ANH-USA Files Emord-Drafted Analysis with FDA that Reveals Cockeyed Assumptions Behind Proposed New Supplement Guidance

August 23, 2011
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The FDA says all new supplements since 1994 must be approved, but this will result in only 55 new applications. Huh? Experts predict as many as 125,000, and sale of these supplements will be illegal while the FDA decides what to do with them all.

If you’re new to this issue, please read about the FDA’s new scheme here. And if you haven’t already done so, please contact Congress immediately and voice your opposition to it!

Our analysis was created in response to an FDA statement in the Federal Register which grossly underestimated the burden of the proposed new guidance. It was drafted by renowned constitutional law attorney Jonathan Emord, with economic analysis by Dr. Joanna Shepherd Bailey, Associate Professor of Law at Emory University. Here are some additional findings:

  • The FDA’s new guidance can be expected to cause major disruption in the dietary supplement industry, forcing significant numbers of products off the market, losing over $1 billion in revenue, and forcing over 100,000 Americans to lose their jobs.
  • Rather than the 20 employee hours the FDA says are needed to do an NDI submission, our analysis shows it will cost between 100 and 350 hours of employee time. This will place the total cost to prepare these supplement approval applications (“notifications”) at between $845 million and $6.1 billion in employee wages.
  • Animal and human product safety studies will cost between $450,000 and $6.6 million per notification, for a total cost to industry of between $2 billion and $165 billion.
  • Where will industry be expected to get this money except from price increases? Supplements are already expensive. Millions more Americans won’t be able to afford them—just what the FDA and the drug industry would seem to want. It is a one-two thrust: Fail to approve many supplements, then make the rest too expensive for the average consumer.
  • The federal government will lose between $1.84 billion to $3.54 billion in federal tax revenues; state and local governments will lose between $1.64 billion and $3.07 billion in taxes.
  • Natural health is a huge growth industry. It is an area in which America has a competitive advantage. It can save billions in medical costs. But the federal government in the form of the FDA seems to want to shut it down. It is up to us, citizens and consumers, to tell them no.

Save the Date!

We are organizing a Call-In Lobbying Day on Thursday, September 8. This will be a coordinated effort and we are asking each of you—members, grassroots activists, readers, and friends—to set some time aside on that day to phone your senators and representatives and voice your opposition to the NDI (dietary supplement) guidance. We will have full details for you soon, including contact information and clear talking points so you can make your phone calls with confidence.

42 Responses to “ANH-USA Files Emord-Drafted Analysis with FDA that Reveals Cockeyed Assumptions Behind Proposed New Supplement Guidance”

  1. Nancy Stephens says:

    1000’s of years, people and cultures have been ‘living off the plants & trees” for their health.
    Researchers for Pharma discovered that these plants, trees etc. DID have pharmaceutical benefits to humans, thus prescriptions sure started. The FDA normally requires little info and often relies on Pharmas Word that their new drug is ok. Often Pharma waits to see what the EU does with their trials of drugs and then just Ok’s them here. So, drugs are put out by Pharma and then private industry ends up running “trials” on them to see effects. This is normally done with few people and/or people in other countries. IF everyone survives, they take a whopping guess it is all ok. It takes many years of the Public Patient to take new drugs before real life or death decisions can be made by the medical profession. Life or death? Serious side effects? Cures 1 thing and gives you 5 more serious ones? NO thanks. I take supplements and couple vitamins. My doctor has watched me and done blood work when due and low and behold, the surprise! The Supplements solved my problem better than RX, no side effects, so now my doctor is studying them too. PHARMA wants the supplements with FDA”s approval, so they can make all the money because many of their RX drugs are now becoming generic and cheaper. Just READ the medicine inserts on your prescriptions and that is enough to turn to supplements & vitamins.

       1 likes

  2. I strongly oppose the FDA regulations. They have harmful products in the Market now, and they are not taking action on correcting their mistakes. Instead they are reaching out to the supplement companies, this violates our rights.

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  3. Herminio Perez says:

    Over powering all natural dietary supplements, form business that depend and run on their own would be unfair, if the FDA takes advantage of the people do to regarding the price,supply and ownership, it could really affect the business by do to the a rules & regulations that may be applied. Business that associate with all natural supplement don’t need help and should be left alone.

       0 likes

  4. lone voice says:

    PS and it is also a crime to rob people of their jobs, particularly for one’s own profit.

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  5. lone voice says:

    Our “First Do No Harm” FDA is cmmitting a major health crime against the People. In some cases, this may even lead to death. IE, murder from afar. Got to clamp down on them accordingly. Criminals need to be jailed. The FDA is begging for it.

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  6. Gene Semon says:

    Please go to the following link where Dr. Mercola describes a problem for consumers of supplements – toxic multivitamins with synthetic ingredients that don’t work in the body.

    http://articles.mercola.com/sites/articles/archive/2011/08/22/is-your-multivitamin-toxic.aspx?e_cid=20110822_DNL_art_1

    I think it’s important for your lawyers to determine – if they haven’t already done so – whether the FDA has existing authority to ban such products without the NDI rules.

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  7. S. McIntyre says:

    I can’t live without my supplements. I can’t take many prescription drugs because of allergies and severe side effects. The herbs and other supplements work better and are the only thing I can tolerate… they’re much safer, and I just can’t get by without them.

       0 likes

  8. Lou says:

    “Natural health is a huge growth industry”

    Sadly depopulation is also a huge growth industry. Hard to believe? Consider.

    Depopulation Producing

    o Cancer “Treatments” that rarely cure. These “treatments” slowly bleed the patients resources; when his resources are exhausted his life is over. Doing NOTHING is proven to often result in a longer more enjoyable life. In a scientifically advanced society there can be no other reason for this outcome besides depopulation politics.

    o Heart Disease: In the late 1980s Doctor Matthias Rath proposed and verified a unified rational theory of CVD. Our HHS could have easily clinically tested Doctor Rath’s work; they did not. If you follow Doctor Rath’s instructions IMO you will likely never be bothered by CVD. CVD results in about half of the deaths in this country. Instead the medical industry is allowed by the FDA et al to foist on us the most scientifically ridiculous theories of CVD such as “cholesterol done it”. In a scientifically advanced society there can be no other reason for this outcome besides depopulation politics.

    o The FDA rules only TOXIC drugs can treat disease: Now folks think about this a little. In a scientifically advanced society there can be no other reason for this outcome besides depopulation politics.

    o Our Political Pandemic: This pandemic they tell us is inevitable. Yes it is inevitable because it has been created by politics at the highest level. The proof of this blockbuster statement can be found in the FACT that Baxter Labs put the deadly live H5N1 virus in a “Seasonal Flu Vaccine”. If this “vaccine” had made it to its intended market of millions of poor trusting souls THAT would have been the start of the INEVITABLE pandemic. Baxter Labs suffered NO consequences for genocidal act and was picked the following year by HHS to produce the “vaccine” for the H1N1 virus. Baxter Labs is a creature of the Rockefeller clan. HHS is also a creature of the Rockefeller clan.

    To me it seems as natural as night follows day that the FDA wants to get rid of salubrious supplements, sunlight, food, rational medicine and all else that sustains us in LIFE.

       0 likes

  9. B. Talbert says:

    The FDA wants to shut down everything that is not controlled by Big Food, BIg Pharma and Big Chem. The FDA and the USDA need to be shut down and re-built from the ground up in the interests of real science. They are no longer protecting the people.

       1 likes

  10. Great idea! We will be supporting this effort all the way.

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  11. gary schnakenberg says:

    I have been taking vitamins and herbals for 45 years.At age 69 i take no drugs and my VA blood work is excellent..The FDA is corrupt,based on many studies done by independent researchers over the years.. thank you.. Gary

       0 likes

  12. Gerald Bruno says:

    I’m afraid that a massive grass-roots response is about the only thing the FDA might listen to. Will you be organizing an EMail campaign in conjunction with the call-in? Will you be sending us contact information for our Senators & representatives?

       0 likes

    • ANH-USA says:

      Dear Gerald, we have been running an email petition since early July which will remain active until the end of the comment period in October. Please see the second paragraph, in bold and italics, for a link to the email petition.

         0 likes

  13. Grace Adams says:

    Of course the object of all this is to either drive off the market altogether or much increase the price of supplements. The FDA sees its mission as protecting the market share of the ethical drug industry from competition from anything that could substitute for ethical drugs. If the federal government were not so broke, it would make sense to try to hold the cost of health care to 20% of GDP by cutting deals with the corporate leaders in the health care industry to turn them into federal contractors and to make 20% of GDP both floor and ceiling on health care expenditures. Divide that 20% of GDP between drugs, hospitals, large group practices including HMOs, insurance companies, stand alone labs, and small outpatient providers in proportion with market share during some base period and in proportion with market share within each kind of provider among the providers within that kind. Small providers being either solo practices or small partnerships would remain open to turnover and competition. This 20% of GDP for health care would be both ceiling and floor. Health care providers would get more when the GDP increases and less when the GDP decreases. Since drugs are 11% of health care cost and 11% times 20% is 2.2% that 2.2% would be divided among the drug companies in proportion to their market share in the base period. With drugs over 90% is fixed overhead including monopoly price profits and less than 10% is marginal cost of manufacturing including ingredients. So drug firms should divide 2% of GDP by market share for being grandfathered and be assigned contracts to earn 0.2% of GDP for manufacturing what the federal government tells them to manufacture, the feds acting as clearing house for orders from hospitals, chain retail drug stores etc. Everybody who gets their health care including drugs through insurance uses this system and those paying out of pocket are on their own in the free market.

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  14. Unfortunately, one is never certain as to exactly what the contents are in the supplements we purchase: the dosages, the efficacy, the claims made on labels, etc. We need clarity which can only be provided by regulation of standards.

       0 likes

    • S. McIntyre says:

      you have to get quality supplements, then you know what you’re getting. As with anything else.

         0 likes

  15. To whom it may concern

    Under communist rule, e.g. in former East Germany, crimes we talk about (intention of the FDA) were not imaginable. On the contrary: under communist rule – in all communist countries ! – prophylactic medicine was most important.
    One example only: Aronia melanocarpa, a shrub native North-West of Boston was grafted in the Soviet Union since 1922. Later on they cultivated this shrub on more than 17.000 hektar.
    In the seventies of the last century all communist countries were busy with this shrub because of the protective characteristics of its fruits (ORAC 16.020 – see http://www.OxygenRadicalAbsorbanceCapacity) – in USA this fruit was neglected.
    If we (as physicians) were allowed to do what we know 70 % of hospitals could be changed into schools. Under imperialist conditions nobody is interested in education. Thus the Western world returns to Middle Ages. East Asia will be the leading region of the world !
    Summa summarum: Physicians prefer communist rule. Lets return to communism !

    Dr. med. S. Boehm, Internist
    East German Education
    P.S.: I was jailed in East Germany for political reasons, later on sold to West Germany.
    If I had known what West Germany is I’d not agreed to be sold !

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  16. Paul A. Shafer says:

    The ANH should contact the Commerce Commission and the IRS and let them know that their revenues will soon be reduced because the FDA is propagating negligently false information to Congress just at a time when the USA needs all the possible professional scientific and industrial production jobs it can create and ultimately tax. Individuals would be healthier and the country would be stronger financially since payroll and payroll taxes would be increased.

       0 likes

  17. Dr Nydia L Welles says:

    I wrote to Senator Durbin, I live in Illinois and he is my senator. His reply to my letter indicates tha he does not know about the subject of nutritional products. Senator Durbin might be hearing only the lobbysts from the pharmaceutical companies. He will need to learn and inform himself of the other side of medical research, the one that uses natural products to heal the human body. Of course, Senator Durbin migh not have the time to learn about altenative medicine and nutritional products, it takes years to find the information and increase the knowledge because the noble physicians dedicated to heal the body naturally have to do it under the fear of being ostracized by their colleages. In the meantime I am outraged by his bill, he is not representing me!!!

       0 likes

  18. Lloyd Downs says:

    Sir / Madam:
    It is apparent that the drug companies want to wipe out natural methods of healilng just to
    increase the profits
    Lloyd Downs

       0 likes

  19. Marc Miller says:

    Since when has the absurd become the norm in this country? Dietary supplements, statistically are HARMLESS when compared to prescription drugs and OTC Medications. Seriously when is the assault going to stop?!

       0 likes

  20. Christy Elamma says:

    This is just another dirty tactic by Big Pharma and their bedfellows, the FDA, to hand over the vitamin and supplement industry to them so they can control everything, and raise prices to whatever they want. If this is passed into legislation it will hurt most of the population in this country through increased prices, and fewer choices. I for one will look to buy my supplements from another country!

       0 likes

    • wvhillbilly says:

      Notice to big pharma big shots and FDA lackeys: “What will it profit a man if he gains the whole world and loses his own soul?” Spoken by no less than our Lord Jesus Christ.

      You may gather all the money in the world while you’re here, but be advised: When you leave this world you’re taking NONE of it with you! Not even a penny. And be further advised, in the next life you will give account to a far higher power than yourself for everything you’ve done in this life. Think about that, then ask yourself: “Is what I am doing in this life going to be worth it for what I will have to face in the next life?” Far better to turn your life over to Jesus and revel in His riches, than to gain all this world’s riches and be thrown into the lake of fire.

         0 likes

  21. Mitchell Fleisher, M.D., D.Ht. says:

    The FDA should and must withdraw the draft NDI notification as it is an outrageous, and unacceptable, approach to re-classifying hundreds, if not thousands, of safe dietary supplement ingredients.

    My medical professional colleagues across the U.S., my many thousands of medical patients and I will not stand for this egregious attempt to roll back the clock on innovation by nearly 20 years, to grievously harm the health food industry, and to set the stage for far less choice, and for virtually no more cutting edge products going forward.

    The FDA must adhere to the mandate of the U.S. Congress whose clear intention in DSHEA was to protect the public’s access to safe dietary supplements, and also to information regarding the appropriate indications and use of said supplements.

       0 likes

  22. Jay Gordon says:

    This latest “Determination” by the FDA is just another reason to trash the FDA !
    They are just another part of the “One World Order’ which wants to trash the existing world and remake it in their own way. Of course those in charge will benefit financially in the extreme !
    The sooner the FDA is replaced with an organization that will actually Help the people – the better !

       0 likes

  23. Evangeline Caridas says:

    If we are serious about reducing healthcare costs and keepint people healthy, then the FDA should not put such tight restrictions on supplements. Why don’t they focus on perscription drugs which kill thousands of people every year???

       0 likes

  24. Mary Frisone says:

    Thank you; I think the phone in day is an awesome idea and I intend to particpate!

       0 likes

  25. I strongly oppose the idea of NDI regulation by the FDA. This will be another type of burocracy that we can not afford. It is a wasted time and very costly. The dietery supplement industry is the safest in the market. It is a lot safer that the drug industry. The dietery industry is good as it is now because millions of US citizens use the products to prevent illnesses and can save billions of dollars in medical costs. Now with the economic situation in the country and with so much unemployment, we can not afford this usless regulation.

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  26. Suzanne Horburgh says:

    There is a huge consortium of mega rich who take advantage of the masses. For example, industry pour toxins in our collective drinking water, so another mega rich corporate buddy can sell the masses, water filters,plastic bottled water etc..Plastic breaks down into tiny pellits…which is in turn eaten by fish, wildlife…we eat the fish…we get sick…we go to the doctor….It goe’s on and on and on……….Raise YOUR Voice! Change the Paradigm

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  27. Sonia says:

    You go guys!!!! This is EXCELLENT work. We need someone to point out the hideous economic burden and damage this bill would wreak. Even if folks don’t believe in alternative anything, everyone will know that this move doesn’t make and CENTS!

       0 likes

  28. allison says:

    Thanks for keeping us updated and for all you do, with this action item. We CANNOT let this happen here in the USA. No way, no how. This is SOOOO important to our health freedom!!!

       0 likes

  29. Dennis Riehl says:

    My wife and I take about 15 different sup laments per day. We buy them from life Extention and are members. We know they have helped us physically. I have been able to get off high blood pressure medicine (captropil) because of them.
    I am a big fan of suplaments and not of pharmaceutical drugs unless absolutely necessary.
    I support the suplament industry and will help any way I can!

    Dennis Riehl

       0 likes

  30. Vivian Collins says:

    It is going to hurt us that is on a set income to get the supplements we use.
    It is like we have said before that we will have to make a choice of getting our medicine & supplements and leave off most of our food.
    I can not see why they do not leave our vitamin an supplements alone, if we had not had them whn growing up it would have been a rougher life. We did not have doctors around close enough to go too so we did the natural thing an treated our self, that is how we survived.
    We did not have any one to go to so we did what we could to get by an not they want to make every thing so high priced we will have a rough time getting by.

       0 likes

  31. alexa gusick says:

    i want freedom to buy supplements

       0 likes

  32. Anita says:

    Please construct a petition to send to FDA. Thanks.

       0 likes

    • ANH-USA says:

      Dear Anita, we have been running an email petition since early July which will continue through the end of the comment period in October. Please see the second paragraph of this article, in bold and italics, for a link to the petition.

         0 likes

  33. DR. JOHN DAVID BAROSKI says:

    The FDA should be abolished. It only exists as a pawn of the big drug companies. The FDA approves harmful and deadly drugs with a wink of the eye but tries to outlaw healthy supplements.

       0 likes

  34. Arlene Foreman says:

    The wisdom of the citizens made this country great. We do not need the FDA controlling our supplements. Let us alone . We can figure it out in a free country with openness in information.

       0 likes

  35. Norm McEachron says:

    Challenging the FDA on this issues is vital to the future of natural health and the freedom of consumer choice. Thanks for taking this on!

       0 likes

  36. Susan Crawford says:

    Please also initiate a petition for those of us who can only participate that way. Thank you.

       0 likes

    • ANH-USA says:

      Dear Susan, we have been running an email petition since early July which will continue through the end of the comment period in October. Please see the second paragraph of this article, in bold and italics, for a link to the petition.

         0 likes

  37. David says:

    What else do you expect from an out of control Federal Agency!?As for the useless politicians, I give up!

       0 likes

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