consensus statement draft

[Guest guest]

The following is a summary of my perception of the consensus of the CHA

membership on the issue of herb safety in general and AA toxicity in specific.

Please comment over the next month, then we will take a vote and then we

can submit this to the FDA. Everything should be considered tentative

till the final resolution.

1. TCM has a long history of concern with medicinal toxicity.

Many herbs are prohibited for long term use or restricted to certain dosages.

Other herbs are processed to reduce or eliminate inherent toxicity.

2. The actual safety record of licensed practitioners of chinese

herbology in the US is exemplary. All serious adverse incidents have

involved OTC sales and practice by those not trained in TCM (such as medical

doctors)

3. The actual total number of all serious adverse chinese herbal

incidents is a mere fraction of those caused by the highly regulated (and

thus supposedly safe) pharmaceutical market.

4. Nevertheless, certain herbs have been implicated in serious

adverse effects worldwide. While these incidents involved OTC sales

and practice by those not trained in TCM, the fact remains that there is

no way to currently regulate the sales of Chinese herbs such that the public

could be distinguished from licensed practitioners (I am actually waiting

for comment from the FDA on this one).

5. In the case of aristolochic acid toxicity, the risk of certain

herbs to be freely available to the general public outweighs the harm done

to the profession of TCM if such herbs are banned

6. However, we insist that the FDA identify specific toxic herbs

using a latin botanical standard of herb identification and biochemical

analysis of samples to verify AA as a standard component thereof.

Anything else would harm our livelihood without due process and thus constitute

a taking by the federal government.

7. We strongly oppose any attempt to ban herbs solely on the basis

of their chinese names.*

8. We support the proposed rule banning AA containing herbs which

have been identified according to modern scientific standards of pharmacognosy,

as detailed in #6 above.

9. We also support the proposed rule that if there is a question

of herbal identification (and thus safety) that such question may be satisfactorily

addressed by providing certificates of analysis proving the absence of

AA.

10. We request that this issue of AA toxicity be formally identified

as such in FDA publications and no longer referred to as Chinese Herb Nephropathy.

This implication, which does irreparable harm to our profession ignores

the actual fact that to this date only a handful of the hundreds of herbs

used commonly in TCM have been even remotely implicated in causing kidney

damage.

11. To the contrary, a substantial body of basic animal research

demonstrates many herbs may actually have beneficial effects on the kidneys.

 

*For example, we have researched Xi Xin and found that the species we

use is not the one listed by the FDA.

Han fang ji ( stephania) contains no AA. The incorrect substitute

(guan fang ji) does. We support a ban on guan fang ji and required

COA's for han fang ji to avoid confusion. Though it is simple to

differentiate visually between Guan Mu Tong (Aristolochia) and Chuan

Mu Tong (Clematis), we support the requirement of COA's for herbs labeled

mu tong to avoid confusion.