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A question regarding new dietary ingredient notifications

supplements FDA NDI new dietary ingredient

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itayuri

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Posted 29 July 2020 - 10:12 AM

Hello all,

 

I'm looking into the requirements for food supplement in the US.

As part of my research I'm trying to understand what ingredients are permitted for use, but I'm having trouble understanding the New dietary ingredients regulation and it's application in real life:

 

I'll use Moringa leaf as an example:

 

As far as I can tell it is a new dietary ingredient ( not sold before 1994 etc.) and I found two NDIN's that where submitted and rejected for technical reasons and for lack of sufficient information, so I would assume the ingredient is not approved / shouldn't be sold.

But - I can see many Moringa supplements sold in the US (Amazon and other outlets) which may suggest that it is approved.

Am I missing something? or is it simply a case of lack of enforcement?

 

Thanks in advance,

 

Itay



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Posted 29 July 2020 - 01:02 PM

I knew a grower in Panama that began a harvest a supplement business about four years ago and now sells on Amazon in capsule/powder form and also as a tea loose and in tea bags.

 

My information is that Moringa was introduced to the American market around 1985 and he told me that it is classified as a vegetable.

 

Moringa is a dietary supplement and you will find a bit of information on Moringa on the FDA website - it appears a number of companies have made health claims and that is where the FDA comes in as they will then classify a company's Moringa as a drug - here is one such action:

 

https://www.fda.gov/...575934-06042019

 

I remember the grower I knew had to go thru a number of hurdles as he wanted the USDA organic status and SQF - GFSI certification, however they went with IFS and did get the USDA seal as well.


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itayuri

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Posted 04 August 2020 - 06:51 AM

Thank you Glenn,

 

I guess the main point is that it is in the food supply.

 

Itay







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