If you have been a reader of this blog for some time you may have read the earlier articles that I wrote concerning NDI's which stands for New Dietary Ingredient. The thrust of those articles were to bring to your attention the threat that we were all facing, industry and consumer alike to the on-going access to dietary supplements.
The US FDA published a ‘guidance’ document on what they required to have done in order to register a new dietary ingredient. The industry had been waiting 17 years for this document which apparently was prepared in just 180 days under a congressional mandate.
The bottom line is that the document was ill-conceived and was unworkable and impractical in many different ways. In fact, if it had gone ahead in the form that was published most of the supplement industry would have had to close their doors. I won’t go into the reasons for this as it is too involved but I did outline some of these in the previous blog posts which you can access.
I should point out that this over the top ‘guideline’ had nothing to do with either safety or efficacy.
There was a comment period which the FDA, under industry and consumer pressure extended until the beginning of this month. The industry responded in a coordinated manner. If you are interested in knowing the arguments that were submitted and some further background you can do so by reading an article published by ‘Natural Products Insider’. Just click here
to access it.