is ban xia really banned?

[Guest guest]

, wrote:

In fact, unprepared Ban

> Xia has 0.00344% or 34 PPM of ephedrine alkaloids and prepared Ban Xia

> has ND (non-detectable) at a testing limit of 3PPM.

 

FDA cites

> significant Adverse Event Reports for the herb Ephedra but none were

> related to any product sold to or by professional practitioners. No

> Adverse Event Reports at all have been associated with Pinellia (Ban

> Xia).

 

 

the inclusion of ban xia in the ban at all seems clearly illegal and not what

congress

intended when they passed DSHEA. congress did not give the FDA the right to ban

naturally occuring molecules, but rather specific natural substances that had

been

show to be harmful. Not a single document was presented that implicated ban xia

in

anyway. No public testimony was made on ban xia. No notice was given to anyone

that it was a matter of concern. Its like banning homeopathic arsenicum because

arsenic can kill you.

 

But even more to the point, the FDA rules bans substances that contain ephedrine

alkaloids. Prepared ban xia, which is the form used in all patents, apparently

does

NOT contain ephedrines (see above). I will point out that just as the actual

FDA rule

does not exempt chinese remedies in patent form, the same rule also does not

mention ban xia by name. the preamble mentions ban xia as an example of such

ephedrine containing herbs. However, if your products do not actually contain

ephedrines, I would submit the rule does not apply to you, even if ban xia is

present

in the product. Since the rule does not mention ban xia, it seems like the FDA

would

have to accept proof that the product contains no ephedrines and could not

pursue

the matter just because of ban xia being present. I don't think the rule as

written

allows them to ban ban xia that has no ephedrines. Just as the rule as written

does

not ban mormon tea, which is an ephedra species with undetectable levels of

ephedrines. So product makers should test your products for ephedrines before

proceeding further.

 

[Guest guest]

 

 

Your points are good ones. In theory, I agree with everything you say. As you

know, the FDA's ruling was poorly thought-out and

poorly written. Frankly, it is not clear exactly what they meant to do. But,

according to spokespersons at the FDA, their intention is to

disallow any dietary supplement which contains Ban Xia. This includes all of our

products which are only sold legally under DSHEA.

 

While the ruling is debatable, companies with lots and lots at stake cannot

operate in such a poorly defined regulatory atmosphere.

Are we supposed to wait until we are hit by a fine of thousands of dollars per

day for every day we have not complied after April 12?

What about our product liability insurance. If we continue selling these

products after Apr. 12, they will not be covered by our

insurance. That creates extreme potential legal libability.

 

This is why it's so important to get the FDA to stay implementation of this

ruling so this whole issue can be made absoultely clear to

all the stakeholders.

 

Bob

[Guest guest]

, " Bob Flaws "

<pemachophel2001> wrote:

 

> What about our product liability insurance. If we continue selling these

products

after Apr. 12, they will not be covered by our

> insurance. That creates extreme potential legal libability.

 

Not just for suppliers, but also practitioners. Malpractice insurance assumes

that

product liability insurers will take up some of the brunt of a suit. W/O that

bulwark,

coverage will be dropped. I wouldn't be surprised if coverage for all herb

prescribing

was soon dropped or incurred an additional rider. Oh, there I go again.

 

While I agree that the FDA must be confronted head on, you suggested a few

months

back that someone who has the fortitude should publicly flout a similar law and

create a test case to challenge it. Does anyone know what the penalties are?

 

Finally, while we all seem to be in agreement now on how the rule affects

patents, I

haven't heard anything about raw herbs or granules recently.