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 301-827-6739