ephedra rule press

[Guest guest]

Here is a link for an article in the Feb. 18 New York Times on the FDA

Ephedra rule.

 

http://www.nytimes.com/2004/02/17/health/policy/17HERB.html

 

-roseanne

[Guest guest]

, ra6151@a... wrote:

> Here is a link for an article in the Feb. 18 New York Times on the FDA

> Ephedra rule.

>

> http://www.nytimes.com/2004/02/17/health/policy/17HERB.html

 

 

I read this article and while it has quotes from some famous friends, it offers

no further clarification exceot to say that chinese herbs are not marketed as

dietary supplements. Again I ask. In what universe?> Is there an exemption

in DSHEA for chinese prepared formulas? Not as far as I know. Our patent

meds are indeed dietary supplements by every reading of the DSHEA law. and

ephedra rule does not change that. Until I hear an offical statement from the

FDA saying specifically what they mean, my reading of the actual rule (and not

all the comments and caveats) is that they could confiscate ban xia containing

patents as soon as the rule goes into effect.

 

Where is this supposed exemption actually codified? I do not believe mere

mention of this issue in the background info published with the rule legally

creates a true exemption. It is really commentary on the rule. Thus once the

dems get back into power, we could be really screwed. All the FDA would have

to do is change enforcement policy, not make a new rule. Perhaps I

misunderstand things, but it also seems pretty clear to me that the FDA rule

does not specifically exempt ma huang or ban xia, it just says the rule will

not apply to products NOT ALREADY regulated as dietary supplements. So this

all hinges upon what is and isn't ALREADY a dietary supplement. I ask again.

Let the FDA clarify this. It still appears to me that they only are exempting

loose teas as they ALREADY regulate patents as dietary supplements. Is

someone actually disputing this?

 

If patents are NOT regulated as dietary supplements, why do they have to

adhere to DSHEA rules on labeling and claims? Raw herbs do not have to

adhere to these rules. That is the clearest evidence to me that patents ARE

dietary supplements and raw herbs are NOT. I will not shut up till the FDA

says word for word that " chinese patents medicines containing ephedrine

alkaloids (prepared products in pill,liquid extractor capsule form) are exempt

from the ephedra ban " . If this is true, why will no one say it. Perhaps

because

it is not. Now I am not suggesting our offices will soon be raided, just that

they could be under the law as its written.