The Alliance For Natural Health

The Pulse of Natural Health Newsletter

Stay informed about what is hot in Washington and the states about natural health

New Research Banned on Medical Food and Supplements?

18

The Food and Drug Administration was barreling ahead on this—and breaking the law by doing so. Now they say they’ll think about it.

A year ago we reported on a new FDA sneak attack on medical food and supplements. The idea was simple: just issue a ruling that even studying a medical food or supplement would turn it into a drug.

Perfect! That would be sure to put a stop to competition from medical food and supplements for the drug industry. At the very least, it would stop the development of any new medical food or supplement or new uses for either. Yes, it would also harm the health of Americans. But the health of Americans does not pay the FDA’s bills. The drug companies do.

We swung into action, and with your help and the help of our allies, last year fired warning shots across the FDA’s bow. Now the agency has responded: they will take some time and think about the issue. They aren’t saying they will change their proposed rule, nor are they saying they won’t.

This is standard FDA tactics. If something generates political heat, they back off a bit and wait. If the heat dies down, they move ahead. If it does not, the delay can stretch on for years.

Meanwhile, no one can make any plans. University researchers who might have studied foods and supplements will be afraid to do so—they might be breaking the law by failing to file a new drug application. Everyone, with the sole exception of the big drug companies, will be the losers.

In our prior article about this, we also noted that the FDA was trying to do all this in a way that broke the law. They were trying to do it through a so-called “guidance” document that would actually evade the need to go through the proper administrative procedures to change a rule governing food and supplement research.

At this point, we can take some pride in having slowed down the train. We have made the FDA say it will at least reconsider. But we absolutely must keep the heat on. So please help by sending a message to the FDA and Congress now. If you sent one a year ago, please send another! Please act now.

Take-Action
Meanwhile, here is the article we wrote last year (November 10, 2014) so you will have the full background:

Latest FDA Moves Could Stop Further Research on Supplements

…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 Nestlé, PepsiCo, and Danone/Dannon are taking their research money overseas to avoid the extra cost and time t 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 US 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 Big 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!

Take-Action

 

Other articles in this week’s Pulse of Natural Health:

Say Goodbye to Medical Curcumin!

Share.
  • jonik

    I added the following to the ANH letter about the FDA…..

    >>>>> As further indication that the FDA gives inappropriate priority to business interests of pharmaceuticals and related industries, please note that the FDA, in its job to regulate tobacco, does nothing about the many pesticides (many made by pharmaceutical firms) registered for tobacco use. The FDA also fails to check for, or even warn about, residues of those pesticides in typical cigarettes even though symptoms of “smoking-related disease” are often identical to symptoms of exposure to those pesticides.
    Beyond that, the FDA does nothing to ban or warn about dioxins in cigarette smoke that come from the still legal use of chlorine pesticides and chlorine-bleached paper. And, the FDA does nothing about carcinogenic levels of PO-210 radiation in cigarettes from certain also still legal phosphate fertilizers. To make matters worse, the dioxin, through its Promoter Effect, speeds up cell damage (cancer) caused by other carcinogens.

    It is clear that this FDA does as little as possible to protect people, and as much as possible to serve pharmaceutical…and even cigarette industry…interests.

    • The “U.S. Incorporated government” is an *Enemy Combatant* of ‘We the People’.

      Doesn’t it make sense if you put it in that perspective since the only thing they do is harm us?

  • Laurie J. Willberg

    Why are the Twitter and Facebook share buttons disabled?

    • Because the U.S. govt wants to forcefeed you and your family poison with your own contributions and they don’t want you to complain about it at all. Eat the poison and like it, says the US of Atrocity!

  • Jerri

    Can someone tell me how the supplement Protadim fits into this picture? Because my understanding (although admittedly limited) is that the research being done by the MLM company, Life Advantage that sells it and other supplements, is funded by our government.

    • Most likely, if you didn’t know, most of the Big Pharma or other industries are directly connected to the criminals who run the system (generally, ARE the criminals who run the system) and use Public Funding to do their dirty work.

      They use your money to abuse, poison, deceive, and destroy not only you but all life on this planet. The U.S. really is the worst thing that has ever existed and I will never be apart of it no matter how much pain and anguish I must endure being alone and never having a future or a life to live.

  • grandmaflorist

    They are running scared ever since they realized the research on vitamin d levels over 50 showing no one with cancer. They started the study two years ago. There are also studies from Dr. Stephanie Seneff and leading cardiologists showing heart and diabetes is caused from scar tissue not cholesterol. In fact many studies are showing statin drugs stop the body from absorbing sulfates needed for many reasons and one being weight loss. Oh and the study where the doctor brings her husband out of Alzheimer’s disease on youtube with coconut oil was a big one. (coconut oil is also high in sulfur and good fat needed to raise vitmain d levels).

  • Apparently, I was right to be suspicious and question the Hylands Company about why they took its product called “Insomnia” off the market, replaced it with something called “sleep” and they won’t tell me why they had to reformulate and change the name. I bet we need go no further than the FDA and this is how Hylands got around the issue. I am curious as to why Hylands is secretive when questioned and if that is illegal or at least unethical.

    “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.”

  • Robin Wilis

    Hands off our food supplement, give us the right given gifts that creation designed for humans to consume without restrictions from a government agency . This shows no respect and it is a form of control of the masses and the generation before us and future generation will not benefit from such action.

    Robin Willis

    [email protected]

    • If you want these tyrannical crooks hands off of your stuff you better get your hands on some military grade hardware, and fast.

  • Why don’t we just Ban the FDA instead as well as all the other inept fools who think they run and own the world. Toss em in a volcano and laugh as they melt into the nothing they more appropriately deserve to be.

  • MsFox

    I was told many years ago by a doctor, if I were to take supplements take 3times the recommended dosage! Big pharma (makes most of these) however the recommended dosage is BS. They want you to buy them, but not take a therapeutic amount that could keep you from getting sick, hence when sick you take the pharmaceuticals the docs give you at quadruple or more of the price of a supplement. These people are sick and demented! Doc said if he would recommend any supplement it would be fish oil. But again take 3x the recommended level.

    If you want to know how they are getting away with this….
    YouTube: Gary Nulls War on Health, exposing the FDA

    It gets banned often so sometimes just wait a bit, someone always posts it. It is about 2 hours long, and I promise you 20 minutes into it, you’ll be looking for a white sign and your biggest sharpie! Outrageous!

    Ps I’ve reposted the video myself, it disappears, I’ve tried sharing, it won’t let me. I’ve put a link on FB that disappeared too! SOMEONE DOESNT WANT US TO KNOW THE FACTS!

  • Gail

    Wow, they have a lot of tricks up their sleeves! I bet the pharmaceutical industry has hopes the public will get so fed up with the FDA (who isn’t fed up?) that they will look to CODEX to “solve” the problem. If the FDA is no longer effectively regulating supplements, let’s allow….. From the frying pan into the fire! I am so grateful for the folks at anh – Thank you!

  • Tim Reihm

    Thank you for alerting us to this issue. It should be working now, but please let us know if you have any further issues.

  • DaPle

    The current FDA-Allopathy cartel implemented regulations of supplements already ban the clear but truthful mention of verifiable facts about a product (google “Dietary Supplement Regulation -No FDA Approvals For Supplements!”). It’s censorship of the truth. It’s keeping much of the public unaware of the actual value of supplements. Naturally, fabricated marketing propaganda about medical drugs and products are widely disseminated among the public. Just turn on the TV or read the dribble of the mass media outlets.

  • Daniel Hodun

    My health, my choice. Land of the free, if it fits within the confines of corporate greed.

  • William George

    Sorry I tried to take action, but it seems that one has to live it the US, to be able to complain about situations that affect the people of other counties, Monsanto’s, Dow and Bayer, and companies who are American and aided by the US government through legislation, ultimately and indirectly affect other counties.
    However we have the same problems in Canada, our institutions that are set up to over see our welfare and run by the civil servants (upper bureaucrats) and their political bosses( out MP’s) are subjected to the same temptations of bribes and kick backs as in the US. Greed is their God and money is their Bible. and the public pays for their sins.

  • I’m surprised not to see any attention paid on the move to make kratom a schedule 1 substance. If this happens, people like me may die.