraw the draft guidance at the earliest possible moment.

Now that the FDA’s comment period is closed, the agency is supposed to review the comments and prepare a final version of the guidance document—though they are under no legal obligation to do so. In fact, because it is guidance, they are under no legal obligation even to take public comments into consideration. Nor is there any timeline: the agency is still sitting on a guidance, now nearly three years old, that was meant to create a distinction between beverages and liquid dietary supplements.

Even worse, since this is presented as guidance and not formal rulemaking, the FDA is very likely to enforce the provisions in the draft guidance as though they were final—with limited legal recourse for affected parties!

We believe FDA’s actions require them to follow the Administrative Procedure Act, which calls for a formal rulemaking procedure. Under this law:

  • FDA will be forced to have a formal comment period, and to review and consider all comments before they issue a final rule. This includes a rulemaking record that shows the data and analysis behind a proposed rule, and sometimes even public hearings.
  • If the result is not to the liking of interested parties, “Each agency shall give an interested person the right to petition for the issuance, amendment, or repeal of a rule.” This means, that unlike a guidance, it is possible to challenge a rule in court. It is very likely that FDA conveniently issued a guidance, instead of going through the rulemaking process, to avoid this very outcome.

Now that the NDI comment period is closed, we will start implementing the next phase of our strategy—which will include both legal and legislative components. We will, of course, keep our supporters and allies in the loop.

Thank you all again for your tremendous outpouring of letters and phone calls! It has laid important groundwork for our next actions.

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  • Charles

    Are the lawmakers actually that crooked that they are trying to take away our freedom to buy dietary supplements on our own, cheaply, just so their buddies in Big Pharma can sell them to us for insane amounts of money, AND tell us how much we can have?
    Or are they really so clueless they think dietary supplements need to be sold as drugs?

    • jrickowens

      yes they are and because they are all like that we have almost no way to change it. except to vote them out. boy could we use Mr Smith (Jimmy Stewart)

    • The FDA is clearly a criminal enterprise working for big Pharma, Monsanto, and any large corporation that is working to depopulate the globe while making billions of dollars thru fascist illegal rules that are completely unconstitutional, immoral, and unnecessary. Over 100,000 deaths reported every year from FDA approved drugs, not ONE from a natural dietary supplement.

    • Given the responses from my representatives, all of them are on Big Pharma’s payola. This is corporatism at its most evil. Working with children with autism, supplements have been a true blessing to many. But the new rules are restrictive to the point that they will eventually reduce the amounts avaialble OTC to that amount of any supplement that is REQUIRED to merely minimally sustain life, not to do any therapeutic good. Given that Big PHOOD and Big PHARMA are in bed with each other, and with BIG GOMMIT, there will soon be no way to maintain health. And a sick population is a “manageable” population….baaaaaaaaaaaaaaaaaa….moooooooooooo….like lemmings over the cliff we’ll go.

      It won’t stop with supplements, either.

    • Joe

      The “lawmakers” turned their authority over to the bureaucrats. This is another family of rats related to demon rats and democrats! Rules and regulations are forced on us by the civil courts, even though they are not passed legally according to State of Federal Constitutional guidelines. Seems the rats have multiplied with the ever-expanding government handouts. We have lost the rat race, sorry, America is no longer a Republic, just a collapsed shell of prior greatness. I miss the Constitution and Reagan.

    • Valerie

      Yes, they are.

    • Trinket

      Crooked and clueless.

    • Nancy Parker

      this isn’t congress making law, this is the FDA, which is financially dependent on the drug companies and therefore completely in their pockets. Yes, the FDA is that crooked. I suspect Durbin is too, he can’t possibly be as clueless as his proposed laws suggest.

    • Nikki

      Yes Charles they are crooked. The Pharmas give the people we vote in a lot of money and support to keep them in line with what they want. We have to remind all of them that we want our country back and that in our numbers we can be a force to be reckoned with.

    • Kathy

      YES. they are that crooked. The FDA is a government agency controlled directly by big pharma lobbyists.
      If they can get away with allowing aspartame to be ok’d because Rumsfeld needed to call in a favor for Searle. Yes.
      My guess is they paid off people in Japan, removed tryptophan from the market so magically 10 days later Prozac could be debuted and a mass scale human drug test could occur. Amazing how big pharma had that in the bag so they could “protect us” from the dangers of an amino acid.
      Yes, if they declare mercury is harmful in immmunizations but continue to say it is safe for dental amalgams, merely because a mercury stock holder is part of the FDA.
      Yes, they knowingly put fluoride in the water so the aluminum and nuclear industries do not have to pay for toxic waste disposal.
      Yes, if they can get away with allowing pyridoxamine to be taken off the market. In favor of a pharmaceutical company.

      That is what the FDA is all about, lining the pockets of themselves and their friends, investor payouts.. I would be surprised that you think they are trying to protect us. We have corruption to the core. They are not protecting us, they are about making us sick and then trying to sell us something to make us better.
      When you have government invading your churches , synagogues and mosques so big pharma can push for vaccines that don’t work. That my friends is true corruption.

  • barney and peggy williams

    GOD has a plan for us and we need to pray for our COUNTRY. it would be nice to get these idiots to leave us alone however, until he is removed from the white house things are going to be very rough.

    • joe

      until who is removed from the whitehouse, GOD?
      You think replacing a D with an R in the whitehouse will somehow produce a better result for you? Get it through your heads that D = R = D = R = corporate controlled treasonous terrorists.

    • Walter Gillmore

      I didn’t know God was in the White House! Tell us more.

    • Robin Young

      Until God is removed from politics, things are going to be very divided between the greedy right-wing Nuts and the Humanists. The Republican circus has many ‘flying Dumbo’ elephants who think they are better than everyone else. The Democrat donkey is still carrying Mary, Joseph and [Barak] the Christ child of Hope and Change. The FDA may or may not be influenced by big Pharma.

    • Robert Renner

      God is dead! Obama will be re-elected! Find another excuse!

    • lucy

      Only when people like you understand that the government has been indebted (sold out) little by little to Corporations and Banks for the last century-will they be able to quit blaming a Republican or Democratic president. Follow the money. If you were President and you did everything in your power to stop Corporate lobbyists right now you’d have a gun at your head just like some past Presidents have had. Quit believing politics is transparent and not a dangerous game. Once a government sells out to Big Money interests, then your freedom is the next thing to go. What do you think Thomas Jefferson was railing about over 200 years ago? Precisely that. So argue all day about Democrat vs. Republican while those running global cartels laugh at people like you. They have the best lawyers and marketers to manipulate language and keep people distracted on the wrong battles. Change must begin and end with informed people–not with one guy caught in the middle in the White House.

      • Lou

        “Change must begin and end with informed people–not with one guy caught in the middle in the White House”

        Bingo!

        Ever since the evil people running things shot JFK things have gone downhill. JFK wanted to get rid of the CIA and the FED. The puppet presidents foisted on us since have been seriously flawed, mostly morally flawed puppets, Reagan who was not a puppet they almost killed to get mister evil himself as president. The last few puppet presidents have been sexual deviants who whiled away their time while awaiting orders. The thousand page “laws” are being written by corporations (representing the Rothschilds and Rockefellers) and passed by “our representatives” who do not read the bills.

        Evil has captured our government. Things are going to get VERY bad. Right now we see an FDA willing to indirectly kill us. Soon, I fear, the organs of “government” are going to be DIRECTLY killing us. All the hundreds if not thousands of “laws” required to do this “legally” have been passed. This week KBR sent out a request for services to make the FEMA camps operational.

        Only the truth can save us. Please help spread it.

    • john

      Barney and Peggy,

      Removing “him” from the White House has little too nothing to do with this. This is not a Republican or Democratic issue. Both parties are controlled by big business and both parties are therefore Fascist in nature. It is our job to apply enough pressure so they will not allow these very negative changes in our rights to free access to supplements. It is almost as if we have to pressure them and educate them in the process. I prefer action over praying but whatever works is good for me.

    • Nancy Parker

      what has the white house got to do with it? This is the FDA we’re talking about. Don’t blame the president for something that has been going on for upwards of fifty years!

    • SHelly

      typical answer blame it on the president . Ignorance at its best . Good grief read people read.

    • Karen Carr

      Amen!!!

      • MeganL77

        It will take an act of God to straighten out the white house!
        Please make it so.

  • David

    They will just do th drug companies bidding as per usual.

    • Dr. Richard Edlich

      The FDA should not be monitoring dietary supplements, but rather encouraging the manufacturers to make more supplements to prevent illnesses.

      Dr. E

    • jfmorg

      The FDA continues to be a threat to us. Bought by pharma which continues to ignore disasterous side effects of approved med which help symptoms sometimes but are not designed to cure.. Pharma keeps trying to isolate the compounds in herbs and plants which heal and make it impossible for us to get the rwal thing.
      I keep writing to my congressman asking that the FDA be abolshed.,

      • Lou

        HHS spends one trillion bucks a year. The first head of HHS was a Rockefeller. HHS and its child agencies which includes the FDA are still carrying out the EUGENIC Rockefeller agenda; DEPOPULATION.

        This explains a lot. No?

  • Cindy

    Thank you for all you do. Seems like everyday, some government person or body is out to destroy our freedoms for the sake of profits. Our government is a dirty as dirty can be.

    • Lou

      Profit is a MEANS not the ultimate goal IMO. IMO the goal is a totalitarian world. A world with a population of 500 million or so.

  • Nancy Jo Cornett

    Unconstitutional. Illegal. Immoral. Criminal.

  • Alan8

    The FDA is a corrupt agency that has been “captured” by the corporations it was created to regulate. It sees these corporations as its clients, rather than the American people

    This latest power grab is an attempt to eliminate natural and inexpensive competitors to the expensive prescription drugs pushed by the pharmaceutical corporations.

    Kudos to ANH-USA for standing up to this abuse of power!

  • margaret venske

    Supplements are an absolute necessity as far as my recovery from major medical error pertaining to exceedingly low B-12 deficiency. MDs and the FDA seem to be totally ignorant of the fact that B-12 deficient persons must have additional nutritional supplementation to recover and maintain optimum health overall. Even many dietitians seem unaware of the fact that supplements (not pharmaceuticals) are crucial in this day and age, especially with processed foods lacking quality nutrients. Old government ranges/”guidelines” are simply outdated as far as proper nutritional intake for optimal body function!, especially as the population ages.

    • wake up world

      Margret I don’t believe for a second that these agencies are ignorant. They know exactly what they are doing and the harm they are causing which is even worse but it gives you more reason to fight for what you know to be necessary in your own life and the life of others. The government is not going to help us and we can not depend on them. We the people will have to stand up for our selves and do this together. I wish you the best.

  • We have to change the popular perception that the FDA is doing something to help the American people.

    They’re doing things that help their own paychecks.

    And insurance companies are using the FDA as an excuse to refuse to pay for drugs that are natural, safe, and have been in use effectively for long time periods to push patients into using newer, patented drugs that are either unsafe, or have not really been proved to be of benefit.

    This policy of the insurance companies is driving insurance costs up and producing a population of people who have physical problems that aren’t being addressed, and who keep taking more and more drugs to solve the problems that the original drugs either don’t handle or, in fact, CAUSE.

    I was tired of this a long time ago, and it’s got to end or the drug companies will bankrupt the entire country. About 5 years ago, I was listening to a radio program on the subject, and the author of a book about this said that 75% of the bankruptcies in the US are caused by medical costs!

  • Donna Chevrier

    This excerpt from the article caught my attention…….”The FDA has arbitrarily determined that supplement companies need to show at least “25 years of widespread use” in order it to meet the “history of safety” standard in NDI notification.”
    My comment is, how about the drug companies living by that rule. Think of the lives that could be saved from the deadly side effects of patented drugs.

  • Terri

    Please keep after them! This is just another underhanded, back stabbing, sneaky action from our lovely government which feels they are missing out on our money, for their wallets.

    Supplements are necessary since many are not able to afford medications any longer due to all the government, FDA, Big Pharma, Too big to Fail Corporations riduclous greedy actions. They do not care about our safety.

    Government only cares about how much money they are missing out on. Why would they even think that they are pulling the wool over the eyes of the public. The days of that are long long gone.

    We are watching EVERYTHING VERY CLOSELY! No more secrets, we are finding them all out, only a matter of time. Then, maybe, we can close down yet another branch of a corrupt government.

    FDA probably ok’d Monsanto and Chemtrails (Aluminum & Barium), Flouride in our water and considering Librium to be added to our drinking water. Do they care about safety? Oh, Hell NO!

    BTW, it isn’t like they test their drugs for 25 years, if they did, there wouldn’t be so many commerical for law suits over B A D D R U G S!

    FDA ok’d the injection to prevent “certain” cancers given to young girls and now touted for young boys? The stuff is directly causing sickness in those who take the lovely FDA approved injections. Mercury in childhood vaccines? And they wonder why parents are finally getting educated and saying: NO!

    Keep up the good work please!

  • John Z.

    It is clear that the FDA is now and has been in bed with the big money pharmaceutical companies. Their fondest wish is to do away with the food and health supplements business and deprive Americans of the right to choose healthy alternatives for themselves.

  • Richard Pawley

    Not everyone understands the power of prayer but in the classic Christian paperback, GOD CALLING, edited by A. J. Russell, and available everywhere, one of the 360 plus short things that Jesus instructed a woman in England some 75 years ago, was that the prayers of the two of them could change the laws of Parliament without their ever leaving their kitchen. Well, I always get inspiration from this great little book and this was certainly something I was praying about.

  • The law takes away MY RIGHTS & the FREEDOM to chose products which are SAFE & pose a alternative to DANGEROUS prescription drugs ( the # 1 cause of accidental DEATH now )

    Please amend !

  • Joseph

    A point to make in your objections is that those of us outside the US buying these supplements will look for other countries where we can buy them, so USA loses export market.

    • To be fair, the FDA MUST outlaw sunlight, as 20 mins out in the sun at midday makes sufficient vitamin D3 and Ithink this is pretty much the same thing we are seeing here……take away our SUN, next , you @#$%^&*(#$%^&*$%^&*(%^&* corrupt #$%^&%^&*&*…………these dummies have to go…….

  • Suzanne

    How can they be allowed to do this — to skirt the law? This is disastrous and Congress just lies down and lets them walk all over them.

    • Ginger Ferrer

      When if ever will some in this country realize that this current administration had nothing to do with the long termed establishmentarianism of the FDA? This has been ongoing and going on for decades.

      Our country and its Constitutional expectation has been used, abused, misused since WW2. The hierarchy of cronyism’s has been the one and only dictatorship type of governing allowed by the powers that be. No matter how many new Presidents we put into office. The corruption is in place and We the people continue to be used as human currency in exchange for the billions of dollars these pharmaceutical companies and their associated connections to Senators, Congressmen/women and any other titled individual who buys a ticket on the gravy train of these violations and crimes against humanity are allowed to get away with.

  • Philip A. Whary

    I think that if you looked at the FDA leaders bank statements you would find that they have been paid to do this One durg that was put out on the market was known to kill the taken. They were paid 7 millio dollars

    The drug companies do not want the health suppliments to take business from them; they would like to make and sell them selves.

  • Richard Orloff

    The FDA is made of Special Interest biased “sellouts” with pre determined ‘agendas” which favor pharmaceutical companies. I am incessed, angry, and ready to break windows in reference to the high handed, ongoing, and lying agenda of the FDA which is staffed by ex pharmaceutical executives. It’s never ending in this country of how big business surreptitiously buys its power and then lies about its agenda. It’s all about protecting and increasing profit for big companies.

  • Mat

    Just like most of the other agencies in our government the FDA is totally out of control. We’ve got an rogue agency that represents large corporations/Pharma with very little interest in representing the citizens of United States. And why should they when the head of the FDA sees the corruption from lobbyists on all our politicians in Washington. Do you really expect FDA to police themselves or lookout for the citizens of the US when a nice cushy job is waiting for them after they give up their position at the FDA. We the people of the United States need to vote out all the committeemen that are supposed to govern the FDA, for change has to start in Congress. With new regulations and oversight on the FDA we might be able to get a food and drug administration that is really looking out for the citizens once again. I know it sounds like a dream because the corruption is everywhere! Go Ron Paul!

  • Mike88

    Abolish the FDA since they only work for the Pharmaceutical Industry which is against their stated missions to protect the public from the Pharmaceutical Industry.

  • Paige McAdoo

    With 450 million Americans going without health insurance, many of them have to rely on supplements to maintain any standard of health. Moreover, the allopathic model of medicine is woefully inadequate for certain chronic conditions, which many supplements are proven to be much more adapt at handling. One wonders if “Big Pharma” is behind this latest push to deny people their supplements. Kindly keep your regulations off my supplements; for some of us it is a matter of whether or not we can lead quality healthful lives

  • Tim Bigelow

    Thank you so much for keeping me updated on what the latest goings on are with the FDA.
    There is strength in numbers, and you are helping the good guys stay nicely informed.

  • Martha Hinton

    I do not like the gov. over reaching and taking our rights away. Natural Vitamins are not drugs and they come from nature.

  • Gary

    Keep going guys – we need your help. I’ve posted, tweeted, etc. Thank you for your efforts.

  • Arnie Welber

    🙂

  • rebecca fong

    Hi,
    please don’t take away our vitamins! Me an my whole family ( both parents, aunts, uncles, grand parrents neices nephew’s all our friends) has taken vitamins for a very long time!
    My uncle who is now 89 years old, has very severe gout and if you know anyone who has gout know it’s hell on earth. Cherry supplements he bought at a Vitamin Cottage at a great price was the only thing that helped him.
    My father who was hospitalized for nearly two months with C.O.P.D. When he was finally released the doctors told him he had six months to live, when he got home he reseached some supplements then went to Vitamin Cottage purchased those supplements and he lived for an additional fifteen HAPPY years after that, his doctors could’nt believe it! He was 89 when he passed away an 74 when he got sick, and was given maybe 6 months to live. An me I’ve always had VERY severe allergies untill I started taking supplements several years ago, now my allergies are nearly gone. Both my husband’s and my own immune system grown stronger making us healthier, because of supplements.
    Many people in my family an in my life takes supplements for several reasons, some for just the plain reason to stay healthy. Supplements are a very important part of my life as well as everyone I know, my friends and aquiantances have seen the differance supplements has made in my life so now they’re strong believiers themselves, and they have their own storys.
    My family and friends aren’t rich an can’t afford to pay a huge price for our supplements We can’t afford to have our supplements to be put under the FDA restrictions due to the facts that many of our supplements will be removed and what’s left would be VERY expensive! We need to keep our supplements available to everyone an with fair pric. If you take them away so many people will loose their health, happiness and their free will to choose preventive care for themselves. Plus many hard working people will lose their jobs an what good will that do to our economy?
    So PLEASE I BEG of you not to put our supplements under the FDA’s restrictions because of what I’ve written above. We deserve the right to choose our own preventive care for ourselves.
    Thank you for taking the time to read this.
    Rebecca Fong

    • David Shelton

      Stop begging and start demanding.

    • Clicking the link to a website will show you a product (specialized water) that will help rid your body of gout. Check it out. A solution has been found and you can read about it there. Then let others know.

      I too abhor what FDA stands for today. They are bought out by corporate killers bent on making money for themselves at our expense, even unto our deaths. Like they say, follow the money for behind where the money is coming from is power.

      Thanks to ANH for all they do. I remember Ron Paul stating that when he becomes president, he would abolish all these departments including FDA and bring control back to us the people.

  • Lou

    “FDA has arbitrarily determined that supplement companies need to show at least “25 years of widespread use” in order it to meet the “history of safety” standard in NDI ”

    Is this the same FDA that allowed at least 66,000 Americans to die and one quarter million to be grievously injured, from VIOXX while the FDA sat on the evidence that this was happening for THREE YEARS? Is this the same FDA that watches hundreds of thousands of Americans to die from big pharma drugs each year?

    How many Americans are dying from these “dangerous” supplements the FDA is spending so much time, energy and money on “regulating/eliminating”?

    http://www.laleva.cc/petizione/ron_law_tables/tabella.html

    By my calculations supplements will need about 100,000 years to kill as many Americans as the FDA allowed/helped to be killed from VIOXX alone.

    The FDA is a joke; a bad joke; a murderous joke; an anti-American joke; a joke that needs to be quashed; the sooner the better.

  • Sandy Labrecque

    I want to thank ANH-USA for all the work you do on behalf of each member and indeed each citizen of the US whose views you represent. I follow many advocacy groups and yours is one of the best.

    I appreciate that you do your homework and provide educational articles with links to original documents, often including the clinical studies you refer to in your articles, so that readers can see where you’re drawing your data from and decide for themsleves. I appreciate that you don’t yell ‘The sky is falling’ at every turn but rather focus on the critical items and offer easy ways for readers to get involved in protecting our access to the healthcare we care about, such as access to safe, effect and affordable supplements.

    I’ll be posting your article on my Facebook page and contributing again in order to help you fight to keep supplements available to all of us. Thank you again for all your hard and effective work.

    • Thank YOU Sandy! Your advocacy, readership, and donations are what power us!

  • debora tyler

    why would you try to enforce supplements , some which have been grandfathered for over a thousand years, tried and true. noone has ever died from vitamins or supplements.
    but there have been over 225,000 bad reactions , adverse reactions and 100,000 unexpected deaths in hospitals per year!
    case in point is avandia, celebrex, lexapro and 1, 479 drugs black boxed (last 3 yrs) by the fda!!!! and over 49 deaths on gardasil and cervarix, which did not go through 12 years of testing on human studies. fda pushes them through in maximum 3 years?
    the studies and stats are falsified by non medical pros, or drugs maker shills, yeah right fda , nih and cdc………………

  • Elizabeth Hudetz

    Pharma wants their finger in everyone’s pie!

  • The recent Guidelines are NDI are quite flawed and will damage the economy. In a time of great economic instability your misguided attempt at regulation is inappropriate and dangerous.
    Allowing Pharmaceutiical companies to exclusively market supplements is incredibly unethical.
    Please stop this process before you harm this country any further.

  • Nancy Stephens

    I wonder if FDA were to get away with this, it needs to be considered whether there can be an argument and/or demand for Drug Insurance, Medicare or Medicaid to cover the expense of
    Doctor Ordered Vitamins and any supplements?? I take Doctor ordered Vitamins, and couple Supplements, as a result of blood tests and other symptoms.

    At this time, NO doctor ordered vitamins or supplements, perhaps those that can be bought over the counter, will be paid or covered by any drug insurance.

    I think the FDA needs to be aware of this fight that many of us, especially those on Medicare, will put forth if Insurance or Medicare ends up having to pay for expensive Big pharma vitamins and supplements.

    Someone in my close family manages 3 supplement/vitamin stores and would literally have to go out of business, be out of work and income if this FDA new rules come to pass.

    It is really infuriating that so many prescription drugs kill, or cause severe side effects, people hospitalized because of some prescription drugs and certainly every prescription has many many possible warnings of side effections, some severe, some moderate plus contradictions with other medications one may take. Certainly not aware of people dying from taking supplements?

  • Larry Wallace

    Just one of a plethra of reasons we can no longer trust the federal govenment!!

  • Esther Miller

    This is the result of the high dollar influence of the pharmaceutical industry. I am 84 yrs old & only on a mild blood pressure med & rarely see a doctor. Otherwise I take supplements. I will not go to the doctor for prescriptions or vitamins.

    I will send this to everyone on my email list & suggest everyone else do the same. We must hit them with gigantic backlash.

  • jamea mcenaney

    i served in the war9i am currenlky in law enforcement)we need freedmn for health and personal choice!!!i served as a medic,my dad was disabled WWII,sorry we did not have supplements in the 50s when he had arthritis.do yr part and allow us freedom at home!! best jimmy mack

  • Vindi

    When are people going to “wake up” to the fact that our FDA is in cohoots with Big Pharma?
    They get their kickbacks, grant money, etc. The whole idea is this: Deny people the ability to eat nourishing foods, deny them supplements to keep themselves healthy, and this way the doctor visits will increase (they can decide if you can see a doctor, of course), and being everyone is broke, can’t afford organic foods, they are forced to eat the junk GMO foods….eat all the chemical laden foods…..’cuz they’re cheaper. This is criminal!!!! The chemtrails are keeping peoples gardens from growing, normally, thus making folks buy the irradiated veggies which are NOT healthy!!!! It’s all tied in together.
    Doesn’t take a rocket scientist to figure out the big picture.

  • mary

    Thank u very much for stopping the f.d.a. from playing god w/my food.Having a brother that died from chemo/not the actual cancer.My supplements I use or will ever use is my body and what I choose to put in it is none of their business.If I choose herbs to fight cancer that is MY choice,not any governments.They will keep trying guys to take away are god given right to use nature as our healer,so please keep up the fight,mw

  • deafy

    I may be off subject here … but what’s with the “Respect for Law” emblem in the article?

    Back to the matter … This is bad … but not the problem

    The problem is Obama … he is illegal usurper that needs to be removed and his doings undone, before anything else. It is going to constantly get worse and worse every day we fight about all of those little things, while he makes it possible to cause a lot more damage in other ways. This is actually a part of his plan.

    It is like fighting about amnesty while leaving the border wide open.

    • Gary

      Deafy> Obama is not the problem. The FDA is an agency that was established decades ago. It is a non-partisan agency that runs on its own and supposed to be following the rules given it to protecting our American citizens. They aren’t following the rules anymore because they’ve become greedy for money and are getting it from the pharmaceutical companies and others connected to it.

      Anyone that blames Obama has to rethink what they’re saying because it is silly to do that. No one can bring up evidence that Obama is behind this. Even his wife Michelle is a strong supporter of vitamin supplements and she wouldn’t want for this to happen. It is also a fact that several members of congress are scared of FDA and their people because of the power they’ve gotten over the past decades of putting their plan in together to taking away our rights of our health needs. But in the end, we the people will win because “with knowledge is power”. So as long as we are aware, we can get enough people to see what’s going on and change things no matter the power FDA holds. We will get through this, but not by blaming the wrong people.

  • Many of us would say that what the FDA is attemptiing to do, like much of what they already do, is not only in violation of federal law but is also in violation of the Constitution. Nowhere does our constitution give the FDA and other alphabet soup agencies the powers to make law via administrative ruling – especially laws which would restrict what should be our very private and unalienable right to address our health and our private bodies however we see fit.

    If we are to remain free and escape utter tyranny, someday we must forcefully say “No more!” and there will have to be a reckoning for all the abuses against us.

  • Donald G Meyer

    Thanks to ANH for hiring Emord to go after the FDA. He is the finest lawyer in the US in this area, and if anybody can win it is Johnathan Emord. I read all your stuff, and you are on the right side of all the issues so far as I am concerned. Keep up the good work, and I put you in God’s hands.

    May the blessings be.
    Love, Don

  • The way to straighten out the FDA is as follows;
    1, Make all support for the FDA from general taxation and all fees to the FDA to go into the general treasury.
    2. Replace all FDA employees with professors from universities who have received no grants from industry. The current employees can be used as border gaurds.
    3. Make their employment conditional on NEVER accepting a payment from industry even after they leave.

  • fixer

    The problem is big business runs this country. Congress and legislation is for sale. We must change congress. No money contributions from anyone. They are there to work for us.

  • Ron

    I have been in the herbal business for over 20 years. Herbs/vitamins/minerals have saved my life. Even back 20 years ago the drug companies were trying to get the FDA to outlaw the sale of herbs, vitamins and minerals, so they could only be sold through prescriptions, supplied by the “drug” companies. We have fought a long battle and won so far, but anything could happen with the corruption in the USA and the power of the drug companies. About 15 years ago some countries in Europe banned the sale of over the counter herbs/vitamins/minerals – in one country a bottle of vitamin C selling for under $7 went up to $86. – by prescription only. The drug companies won there, let’s not let them do so here in the USA.

  • KAy

    Keep up the good work! Keep us informed and we all will support you!

  • Marym

    Thank you ANH-USA for fighting for our freedom. Your article will be going on my facebook. I appreciate all the work that you do. Keep up the great work! Thanks again!

  • barry parks

    dont forget these r the same people who r cowtowing down to the agri-giants like monsanto who r screwing up our food.people r being arrested in some states 4 growing their own food.our congress is selling us all out 2 corporate america.do not reelect these jerks rep. or dem. vote 4 someone who is not bought and sold. any one other than what weve got in dc its all about control.

  • David Shelton

    I sometimes wonder if this gigantic hidebound bureaucracy has the ability to accomplish anything other than indulging in endless paper shuffling. They have been threatening to control and regulate dietary supplements for a number of years. The fact that they may finally act keeps everyone nervous, and rightly so. The only direction they know how to take is to expand control and regulation; otherwise, they may have to shrink a little bit.

    I think it’s time to DEMAND that this parasitic monster stop feeding on our tax dollars so that they can treat us like their minions and REGULATE us to death. They can’t seem to either recognize or accept the fact that many of the drugs they approve lead to sickness and death, while those they don’t, like dietary supplements, harm no one, yet they continue to succumb to the demands of their masters in the drug industry, and make as if they are actually going to clamp down on supplements for them, but first, there must be more studies, more meetings, more tests and evaluations, more creating tons of indecipherable documents to pile up in file cabinets.

    If enough angry consumers write them expressing their anger at being continually threatened in this way, perhaps they will be forced to do more studies, which will hopefully keep them busy and out of our hair for ten or twenty more years.

  • Amy

    The FDA is an out of control unconstitutional tyrannical administrative bureaucracy. Time to reign them in.

  • Herb Anderson

    Keep the FDA out of any regulating of vitamins. They have screwd enough things up. Stay out FDA

  • Kathi Buffalo

    Supplements are classified as food not drugs-therefore we can buy what we want when we want. Why aren’t they going after Monsanto if they are so worried about what we eat???? FDA lets see you tackle food that causes harm to our children and we can’t sell corn nor seed to other world countries doesn’t that say something about Monsanto????

  • john hitchin

    Another way for government to support corporations putting profit before individual choice and profit

  • Mark

    The FDA should simply be declared a terrorist organization. They are far worse than Al Qaeda.

    • Lou

      Bingo!

      Far, far worse.

  • Nikki

    There’s another interesting note to support what the FDA and Pharmas are doing. I have a horse and she’s 22 years old. She has Cushing’s Disease and I’ve been giving her Pergolide which is compoounded (I pay $25 a month). I went to renew this with my vet who told me that Pergolide can no longer be used per the FDA and that using it would violate the vet’s license. Instead I will now have to get a drug called Prascend and that is the only thing I can give her at $65 a month.

    • vicki

      There is a company in California called Great Life Pet Products PH # 805-529-3647 I contacted them in 2006 about a Beagle I had which I suspected of having Cushings. They had a product which they used in a trial to eliminate Cushings in a pony or horse. You might give them a call and see if they are still making the product.

      Sorry you cannot get the product you were getting from your vet.

      Vicki Hcks

    • Nikki, would you be willing to try an organic herbal formula on your horse? Cheaper and safer.
      If so, contact me.

      Blessings! 🙂

  • Debbie

    What a bunch of prostitutes we have in our government! They sell us out to line their own pockets. It’s disgusting. We need to oust the vast majority and find some people who actually value our country and its people. This “hyper-greed” is ruining a once great country.

    • Jack

      Debbie,

      That will take lots of us getting organized and acting to choose people who will work for us and work and organize like hell to elect them to Congress, throwing out the incumbents who don’t. Look around locally, join Occupy and the organizations who have been trying to get this to happen: Progressive Democrats of America, Alliance for Democracy, maybe Working Families Party, Jobs with Justice, and whoever is hot where you are.

    • We recently elected a bunch of representatives who profess to belong to the “Tea Party” and who espouse a smaller government and an objection to the “Nanny State.” The FDA is the worst possible example of the Nanny State, protecting us from making decisions about our own health care, or even getting the information we need to make those decisions. Contact your representatives and senators, and urge thm to live up to their campaign promises by eliminating the FDA.

    • VOTE RON PAUL!!!!

  • Dee

    What we are witnessing is the beginning of the end of world governments.

    The foundations of the gov’t are immoral, corrupt, and diabolical. When a foundation of a
    building (gov’t) is so decayed and rotting, its not long before it crumbles and falls
    to the ground. That time is coming very, very soon.

    There’s no leaders, if there’s no followers—we need to pull back the curtain, like in
    the Wizard of Oz, and expose them for the greedy, corrupt cowards they really are.

    To ANH, I’d like to say, KEEP UP THE GOOD WORK!! We will win.

    • Lou

      “The foundations of the gov’t are immoral, corrupt, and diabolical”

      IMO this is all being done by intention. These same corrupt governments have allowed and HELPED a pandemic plague to be created in their bio-weapons labs. This plague may be released this year.

      The “vaccination” they will attempt to force into your body and the bodies of those you love CANNOT be the solution as BOTH the plague and the “vaccine” are created by the criminals running this sorry world.

      http://healthyprotocols.com/2_pandemic_update.htm

  • wvhillbilly

    As usual, the FDA has demonstrated it has about as much interest in protecting the public as the proverbial fox has in protecting the chickens it is about to kill and eat. The only thing I can see that the FDA is interested in protecting is the profits of their drug company overlords.

    If the FDA were truly interested in protecting the public, they would have never allowed Aspartame to be approved, and would have quickly banned it once its toxic effects became known, rather than stalling all efforts to have it removed from the market. Same for bad drugs, which have been allowed to remain on the market until they have killed tens of thousands of people unnecessarily. Instead they focus on staging armed raids on natural food stores, supplement makers, cherry growers and the like who have done no harm, and coming up with all sorts of stealthy schemes for outlawing natural supplements whose only possible damage has been to drug company corporate profits.

    It’s high time to dump the FDA and their drug company lobbyist buddies and other cronies, and replace them with disinterested parties who will truly have the public’s safety in mind.

  • Gloria Jones

    I find it rather amusing that the FDA continues to allow deadly drugs which are about as safe as having a ticking time bomb in the basement, and at the same time are targeting our supplements as being unsafe. How ridiculous is that? I think the families of people who have died as a result of Big Pharma’s poisons should get into a class action suit against the FDA, Big Pharma, and other proponents of drugs for profit. And that’s all it’s about. I don’t feel sorry for those killers who profit from people’s misery and death. How dare they attack supplements and natural foods that have cured people and kept them healthy. And the only reason they’re doing this is because they might lose some of their almighty bucks. They should hang their heads in shame, because they are putting a pox on this country. People will die in epidemic numbers because of their greed. I certainly hope God is keeping track of these monsters and will punish them accordingly.

    • Robert

      If there were a class-action lawsuit against Big Pharma, I’m in, They killed my father and then my mother. My father was killed with the blood-thinner Warfarin, which is one of the top 3 killers of all pharma drugs. The doctor’s defense would be that it was administered in accordance with AMA standard of practice. So, the AMA should be sued as well, for recommending deadly drugs instead of non-toxic alternatives. Blood can be thinned safely with garlic, cayenne pepper, or simply drinking more water.

  • J Meeks

    FDA- Hitler comes to mind.

  • Mother Earth is fast becoming a battleground for good and evil with FDA (Fascist Drugging Association) and CDC (Center for Deceitful Communication) leading the evil. Sure wish I could say, “Forgive them Father for they know not what they do”….but they DO know and the world is waking up, Thank God.

  • Norma

    Cannabis should have been Grandfathered in too….5000+ years of use and NO HARM!

  • I was going to say that I cannot believe that this is happening but I really can..Our freedoms as we know it are being taking away, thanks to our wonderful president. If it is not broke why try to fix it, this is working just find, I feel that they just need to leave well enough alone..The government is corrupt and it is all about the money that they are not making off of the people for drugs. People are staying healthier longer and they don’t like it..There is big money in sickness..

    To ANH good job in representing the people..It will work out somehow..

  • BrianMoraghan

    My wife and I are near 70 and in great health. We attribute our health to supplements. We hardly spend any money on prescription drugs which more than likely will have side-effects. We are the type of people that Big-Pharma is trying to target so they can milk even more money. The FDA is their agent. It is hard to prove but we suspect that FDA people take bribes to do Big-Pharma’s work. Certainly, many FDA people “retire” to cushy jobs with Big-Pharma once they leave FDA. No wonder people are getting fed up with government corruption. Is the US any better than Russia or third world countries far as corruption?

  • Tamilyn Simard

    Well said to all who have posted a comment. I would also like to say that my supplements, and natural medication has never sent me to the hospital with liver failure, a heart attack, blood clots, etc.

    I have a vote of no confidence in the FDA or their antics towards public safety. These killer pills that they deem safe to the public at the cost of human life for the sake of corporate greed in nothing short of murderous acts on the people of this nation. But as Wall Street had a play in the demise of the financial system of this fine country and not 1 person has been convicted so too will no one be punished for the murders of American’s trusting in their Dr’s to give them safe medications to help their ailments.

  • Cathy

    There are many supplements that literally keep people alive. My own family’s lives were saved MRSA and Lyme by using powerful natural antibiotics. MRSA and Lyme are drug resistant and these diseases would have killed us since the medical industry couldn’t help us.

    I believe that millions will lose their lives if the health supplements are taken away by the FDA. It is all about money not about the value of life. FDA, you will have the blood of millions on your hands!

    Want to kill the monster? Don’t do any drugs. Where we spend our dollar will make a difference. This is how this monster has grown out of control. Our society has surrendered it’s health to the medical industry. Take back control and run from the seduction of the media and your doctors who say that you need drugs. We need to get back to the basics of good food and food supplements. Drugs are poison!

  • Lou

    Congratulations to us all!

    The FDA seems to have been revealed as EVIL. Not mistaken, not inappropriate, not unbalanced, not misdirected but EVIL. EVIL in that it blatantly is promoting an anti-Americian murderous agenda.

    IMO this is the first and REQUIRED step in regaining our freedom.

    Please spread this far and wide and CONVINCE your immediate circle of friends of this CRITICAL truth.

  • Hello,
    I am in favor of all your comments, I totally agree with everyone here. The Govt., including Big Pharma, Big FDA, and Big CDC along with Big Agra are all corrupt equally. I really think and believe that our supplements should be overseen and managed by a totally different department, one that is managed by someone who believes in taking supplements for good health. Someone like a naturopathic physician, a homeopathic specialist, doctor of oriental medicine, or a professional nutritionist who is a certified practitioner. The FDA has no right whatsoever to manage or oversee our supplements, they just do not know what they are doing and do not know anything in regards to supplements, they have no knowledge how they function.
    If the public cannot have access to their supplements, people will become sick and die as a result of the FDA’s doings and therefore there will be less people on the planet earth, I guess that is the FDA;s and Big Pharma’s plan and goal. Well, I have a lot of faith that this whole thing will just collapse in the FDA’s lap and make them look completely embarrased and will have egg on their face.

    To Jonathan Emord: I really hope and pray that with his expertise, he can work real hard to help keep our supplements where they should be, in the hands of comsumers who believe in taking them to prevent illness and for good health maintenance. When you really think of it, taking suppelments should not ever get in the way of the FDA or Big Pharma, but they do somehow. We should be able to take whatever supplements we want whenever we want, without disrupting the FDA or Big Pharmas workings. Who are they to control our supplements. I am really getting tired, if I am not at that point now, of the Big Govt. wanting to control our lives. After all, this is America, the United States, we should be enjoying our freedoms, not be afraid that someone or something is going to take them away. We sure live in crazy, crazy times anymore, I don’t even know from one day to the next what will happen, need to keep abreast and up to date anymore what is happening or else we will lose out and get caught off guard. And anymore I sure want to know what is going on in our messed up world we live in.

  • I am 59 and this is the first time since the Vietnam war, that I have seen U.S. citizens amass in public groups to continually protest things about our government which they do not like. Although these groups are still not very organized, it at least appears possible that maybe something can be done to get beneficial change to occur. . The people have the ability to make our legislators effect changes in government and in regulations. The FDA is one of the better examples of where significant changes are needed so that they will be required to do what they were designed for, and NOT what big business interests want them to do. Most voters continue to be stupid enough to not vote for the candidate who they believe will do the best job, and instead to either vote “their” party line, or the lesser of two evils of the two useless major parties. This can never send the message that we are fed up, since the two major parties still know that they can do whatever they wish and yet we will still vote one of their candidates into office. Until the voters understand that both parties represent mostly a continuation of the status quo, we will keep going in the wrong direction. In the past few elections, the only candidate whose views represented health freedom has been Ron Paul and so I will most likely vote for him once again as I continue to fight for my health freedom rights and the rights of my patients, students, family and friends

  • BLAKE VAN

    The FDA is no longer a Protection Agency “of or “for the People”, they have been Hijacked by Big Pharma which makes more money than all of the Fortune 400 on wall St. combined in a year.
    We The People need to dissolve, Close the current FDA and make a new Protection Agency: Peoples Food and Drug Agency The PFDA.