AAAOM: Position on FDA's Good Manufacturing Practice

[Guest guest]

*AAAOM's Position Paper

on the

FDA's proposed regulations on

Dietary Supplements Good Manufacturing Practices (GMPs)*

 

*May 4, 2007*

 

The AAAOM has reviewed the GMP regulations proposed by the FDA. Our goal is

to develop a policy that respects the need for public safety assurances,

while limiting excessive regulatory burden to individual practitioners and

suppliers of traditional Chinese medicinal herbs.

 

Traditional Chinese herbs are an important aspect of acupuncture and

Oriental medicine, and are used by many AOM practitioners. These herbs have

been used for thousands of years, and recent research has confirmed their

efficacy. We believe that the profession needs to expand consumer confidence

in using custom Chinese herb prescriptions. Appropriate GMP standards can

help to improve public confidence.

 

Only herb manufacturers and distributors have to comply with GMPs, not AOM

practitioners or school pharmacies, who obtain herb supplies from them.

Therefore, we believe the new GMPs can be reasonably and fairly applied.

 

The proposed GMPs state that herbal importing companies must demonstrate

through TLC (Thin Layer Chromatograph) that every lot of herbs they are

buying and selling is the correct species of animal, vegetable or mineral.

Thus, the burden of correct species identification currently exists and is

borne by the herb manufacturer or distributor, not by the individual

practitioner.

 

The cost of TLC testing will be passed on to the consumer, and we advise

herb manufacturers and distributors to refrain from inflating this cost. All

the other normal testing (e.g., heavy metals, pesticide screens, bio-load)

will continue to be performed. The company that manufactured or distributed

the herbs to the practitioner will have to document that the herbs were

properly sourced and tested. Labeling the product will need to comply with

FDA standards to accurately reflect the true contents. These requirements

remain unchanged.

 

If an herbal product has been fully tested by a reputable testing agency, we

believe it is unnecessary to test again when the product is imported into

the U.S. Testing of each custom made herb prescription, as long as its

individual ingredients have been properly tested, would create an undue

economic burden on the individual practitioner or school pharmacy.

 

Following these guidelines should impose no added burden on schools or

individual practitioners. The current GMPs already require levels of

sanitation, precise identification, and appropriate record keeping when a

" new " custom herb prescription is compounded or manufactured.

 

Liabilities already exist for schools or individuals prescribing custom made

herbal formulas. Proper documentation and appropriate " standard operating

procedures " are the best way to protect oneself from these liabilities.

 

This recommendation is intended to improve patient confidence in using

custom Chinese herb prescriptions by complying with the old and new FDA

GMPs. By complying with these appropriate FDA requirements we can continue

to engage with the FDA and provide guidance to them. We will also continue

to advocate for further research and clinical trials to demonstrate the

value of Chinese herbal medicine. Additionally it remains an important goal

to provide accurate information to the FDA and the news media when concerns

about the safety of Chinese herbs arise.

 

We hope the AAAOM position as stated in this paper will provide guidance to

our profession as to the best response and most effective engagement with

FDA regulatory actions. The AAAOM Herbal Committee will remain involved and

vigilant to maintain our right to access to Chinese herbs.

 

Sincerely,

 

 

Leslie McGee, RN, LAc, DiplCH

President, American Association of Acupuncture and Oriental Medicine

 

The AAAOM welcomes your feedback on this Policy Statement and the Policy

Statement Email Tuesday, April 24, 2007, covering the FDA Draft Guidance for

CAM Products. A feedback form for each is provided for comments and

additional inquiries.

 

__Dietary Supplements Good Manufacturing Practices (GMPs):

http://www.cfsan.fda.gov/~lrd/fr030313.html

 

A form for your feedback:

http://www.aaaomonline.org/interactive.asp?ID=11

 

__FDA Draft Guidance for CAM Products:

AAAOM's Response <http://www.aaaomonline.org/pressroom.asp?pagenumber=48256>

 

A form for your feedback:

http://www.aaaomonline.org/interactive.asp?ID=12

 

*Note:* Should you no longer choose to receive AAAOM Updates and News

Alerts, please notify us <techservice. Your name will be removed

from our files, and we apologize for the inconvenience.

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

 

*AAAOM

PO Box 162340

Sacramento, CA 95816

916-443-4770

916-443-4766 Fax

866-455-7999 Toll Free

info | www.aaaomonline.org *

 

 

 

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--

Kath Bartlett, LAc, MS, BA UCLA

Oriental Medicine

Experienced, Dedicated, Effective

 

Asheville Center For

70 Woodfin Place, Suite West Wing Two

Asheville, NC 28801 828.258.2777

kbartlett

www.AcupunctureAsheville.com