[MPWG] Questions about New Dietary Ingredients

[Patricia_DeAngelis at fws.gov]

I have some questions regarding the handling of New Dietary Ingredients
(NDIs)...

According to FDA-Centor for Food Safety and Applied Nutrition:
<http://www.cfsan.fda.gov/~dms/ds3strqa.html>

Q: What is a "new dietary ingredient?"


A: A "new dietary ingredient" is a dietary ingredient that was not marketed
in the United States before October 15, 1994. The act requires dietary
supplement manufacturers to submit a premarket safety notification for
certain new dietary ingredients (specifically, any new dietary ingredient
that has not been present in the food supply as an article used for food in
a form in which the food has not been chemically altered). One of today's
announced initiatives, the public meeting on new dietary ingredient issues,
is intended to result in clarification of when an ingredient in a dietary
supplement is a "new dietary ingredient" that requires a pre-market
notification to FDA and what information should be included in the
notification.

NOW, HERE ARE MY QUESTIONS:

1. Are NDIs addressed ingredient-by-ingredient or company-by-company?  In
other words, if company A gets approved to sell new ingredient X, does that
mean ingredient X is no longer "new" and any subsequent companies can now
sell it on the US market?  OR, does every product containing ingredient X
from every company have to go through the premarket notification process?

2. If a dietary supplement is marketed over a website (based outside the
US) and someone within the US buys it, do the same regulations apply
regarding NDIs?  Who in the U.S. has legal jurisdiction over this product
if it comes in by mail, for instance?

3. What about import and export of dietary supplements - who
monitors/regulates that?

THANKS!
-Patricia

Patricia S. De Angelis, Ph.D.
Botanist - Division of Scientific Authority
Chair - Plant Conservation Alliance - Medicinal Plant Working Group
US Fish & Wildlife Service
4401 N. Fairfax Dr., Suite 750
Arlington, VA  22203
703-358-1708 x1753
FAX: 703-358-2276
Working for the conservation and sustainable use of our green natural
resources.
<www.nps.gov/plants/medicinal>