Political Action Pays Off!

05/04/07

By Nurse Mark

The Update...

On the legislative front, the efforts of health crusaders like Dr. Myatt and others in educating the public and our political representatives, along with your hard work in contacting those very same politicians to tell them "Hands off our dietary supplements and complimentary and alternative medicines" has paid off.

Your letters, calls, faxes, and emails have saved dietary supplements from being turned into "drugs" by a stroke of the FDA pen through their draconian "CAM Guidelines."

These "guidelines" would have turned virtually all dietary supplements along with many common foods and even (unbelievably, but true) bottled water into "unapproved drugs" resulting in their removal from the marketplace. Even something as simple as a smooth warm rock, if used in "Hot Rocks Therapy" would have come under the FDA's scrutiny and control as "medical devices."

Imagine - the FDA kicking in doors to confiscate rocks because they are "unapproved medical devices"!

This was a bitter struggle, with some of those opposing the FDA claiming that their efforts were being sabotaged and their websites interfered with.  Would Big Pharma do such a thing? Would these giant industries stoop so low? These are some very high stakes...

The History...

Last week we reported that the deadline for commenting on the CAM Guidelines had been extended by a month, until the end of May. The FDA quickly quashed that, blaming some poor, unnamed employee for erroneously changing the date on their website and ending comment retroactively to the end of April.

The entire process of these "CAM Guidelines" has been a curious one at the FDA - the first draft was issued the day after Christmas Day in 2006, but it took the agency until February 26 to post them in the Federal Registry. Though the agency's own guidelines call for a 90 day public comment period, the closing date for comments was listed as April 30 - just over 60 days from the time it was made public. When this was pointed out, and the FDA received tens of thousands of complaints from you about the error, they changed the closing date for comments to May 29th as it should have been. Perhaps realizing that this would allow far too much time for folks like you to register far too many dissenting comments, they then backtracked as noted above, blamed some unfortunate, faceless employee for a "mistake", and shut down any further opportunity for you, the public, to make their voices heard.

It looks like the FDA found themselves caught between a rock and a hard place - with Big Pharma on one side pushing for monopoly control over dietary supplements, and the public (that's you!) on the other side - registering outrage over the audacity of their proposals.

The Results...

Here is what lawyer Ralph Fucetola had to say about the impact of your activism in an email today on the topic of these CAM Guidance proposals:

"And some very good news: Congress has accepted the following amendment to S.1082 - Enhancing Drug Safety and Innovation Act of 2007 - from Sen. Durbin. It appears that Congress heard our concerns! Hundreds of thousands of messages to FDA no doubt reverberated through the halls of Congress. The
amendment was adopted by the Senate 94 to zero."

The amendment that was adopted reads:

Sec. X08. Rule of Construction
Nothing in this title (or an amendment made by this title) shall be construed to affect--
(1) The regulation of dietary supplements under the Dietary Supplement
Health and Education Act; or
(2) The adverse event reporting system for dietary supplements created
under the Dietary Supplement and Nonprescription Drug Consumer Protection Act.

What it means...

Our understanding of this is that the Dietary Supplement Health and Education Act - which protects your dietary supplements, and which is a constant thorn in the side of Big Pharma profits, will be left alone - for now. Likewise, the adverse event reporting system, which Big Pharma and the FDA wanted to change into a tool with which they could cripple and eventually destroy the dietary supplement industry, is to be left unchanged - for now.

What of the future?

This is a bitter blow for the FDA and Big Pharma - and they will be back. We can expect this and similar legislation to be put forth again, and again, and again - Big Pharma has nearly unlimited resources, and they are not afraid to spend their money to win the influence they need to safeguard their obscene profits. We will continue to be vigilant, and to keep you informed, and we will from time to time ask you to become health activists again and to contact your public representatives with your opinions.

When you have a moment, take the time to send a quick note to the representatives that you contacted about this issue and thank them for their wisdom and good sense. Many of these people work hard for us for very little praise or support - a few kind words will leave them remembering you fondly if and when you must write them again on this or another issue.

And for now, we suggest that you give yourselves a well-deserved pat-on-the-back and lift a glass of whatever you prefer to toast with and celebrate this victory with us!