[MPWG] Questions about New Dietary Ingredients

[wendy.applequist at mobot.org]

Where the first question below is concerned, a new dietary ingredient only
has to be approved once (I could imagine FDA trying to dodge this, but so
far they have not).  However, approval is not easy.  Presenting evidence of
millennia of safe use as a medicine counts for little or nothing and can
actually work against you, because it suggests bioactivity, of which FDA is
deeply suspicious.  FDA chooses to treat dietary supplements sometimes more
like conventional foods and sometimes more like drugs, and in this case they
interpret "safety" to mean safety as a conventional food.  (Of course,
spices and culinary herbs would not meet a standard that demanded that you
could eat a heaping plate of whatever it was for dinner every night without
suffering any undesired bioactivities.)

Using the excuse of feared bioterrorism, Congress a couple of years ago
empowered FDA to register and inspect *all* producers and handlers of food,
require them to document who purchased every batch (retail outlets
exempted), etc.  Part of this included the requirement that every foreign
manufacturer who wishes to sell in the U.S. must register with the American
FDA and allow inspections of their facilities on demand, as well as
providing advance notice of every shipment to be made.  Foreign
manufacturers selling to American buyers therefore are supposed to comply
with all American standards, which would include use only of legal
ingredients.  As for exports, anything that is made in this country is
directly regulated by FDA, whether it is for export or domestic use.

As for the second question, I suspect that it is illegal to mail unapproved
products to buyers in the U.S. but that such individual-scale commerce is
left alone because enforcement would be too difficult.  Travelers can bring
most FDA-unapproved prescription drugs into the country for their personal
use, so I presume that mail-order purchasers of unapproved products (so long
as they had no recreational use) would not face legal risk, only the
sellers.

Wendy

>-----Original Message-----
>From: Patricia_DeAngelis at fws.gov [mailto:Patricia_DeAngelis at fws.gov] 
>Sent: Wednesday, January 04, 2006 3:46 PM
>To: mpwg at lists.plantconservation.org
>Subject: [MPWG] Questions about New Dietary Ingredients
>
>
>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>
>
>
>
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