ACTION ALERT! Stop Your $10 Supplement from costing $40,000 as a "Drug"

Many diseases and conditions are linked to poor gut health. Individuals have sought ways to support their bodies with diet and supplements. L-glutamine is one of those supplements. While not appropriate for every condition, access to this supplement is vital for some families working on healing gut issues. A move by drug companies to turn supplements into drugs and REMOVE THE SUPPLEMENT VERSIONS from the market is underway. Join Health Freedom Idaho as we Tell Congress to leave our supplements ALONE! 

For years, consumers have benefitted from access to cheap, safe, and effective CBD oil and L-glutamine supplements. But now the FDA says that CBD is a drug, not a supplement--a drug which will be sold for $32,500 a year. Legally the FDA could at any time remove all CBD supplements from the market, on its own volition, or if the drug company who holds drug market exclusivity requests FDA do so. A newly approved drug means L-glutamine faces a similar threat.

This excerpt from Alliance for Natural Health:

Earlier this year, we told you about an FDA back-channel that allows drug companies to turn supplements into drugs—and remove the supplement versions from the market. This has happened to a popular and medically important version of vitamin B6 (pyridoxamine), and with the FDA’s approval of a new drug to treat sickle cell anemia, the same could happen to L-glutamine. Unless we close a back-channel at the FDA, more and more supplements will be turned into expensive drugs, and consumers won’t be able to manage their health cheaply and naturally with the supplement versions.

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.

Benefits of L-Glutamine

L-Glutamine is constantly being used in our bodies. Normal function in multiple systems is dependent on proper blood glutamine levels. When our bodies undergo trauma or severe stress or illness, cortisol levels increase in our bodies and glutamine stores can be depleted at the same time. This is one of the reasons why we often feel sick after we experience a lot of stress, and why athletes often catch illnesses after grueling workouts or intense performance. Supplementing with L-Glutamine can alleviate some of these symptoms and lead to enhanced recovery. [1]

In addition to general stress, recovery from trauma and damage to muscles specifically can be alleviated by L-Glutamine supplementation. This is simply because our bodies have to make more protein when protein rich tissues like muscles are damaged, and when our bodies need to build protein, glutamine is one of the amino acids that is highest in demand. [3]

Immune System Support

Just as our bodies use L-Glutamine for energy in intestinal and brain cells, our bodies’ defense cells (leukocyte) also use glutamine for energy (See ‘Digestive Support’ above). Because of this, in order to maintain a healthy immune system, keeping glutamine levels up is essential, especially in times of strain when our glutamine stores are often running low. [4] 

CBD oil faces a similar threat. 

For years, consumers have benefitted from access to cheap, safe, and effective CBD oil supplements. But now the FDA says that CBD is a drug, not a supplement—a drug which will be sold for $32,500 a year. While the FDA has not removed CBD oil supplements from the market yet, FDA’s declaration indicates it may be only a matter of time.

Until we close down the IND back channel that allows Big Pharma to turn supplements into drugs, we will continue to see this happen. There’s too much money to be made. That’s why ANH is advocating for a legislative change that will protect natural substances from being turned into drugs by eliminating the market exclusivity that drug companies get when a new drug investigation is on a dietary ingredient currently being sold in the market in a dietary supplement. These rules should apply retroactively to protect CBD oil, pyridoxamine, L-glutamine, and other substances that have already (or are likely to be) removed before this legislation becomes law.

Action Alert! Write to Congress and urge them to close the FDA back-channel that turns nutrients into expensive drugs. Please send your message immediately.


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