<!DOCTYPE HTML PUBLIC "-//W3C//DTD HTML 3.2//EN">
<HTML>
<HEAD>
<META HTTP-EQUIV="Content-Type" CONTENT="text/html; charset=US-ASCII">
<META NAME="Generator" CONTENT="MS Exchange Server version 5.5.2654.45">
<TITLE>RE: [MPWG] Questions about New Dietary Ingredients</TITLE>
</HEAD>
<BODY>
<P><FONT SIZE=2>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.)</FONT></P>
<P><FONT SIZE=2>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.</FONT></P>
<P><FONT SIZE=2>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.</FONT></P>
<P><FONT SIZE=2>Wendy</FONT>
</P>
<P><FONT SIZE=2>>-----Original Message-----</FONT>
<BR><FONT SIZE=2>>From: Patricia_DeAngelis@fws.gov [<A HREF="mailto:Patricia_DeAngelis@fws.gov">mailto:Patricia_DeAngelis@fws.gov</A>] </FONT>
<BR><FONT SIZE=2>>Sent: Wednesday, January 04, 2006 3:46 PM</FONT>
<BR><FONT SIZE=2>>To: mpwg@lists.plantconservation.org</FONT>
<BR><FONT SIZE=2>>Subject: [MPWG] Questions about New Dietary Ingredients</FONT>
<BR><FONT SIZE=2>></FONT>
<BR><FONT SIZE=2>></FONT>
<BR><FONT SIZE=2>>I have some questions regarding the handling of New Dietary </FONT>
<BR><FONT SIZE=2>>Ingredients (NDIs)...</FONT>
<BR><FONT SIZE=2>></FONT>
<BR><FONT SIZE=2>>According to FDA-Centor for Food Safety and Applied Nutrition:</FONT>
<BR><FONT SIZE=2>><<A HREF="http://www.cfsan.fda.gov/~dms/ds3strqa.html" TARGET="_blank">http://www.cfsan.fda.gov/~dms/ds3strqa.html</A>></FONT>
<BR><FONT SIZE=2>></FONT>
<BR><FONT SIZE=2>>Q: What is a "new dietary ingredient?"</FONT>
<BR><FONT SIZE=2>></FONT>
<BR><FONT SIZE=2>></FONT>
<BR><FONT SIZE=2>>A: A "new dietary ingredient" is a dietary ingredient that was </FONT>
<BR><FONT SIZE=2>>not marketed in the United States before October 15, 1994. The </FONT>
<BR><FONT SIZE=2>>act requires dietary supplement manufacturers to submit a </FONT>
<BR><FONT SIZE=2>>premarket safety notification for certain new dietary </FONT>
<BR><FONT SIZE=2>>ingredients (specifically, any new dietary ingredient that has </FONT>
<BR><FONT SIZE=2>>not been present in the food supply as an article used for </FONT>
<BR><FONT SIZE=2>>food in a form in which the food has not been chemically </FONT>
<BR><FONT SIZE=2>>altered). One of today's announced initiatives, the public </FONT>
<BR><FONT SIZE=2>>meeting on new dietary ingredient issues, is intended to </FONT>
<BR><FONT SIZE=2>>result in clarification of when an ingredient in a dietary </FONT>
<BR><FONT SIZE=2>>supplement is a "new dietary ingredient" that requires a </FONT>
<BR><FONT SIZE=2>>pre-market notification to FDA and what information should be </FONT>
<BR><FONT SIZE=2>>included in the notification.</FONT>
<BR><FONT SIZE=2>></FONT>
<BR><FONT SIZE=2>>NOW, HERE ARE MY QUESTIONS:</FONT>
<BR><FONT SIZE=2>></FONT>
<BR><FONT SIZE=2>>1. Are NDIs addressed ingredient-by-ingredient or </FONT>
<BR><FONT SIZE=2>>company-by-company? In other words, if company A gets </FONT>
<BR><FONT SIZE=2>>approved to sell new ingredient X, does that mean ingredient X </FONT>
<BR><FONT SIZE=2>>is no longer "new" and any subsequent companies can now sell </FONT>
<BR><FONT SIZE=2>>it on the US market? OR, does every product containing </FONT>
<BR><FONT SIZE=2>>ingredient X from every company have to go through the </FONT>
<BR><FONT SIZE=2>>premarket notification process?</FONT>
<BR><FONT SIZE=2>></FONT>
<BR><FONT SIZE=2>>2. If a dietary supplement is marketed over a website (based </FONT>
<BR><FONT SIZE=2>>outside the</FONT>
<BR><FONT SIZE=2>>US) and someone within the US buys it, do the same regulations </FONT>
<BR><FONT SIZE=2>>apply regarding NDIs? Who in the U.S. has legal jurisdiction </FONT>
<BR><FONT SIZE=2>>over this product if it comes in by mail, for instance?</FONT>
<BR><FONT SIZE=2>></FONT>
<BR><FONT SIZE=2>>3. What about import and export of dietary supplements - who </FONT>
<BR><FONT SIZE=2>>monitors/regulates that?</FONT>
<BR><FONT SIZE=2>></FONT>
<BR><FONT SIZE=2>>THANKS!</FONT>
<BR><FONT SIZE=2>>-Patricia</FONT>
<BR><FONT SIZE=2>></FONT>
<BR><FONT SIZE=2>>Patricia S. De Angelis, Ph.D.</FONT>
<BR><FONT SIZE=2>>Botanist - Division of Scientific Authority Chair - Plant </FONT>
<BR><FONT SIZE=2>>Conservation Alliance - Medicinal Plant Working Group US Fish </FONT>
<BR><FONT SIZE=2>>& Wildlife Service</FONT>
<BR><FONT SIZE=2>>4401 N. Fairfax Dr., Suite 750</FONT>
<BR><FONT SIZE=2>>Arlington, VA 22203</FONT>
<BR><FONT SIZE=2>>703-358-1708 x1753</FONT>
<BR><FONT SIZE=2>>FAX: 703-358-2276</FONT>
<BR><FONT SIZE=2>>Working for the conservation and sustainable use of our green </FONT>
<BR><FONT SIZE=2>>natural resources.</FONT>
<BR><FONT SIZE=2>><www.nps.gov/plants/medicinal></FONT>
<BR><FONT SIZE=2>></FONT>
<BR><FONT SIZE=2>></FONT>
<BR><FONT SIZE=2>></FONT>
<BR><FONT SIZE=2>>_______________________________________________</FONT>
<BR><FONT SIZE=2>>MPWG mailing list</FONT>
<BR><FONT SIZE=2>>MPWG@lists.plantconservation.org</FONT>
<BR><FONT SIZE=2>><A HREF="http://lists.plantconservation.org/mailman/listinfo/mpwg_lists" TARGET="_blank">http://lists.plantconservation.org/mailman/listinfo/mpwg_lists</A>.</FONT>
<BR><FONT SIZE=2>>plantconservation.org</FONT>
<BR><FONT SIZE=2>></FONT>
<BR><FONT SIZE=2>>To unsubscribe, send an e-mail to </FONT>
<BR><FONT SIZE=2>>MPWG-request@lists.plantconservation.org with the word </FONT>
<BR><FONT SIZE=2>>"unsubscribe" in the subject line.</FONT>
<BR><FONT SIZE=2>> </FONT>
<BR><FONT SIZE=2>>Disclaimer </FONT>
<BR><FONT SIZE=2>> </FONT>
<BR><FONT SIZE=2>>Any advice given on this list regarding diagnosis or </FONT>
<BR><FONT SIZE=2>>treatments etc. reflects ONLY the opinion of the individual </FONT>
<BR><FONT SIZE=2>>who posts the message. The information contained in posts is </FONT>
<BR><FONT SIZE=2>>not intended nor implied to be a substitute for professional </FONT>
<BR><FONT SIZE=2>>medical advice relative to your specific medical condition or </FONT>
<BR><FONT SIZE=2>>question. All medical and other healthcare information that is </FONT>
<BR><FONT SIZE=2>>discussed on this list should be carefully reviewed by the </FONT>
<BR><FONT SIZE=2>>individual reader and their qualified healthcare professional. </FONT>
<BR><FONT SIZE=2>>Posts do not reflect any official opinions or positions of the </FONT>
<BR><FONT SIZE=2>>Plant Conservation Alliance. </FONT>
<BR><FONT SIZE=2>> </FONT>
<BR><FONT SIZE=2>></FONT>
</P>
</BODY>
</HTML>