The publication of the NDI guidance draft by FDA on July 5, 2011 has clearly sent ripples throughout the industry. It represents FDA’s current thinking on how to regulate the New Dietary Ingredient (NDI) Section 413 of the Public Law 108-417-Oct 25, 1994 known as the Dietary Supplement Health and Education Act. Regardless of how you view this guidance draft, the point is that you still need to obey the law as it was written in 1994 and in the 21 CFR 190.6 regulations.

So you may ask your raw material suppliers whether their ingredients are NEW under the law and whether they HAVE ALREADY SUBMITTED a NDI NOTIFICATION. Your supplier’s reaction may be that “we have sold this product for many years so there is no need to spend money to get the notification done”.

You may decide to use this ingredient regardless of its status. This is your business decision and you are willing to assume the risk.

What if some of the key ingredients you use in your products are imported?

Imagine the scenario where FDA detains the products at the borders because FDA has determined that they contain new dietary ingredients. Without pre-market notification, FDA considers them adulterated or unsafe. No only you will not be able to get the material and you will probably lose sales, your supplier will have to pay the new FDA fees for re-inspection of the products (starting October 1) and probably will pass some of the cost to you. The bottom line is that you better inquire and be sure so you can make a sound business decision.

If you decide that you want to help your supplier get the notification done, hire or recommend a reputable group to them that will help put the NDI notification together.

What is the essence of a NDI notification? It is to show that the new ingredient is reasonably expected to be safe when used under the conditions recommended or suggested in the labeling of the dietary supplement.

Only 25% of the NDI notifications are filed without FDA’s objections. Why such a low percentage? First many notifications do not clearly indicate the nature and the composition of the ingredient. Secondly the safety data given in the notification do not pertain to this new ingredient. Thirdly many notifications contain drug and/or disease claims. Therefore the details and the language used in the notification are KEY when submitting it to FDA.

Feel free to contact me if you have any questions. I would be happy to assist anyone who needs to have a NDI notification done.