Here is a factual and effective FDA alert message

[Guest guest]

From my friend Jon Barron:

On April 30, 2007 the FDA will close the public comment period on a

"Guidance" which will effectively classify many alternative health

practices and supplements as drugs. www.fda.gov/OHRMS/DOCKETS/98fr/06d-0480-gld0001.pdf

These proposed guidelines are, of course, total nonsense. The key point in the guidelines is that any

herb or supplement that actually has any beneficial effect should be

regulated by the FDA as if it were a drug if it actually helps with any

medical condition unless it is "generally recognized, among experts

qualified by scientific training and experience to evaluate the safety

and effectiveness of drugs, as safe and effective for use under the

conditions prescribed, recommended, or suggested in the labeling."

This is nonsense for two different reasons.

 

First, who are these experts? Are these the same experts

that approved Vioxx even though it caused heart attacks? Are they the

same experts who approved angioplasty -- now proven to be a waste of $48 billion a year?

Are they the same experts who condemned hundreds of thousands of

children to birth defects because they took forever to acknowledge the

importance of folic acid -- whose benefits were long promoted in the

alternative health community? Are these the same experts who refuse to

accept the safety of stevia even though billions of servings have been

safely used in countries throughout Asia and South America? When the

failures of these so called experts are so apparent, time after time,

it is nonsense to propose that they be the gatekeepers for herbs and

supplements that have been used safely for decades, if not hundreds, or

in some cases even thousands of years. And if the safety of these

alternative remedies is long established (certainly far longer than for

any pharmaceutical drug) why deny people access to their possible

benefits -- even if the proof of those benefits is merely anecdotal?Second,

the regulations are so poorly written that they are guaranteed to lead

to absurdity and self contradiction. For example, if you were to claim

on a label that drinking bottled water helped relieve a medical

condition such as…severe dehydration (not just a medical condition, but a medical emergency), the new guidelines would mandate that water now be regulated as a drug.

These are badly written guidelines that will lead to:

More confusion.More cost.Less access to health.Denial of freedom of access.And

ultimately, an increase in civil disobedience, a further diminution of

FDA authority as people look for ever more creative ways to flaunt the

guidelines in order to maintain access to those herbs and supplements

they want.

You might want to contact the FDA and let them know what you think of the proposed guidelines. Make sure to include the docket # (No. 2006D-0480) with your comments. You can write to them at:

Dockets Management Branch (HFA-305)

5630 Fishers Lane, Rm. 1061

Rockville, MD 20852

Or you can shorten the process and comment online.

An if you have any questions or just want to chat live with them to

let them know you feel, the contact numbers listed on the document are:

Sheryl Lard-Whiteford at 301-827-0379

Daniel Nguyen at 301-827-8971

Ted Stevens at 301-594-1184

Wayne Amchin at 301-827-6739This is the message we should be spreading!Tony