Fwd: FDA and ephedra (long)

[Guest guest]

, " "

 

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 have divided the information from the large pdf document in two

sections. In the bottom of this post you'll find the response from

the FDA on the various comments regarding Ephedra.

 

I also think we should take note on their comments regarding a lack

reporting mechanisms within our professions.

 

There may be some typos as I could not cut-and-paste the text.

 

 

5 Traditional Asian Medicine

 

(Comment 44) Many comments stated that the use of ephedrine alkaloids

in dietary supplements is safe based on its traditional use in Asian

medicine for thousands of years. Several comments asserted that few

or no adverse effects have been recorded with the use of Ephedra in

traditional Asian medicine. Numerous other comments, including those

by traditional Asian medicine practitioners, disagreed with these

comments about dietary supplements, highlighting the differences in

the products themselves and how they are used from what is used in

traditional medicine.

 

Several comments suggested that the raw Ephedra and Ephedra

extracts used in traditional Asian medicine formulae differ in

potency, toxicity, pharmacokinetics, and pharmacological and

physiological effects from many dietary supplements containing

ephedrine alkaloids and, therefore, that these formulations should be

considered distinct in scientific, medical, and regulatory contexts.

Comments stated that " Ephedra " properly refers to dried aerial parts

of medicinal plants, or crude extracts thereof, not to isolated

alkaloidal constituents.

 

Several comments further distinguished the various products

containing Ephedra as follows: Herb and extracts of raw herb of

medicinal Ephedra plants containing naturally occurring alkaloids and

other compounds without further manipulation, concentration, or

adulteration; Ephedra extracts that are concentrated, manipulated, or

adulterated such that naturally occurring proportions and/or

quantities of ephedrine alkaloids are altered; products containing

ephedrine alkaloids combined with other agents such as caffeine,

caffeine-containing herbs, salicylate-containing herbs, synephrine,

and other substances; and traditional Asian herbal medicinal formulae.

 

Several comments asserted that traditional Asian medicine

Ephedra formulae often deliver lower amounts of ephedrine alkaloids

compared to other types of ephedrine alkaloid-containing products and

that traditional formulae rarely contain more than 15 percent Ephedra

in the herb mixture. Comments also asserted that Ephedra in

Traditional formulae us usually combined with other botanicals that

typically modify Ephedra's inherent stimulant effects.

 

Another comment Attributed the relative safety of Ephedra to

the mixture of ephedrine alkaloid isomers not present in purified or

synthetic alkaloids. One comment suggested that the established

therapeutic dose range of Ephedra sinica in herbal medicine formulae

is 60 to 90 mg total alkaloids per day (adults), which falls within

the dosage range established for OTC ephedrine/pseudoepherine-

containing drugs (150 mg and 240 mg alkaloids daily, respectively),

and the recommendations of the Germany Commission E (maximum daily

Ephedra alkaloid dose of 300 mg daily). Other comments asserted that

infusions or teas of Ephedra are effective in relieving respiratory

symptoms but have fewer side effects and are safer than formulations

containing isolated or synthetic ephedrine alkaloids or prescription

drugs.

 

Another comment stated that supplements in a liquid tea form greatly

reduce the risk of excess acute consumption by the public. In

contrast, several other comments stated that the presence of varying

amounts, proportions and chemical configurations of ephedrine

alkaloids in crude Ephedra and prepared Ephedra extracts, as well as

the presence of unknown compounds, leads to uncertainty as to dose,

purity, and composition and to a greater risk of adverse effects.

Comments noted that this variability is not an issue of synthetic or

pure isolated ephedrine alkaloids.

 

Numerous comments, including those by traditional Asian

medicine practitioners, also noted differences in how the products

are used. Several comments stated that most traditional Asian uses of

Ephedra are the same as the indications of OTC ephedrine and

pseudoephedrine drugs (e.g., short-term use to improve respiratory

function) and that few if any adverse effects have been recorded.

Several comments stated that use of Ephedra (ma huang) for weight

control or for its stimulating effects, for more than a short period

of time, in combination with caffeine and other botanical stimulants,

and without the supervision of a health care provider, is

irresponsible and dangerous. A number of traditional Asian medicine

practitioners maintained that many consumers experienced adverse

effects because of this improper use, over-dosage, or conflict with

their illness.

 

Because of these differences, many practitioners of

traditional Asian medicine commented that they support our June 1997

proposal except to the extent that it would restrict their use of

Ephedra in traditional Asian medicine. Several comments asserted

that since most serious adverse effects involve use of ephedrine

alkaloids and not whole herb or whole herb extracts of Ephedra, any

rule must exempt whole herb Ephedra or whole herb Ephedra extracts

that contain no added ephedrine alkaloids. Furthermore, ephedrine

alkaloid-free species of Ephedra should also be exempted.

 

Numerous comments asserted that because traditional Asian

herbal products are prescribed by appropriate practitioners

(licensed, certified, and registered acupuncturists, herbalists, and

naturopathic physicians) and because these products are not

associated with serious adverse effects, the products do not appear

to constitute a public health risk and their use should not be

prohibited. Many traditional Asian medicine practitioners stated

that Ephedra is an essential medicine and requested an exemption from

the final rule for use of Ephedra by traditional Asian medicine

practitioners and acupuncturists. A few comments asserted that

Ephedra should not be used commercially, but be restricted to

professional use, to be dispensed by licensed health care

professionals trained in the appropriate use of traditional Asian

medicine.

 

--------------------------------

 

(Response) This final rule does not affect the use of Ephedra

preparations in traditional Asian medicine, although we considered

the comments' views and information on the use of Ephedra in

traditional Asian medicine in the context of their possible relevance

to the risks of dietary supplements containing ephedrine alkaloids.

This rule applies only to products regulated as dietary supplements

(See 62 FR 30678 at 30691). Traditional Asian medicine practitioners

do not typically use products marketed as dietary supplements.

 

With respect to the absence of adverse effects recorded with

the use of traditional Asian medicine, as we stated in the June 1997

proposal, we are not aware of any systematic collection of data

related to adverse effects occurring in individuals treated with

Ephedra in traditional Asian medicine. The absence of recorded

adverse events with the use of Ephedra, therefore, may be related to

the lack of a mechanism for reporting. Under these circumstances,

there are no data to evaluate. We note that the potential for

adverse effects resulting from the traditional Asian use of Ephedra

is implied in several reference texts that list precautions and

contraindications for the use of the botanical Ephedra in traditional

Asian medicine preparations (Refs. 3, 107, and 108). Moreover, even

if we could say that the absence of recorded adverse events with the

use of Ephedra in traditional Asian medicine was due to its safety of

that use rather than due to a lack of mechanism for reporting, the

history of use of Ephedra in traditional Asian medicine primarily for

the treatment or mitigation of respiratory illness cannot provide

assurance about the safety of dietary supplements containing

ephedrine alkaloids for other uses.

 

Fernando

[Guest guest]

, " Fernando Bernall " <

fbernall> wrote:

 

> This rule applies only to products regulated as dietary supplements

> (See 62 FR 30678 at 30691). Traditional Asian medicine practitioners

> do not typically use products marketed as dietary supplements.

>

 

Fernando

 

Thanks so much. Do you know what the above refers to. it appears to be a

reference to a definition of dietary supplements that canbe found somewhere

perhaps inthis same document. I am holding a blue poppy product in my hands

right now and the label is clearly designed to conform to dietary supplement

labeling standards (under DSHEA). I still read this as meaning teas or perhaps

chinese label teapills (which I thought were illegalunder DSHEA anyhow). But

isn't any tableted or encapsulated product manufactured in the US that

contains herbs regulated under DSHEA? Does anyone actually know the answer

to this very precise question?

 

[Guest guest]

, " Fernando Bernall " <

fbernall> wrote:

 

> This rule applies only to products regulated as dietary supplements

> (See 62 FR 30678 at 30691). Traditional Asian medicine practitioners

> do not typically use products marketed as dietary supplements.

>

 

Fernando

 

Thanks so much. Do you know what the above refers to. it appears to be a

reference to a definition of dietary supplements that can be found somewhere

perhaps inthis same document. I am holding a blue poppy product in my hands

right now and the label is clearly designed to conform to dietary supplement

labeling standards (under DSHEA). I still read this as meaning teas or perhaps

chinese label teapills (which I thought were illegalunder DSHEA anyhow). But

isn't any tableted or encapsulated product manufactured in the US that

contains herbs regulated as a dietary supplement under DSHEA? Does anyone

actually know the answer to this very precise question?

 

[Guest guest]

, " "

wrote:

> , " Fernando Bernall " <

> fbernall> wrote:

>

> > This rule applies only to products regulated as dietary

supplements

> > (See 62 FR 30678 at 30691). Traditional Asian medicine

practitioners

> > do not typically use products marketed as dietary supplements.

> >

>

> Fernando

>

> Thanks so much. Do you know what the above refers to. it appears

to be a

> reference to a definition of dietary supplements that can be found

somewhere

> perhaps inthis same document.

 

 

This refers to the FDA's proposed rule, back in '97, recorded on the

Federal Register, to regulate dietary supplements containing

ephedrine alkaloids that also include other stimulant ingredients

such as caffeine and others similar substances. It also seems to deal

with labeling.

 

Here's a link I hope does not truncate:

 

http://courses.che.umn.edu/02fscn1102-1s/pdf_files/2002%20reading%

20pdf/Herbal%20Phen%20Fen.pdf

 

Here's an excerpt of such proposal:

 

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

21 CFR Part 111

[Docket No. 95N–0304]

RIN 0901–AA59

Dietary Supplements Containing

Ephedrine Alkaloids

AGENCY: Food and Drug Administration,

HHS.

ACTION: Proposed rule.

SUMMARY: The Food and Drug

Administration (FDA) is proposing to

make a finding, which will have the

force and effect of law, that a dietary

supplement is adulterated if it contains

8 milligrams (mg) or more of ephedrine

alkaloids per serving, or if its labeling

suggests or recommends conditions of

use that would result in intake of 8 mg

or more in a 6-hour period or a total

daily intake of 24 mg or more of

ephedrine alkaloids; require that the

label of dietary supplements that

contain ephedrine alkaloids state ``Do

not use this product for more than 7

days''; prohibit the use of ephedrine

alkaloids with ingredients, or with

ingredients that contain substances, that

have a known stimulant effect (e.g.,

sources of caffeine or yohimbine),

which may interact with ephedrine

alkaloids; prohibit labeling claims that

require long-term intake to achieve the

purported effect (e.g., weight loss and

body building); require a statement in

conjunction with claims that encourage

short-term excessive intake to enhance

the purported effect (e.g., energy) that

``Taking more than the recommended

serving may result in heart attack,

stroke, seizure or death''; and require

specific warning statements to appear

on product labels. FDA is proposing

these actions in response to serious

illnesses and injuries, including

multiple deaths, associated with the use

of dietary supplement products that

contain ephedrine alkaloids and the

agency's investigations and analyses of

these illnesses and injuries. FDA is also

incorporating by reference its

Laboratory Information Bulletin (LIB)

No. 4053, that FDA will use in

determining the level of ephedrine

alkaloids in a dietary supplement.

 

 

Fernando