What To Expect From FDA’s Draft Guidance On NDIs

What To Expect From FDA’s Draft Guidance On NDIs

The industry has been patiently waiting for the New Dietary Ingredients (NDI) Draft Guidance to be released. With much anticipation NPA has put together a webinar that will give you some tips on what you could expect in a re-draft of the NDI Guidance. NPA has a panel of industry experts that will give you valuable information on NDIs so you can start preparing now. Some areas of discussion will include:

  • When do I have to submit an NDI?
  • What defines a NDI?
  • If an ingredient is already approved for use as a conventional food, do I still have to submit a NDI?
  • What information do I need to show if the ingredient was marketed prior to October 15, 1994?
  • The different responses you can expect to receive from the FDA and what they each mean
  • What changes to an ingredient would require you to file an NDI submission
  • Advantages of submitting NDI notifications and how to avoid the threat of NDI enforcement
  • What does filing an NDI submission get you
  • General framework for assessing the safety of NDIs
  • Intellectual Property Protection and Importance
  • Alternative avenues to market for NDIs outside the NDI notification process

NPAs Daniel Fabricant will give you insider perspective as he was the Director of Dietary Supplements Division at the FDA during the initial writing of the guidance that was released in 2011. Also joining Dr. Fabricant is Ashish Talati (Amin Talati & Upadhyde LLP), Kevin Bell (Porzio Bromberg & Newman LLP), Jason Sapsin, (Faegre BD).
You will not want to miss this webinar and asks our experts questions during the Q & A session.

Contact the NPA team for webinar content.