FDA has just released the long-awaited New Dietary Ingredient Guidance (NDI Guidance).  A link to the document is provided here:http://www.fda.gov/Food/GuidanceComplianceRegulatoryInformation/GuidanceDocuments/DietarySupplements/ucm257563.htm#iii-scope

As expected, there are a number of big issues arising out of this watershed document.  Here are just a few examples:

1)    Many common manufacturing changes to existing NDIs or ODIs trigger a new NDI status.

2)    Changing solvents will usually trigger NDI status.


3)    Synthetic dietary ingredients are not dietary supplements at all.  They have been kicked out of the DS category.

4)    Changing agricultural or fermentation conditions may trigger NDI status.

5)    Manufacturers must describe how the combination of all the ingredients in their formula relate to the history of safe use of the dietary supplement.

6)    Manufacturers must explain how adulterants such as non-food solvents, pesticides, heavy metals and filth are excluded.

7)    If manufacturers put an expiration date on their label, they should submit appropriate supporting stability data to FDA.

8)    If fermentation is a part of the manufacturing process, manufacturers should be prepared to explain precisely and in detail the fermentation process.

Many marketing companies will now need to file NDIs for their finished products -- something they have never had to do before.

Every dietary ingredient and dietary supplement manufacturer and marketer must now "audit" their ingredient portfolio to determine NDI/ODI status and activate an NDI compliance program.

UNPA is presenting a two-day seminar on the new guidelines; seating is limited to 175 people.  The final program will be available on July 5. The event will be held July 26-27 at the Little America Hotel in Salt Lake City, Utah. For more information, visit: http://unpa.com/login.php

From the July 5, 2011, NutraSolutions' Daily News.