…and turn supplements into drugs. What is this agency thinking? Action Alert!
What the FDA does about supplements is usually complicated—we think intentionally so, in order to confuse Congress and critics. Bear with us as we try to disentangle the threads.
We need to get this story out now because the FDA has just opened a public comment period. It is vital to flood the agency and especially Congress with messages.
The FDA has a history of preventing scientific information about food and supplements from being disseminated. Now, if the agency gets its way, the FDA will be able to keep scientific research from being performed in the first place. In fact, our confidential sources tell us that studies on nutrients and dietary supplements are already coming to an abrupt halt. And it’s all because of the FDA’s guidance on INDs, or Investigational New Drug applications.
By law, if any nutrient studies actually do get published, the FDA in most instances won’t allow the nutrient in question to be purchased in supplement form. Even more shockingly, if a drug company wants to turn the supplement into a drug, they will have market exclusivity because the supplement forms would be banned. That’s right: the public will no longer be able to obtain the nutrients and supplements that were studied, because the FDA says they may become drugs. The FDA is essentially making sure their drugs have no competition from supplements.
The FDA’s guidance requires companies to start a burdensome and expensive drug approval process if a nutrient is to be studied for its potential disease prevention or treatment—even if the supplement won’t make any related health claims or be marketed as a drug.
Companies are required to submit an Investigational New Drug (IND) application if their research could support new health claims or the expansion of existing health claims. Historically, INDs haven’t been required for nutrients or food products simply because research does not speak to the intended use of the food product.
More to the point, nutrient studies are important because they include adverse event reporting (and so can help assess safety), and they give us better understanding about the effects of the nutrient on the body, as well as any potential uses for the nutrient in the future. The public relies on such research (increasingly available on the Internet) to make informed health decisions.
There is absolutely no reason for this guidance to include food and nutrients since they are already regulated. DSHEA (the Dietary Supplement Health and Education Act) and the Orphan Drug Act already establish that dietary supplements and medical foods are not considered drugs. Having to submit new drug applications makes the companies publicly claim they’re marketing drugs—even if they’re not.
Even worse, medical foods have always been able to make disease claims—that’s their sole reason for being, after all—but this guidance means that all medical foods would now require an IND—even if a New Dietary Ingredient (new supplement) notification has already been filed. (Medical foods can still stay on the market after the research is published if they had filed an NDI, but they still have to apply for an IND and pay the $2.3 million.)
There is so little research done on nutrients because of the Catch-22 of drug economics, but now with this new rule, there will be even less incentive for research. There is an exception to a supplement being classified as a drug once study data is published: if a New Dietary Ingredient (new supplement) notification has previously been sent to the FDA. But because the FDA is twenty years behind schedule on the NDI guidance, very few notifications have been filed, making this exception a very rare one.
There is also an exception if the supplement was sold before 1994. But there is no agreed upon list of these, and in the past the FDA has interpreted this provision of the law as narrowly as possible. It is not at all clear which supplements will eventually be found to qualify, and this might take years of litigation.
Here’s the final kicker: this guidance is changing the industry even though the FDA hasn’t taken it through the Administrative Procedure Act’s formal rulemaking process. The nutrient industry has no choice but to act as if this guidance is binding law—it is especially difficult to challenge, since it is not actually law:
- According to our sources, institutional review boards (IRBs) are currently rejecting clinical studies about supplements, mainly because the boards aren’t clear about the FDA’s authority or the ramifications of this guidance.
- Insiders also tell us that industry giants like Nestle, PepsiCo, and Danone/Dannon are taking their research money overseas to avoid the extra cost and time to get the required IND—it takes years!—avoiding the process altogether.
Connie M. Weaver, PhD, is distinguished professor and department head for the nutrition science program at Purdue University. In an interview with ANH-USA, Dr. Weaver told us that many are worried that the effects of this guidance “would decrease the competitive edge of US research.”
Joshua Miller, PhD, professor of Nutritional Sciences at Rutgers University, told us, “As an academic department chair, I would be hesitant to advise junior faculty to take up precious time applying and waiting for IND approval [for a nutrient study] as they work toward tenure. For academic research, it’s a major burden. This [guidance] may shut down new research on dietary supplements in academia. It also reduces U.S. jobs—industry will take the research overseas where they won’t need an IND.”
The cost of an IND application is currently $2.3 million. Supplement and medical foods companies can’t usually file for an IND without Pharma money—and a way to recoup their investment on a nutrient, which is not usually patentable.
Research proposals are dropped because the whole process becomes “too daunting,” which in turn limits innovation. A large pharmaceutical company told us that a proposed study to investigate a popular medical food for secondary uses was rejected by an IRB for not having an IND. Another source told us that their grant was approved by the IRB, but they were told that the proposal needed to be cleared with the FDA regarding the IND requirement.
And all of this is by design: it is the FDA making the rules, and the FDA ultimately benefiting: they get $2.3 million and full regulatory authority over the product being researched, which is now classified as a drug.
Let us say that again: as soon as the research is conducted and published, these nutrients and supplements would essentially become classified as drugs. This alone will stop most research dead in its tracks, and any research that does occur is likely to eliminate access to the very nutrient being studied. Filing the IND application sets up a process that virtually guarantees that any nutrients that are studied become drugs and can no longer be marketed as supplements once that research is published.
This is nothing more than “an administrative power grab.” With this guidance, the FDA is vying for more administrative control over medical foods, dietary supplements, and conventional foods—even those whose manufacturers don’t intend to market for their ability to treat diseases. US food science research is suppressed once again.
Action Alert! The FDA has opened a request for comments regarding the burden of filing an IND, the first step toward drug approval. Tell them that food nutrition research has no part in the drug approval regime. And tell them to make clear through their website or letters to IRBs that the guidance has not been finalized and therefore legally cannot be enforced, to help the boards know they are acting according to current regulations. Send your message today!
The FDA has earned the reputation of not protecting consumers from dangerous pharmaceutical drugs making it very clear who they support…the large pharma companies. This is just another tactic they are trying to use to prevent us from adequate self-care to maintain good health so we will be further reliant on the medical and pharmaceutical industry. Don’t let the FDA wield so much power over us. It’s already oppressive enough.
A new prison offense, pushing vitamins ! Jack up the price, they’ll make more billions !
There is something wrong when the big money corps. , over rule what is good for the majority of people.
I would hazard a guess that if the internet is regulated by the govt. that information like this will no longer be available either.
This is absurd. Our food isn’t monitored correctly so don’t get in and mess up the supplements.
We need less government involved, NOT more. Thank You Gary
This makes me wonder if some new unpatentable “super” nutrient has been discovered to increase longevity, or cure obesity or something. What specifically are they after?
Glad we have ANH to alert us. Thank you, we appreciate what you do.
The FDA must stop further regulation of and interference with studying and marketing of nutritional foods and supplements.
Stop selling out to the pharmaceutical industry. People would have FAR more control of their own health if you focused on EDUCATING about nutrition and supplements instead of treating everyone like they are idiots and treating food like a dangerous drug.
Get some of the truly dangerous crap off the OTC list and put things like Zantac back on prescription. Do your job, leave nutrition alone if you aren’t going to educate YOURSELVES about it.
*note this comment has been edited by the moderator for language.
To the ANH: Please, will you re-write your discussion of the FDA’s newest assault on supplements and supplement research. I couldn’t understand what you’ve written at
http://www.anh-usa.org/the-fda-doesnt-want-you-to-know-the-healing-power-of-your-nutrients/
–and I’m not stupid. Probably the FDA is purposely making things confusing; still, a good technical writer should be able to clarify this matter for your readers.
Or maybe someone can refer me to another organization’s discussion of this?
how far will we let this go? “WHY” are our tax dollars being spent to fund an agency that wants us to die 6 weeks after we retire??????????????????????????????????????????????????
Supplements SHOULD NOT be labeled as drugs!!!
This is just down right illegal! It is our right to decide what we want to put into our bodies and should not be left up to the government to decide. This type of movement with only further cripple our economy. I am disgusted!
“Don’t Tread on Me!”
Dear Sir,
Vitamins, minerals, and other chemical substances naturally present in nontoxic commonly ingested substances should not be controlled unless concentrated so as to be toxic or harmful, should be available without prescription in nontoxic food supplement preparations, and do not need an Investigational New Drug (IND) application; but perhaps a warning about the pitfalls of self-medicating should be added to the label and should be required to be read aloud to the ultimate user by the salesman. Perhaps a recorded message should be played each time the substance container is opened, and it should be illegal to transfer the substance to another container for use by another person who has not heard the message.
Sincerely, James R. Schueler
Food nutrition research should be separate from the drug approval process.
See my review of the JUPITER trials for CRESTOR, where nutrition research
indicated significant alternatives to the use of statin drugs.
Scientists are doing an amazing job with discovering innovative health-promoting natural supplements, such that if we choose we can manage our health just fine with natural substances, that occur in nature. Who exactly would be served by taking away the availability of all the scientific innovation of the past several years and years to come?? As far as I can tell the only winners are the pharmaceutical companies and those affiliated with them. This is a perfect example of government interference where it doesn’t belong. This action would squelch science (outside the pharmaceutical community) and free speech. I thought this was a free country.
This problem can be solved very easy. Gather enough money and grease the palms of the Politicians, FDA corrupt Bureaucrats with payola and like the approved poison drugs supplements will be OK. Why do I write this is because the Pharmaceuticals grease their palms with payola and poison drugs that kill over 100,000 citizens each year is approved. Drugs that have a profit margin in the thousands of percent, and never mind research cost as the taxpayer get hit in the neck with that cost. So once again, a great amount of Payola to grease palms with change things. I know this to be true as I have answer back from my so call Senators and Representative which reply with insults when I write, or in person give them the facts. They all should be Charge with Accessory to murder, tried in court, convicted and Jail for years. Chef Robert Morrow
What are you doing trying to get food nutrition research included in drug approval. Food is so under nourishing anymore you need to take supplements. You are going to try to make us have to get a prescription (eventually) for vitamins and minerals? Leave food nutrition out of drug approval regime. I was messed up really bad by doctors and their “prescriptions” and it was supplements that corrected it –on my own. They don’t even go by what the label use is for anyway so don’t turn these good helpful supplements and foods over to “big pharma” and the conventional medicine machine. Thanks
FDA: Please leave the supplements alone. I do not feel that the big drug companies have the best interests of the American people as their main concern. I feel they are only concerned with profits. Supplements help many people.
The founding father of the United States and of Canada would not for one moment stand for the guidance put forward that would cripple the rights of the citizens to make use of the God given nutrients for good health. Such being the case Why would the FDA embark on such an ill conceived rights destroying course of action?
I could not send your suggested letter + my comments as I was told my ZIP code (actually postal code Canada) was not of file.
Too bad!!!
Hey, FDA, Isn’t scientfic research regarding the efficacy of food, nutrients, drugs and dietary supplements a vital part of your entire reason for actually existing? WHY are you now attempting to prevent scientifc research information about food and supplements from being disseminated?
In fact, the FDA is even preventing the scientific research from being PERFORMED in the first place? WHO bought you? Was it the Koch brothers?
The investigation of New Drugs (INDs) are no longer being published and a good part of the reason for that is that the FDA has made the cost of IND research prohibitable. How could it possibly be beneficial to make the scientific research of the advantages or disadvantages of food,nutrients, dietary supplements, etc., (research that is the responsibility that your office has been charged with as its key function) unaffordable and therefore unavailable?
Are you kidding me? WTF? I thought our Federal US agencies were supposed to operate for the benefit of and on behalf of the country and its citizens. Why have you turned against us and still continue to exist? Something’s gotta give. We need an HONEST explanation.
Hey, FDA, Isn’t scientfic research regarding the efficacy of food, nutrients, drugs and dietary supplements a vital part of your entire reason for actually existing? WHY are you now attempting to prevent scientifc research information about food and supplements from being disseminated?
In fact, the FDA is even preventing the scientific research from being PERFORMED in the first place? WHO bought you? Was it the Koch brothers?
The investigation of New Drugs (INDs) are no longer being published and a good part of the reason for that is that the FDA has made the cost of IND research prohibitable. How could it possibly be beneficial to make the scientific research of the advantages or disadvantages of food,nutrients, dietary supplements, etc., (research that is the responsibility that your office has been charged with as its key function) unaffordable and therefore unavailable?
Are you kidding me? WTF? I thought our Federal US agencies were supposed to operate for the benefit of and on behalf of the country and its citizens. Why have you turned against us and still continue to exist? Something’s gotta give. We, the people, need an HONEST explanation.
The human race, through eating foods from its surrounding environment for tens if not hundreds of thousands of years, has managed to mature and grow into what it is today. It is irresponsible and completely immoral to try to subvert information about our foods by classifying them as drugs.
While we’re on this subject, Why have you allowed Genetically Modified Foods to be sold clandestinely throughout the American market without any testing/investigation of their considerable and dangerous effects on our health and bodies???
Why vitamins and not GMOs?
Keep your all powerful, greedy hands off natural remedies, bio identical natural drugs and anything else truly healthy that you want to destroy because YOU can’t make billions on them….Marijuana, Colloidal Silver Water, natural hormones etc. are wonderful, safe replacements for the nefarious, expensive and often dangerous drugs and vaccines made by the mega pharmacies….
I have the right to put nay natural product in my that I wish. Natural as in the way it was grown in the earth and matured. I have the right to nay supplements, herbs and food that I want to put in my body. My body is my temple and I know what it needs and what it wants….that is my right!
There is a mighty difference between “Natural” and “synthetic” supplements. The evidence supporting natural supplements for improved health is strong. Do not throw the baby out with the bathwater.
Food and nutrition research and supplement availability / use has no business being regulated by the FDA or needs to require drug regime approval. Period.
Studies about food and nutrition are critical to the health of nations all over the world. These studies are especially important to those who are trying to alleviate hunger and starvation. Food nutrition research has no part in the drug approval regime. Food is food! Nutrition is nutrition! Drugs are neither.
Make clear through Your website or letters to IRBs that the proposed guidance has not been finalized and therefore legally cannot be enforced, to help the boards know they are presently acting according to current regulations
Food nutrition research has no part in the drug research regime .
I am getting sick and tired of the in-the-pocket-of-Big-Pharma FDA that I could scream! The government bitches and complains about the cost of medical care and yet they continue to let Big Pharma dictate what they can or cannot do regarding vitamins and supplements. Who the hell is in charge of this country? The government or big business??? Get rid of the people who run the FDA and hire nutritionists and naturopaths who actually know what they are doing and will also tell Big Pharma to go shit in their collective hats!! Wanna lower medical costs in this country? Then listen to those in the nutritional field. Dr Joel Wallach has already beaten the FDA in court on a number of occasions, but they still refuse to recognize the fact that there is proof that nutrition works where drugs fail.
Would love to add my name to your concerns about how the FDA are proposing to handle research with supplements. But my letter was rejected as you do not recognise my UK post code!
Food nutritian research has no part in the drug approval regime.
Filing the IND application sets up a process that virtually guarantees that any nutrients that are studied become drugs and can no longer be marketed as supplements once that research is published.
Supplements are food. They’re made directly from food in most cases. Food has healing properties; that doesn’t make it a drug!
The Food and Drug Administration needs to know the difference between food and drugs! If you can’t make that very fundamental distinction, how can you claim any legitimacy as an agency created to protect citizens from harmful drugs?
You must not divorce Americans from supplements, the healing power of food. Do not force INDs on supplement research. Remember your mandate is to serve citizens, not drug companies.
To whom it my concern, All food is given by God to nourish the bodies He created. Hippocrates said to use food as our medicine. Hippocrates predates the FDA ! Your meddling with researchers is costing US jobs as they feel it necessary to go off-shore to have freedom to do their research. The FDA’s main goal is not our protection but controlling us in behalf of the Drug companies. They are losing the game as now played due to exposure of the dangers of their products, so they want to use vague rules to scare off the competition or control it !!! But God is Sovereign over His Creations , food included. The FDA will not win the dangerous game they are trying to play against our people. Remember what happened Nov. 4th ! Respectfully, Mr. & Mrs. Don Patterson
Leave the supplement industry alone!!
When clicking on “take Action” I am forwarded to “secure3 convio site”… Please fix so that i can “take Action” Thanks, Anthonie
Thanks for updating us about this. We have been trying to solve this issue for quite some time now. If you could please forward me the site you’re forwarded to when you click “Take Action”, this would be extremely helpful for us! For now, if anyone else is having this problem, please trying using a different browser or clearing your browser’s cache. We’re working diligently to solve this in the near future so this won’t be needed. Thanks for your patience and feedback. –[email protected]
The FDA should stay out of food nutrition research. You should have plenty to do to keep the drug companies thriving.
IS THE FDA OWNED BY BIG PHARMA?? Americans should be using more natural nutrients – NOT EXPENSIVE PRESCRIPTIONS!
No more hold-ups. FDA – get the studies (information) released and the supplements available to Americans.
Thank you for making it possible for me to make my thoughts on this issue known to those who will vote on them. Here is a copy of my letter:
“I am a small business owner and a homemaker. I do not stand to profit financially from the result of the FDA guidelines or rules. But I take my health and the heath of my family seriously.
Please take time to consider the implications if the FDA renames nutrients as drugs and blocks the ability for Americans to have access to some of the simplest forms of AFFORDABLE HEALTHCARE. We DO NOT need any more powerful lobby meddling in our ability to be well.
Please do not allow the big companies who profit from making drugs to block research on simple alternatives to their drugs.
Keep liberty and creativity in the free market system.
This is so important for the health of our people!!!
Just over a year ago, the FDA released a guidance on INDs for institutional review boards. This overreaching guidance requires companies to start a burdensome and expensive drug approval process if a nutrient is to be studied for potential health claims — even if the supplement won’t be marketed as a drug.
The implications of filing an IND for studies on products intended to be marketed as foods (and not as drugs) are problematic in the extreme. Increased IND filings for non-drug purposes are of particular concern given that filing an IND along with publicly available research typically disqualifies a substance from becoming a new dietary ingredient (NDI).
There is an exception to a supplement being classified as a drug once study data is published: if a New Dietary Ingredient (new supplement) notification has previously been sent to the FDA. But because the FDA is twenty years behind schedule on the NDI guidance, very few notifications have been filed, making this exception a very rare one.
There is also an exception if the supplement was sold before 1994. But there is no agreed upon list of these, and in the past the FDA has interpreted this provision of the law as narrowly as possible. It is not at all clear which supplements will eventually be found to qualify.
This guidance could unnecessarily prevent the dietary supplement industry from creating innovative new dietary supplements with safer, higher quality ingredients. Furthermore, potentially under section 301 of the Food Drug and Cosmetic Act, a preexisting IND may also prevent certain foods from being marketed. This will unnecessarily…
This FDA proposal will be another disaster visited upon the citizens of the US who use supplements and nutrients in order to benefit their good health.
Please allow us the freedom to continue to choose and don’t take that away from us. It isn’t right. Natural remedies have been around since the beginning of time. Regulating this really causes us to wonder why. Is it fear? Control? Population control? I want to know what is behind it, and ask you to think about what truly is best and right. So many are allergic to meds or simply haven’t been helped by them but have had good results using natural means to support health. Why would anyone take that from them and cause people to suffer or not get relief, or worse, have terrible side effects that make them more ill?
I believe that individuals and companies should be free to research any food or herb for its potential benefit to humanity WITHOUT any rules or regulations concerning the outcome. Humanity in general and the united states specifically would be hurt by the restrictions you are proposing to impose. Stop it! Get out of the way and allow free enterprise to work its magic so we can look forward to a healthier future.
DSHEA is doing a fine job. Leave the supplements out of the drug approval process.
You’ll have to excuse me for suggesting such a wild idea. But maybe there is some merit to the idea after all. I’m not the expert, you tell me.
What if placebos in studies were to be replaced with natural ingredients, such as vitamins or herbs. Wouldn’t this be a more interesting test?
If natural ingredients were not beneficial as some claim, then they are perfect for being the “placebo” in the studies.
The reasons to suggest such an idea:
– Natural ingredients get tested for “free”.
– They may prove to be more effective than drugs.
I know there is more to it, but if there is even a chance that it may make sense in some of the double blind studies, maybe it is worth investigating.
Just imagine vitamins giving better results than drugs while going head to head. Direct competition.
Vitamins should no more be turned into a prescription product than food. Another ploy by the drug companies in this country to make another profit. Monsanto, the drug companies, Wall Street, I’m sick and tired of this country being run by the greedy! Stop this insanity!!
Keep your hands off my supplements and essential oils and quit pandering to big pharmaceutical companies! Big government over reach is not in the best interest of the USA. Do your job and quit interfering in my life!
In this day and age we need to explore all possibilities to find cures for illnesses. Please do not stop clinical trials for dietary supplements or conventional foods. One of these unapproved clinical trials reversed the lung cancer in my sister-in-law when all other medical means had failed. Before modern medicines our forefathers had to look to natural means to fight disease and sicknesses. Granted some lived, some died but isn’t this what is happening in today’s world with modern medical treatment methods. I think we all should have the choice to treat our illnesses however we want and it is wrong for the FDA to stop or disapprove clinical trials. If it is the big drug companies behind this move, then that is purely wrong. We all know that there are a long string of complications and warnings from currently prescribed drugs. If more natural supplements are the choice of individuals, then these clinical trials need to continue for the benefit of all in today’s fight against disease.
the FDA is going way to far with regulating foods and nutritional supplements, herbs and oils. Pub Med is loaded with credible Governmental research documenting the health benefits of such yet they want to pull the rug out from those who are making a real difference in people’s lives. We all know this is about big money and pharmacy, and if this country and gov really cared about its citizens this over regulation of natural foods etc should be stopped!!!
The FDA needs to abort its mission relative to hindering nutritional research.
We need to encourage nutritional research for scientific documentation of the multiple benefits
of nutritional supplements.
I have personally funded my own research-development of nutrition over the past 40 years
and have documented therapeutic IV management in the stabilization of a wide variety of health
challenges. We have never ask for outside sources to finance my research.
We have encouraged our radio audience to contact their respective U.S. Senators and Congressmen to not support this blatant FDA abuse of power in attempting to restrict nutritional research.
Furthermore, we have also recommended employment termination of the FDA culprits who are perpetuating attempts to restrict nutritional research and abusing their power.
I have invited members of the FDA on my radio show to defend themselves in this action and they have declined my invitation.
Respectfully submitted,
Daniel W. Koontz, Host of Healthy House Call radio show
Stop trying to punish reserarchers. Your rules will only profit drug companies, who will them take the “new drug” and make a fortune. Less freedom and availability to the “American people” who are your boss. This is not in the best interests of US!
Please do not do this to the American people. Many of us rely on extra nutrients to maintain our health in the face of an increasingly toxic world. Do not remove this choice from us and give even more power to the pharmaceutical industry which, by and large, does not have our best interests at heart. Food is not a drug, and should not be judged as such.
Absolutely ridiculous to have such restrictions against things that improve the life’s of people! !! This has gone to far!:America is turning into a bunch of corporate morons buying EVERYTHING and it has to stop! All so the pharmaceutical companies can make more millions! This is embarrassing!
It is not as if the FDA can even handle what is supposed to be their function now. Let’s see, gee, I think because big pharma has money and can pay off people who work at the FDA and then there are also all of the lobbyists that will benefit, this somehow makes it the right thing to do. WRONG!
Tired of being the 99% left out…
Here is the flip side of this debate.
I used to work in the industry of OTC / Vitamin manufacturers. If you would see how dirty and unsanitary they are, you would think twice about buying any OTC or Vitamins. In addition to this, the ingredients they use are all from: China, Pakistan and India. Unregulated and near or already expired. It is a joke. Sure, not all of them are. I am talking about the smaller ones (under 100 employee). They cut every corner to manufacture for other brand names. So CVS or other big retailers will place an order and send its own labels to pe put on the bottles. Scary. Now, the same does not happen in the prescription industry precisely because they FEAR the FDA (as incompetent as they are). So think about this before you oppose this bill
Thanks so much for this insider perspective. It’s important to note though that supplements ARE already regulated under the Dietary Supplement Health and Education Act, and your experience sounds like there are violations out there that should be remedied (as with any industry). This guidance instead simply de-incentivizes research on supplements in the U.S.
Come to think of it, aren’t ALL foods basically medical foods. Without them we wouldn’t be.
As Americans we have the right to have options and to make choices about our health.
Many of the foods we eat today are not the same our Great Grandparents ingested.
Vitamins are not drugs, and should not be classified as such.
If these choices are taken away, so are our freedoms.
Please reconsider.
Mike Taylor of the FDA and Monsanto had a huge hand in this. How can an attorney with honorary degree’s be making decisions on how much poison is acceptable for human consumption. Only Americans can stop this open conspiracy. The same organization has 90% of the corn and soy in America GMO grown. Wake up people.