NDI's stand for new dietary ingredients. If you have been reading this blog for some time you will be aware that last year the US FDA came out with a bombshell for both industry and consumers alike when they issued a 'guidance' document for NDI's. This document was seen by many as a direct attack on the supplements and much of it was without justification and some aspects of it were technically impossible to comply with.
If you are not aware of how ominous this document is, then you may wish to have a look at some of my earlier blogs which can be accessed from the links below.
Is this the beginning of the end for Supplements?
An Update on the FDA's 'attack' on Dietary Supplements...
An Update of NDI's...
Update of FDA proposed NDI regulations
As a result there has been a significant uproar by consumers and industry alike. The ‘guidance’ if passed would severely undermine the integrity of the Dietary Supplement Health and Education Act of 1994 (DSHEA) as well as restrict the availability of supplements. It would deal a ‘death blow’ to the industry and provide a major victory for the pharmaceutical industry.
The two US Senators who were the prime authors of the DSHEA legislation have come out solidly opposed to the proposed ‘guidance’ document for NDI’s. They have written to the FDA Commissioner requesting that they withdraw the current document and start again. Fortunately they have the support of other influential politicians, but then they have a real fight against those politicians supporting the pharmaceutical lobby.
You can read the letter to the FDA by Senators Tom Harkin and Orrin G. Hatch by clicking here