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

From Jon Barron’s Blog:

"I never said it was a law or a regulation. I referred to it only as a "Guidance," an internal FDA document that clarifies how they intend to interpret DSHEA."

That said, there are three important points worth considering:

1. In its specificity, the document tightens the restrictions on alternative health labeling found in DSHEA.

2. Its very specificity makes manifest fundamental inconsistencies and absurdities in the DSHEA law. If you substitute "water" for "cranberry tablets" and "severe dehydration" for "urinary tract infection," as found on Page 12, then you've turned water into a drug according to these guidelines. Obviously, the FDA would never turn water into a drug, but the guidelines allow them the option to do so. That "flexibility" alone makes the guidelines dangerous. In reality, what the guidelines do is extend the FDAs authority to arbitrarily decide when to enforce their will.

3. And the FDA absolutely does ask for public comment, allowing people a chance to address points one and two above.

Obviously no responsible person wants total license for any and every marketer to claim that herb X cures cancer, but to not be able to mention the possible cancer fighting benefits of herbs like graviola or pomegranate, protocols such as detoxing or energy work, or supplements such as curcumin and green tea is equally wrong. It denies people the chance to make informed decisions.

And as for waiting for the "so called" experts, these people can't even decide whether or not vitamin E provides any benefits or in fact puts you at risk. (And notice when it comes to these experts how non-specific the FDA is in their guidelines as to who they actually are; and how conveniently that allows them to reject any opinion they don't like.)

Is this all a big deal? Probably not. Far more dangerous is the work of the FDA in killing herbs and supplements sub rosa (http://www.jonbarron.org/newsletters/03/7-21-2003.php). Kava kava is a great example.

* Trashed by the FDA based on erroneous reports that it might cause liver damage after hundreds of studies prove that it doesn't. (http://www.jonbarron.org/newsletters/03/5-5-2003.php)

* Denied coverage by most of the major insurers because of their fear of lawsuits that might be triggered by the FDA's statements of possible! liver damage.

* And right on cue, the class action lawsuit that was settled last year based on the liver damage kava kava does not cause. (http://www.lawyersandsettlements.com/settlements/05514/kava_kava_settlement.html)

Ultimately, the danger is not in big legislation, but in the slow and steady erosion of our rights to choose our own health care options that goes on under the table, out of sight and out of mind.

And once again, it's worth restating, the FDA did ask for comments. If no one says anything, then we can't complain tomorrow if we wake up in the morning with that much less access to alternative therapies.

So, while there is indeed reason to be concerned, my point is that it serves no purpose, indeed it detracts, to portray the FDA alert as something it is not and in the alarmist manner that some are doing!