Ephedra Ban New GMPs

[Guest guest]

Hi All

The Acupuncture and Oriental Medicine Alliance Herb Committee

submitted comments to the FDA on behalf of practitioners, patients and

industry regarding ephedra before the comments period closed on April

7, 2003. We also sent out a press release to journalists we had

identified as writing on the topic, (but would love to have more

contacts for future) as well as an email for distribution to

practitioners to encourage everyone to participate in the comments.

(If you'd like to see the press release, just email me) I'd like to

have better email coverage through state organizations as we have a

limited budget and this seems like a good way to reach out.

If you are feeling puny because you didn't get a chance to participate

in comments on ephedra, other issues are currently looming. The FDA

has been working on GMP's (Good Manufacturing Practices) for the

supplement industry for a while and the proposal is now open for

comments. More consistent quality of herbs and supplements across the

board might be a good thing. However there are many concerns. For

example, as individual practitioners with a dispensary we would be

considered manufacturers, and therefore be subject to these

regulations. See page 12175-6 http://www.cfsan.fda.gov/~lrd/fr030313.html

" The risks of adulteration are not eliminated just because the

practitioner is an herbalist. Therefore we decline to exempt

'herbalist' practitioners who manufacture dietary ingredients and

dietary supplements. "

If we are held as manufacturers, as is currently proposed, we would be

responsible for testing each " batch " after making it and saving a

sample of each " batch " for three years. The FDA estimates an

additional $38,000 per year in expenditures for small businesses to

comply. This is not a one time fee. Clearly these regulations don't

make sense for small dispensaries.

FDA rules can come in to play if one is engaged in " interstate

commerce " which can include buying as well as selling across state (or

national) lines. If state laws are in place, they may well take

precedence but how many of us have a clear law on herb practice?

Some things you may want to include in your letter:

-Trained acupuncturist/herbalists currently provide valuable

health care in our communities (include # of patients or visits if you

can)which we will not be able to continue if regs pass as proposed

-There doesn't seem to be documentation showing that herbs

recommended by trained, licensed practitioners are unsafe overall.

-The real issue here is to demonstrate that we have something

like Standard Operating Procedures (SOP's) in our dispensaries for

cleanliness, herb ID, calibration and measurement, preventing

contamination and so on. Who wants to work on this? What do you have

in place already? (email me)

-Drug pharmacies have an exemption from being viewed as drug

manufacturers based on the practitioner/patient/dispensary

relationship ie a prescription for an individual person, no product

advertising, etc. This is an interesting model.

 

When you go to the website, note that the comment period has been

extended. You can submit your letter by email or on paper.

Thank you for taking the time to read this.

 

Best regards,

Mercy Yule

Chair, Herb Committee

Acupuncture and Oriental Medicine Alliance

 

, " James Ramholz "

<jramholz> wrote:

> http://www.worstpills.org/index.cfm?SRC=1

>

> Does anyone know if any of our national organizations has a public

> relations person writing and consulting with organizations like this

> site to help clarify and correct the impression that ephedra should

> be completely banned?

>

>

> Jim Ramholz

>

>

>

>

> Ephedra

> Dietary supplements containing ephedra should be banned because they

> increase the risk for hypertension, stroke, heart attacks and

> seizures

>

> 4/17/03

> PUBLICATION in Science magazine: Ephedra - Scientific Evidence

> Versus Money/Politics. (Article will be available after 2:00 PM on

> April 17, 2003)

>

> Twenty-Year Chronology of Events Concerning Ephedrine Alkaloids

>

> 10/8/02

> PRESS RELEASE 33 deaths among military prompted ephedra ban; FDA

> should follow suit

>

> 10/8/02

> TESTIMONY before Senate Governmental Affairs Committee hearing on

> the dangers of ephedra

>

> 8/15/02

> LETTER to HHS Secretary Tommy Thompson urging him to direct the FDA

> to open a criminal investigation of Metabolife

>

> 6/15/02

> STATEMENT on Health and Human Services (HHS) failure to ban ephedra

> or issue adequate warnings

>

> 9/5/01

> PETITION to the Food and Drug Administration to ban dietary

> supplements containing ephedra