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FDA allowing Drug companies to transform herbs into medicines

                                                             Photo credit – Chris Potter via Flickr

One new way for the FDA to remove supplements and natural products from the market is to allow drug companies to convert them into drugs and then request the FDA to remove all forms of the supplement from the market. They can do this in several steps:

1. First, a drug company files an “IND” application – Investigational New Drug application, in order to demonstrate the use of a dietary ingredient (supplement) to treat a medical condition.

2. Second, if the supplement manufacturers of that herb had not submittted an “NDI” New Dietary Ingredient notification to the FDA after 1994, for any supplement that came on the market since 1994, then the drug company has the right to request the FDA, once they have submitted their “IND” application, to remove the original supplement form of their drug from the market.

This has occurred for the drug Pyridoxamine, an FDA approved version of Vitamin B6, to treat sickle cell anemia, heart disease, cholesterol, PMS, and certain forms of depression.

This now will likely occur with the new drug approved by FDA called Endari to treat sickle cell anemia, which is basically L-Glutamine (an amino acid).  Sixty powder doses on discount at Drugs.com  cost $1166.90. Or you can buy a 1 lb jar of L-Glutamine powder on Amazon for $55.82.  Private insurance companies state that a year’s supply of Endari will cost $40,515.  To pull the plug on L-Glutamine as a supplement the drug’s developer, Emmaus Life Sciences, would just have to request the removal of the supplement form.

This may soon happen to CBD oil, if a drug company named GW Pharmaceuticals which uses CBD oil to create a drug called Epidiolex to treat epilepsy, goes back to the FDA and ask that CBD oil be removed from the market as an unapproved drug. They plan to charge $32,500/ year for Epidiolex.  Those of you presently treating your family or your dog for epilepsy with CBD oil will be thrilled to hear this happening.

Simply all this means is the drug companies going through back channels with the FDA to secure drug approval for a natural plant amino acid or plant chemical that has been in use for many years to treat common symptoms, and cause the FDA to make the supplement version no longer available …. but charge you 1,000s of times more per dose.  You have got to love their manipulation of these laws to cause the FDA to support their own profiteering by turning popular supplements into drugs.

This is of course disturbing, how companies can sit back and limit your access to supplements by converting them into prescription drugs at thousands of times their real cost by taking advantage of some obscure rules by their FDA best buddies. So, my only alternative is go for a dive with some blackbar soldierfish off the Caymans and be thankful to have some insurance and not many medical problems.

Blackbar soldierfish

 

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