NDI Draft Guidance is a Big, Fat Gift to Big Pharma

Want to let the drug industry take your favorite supplements off the market, 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? A follow-up to our recent Action Alert.

As Big Pharma becomes more desperate to boost flagging profits, the industry will likely use this tactic to find new sources of revenue—and shame on the FDA for so blatantly aiding and abetting it!

This coming year, seven of the world’s twenty bestselling drugs will lose their patent protection and can be sold in generic forms. On this list are the top two money-makers ever created: cholesterol fighting (but overall health-threatening) Lipitor and blood thinning (but bone-destroying) Plavix. This wave of expiring drugs patents will have unprecedented and devastating effects on the industry bottom line. One drug recently made available in generic form—Protonix, a medication for severe heartburn (again, not a drug we would use, and especially dangerous when used with the blood-thinner mentioned above)—previously cost about $170 per month when it was still under patent; its generic version now costs $16. With seven of the top-selling drugs expected to see similarly drastic drops in prices, the drug industry is in a panic—especially considering the fact that there are no new “blockbuster” drugs in the pharmaceutical industry pipeline. Under these circumstances, why not try to turn some supplements into drugs?

Even before the draft FDA’s NDI (new supplement) guidelines, supplement manufacturers already faced a “race-to-the-market” threat from the drug companies. The Dietary Supplement Health & Education Act of 1994 (DSHEA) states that a company cannot market a New Dietary Ingredient—that is, a new supplement—if an IND (Investigational New Drug) application for that ingredient has already been filed and research on that ingredient is publically available (a study published in any scientific journal will do).

If the ingredient was already used in a supplement legally marketed before the IND (drug) application was filed, then the supplement company can continue to market it even after the drug filing. But what does “legally marketed” mean to the FDA? It can mean that the supplement was sold in quantity before 1994. Or it can mean that the supplement’s NDI (new supplement) filing has been accepted by the FDA. The problem is that the FDA rejects most NDI (new supplement) filings. And it takes a long time to review even the few it accepts, giving drug companies plenty of time to get a competing drug application in. In complete disregard of the clear intent of the law governing supplements, the FDA has stacked the deck against any new supplement and in favor of any new drug.

Bottom line: If a drug company files an IND (drug) application for a natural substance before a supplement manufacturer can meet the onerous NDI (supplement) notification standards and receive FDA approval, the supplement company can never again sell the substance in its natural form.

This is precisely what happened to pyridoxamine, one of only three natural and bioavailable forms of vitamin B6. And it could also happen to P5P— the ultimate form of natural B6 which all other forms of B6 must convert to before being used by our body. Without P5P we would all die, yet the FDA may turn it into a prescription drug. Please see our Action Alert on P5P.

According to the FDA’s draft guidance, there are 55,600 dietary supplements on the market but only about 700 NDI applications (new supplement applications) have been sent, and the FDA has rejected around 64% of them. Not all of the 55,600 supplements are new (NDIs), but since an NDI is defined as any substance created, modified from its original form, or newly marketed any time in the past seventeen years, we can assume that many of them are! Depending on how the term new supplement is defined in practice by the FDA, there are many thousands of natural substances that can easily be turned into prescription drugs.

At the present time, it is not even possible to know how many IND (drug) applications for natural ingredients have already been filed by drug companies. All this information is kept under wraps by the FDA and not made publicly available.

ANH-USA has read several of the FDA rejected NDI notifications (applications) for very commonly used and essential natural substances—ingredients which are now being investigated as drugs. We don’t want to name them for fear that it would put a target on their back, but the problem is very real.

Wait, there’s more.

Any “new” supplement is already at risk of being converted into a drug—and this risk is greatly increased by the new FDA NDI (new supplement) guidelines. But the new FDA guidelines don’t stop there. While they encourage drug companies to take natural substances, they forbid supplement companies from selling synthetic botanicals.

What does this mean? “Botanicals” refers to plants. For years drug companies have studied plants for medicinal uses. If they find a useful plant, the next step is to try to create a synthetic analog of the natural plant substance, a new molecule that can be patented and then taken through the FDA as a new drug.

Nothing unfamiliar about this. What is new in the draft FDA NDI (new supplement) guidelines is that synthetic versions of botanicals may never be sold as supplements, only as drugs. In effect, the FDA is giving drug companies a monopoly on synthetics, knowing full well that, in general, only synthetics can be patented, and only patented substances can be brought through the hugely expensive FDA approval process.

This is all blatant crony capitalism—a huge gift to the drug industry without any conceivable benefit to the public. There can be no reason for it other than to pad Big Pharma’s pockets—a guaranteed monopoly on synthetic botanicals for drug companies to patent, all of which will lead to larger drug company fees being paid to the FDA.

In saying that drug companies should not have a monopoly on synthetic products, we are not endorsing synthetic products per se. At ANH, we prefer natural products. For one thing, they are generally safer. Why? Because synthetics are new to our bodies; we have not evolved with them. The risk of unintended or unknown side effects is greater. One of the oldest drugs in the world, aspirin, is a synthetic derivative of white willow bark. The herbal form is less likely to cause internal bleeding.

Cholesterol-lowering drugs like Lipitor, Zocor, and Pravachol are synthetics based on the natural ingredient ivostatin found in red yeast rice. The FDA has repeatedly gone after companies that sell red yeast rice products containing ivostatin, on the grounds that this entirely natural substance has now become “an approved drug product” which can only be sold as a drug. Lipitor is the currently the best-selling drug ever made, with 2010 global profits at about $11.7 billion. It is also, unlike red yeast rice, an unrecognized but major health risk for millions of users, as we have pointed out in earlier articles.

Lovaza (omega-3-acid ethyl esters), is the only FDA-approved semi-synthetic omega-3 fish oil, though a second drug, Epanova, is in Phase III of its drug trials. To keep the FDA approval cost down, it is supposedly only approved for the treatment of very high triglycerides. But doctors prescribe it for many reasons, and it is the only fish oil that Medicare and Medicaid and the Veterans Administration is allowed to reimburse. This is wonderfully profitable monopoly for the drug company producing it. Lovaza costs $6.75 per day, over $200 per month. A high-potency natural fish oil supplement with the same EPA and DHA amounts may cost less than 50¢ per day, or $15 per month.

Given a choice between natural and synthetic, we vote for natural. But that doesn’t mean that drug companies should have a monopoly on synthetics. If the FDA has its way, everything we take apart from food would be synthetic, patentable, sold by a drug company, prescribed by a doctor, cost a fortune, and produce a mountain of fees for the FDA itself.

If you have not done so already, please send your message to Congress through our Action Alert on the FDA’s NDI guidance. While you’re at it, be sure to see our Action Alert on the closely related and equally dangerous Durbin bill and let your voice be heard! We cannot emphasize strongly enough how very important it is that we fight on these two issues—your access to natural supplements is at stake!


  1. The articles are too hard(long) to read (I’m mostly trying to read them in between calls at work). Please give a ‘cliff’s notes’ version with the option to read further and a pre-written action step to take!

  2. We need to demand the FDA (I won’t tell you what I think this acronym stands for), is abolished. We are the voters and if we organize and stick together we can end the threat ot hundreds of years of traditional herbal medicine. The FDA and big drug companies are the most evil of organizations. They are evil crooks supreme and need to be snuffed out(the organization) I am PO’d

  3. Please leave our natural food supplements alone. I do not wish to ingest synthetic version of a natural substance.
    Do not let the drug companies patent the natural food substances. They will use synthesised forms as opposed to the natural. I want less of manufactured, genectical enhanced food..
    Please oppose the drug companies trying to patent natural substances.
    I grew up with natural foods I am heathly. Drug companies used to attract MD.’s to exotic trips to see their drugs effeciancy. Tell the drug companies to stop all of those forms of advertising. They don’t work. And tell them to stop trying to synthesis natural substances.

  4. Doctors know next to nothing about nutrition. And now that our health has been sacrificed to the debt we won’t be able to go to a doctor anyway.
    I have been taking supplements for 2/3 of my life and they have saved my health. they have no side effects unlike Big PhRMA meds.
    I sometimes feel like the government want US to be unhealthy as it increases the GDP every time somebody gets horribly ill.
    I need my vitamins, we’ve messed up the land with toxins so badly the food barely contains any nutrients at all.
    I’m sure getting tired of fighting my government which seems to be less and less on the side of the American people.

  5. I love how they want to “protect” us with this legislation, but at the same time, they signed off on the law preventing for labeling products as to GMO content – when there is all kinds of scientific precedent for harm from eating GM foods. Somehow every time they step in to “protect” us, who it ends up protecting is the big multinational corporations instead. Funny thing about that.

  6. The supplements that are available should not be classed as prescription items. It gives an opportunity for the drug company and pharmacy to make money at the expense of citizens of our country.
    Dr. Richard Edlich

  7. Congress,
    Please do not give power to the FDA or big Pharma. I am 69 years old, take no drugs, and I want to continue using natural vitamins and minerals. I have been in health care for 50 years. I stay healthy by not following allopathic docs. They are not on my radar, so please stay away from my whole food supplements. Thank you very much, K

  8. Good God so many Dr’s left me for dead and registered diticains made my food intake unbearable for diabetes and cpod and heart conditions. Why should I give at least a $100.00 more for synthetic phamacuetical drugs……when for less amounts of dollars I can have real food and food supplements that benefit me in a better way than synthetic drugs. We know that Congress and the FDA and the FTC are out of control and are forcing censorhip on us alll for profits..

  9. The price of freedom is eternal vigilance, but dammit, it’s a big pain. (no drug for that pain, either)

  10. The greed of pharmaceutical companies is unlimited. I’ve learned to get along without any of their products, so I boycott them completely.

  11. Do not allow the FDA to be an “enabler” for the pharmaceutical industry. The wellness movement in this country is the only thing that will save our health as a nation. The FDA MUST NOT be allowed to interfere in the health and nutritional choices of ordinary Americans.

  12. This is already happening. Ever hear of Niaspan or Lovaza? Natural supplements repackaged as patented FDA approved drugs. Funny how FDA hasn’t evaluated the effect of niacin, yet somehow can evaluate the effect of Niaspan. When drug companies can no longer deny the effectiveness of supplements they will try “embrace and extend”.

  13. Take your drugs if they’re are so good and you can keep writing me up for not following treatment guidelines because I refuse your medical poisons.

  14. This is just a means of denying the people the right to choose. Now that BIG PHARMA, and their partner, the US Government see that people are turning to supplements for health, and avoiding the health threatening garbage that BIG PHARMA produces they want to use some of these supplements, or ingredients to prevent these helpful supplements from being marketed. SO MUCH FOR AN OPEN MARKET. No one has ever been able to show me or tell what they mean by open “market.” This is just an example of big money rolling over the little guy. OPEN MARKET? You think?

  15. I already receivd a “bug” letter from Kay Bailey Hutchinson Congress woman from Texas when I wrote her. Which said exactly nothing that made any sense.

  16. How long can we afford to allow the Pharms to rule our country?
    The government is really losing it.

  17. Certainly the Rockefellers, Mellons, Astors, Drexels, Windsors, Rothschilds, Warburgs, Kleinworts, Livingstons, Du Ponts, Roosevelts, Vanderbilts, Cullmans, Reynoldses, Dukes, Whitneys et al are out to gut the finances of the middle class and what you’re discussing is a prime target for “seizing the wealth necessary” to take us back to Crown Feudalism. These are the big stockholders in Big Pharma, concealed by a bewildering maze of trusts and foundations. Don’t worry about the Pharmaceutical Manufacturers Association. I offer $5,000 reward for list of The Pilgrims Society, New York, dated 1985 or more recent. All the old “trusts” of the 19th century were drawn into this organization which still holds control over USA finance today.

  18. I am an avid user of all Natural Supplements. I have refused to put into my mouth several prescription medications my doctor wanted to put me on. I finally asked her, why in the world would I put a medication into my body that creates or destroys organs it is suppose to be helping. I was appalled that those drugs were even allowed on the market by the FDA when I read the damage they would do when taken, especially long term use…and cholesterol treatments are long term any way you look at it. Diabetic medications that create high Carbon levels? Whats the point in lowering sugar levels if you are risking dying of toxic poisoning? I could go on and on. The FDA needs to clean up their actions and start doing what is right by the citizens out here who are being treated.

  19. Please do not let our choice to buy and use natural supplements be taken away by giving control to the FDA and the drug companies, with the Durbin bill.

  20. Please do not let our choice to buy and use natural supplements end by giving control to the FDA and drug companies, with the Durbin bill.

  21. Messing with human wellbeing is a crime. Criminals belong in jail, not in public office.

  22. Certainly pharmaceutical manufacturers are huge business all over the world. However, supplement manufacturers and businesses are not small potatoes either. I hope the proprietors of “natural” supplements are also having their voices heard in Congress as this affects them as much as their consumers. I also hope ANH-USA is targeting their alerts to this group and not just individuals.
    Having worked in the medical field as a transcriptionist for nearly three decades, I can assure you, drugs DO make people sick, drugs DO put people in the hospital, and drugs DO kill people. I do not fault the doctors for this; they get their information from the FDA, CDC, AMA, and the drug manufacturers directly. Doctors will prescribe and recommend supplements when there is documentation to support their actual helpfulness to patients. Many of the best doctors in this country even develop and market their own brands of supplements–not drugs– for use by their patients and general public. (Drugs are useful in acute situations, however.) We need to have these doctors’ voices heard in Congress as well.
    I have contacted my representatives regarding my position on supplements. I was contacted by one of them who let me know he would keep my opinion in mind. Hmm.

    1. I want you to know I am in the industry, I am a second generation owner of a supplement company my family started over twenty years ago. We have spent the past seven years working and complying with the cGMPs that FDA established and I whole heartedly agree with, but this is the first time I have really been scared, with this document FDA can and will affectly close down natural medicine. Whoever is in charge right now knows what they are doing, and we are fighing, but it is going to take Congress to stop them, which means every citizen who is concerned must let them know that their jobs are on the line if they don’t support DSHEA. Please we are working hard as manufacturers, but many of us, are family owned and run business, we don’t have the same impact as the drug companies, but you the citizen can and will have the impact if you also band together.
      Citizens saved the supplement industry in 1994, without the petitions and the calls and the letters, we would have had natural medicine swallowed up by drug companies back then. We did it then, we can do it now.
      Good Health to You

  23. The new Draft Guidelines for Dietary Supplements are horrendous, and will take 80% of the supplements that individuals use and depend upon every day OFF the market.
    Please take the 2 minutes to fill in the form to send your Senators a letter of protest. And please pass this along!

  24. Please do not allow large pharmaceutical companies to take control of our supplements. It has become extremely important to stay healthy due to the high cost of health care. Giving more control to big Pharma will most likely push the cost up and most will no longer be able to afford quality supplements.

  25. Money, money, money for the drug companies! Let’s keep the FDA out of controlling natural products – and interfering more with individual’s choices. FDA approved drugs are increasingly proven harmful such as bone density items – a fractured femur is no fun.

  26. I think this is horrible, to try to patent herbs and supplements to try to alter them in the ways that they alter everything else to just be a mass of chemicals and additives is WRONG, plus it will make them more expensive. Those of us who would rather use natural ways to stay healthy don’t need to be forced into being slaves of the drug companies too.
    Read ‘The Great Cholesterol Conspiracy’ for the truth about Lipitol and other Cholesterol lowering drugs. They are actually horrible for you and Americans have been fed a great big fat lie on the whole subject based on one study that wasn’t even valid. The book and several others on this matter are at Amazon.com.
    God Bless you guys!

    These problems must be addressed politically. Our two corporate-funded political parties are both accessories to these outrages, being dependent on corporate cash to run campaigns.
    We can resist by supporting a political party that doesn’t accept corporate money, and that represents CITIZENS’ interests: The Green Party.
    5% of the vote for the Green Party will get them matching Federal funds, and will send a message to the corrupt, corporate-funded parties that selling out citizens to corporate interests will cost them votes. See http://www.gp.org

  28. It is a disaster for the USA and the rest of the world that Big Pharma, Monsanto and some other “Bigs” have hijacked the FDA, FTC, USDA, CFR and largely politics in general. This fact is the biggest threat to all of us, and instead of quarrelling about Federal/State competence, freedom/collectivism, big/small government, global warming manmade or not, and many other hotly debated items, I’d hope that all Americans would unite in reclaiming the Land of the Free from these usurpers, forgetting the other issues. I am convinced that the usurpers stimulate the other quarrels in order to keep their own actions outside the general focus.

  29. Just another feather in FDA’s cap. I have a name for them, but won’t repeat!!

  30. Vince Lombardi, legendary coach of the Green Bay Packers, once said, “The best defence is a good offence!” In keeping with this philosophy, we need to find more aggressive ways to avert the major castrophy to natural health care that Big Pharma would foist on us through the FDA and Congress, by launching more ‘pre-emptive strikes’. Give ’em a taste of their own medicine; make them dance to their own tune!
    Maybe we can find more effective ways to “hit them in the pocketbook” – referring to the Congressmen, Senators and FDA officials who would sell (and have sold!) our access to healthy foods and supplements to the highest bidder: Big Pharma. Completely peaceful and lawful actions, of course.

  31. I also use all Natural supplements whenever possible, and we should be able to do so. The drug companies should not be able to deny us this right, especially when their products do a lot of harm.

  32. I am responding to this as I am listening to the latest food recall- ground turkey-affecting over half the country with 1 person dead so far. . .
    This is yet another “broken” system within government. . . Can we really expect our “elected” officials to vote against this bill? That would be “bitting the hand that feeds them” . Follow the money trail! If you can keep people Sick & Tired- as drugs & GMO’s do to a person’s body- they can not rise up against a corrupt government.
    I “vote” by seeing alternative docs, supporting local farmers, planting a garden, working at & supporting our local co-op.
    We must let our voices be heard at the government level. But, let our “actions” be louder!

  33. we have to be careful and not allow the fda to govern the supplements we want and choose to use.
    we on the other hand have to monitor the quality and cost of our products.
    the insurance industry did not want to bear the cost of prescribed drugs and that is why there are so many now over the counter meds like ibuprofin and prilosec, let the consumers bear the cost.
    big pharma by no means has our best interests in mind by any means.
    i would like to point out that supplements and botanical products and those who sell them are also in the big business of making money. when i buy and bottle of nutrimedix sawmento for $45 and find out that the cost for that is $14 i am a little more than disappointed. that herb is for lyme and if i do not want to take antibiotics i get to take not just that one but 4 others too. the mark up is at 200% and i thinking we need to start monitoring ourselves for quality and cost. when i pay 2 times the cost of a metagenics product and i can only get it from an approved provider what does that say about how we charge for those wonderful botanicals and supplements.
    did you know that many off the shelf vit b supplements are made from medical waste? so lets monitor both BIG pharma and those who manufacture and sell our precious alternatives.

    1. If you have Lyme disease, I would recommend you consult the healer John Douglas (his website is http://www.spirit-repair.com). He has helped at least 3 people I know that had Lyme disease for many years and were very debilitated from the disease.

  34. I have a solution: Supplement manufacturers should refuse to play the game of being regulated by the FDA. Instead of selling supplements, sell “decorations”. So their web page would list items such as “Product Number 145828, these ornamental capsules will add beauty to any decor.” The web page and the product will not suggest that the item should be used for anything other than a decoration, and thus does not even fall into the realm of FDA jurisdiction.
    However, by grass roots word of mouth, everyone will know to go to a central independent third-party website, perhaps called something like http://www.healthfreedom.com, where they can look up the product number and see the actual nutritional description and details, all unregulated by the FDA since this site does not sell anything; it is merely a site that exercises freedom of speech by publishing a bunch of pixels and alphabetic characters. Nothing the FDA can do about that.
    Health product manufacturers and distributors would come to this central site to generate new product numbers, which would be unique across all vendors. They would enter the truthful actual description of their product, only now they won’t be censored by FDA regulators, so if the product helps the body to cure cancer, they can say that.
    Consumers would visit the central web site to look up an actual product number of a “decoration” for more detail, or they could search the entire site of vendor products with advanced filtering capability: perhaps by category (vitamins, lotions, beverages, herbs, minerals, etc.), by vendor, or a key word. This would actually be a great way to compare products quickly, across all vendors. For example, if you were looking for vitamin C, you could find all vitamin C products from all vendors in one quick search. And since this site does not sell anything, and is thus protected with the virtue of free speech, a link could be provided back to the vendor’s site where the product could be purchased per the vendor’s own online store. Vendors’ sites, however, could not publish a link to this central web site that hosts the database of product info because such info would be under the jurisdiction of the FDA. Instead, the vendor’s site just sells “decorations” with no health claims mentioned at all.
    For safety’s sake and consumer convenience, the labels on the “decoration” products should have ample space for the customer to write what the actual contents are. The product description on the central web site could also have a label that could be printed by the consumer and affixed to the bottle. Perhaps the site would allow consumers to set up a profile where they could save their favorite products and print a sheet of labels of their selections at one time.
    The FDA would soon discover what is going on, but they could not do anything about it because they have no authority to regulate the decoration industry, and they cannot exercise any control over a web site that offers information only but does not sell anything.
    I don’t know if anyone has conceived this idea before, but I dreamt it up after reading what the FDA (i.e., big pharma) is doing and just got disgusted and fed up with their games. Let’s just not play their silly games anymore! We can always beat them because we have passion and sharp healthy minds, while they have greed, corruption, and are brain-damaged from their own products.

    1. I have been thinking along the same lines as Steve, i.e. that supplement manufacturers find creative ways to circumvent or otherwise avoid FDA regulation. I’m sad that it has come to this, but I think manufacturers need to be seriously thinking about it.
      One potential problem is that the government won’t always obey its own rules. So, even if they can’t LEGALLY stop you from doing something, that won’t necessarily stop them from raiding your facilities and confiscating your inventory. Even if you fight them in court and win, you’ve still suffered from their actions.
      The bottom line, though, is that it IS possible to do what Steve suggests, in one way or another. The ingredients in our supplements are not regulated, as far as I know, so therefore they can be sold without regulation – if they are not sold as nutritional supplements.

      1. Thanks for the comment John, agreeing that some sort of way to circumvent the FDA may become necessary. I also agree with you that corrupt government officials may decide to not follow their own laws and just raid manufacturer’s inventories anyway; that is the time when physical force and retaliation are necessary…. could be the start of a civil upheaval. Hopefully we can avoid that scenario, but with the recent raid of Rawsome Foods I fear it may be just around the corner.

  35. My grandson was the victim of a vaccine injury when he was 20 months old. Natural foods, vitamins, minerals, amino acids and other various supplements re-built his damaged immune system . From this point, he began to respond to conventional education and therapies. We continued to use biomedical supplements to (in simple terms) open pathways to his brain. His body began to detox heavy metals on a slow, steady basis. During this process, he began to recover from regressive autism with moderate brain dysfunction… He is highly recovered now, but we still keep him on various “alternative” albeit “natural” products. We CAN’T let the FDA, big pHARMa, the AMA or ANY powerful gov’t agency or corporation take our alternative health choices away. Millions of children and adults are being sickened with chronic illnesses that mankind never dealt with before… and I’m convinced that one-size-fits-all drugs and vaccines are the cause of many of them. Let us choose what’s right for ourselves and our children. The majority of the population will continue to make the choice to receive conventional medical care. I highly doubt that we are a serious threat to their profits! FREEDOM OF MEDICAL CHOICES!!!!

  36. This really makes me sad to see this. Is the human nature this ugly? How are you going to take health supplements away from us? I’ll die before I take a prescription drug. Big Pharm, the fda and our government can go to hell. I am moving to Mars.

  37. If this were to pass, not only would supplement contract manufacturing suffer (which is what Big Pharma wants) but consumers would have limited options for meeting their health needs through quality nutritional supplements. It’s definitely something we all (consumers and those in the industry) need to fight for, so be sure to send your message to Congress!

  38. there is no need for them to do this to us. it is just greedy people wanting to make more money. i love going and spending my money on supplements that will help me but i also love when things are on sell. but if this passes i will have to stop buying supplements wont be able to buy at there prices.

  39. the dangerous Durbin bill:
    is all blatant crony capitalism—a huge gift to the drug industry
    without any conceivable benefit to the public. There can be no reason
    for it other than to pad Big Pharma’s pockets—a guaranteed
    monopoly on synthetic botanicals for drug companies to patent, all of
    which will lead to larger drug company fees being paid to the FDA.’ unquote anh article… do we really need a Congress when it has people like Durbin sponsoring bills that are against the people they are supposed to benefit and represent? ! Throw the bums out, I say!

Comments are closed.