Fwd: FDA and ephedra

[Guest guest]

Well, this is supposed to make us happy.

 

'the agency stated that the final rule “does not affect the use of

Ephedra  preparations in traditional Asian medicine,” and that

“[t]raditional Asian medicine practitioners do not typically use

products marketed as dietary supplements.” This language implies that

FDA will exercise enforcement discretion for products that are marketed

to health care practitioners for traditional use so long as their

labeling does not identify them as dietary supplements.'

 

what category of products do chinese herbs fit into if they are not

dietary supplements? if something is not a dietary supplement, then it

is a food or food additive or an untested OTC or rx drug. I assume

ephedra will be considered a food as that is the only other category

besides dietary supplement that would still allow us to recommend to

patients in CA. BTW,if one lives in a state where herbs are not

explicitly part of of one's scope should tread lightly here. It has

always been illegal to use chinese herbs in such states and now px will

be under even more scrutiny there. However, if ephedra is to be

treated as a food for our purposes, what form does this refer to. I

think the answer still remains unclear in this email. So we return to

this,

 

" products like herbal teas that are regulated as conventional foods.”

 

so once again I ask. are we going to be allowed to use ma huang only

in tea form. It was my understanding that our patent remedies are

CURRENTLY regulated as dietary supplements (not diet medicine, but

dietary supplements under DSHEA. Am I wrong?) Perhaps Bob Flaws or

Steve Morissey can tell us if their products are regulated under DSHEA

even the ones that are sold only to licensed px. We will not be safe

until congress creates a class of traditional chinese remedies.

Perhaps the bill in congress that would give the sec of HHS the right

to ban even our use of ma huang across the board can be used as an

opportunity. We should lobby for an official federal exemption as a

class of px from all laws (past, present and future) concerning chinese

herbs, which are directed at the general public, unless we ca be shown

to be contributing to said safety issue. We should not be lumped with

the lay public and have to fight this battle over and over again. here

is the link to that bill again.

 

http://www.congress.org/congressorg/issues/bills/

?billnum=H.RES.435 & congress=108

 

 

February 6, 2004

 

FDA Posts Final Rule to Ban Ephedrine Alkaloids in Supplements

-  April 12, 2004 Effective Date -

 

The Food and Drug Administration (FDA) today posted a pre publication

copy of its “Final Rule Declaring Dietary Supplements Containing

Ephedrine Alkaloids Adulterated Because They Present an Unreasonable

Risk” at the agency's Division of Dockets Management web site. The rule

will be published next Wednesday, February 11th and will become

effective on April 12th.

 

As is normal for a federal notice of a final rule, the largest part of

this document is taken up with the agency's preamble, in which it

provides background information and a response to comments received

during the rule making process. The final rule itself consists of only

two sentences, as follows:

 

[21 CFR] Part 119—Dietary supplements that present a significant or

unreasonable risk.

 

 

§119.1 Dietary supplements containing ephedrine alkaloids.

 

Dietary supplements containing ephedrine alkaloids present an

unreasonable risk of illness or injury under conditions of use

recommended or suggested in the labeling, or if no conditions of use

are recommended or suggested in the labeling, under ordinary conditions

of use. Therefore, dietary supplements containing ephedrine alkaloids

are adulterated under section 402 (f)(1)(A) of the Federal Food, Drug,

and Cosmetic Act.

 

In discussing how it evaluates the evidence to make a determination of

unreasonable risk, FDA stated that it “performs a risk/benefit analysis

to ascertain whether the risks of the product outweigh its benefits.”

The agency added that it had considered only the “known and reasonably

likely benefits, not speculative benefits” and that its burden of proof

of an unreasonable risk “can be met with any science-based evidence of

risk and does not require a showing that the substance has actually

caused harm in particular cases.” AHPA will examine the entire preamble

to evaluate the potential impact of FDA's rationale on dietary

supplements generally.

 

FDA had stated in documents posted on its web site on December 30, 2003

that the final rule would not pertain to “traditional Chinese herbal

remedies” or “generally… to products like herbal teas that are

regulated as conventional foods.” In addressing the issue of

traditional products in the pre publication preamble, the agency stated

that the final rule “does not affect the use of Ephedra  preparations

in traditional Asian medicine,” and that “[t]raditional Asian medicine

practitioners do not typically use products marketed as dietary

supplements.” This language implies that FDA will exercise enforcement

discretion for products that are marketed to health care practitioners

for traditional use so long as their labeling does not identify them as

dietary supplements. Marketers of ephedra products for traditional use

are invited to contact AHPA to address the issues raised with respect

to such products.

 

The pre publication document can be downloaded at

http://www.accessdata.fda.gov/scripts/oc/ohrms/advdisplay.cfm. AHPA

cautions, however, that this document is excess of 21,000 MB and was

erroneously formatted so that it repeats the first 100 (of 263) pages.

The notice that will appear in the Federal Register next Wednesday will

be far less unwieldy.

 

 

 

Chinese Herbs

 

 

FAX:

 

 

 

[Guest guest]

At 8:41 PM -0800 2/6/04, wrote:

>so once again I ask. are we going to be allowed to use ma huang only

>in tea form. It was my understanding that our patent remedies are

>CURRENTLY regulated as dietary supplements (not diet medicine, but

>dietary supplements under DSHEA. Am I wrong?) Perhaps Bob Flaws or

>Steve Morissey can tell us if their products are regulated under DSHEA

>even the ones that are sold only to licensed px. We will not be safe

>until congress creates a class of traditional chinese remedies.

--

 

 

 

You know, I think the FDA has signalled pretty clearly that so long

as we are prescribing ma huang for traditional reasons, and not for

weight loss or athletic enhancement, they are not going to be

interested in us. Given what they've said, and the fact that they've

had their victory, I feel quite safe trusting them with this. The

only risk I see is to our suppliers in the event that they don't

carefully follow the new ruling.

 

Rory

--

[Guest guest]

In a message dated 2/7/04 12:10:02 PM, writes:

 

<< Since the FDA cannot regulate practitioners, how do they decide who can

sell

 

ma huang products or not (a site called healthy magnets, in the top 5 on

 

google, brings you right to a page selling ding chuan tang). There is just

no

 

way for the FDA to enforce their vague exemption and that will rapidly

 

become apparent. >>

 

My understanding of the ephedra situation is that the FDA doesn't really

think people are GOING AFTER ephedra. The FDA thinks consumers are being DUPED

INTO INGESTING harmful substances (ephedra) by the manufacturers of weight loss

and body-building products sold in health food stores and such. Because of

their viewpoint, I don't think the FDA envisions comsumers starting to purchase

Chinese patent medicines just to get the ephedra effect. And they are

probably right. There are many more potent stimulants than ephedra available

for

purchase over the internet for those who seek them.

 

I know this won't make you feel any more secure either, but just thought I'd

offer my point of view.

 

--RoseAnne

[Guest guest]

Rory Kerr wrote :

 

> You know, I think the FDA has signalled pretty clearly that so long

> as we are prescribing ma huang for traditional reasons, and not for

> weight loss or athletic enhancement, they are not going to be

> interested in us. Given what they've said, and the fact that they've

> had their victory, I feel quite safe trusting them with this. The

> only risk I see is to our suppliers in the event that they don't

> carefully follow the new ruling.

>

The resolutions currently before the house and senate subcommittees

concerning changing the DSHEA rules to ban herbs containing ephedrine

alkaloids have no mention whatsoever about exempting Chinese medicinal herbs

(this includes all herbs that have even trace amounts, including ban xia).

The FDA can _say_ they will exempt us all they want, but if HR435 and SR260

pass as currently written, _all_ herbs containing _any_ amount of ephedrine

alkaloid will be permanently banned.

 

please see

http://thomas.loc.gov/cgi-bin/query/z?c108:H.RES.435:

and

http://thomas.loc.gov/cgi-bin/query/z?c108:S.RES.260:

 

Judy Saxe, L.Ac.

Qing Ting Acupuncture LLC

Denver, Colorado

[Guest guest]

, Rory Kerr <rorykerr@o...> wrote:

 

>

>

> You know, I think the FDA has signalled pretty clearly that so long

> as we are prescribing ma huang for traditional reasons, and not for

> weight loss or athletic enhancement, they are not going to be

> interested in us.

 

That hardly makes me feel secure. Especially since the case against ephedra

containing weight loss supplements is pretty trumped up itself. 150 deaths

and thousands of completely unsubstantiated complaints to companies, most

of which were probably unrelated to the labeled use ofephedra. And while you

and other keep attempting to reassure me onthis matter, not a single person

at any level of lobbying or government can tell me HOW the FDA plans to

handle this exemption.

 

Let me give an example. Do you ever sell patents to the general public?

Perhaps someone moves to your area, looks you up and says they take ding

chuan tang for asthma and have run out. Will you sell them this patent w/o a

consult? Or what about the internet. Mayway also says not to worry, yet

their products are available directly to the public in dozens of stores on the

internet.

 

Since the FDA cannot regulate practitioners, how do they decide who can sell

ma huang products or not (a site called healthy magnets, in the top 5 on

google, brings you right to a page selling ding chuan tang). There is just no

way for the FDA to enforce their vague exemption and that will rapidly

become apparent. I think it is shortsighted to think we can sit back, the FDA

is on our side. It looks more like FDA reps told us what we want to hear.

Notice that the AHPA press release says the FDA will exercise dicretion in

who they prosecute for selling ephedra. In other words, the law will not be

enforced against a certain group? I do not think the FDA has the right to pick

and choose who it applies its rules to. I can see a lawsuit on the horizon

already.

 

We still need futher clarification from FDA onthis matter and SPECIFIC

protection from congress. As I write, congress is planning to grant authority

to the sec of HHS to make his own ephedra rules w/o FDA involvement. Does

anyone thinks its suspicious that after all the fuss over how they plan to

exempt us that they failed to lend any real further clarification in the final

rule. Even if FDA agents plan to look the other way for now, it is clear that

the vagueness of the exemption in the final rule gives them the authority to

enforce this rule against us at any time, if they so choose. All it would take

is for someone new to get into power and change their minds.

 

Or is this exemption spelled out more specifically in the rule. the document

is very hard to search and I cannot as yet find any more details than were

included in the AHPA press release.

 

[Guest guest]

At 5:07 PM +0000 2/7/04, wrote:

>Or is this exemption spelled out more specifically in the rule. the document

>is very hard to search and I cannot as yet find any more details than were

>included in the AHPA press release.

--

 

I looked at the condensed version, and the language is the same as before.

 

OK I'm now one of the few examples of someone changing their

mind on this list as result of discussion -- you've converted me to

rationally paranoid.

 

Rory :-{

--

 

 

 

[Guest guest]

I think this is a good point and hopefully, hopefully the FDA will be reasonable

with

our profesional use of Ma Huang.

The Feb 2 New Yorker has a long article about supplements and the issues facing

the

FDA as a response to the 1994 Dietary Supplement Health and Education Act.

Although we all would probably object to the tone of the article there is a lot

of good

information.

doug

 

>

> My understanding of the ephedra situation is that the FDA doesn't really

> think people are GOING AFTER ephedra. The FDA thinks consumers are being

DUPED

> INTO INGESTING harmful substances (ephedra) by the manufacturers of weight

loss

> and body-building products sold in health food stores and such. Because of

> their viewpoint, I don't think the FDA envisions comsumers starting to

purchase

> Chinese patent medicines just to get the ephedra effect. And they are

> probably right. There are many more potent stimulants than ephedra available

for

> purchase over the internet for those who seek them.

>

> I know this won't make you feel any more secure either, but just thought I'd

> offer my point of view.

>

> --RoseAnne

[Guest guest]

If we were dealing with an organization who's main concern was with the

health of people, then of course your rational would make sense. Hey, they

just want to keep people from hurting themselves.

Unfortunately, this is not the case.

The FDA's goals are to maintain a system of " symptom control through

drugs " . It is about money and power. People come after profits.

It is sad, maybe enraging, but true. Be aware of the true desires of the

FDA.

With research this sobering truth becomes obvious.

 

Chris

 

In a message dated 2/7/2004 3:56:30 PM Eastern Standard Time, ra6151

writes:

In a message dated 2/7/04 12:10:02 PM, writes:

 

<< Since the FDA cannot regulate practitioners, how do they decide who can

sell

 

ma huang products or not (a site called healthy magnets, in the top 5 on

 

google, brings you right to a page selling ding chuan tang). There is just

no

 

way for the FDA to enforce their vague exemption and that will rapidly

 

become apparent. >>

 

My understanding of the ephedra situation is that the FDA doesn't really

think people are GOING AFTER ephedra. The FDA thinks consumers are being

DUPED

INTO INGESTING harmful substances (ephedra) by the manufacturers of weight

loss

and body-building products sold in health food stores and such. Because of

their viewpoint, I don't think the FDA envisions comsumers starting to

purchase

Chinese patent medicines just to get the ephedra effect. And they are

probably right. There are many more potent stimulants than ephedra available

for

purchase over the internet for those who seek them.

 

I know this won't make you feel any more secure either, but just thought I'd

offer my point of view.

 

--RoseAnne