FDA Back Channel Lets Pharma Turn Nutrients Into Drugs

Supplements become drugs and you pay. Tell FDA- Not this time! Action Alert!
By failing to complete a key supplement policy, the FDA has provided a way for pharmaceutical companies to take natural compounds and turn them into costly drugs. The longer the agency delays, the greater the danger that more and more nutrients will be nabbed by pharmaceutical companies, forcing cheaper supplement forms from the market.
L-glutamine is the most recent example. Last year, the FDA announced the approval of a new drug for sickle cell disease called Endari. Endari is an oral powder comprised of L-glutamine, an important amino acid. The drug company, Emmaus Medical, Inc., says in its materials that an IND (investigational new drug) application for L-glutamine was originally filed on May 15, 1997. According to the FDA’s website, there is no new dietary ingredient (NDI) notification for L-glutamine.
If a drug company files an IND application on a nutrient before an NDI notification on that nutrient is filed, the company can ask the FDA to have supplement version removed from the market.
This means Emmaus can enforce its IND and petition the FDA to remove all L-glutamine supplements from the market, at any time. Keep in mind this is the same thing that happened to the pyridoxamine version of vitamin B6 in 2008, and is fast becoming a standard business practice for Big Pharma.
If Emmaus enforces its IND, the only way that L-glutamine supplements could survive is if the FDA decides to consider L-glutamine an “old dietary ingredient” (ODI) that does not require an NDI notification. In other words, a company would have to prove that L-glutamine was marketed “in or as” a dietary supplement before 1994.
This is a key point, and another tactic the FDA has used to benefit the pharmaceutical industry. Defining an ODI as a substance marketed “in or as” a supplement, rather than anything “sold” or in the food supply before 1994 as Congress intended, is an FDA invention. Fewer supplements will qualify as ODIs under FDA’s definition, which means more nutrients could become Big Pharma’s next target.
This would be a critical loss. L-glutamine helps maintain muscle, boosts the immune system, supports gastrointestinal health, and helps to maintain healthy growth hormone levels. Every cell in the body uses glutamine–it is an essential amino acid that the body cannot function without. Glutamine is food; for a pharmaceutical company to claim glutamine as a drug is similar to claiming walnuts or blueberries as drugs, and insisting they can no longer be sold as foods.
The crux of the problem is the FDA’s NDI notification guidance that we’ve been writing about since the revised draft was released in August 2016. It has now been 24 years since the Dietary Supplement Health and Education Act (DSHEA) was passed, and the supplement industry has been waiting for the NDI policy ever since. Supplement companies do not know which supplements require an NDI notification or the requirements and protocol necessary for such a submission. In the meantime, pharmaceutical companies are taking advantage of the confusion by snatching up nutrients and turning them into drugs.
The FDA must solidify its NDI notification policy, but completing the draft guidance in its current form is unacceptable. As we wrote in 2016, defining ODIs as substances marketed “in or as” a supplement before 1994 was an improvement over the original guidance—but it’s not good enough and will mean many more supplements that consumers rely on could be eliminated. ODIs should be defined as supplements sold in the food supply, in any form, before 1994, period. The agency must fix the problems with the draft guidance, and then complete the guidance.
Action Alert! Tell the FDA to fix the NDI guidance, and then complete it to prevent more natural medicines from being taken away by the pharmaceutical industry. Please send your message immediately.


      1. No they don’t, I dispense vitamins < they are synthetic - not organic or natural > all the time…

      1. All my clients have vitamins included in their Medicare/Medicaid programs. The problem is, the vitamins are made in a lab

  1. My advice is to take no drugs whatsoever. All of them are toxic to the human body. Why do you think that there are so many side effects. Plant based medicines have many times less side effects and also better long-term health outcomes. It’s a no brainer! If you want to live an unhealthy lifestyle and try to take toxic medication to overcome it, well good luck with that.

    1. You dont get it: they are wanting to mandate a prescription for vitamins and nutrients. As we age, we lose our ability to make nutrients from the food we eat so we NEED nutrient supplementation. Nutrients are NOT DRUGS!!!!! But They want to call them that.

      1. Oh I get it. Writing the FDA is like casting pearls before swine. If you want to stop the nonsense cut their ability to fund their immoral dealings. You do this by not buying their toxic crap that you don’t need anyway!

  2. The FDA has always been a front for Big Pharma. If the FDA cared one cahoots about people, it would never allow the drugs it approves to see the light of day. Now Big Pharma has decided that the billions it makes are not enough and so, the FDA has been asked, once again, to do Big Pharma’s bidding by changing the classification of supplements and Homeopathic preparations to DRUGS which changes the regulation and makes these preparations inaccessible as over-the-counter sales.
    It’s a damned disgrace. We are paying the FDA with our taxpayer dollars so they can control and deny our ability to maintain our own health. I wouldn’t touch a western drug, no matter what the health problem. Western meds kill!!! so no thanks.
    What people who use these supplements and preparations need to do is to get the places they purchase these items to start petitions to the FDA and we all need to push back against the onslaught of greed and criminality in our government. We need to stop being sheep led to theslaughter.

    1. Actually, a large part of the problem is that the FDA isn’t paid with our tax dollars, but with fees charged to the companies they are supposed to be regulating. The FDA is largely funded with corporate money, more so every year. Hence, they are no longer answerable to the American people, but to the corporations that effectively pay their salaries!

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