Latest Developments on NDI's...

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.

6 Comments

  • “I have exzema and have to be very careful of purity of the vitamins and herbs that I use. My vitamins and herbs are expensive….but the purity is there in these products. I purchase thur Andrew Lessman hsn.com or Pro-capsvitamins.com I would use no other products.”

    Georgine January 27 2012

  • “On the first of February I will be 89 years old. I have been buying several of your products for awhile now, and I am very confident that your products do and are what you say about them. Your staff have been helpful and understanding when I need help. Thank you, and I hope you will be able to continue supplying your customers with your good supplements. ”

    Barbara Martin January 27 2012

  • “Hi Warren, It is worth the effort to resist this in the USA as the Australian "authorities" are keen on implementing similar legislation and of course our bureaucrats are no less willing to keep their jobs as any. If it succeeds in the US, we will have it here in NZ – if simply for "harmonisation purposes" under CER.”

    Murray January 27 2012

  • “I have been using your memory supplement for two months now and definately notice the difference as does my husband. I certainly do not want some politician telling me what supplements I can use or not use. ”

    Virginia Brown January 28 2012

  • “I am sick and tired of government intrusion into my private life, including trying to tell me what supplements, etc., I can or cannot purchase if I so choose.   Someone at that agency obviously is being paid "under the table" to come up with such garbage.   Hopefully we will be getting a new  President (U.S.) next year who will put some sensibility back into government.  ”

    MillieK January 29 2012

  • “Well I agree with all the other comments, and specially what Mr. Millek had to say, someone in the Government seems to be always smarter then everybody else, and suddenly becomes an expert in a subject he or she has very little if any understanding. I have been using this product over the last five years, and I can only make this statement, If these people in government would use the product before they make all these fancy decisions, to their surprise they woud discover how well the product works. ”

    Terler January 30 2012

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