The United Natural Products Alliance will hold an intensive two-day seminar on FDA's recently-released NDI guidance on July 26 and 27 in Salt Lake City, Utah. The seminar, which will be held at the Little America Hotel, will lay out the critical issues, challenges, opportunities and a work plan for how companies should approach their NDI/ODI evaluation process.
Dr. Daniel Fabricant, Director of the Division of Dietary Supplement Programs at FDA, has been invited to act as keynote speaker. The seminar will also feature speakers covering the world of toxicology, a major component of this guidance, as well as the GRAS affirmation process, which is the sister of the NDI process for food ingredients. UNPA will also provide attendees a list of GRAS and NDI consultants to assist companies. In addition, attendees will receive a unique legislative history of the development of the NDI concept to help understand where we were, where we are, and where we may need to go.
A number of concerns identified in the guidance will be covered in the seminar. Among these are:
- Many common manufacturing changes to existing NDIs or ODIs trigger a new NDI status.
- Changing solvents will usually trigger NDI status.
- When can existing GRAS affirmation status give you NDI status?
- Synthetic dietary ingredients are not dietary supplements at all. They have been kicked out of the DS category.
- Changing agricultural or fermentation conditions may trigger NDI status.
- You must describe how the combination of all the ingredients in your formula relates to the history of safe use of the dietary supplement.
- You should address bioavailability of the ingredients as formulated.
- You must explain how adulterants such as non-food solvents, pesticides, heavy metals and filth are excluded.
- If you put an expiration date on your label, you should submit appropriate supporting stability data to FDA.
- If fermentation is a part of your manufacturing process, be prepared to explain precisely and in detail the fermentation process.
Attendance will be limited to 175 seats. Attendees who book by July 20 receive a special rate at the Little America Hotel. The seminar runs 9 a.m. to 5 p.m. July 26 and 9 a.m. to 4 p.m. on July 27 to facilitate attendees' travel plans. Click here to register.