AAOM bulletin on Ma Huang

[Guest guest]

Taken from the AAOM newletter bulletin:

 

Dear Oriental Medicine Professional:

 

As many of you know, the AAOM's Executive Committee has been working

with Health and Human Services Secretary Tommy Thompson's office for

the past year, and one of the main issues has been seeking an

exemption for Chinese herbs from FDA rules that seek to either limit

or prohibit their availability. Our letters were hand delivered to

the Secretary and the Secretary directly forwarded our requests to

the FDA. As you also know, the FDA works for Secretary Thompson.

Nevertheless, the wheels of government and its agencies grind on in

their own ways, and the FDA is certainly not an exception. And so,

the FDA has come out with an " ALERT " announcement on ephedra dietary

substances. First off, this is not a law or a rule (yet). The FDA

will come out with a rule in next few weeks. Although it is a bit

unusual for the FDA to delay the issuance of a rule like this, it

may serve as an advantage to us.

 

You may ask, Have the efforts of the AAOM had any effect on the

ephedra ban? The answer is YES. This ban, for now, is only

on " dietary supplements " targeting weight loss and energy

enhancement. We don't think that was the original breadth of the

impact of what the FDA was seeking. It has changed, and the AAOM has

been credit for the work we have done to intercede on the behalf of

practitioners. Below is a quote taken from the FDA Q & A page on the

new " Alert " that explains why I said YES.

 

Are all products containing ephedra affected?

Essentially all currently marketed dietary supplements will be

affected by the rule. The rule does not pertain to traditional

Chinese herbal remedies. It generally doesn't apply to products

like herbal teas that are regulated as conventional foods.

Additional Information.

 

Notice that is does not generally... " apply to...herbal teas. " Also

notice that it does not pertain to traditional Chinese herbal

remedies. I believe that the direct contact that the AAOM has with

the Office of the Secretary for Health and Human Services was

instrumental in the FDA allowing this exception. We are now working

on specific wording for the FDA rule on ephedra.

 

The Office of the Secretary from HHS contacted me on January 2,

2004. In our discussion, the AAOM's contact confirmed that the

new " Alert " on ephedra applies to dietary products for weight loss

and energy enhancement, and that the FDA has not yet published their

ruling. The Office of the Secretary plans to put the AAOM in contact

with an individual at the FDA with whom we can discuss the FDA rule

and specific wording to exempt all Chinese herbs that contain

ephedrine alkaloids.

 

Because of the importance of this issue, you can be sure we will

send you updates on any new developments.

 

Attilio