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Will US FDA Eliminate Gluamine as a Supplement?!
 

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Published: 31 months ago
 

Will US FDA Eliminate Gluamine as a Supplement?!


Glutamine tends to be quite helpful to people struggling with heavy metal toxicity. It is needed for the body to make the important liver antioxidant, glutathione.

It tends to have a calming effect on one's mood, probably because it is a few hops upstream in the body's production of the anti-anxiety neurotransmitter, GABA.

Hypoglycemics might like its ability to help fuel the brain between meals.

It supports muscles, the lining of the digestive tract and kidney health.

I like it for my ADHD and hypoglycemia. It helps me to be a bit more alert but also calmer, especially in between meals. This is far different than coffee, sugar, phenols that will make me more alert but also amp me up too much.

Sadly there is a risk that the US FDA will allow this simple amino acid in whey and other protein powders to be turned into an expensive Rx drug and taken away from us as an inexpensive supplement.


FDA Turned Your $10 Glutamine Supplement into a $40,000 Drug

http://www.anh-usa.org/fda-turned-your-10-supplement-into-a-40000-drug

Last year, the FDA announced the approval of Endari, a drug for sickle cell disease. Endari is an oral powder comprised of L-glutamine, an important amino acid currently available as a supplement. The drug company, Emmaus Medical, Inc., filed an investigational new drug (IND) application—demonstrating their investigation of L-glutamine as a drug—on May 15, 1997. This is important because there is no new dietary ingredient (NDI) notification for L-glutamine. (Think of an NDI notification as a “new supplement” notification; by law an NDI notification must be filed on supplements that came to market after 1994.)

Enter the FDA back-channel. If a drug company begins investigating a nutrient for use in a drug before a supplement company files an NDI notification on that nutrient, the company can ask the FDA to have supplement version removed from the market, leaving consumers with no other option than the drug. Currently, a 120-pill bottle of L-glutamine can be purchased for less than $10; a year’s worth of Endari will reportedly cost consumers more than $40,000.


If Emmaus enforces its IND, the only way that L-glutamine supplements could survive is if the FDA decides that L-glutamine was in the market “in or as” a supplement before 1994. To make matters worse, the FDA has not completed its policy that lets companies know what is and isn’t grandfathered, or even how to file an NDI notification. Given how the current draft of the FDA’s proposal is written, there’s even a real danger that supplements most people would think of as “grandfathered” could require NDI notifications. All of this creates confusion that only helps drug companies further exploit this back-channel.

You can send a message to your government reps

http://www.anh-usa.org/action-alert-close-the-fda-back-channel/
 

 
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