Update of FDA proposed NDI regulations
During the last couple of months, I have posted two articles on this blog concerning the US FDA's guidelines for NDI's (New Dietary Ingredients). As these guidelines stand they will force the majority of supplement manufacturers out of business and severely curtail the availability of supplements in the US.
The link for my first post "Is this the beginning of the end for Supplements" can be accessed by clicking here.
The second post "An Update on the FDA's attack on Dietary Supplements" was is here.
The week before last one of our Directors and me were at Supply Side West in Las Vegas. This is an event we attend each year to keep abreast of developments in the industry including the regulatory ‘landscape’. This year a big issue was the proposed NDI’s. Industry organizations had ‘banded’ together to have an open ‘town hall’ discussion about it. Dr Daniel Fabricant, the architect of the NDI’s from the FDA was also a participant.
Dr Fabricant seems like a nice enough guy but he appears to be very inflexible and certainly got a ‘roasting’ from the industry spokespeople and the participants from the ‘floor’.
One of the participants from the floor was particularly interesting. He was a professor from an LA University and obviously a very knowledgeable person and he spoke a lot of common sense. The main message he got across as a food scientist was that the proposed rules as they outlined by the FDA will be impossible to comply with…simply because the technology is not currently available to do what they are asking.
He proposed that the FDA set up a scientific committee consisting of their own scientists and scientists representing the industry and between them work out a set of regulations that will achieve both the objectives of the FDA and the industry. All responsible manufacturers want to ensure that their products are safe and effective and have no problem with the principle of NDI’s but not in the form that are proposed.
This person also got a good laugh and clap from the audience when he asked Dr Fabricant why the FDA doesn’t focus their resources on the areas that are truly killing people…pharmaceutical drugs! As expected Daniel stayed silent.
Anyway, the take home message from what we learnt in LV was that the NDI proposal has opened up a can of worms which I feel that the FDA may be regretting in that the modifications are going to be major. There are a lot of competent people in industry who are going to fight this tooth and nail so as a consumer I would not be too concerned at the moment as I am sure that the final guidelines are going to take some time and will be significantly modified…but, that is just my opinion, and a slightly optimistic one at that.
I will keep you in the picture as this saga unfolds.
Leave a Comment