Tuesday, April 17, 2007

Thirteen Days Remain for Comments

A quick reminder - the FDA is awaiting comments on their proposed guidance document concerning Complementary and Alternative Medicine. It is Docket No. 2006D-0480 and the full-text is here: Draft Guidance for Industry on Complementary and Alternative Medicine Products and Their Regulation by the Food and Drug Administration.

I previously urged readers to submit comments here, or send comments via snail mail to:

Dockets Management Branch (HFA-305)
5630 Fishers Lane, Rm. 1061
Rockville, MD 20852

Be sure when you do to include Docket Number 2006D-0480 in your submission.

Please carefully read the document and pay attention to the terminology used.

The document, if approved, specifically medicalizes complementary and alternative therapies, along with the products, supplements, devices and even foods often part of those therapies. By using "treatment" rather than "therapy;" - "medical" rather than "modality;" the document terminology sets traditional and alternative approaches to well-being and health inside allopathic or conventional medicine in the United States and will regulate products currently protected by congressional legislation, in DSHEA (Dietary Supplement Health and Education Act of 1994).

The document, if approved, effectively renders the DSHEA null-and-void, not by congressional mandate, but by a cunning use of terminology to eliminate the limitations the law imposes on the FDA in its current oversight of dietary supplements.

Please take a few moments to add your comments that an end-run around congress is unacceptable - DSHEA was enacted into law after extensive public debate and only public debate, in the House and Senate - in our legislature - should preceed any change made to its mandates.

If the FDA wants greater authority to regulate supplements they need to go to congress and make their case to amend DSHEA, not make an end-run around the existing legislation!


  1. Anonymous5:43 PM

    I posted this in the other article but thought it was worth redoing here. Just because nothing "adverse" has happened in Australia yet doesn't mean they can't now do what they like when it suits them.

    People do put in your objections to this insane view on vitamins & minerals. The Government did it here in Australia & as yet there has been no change but as usual the devil is in the detail or lack of detail & we all know how fond governement is of tweaking existing laws when they think they can kid us that it is for our own good. Every single day here in the Australian news media is some story about the latest you beaut drug invention & also a show or news item about how useless vitamins & minerals are & how the man made drugs are much better than the vitamin & mineral type "drugs".
    The reason we were given about why they made this change was so that they could regulate the manufacture of vitamins & minerals (like that wasn't already happening) they manufactured a huge "drug" (read vitamin & mineral) recall - it was actually an over the counter travel sickness medication that caused a couple of people to get sick - but of course it was the dangerous vitamins & minerals that were taken off the shelves ) against Pan Pharmaceuticals who supplied the whole asia pacific reagion - broke them sent the owner into liquidation & financial ruin, closed down hundreds of local small manufacturers & vitamin selling business & put the whole vitamin industry into the hands of the big multinational drug pharma companies. There has been no media coverage at all about the fact that the NSW supreme court has just cleared the owner of Pan innocent of all charges filed against him!! funny that. Don't let a bunch of moral crusading busybodies dictate to you what is right for you! Stand up now before it is too late.


  2. Regina--I have been passing out this info to everyone I knwo----and like everthing else in this world---nobody gives two hoots in a hollar---

    to me it speaks of