Fwd: AAAOM: To Release Analysis of FDA's Final Rule on Good Manufacturing Practices

[Guest guest]

---------- Forwarded message ----------

AAAOM <execdir

14 Sep 2007 17:05:43 -0700

AAAOM: To Release Analysis of FDA's Final Rule on Good

Manufacturing Practices

acukath

 

*AAAOM to Release Analysis of FDA's FINAL RULE: Good Manufacturing

Practice*

 

*Sept 13, 2007*

 

*Dear Members and Colleagues:*

 

On June 22, 2007, the Food and Drug Administration (FDA) issued a Final Rule

that established regulations on Current Good Manufacturing Practices (cGMP)

for dietary supplements. The goal of the Final Rule is to assure that

dietary supplements are produced in a quality manner, do not contain

contaminants or impurities, and are accurately labeled. The AAAOM supports

these goals, and has worked to assure that the Final Rules do not in any way

restrict qualified AOM practitioners from utilizing herbal medicines in

their practice, or limit the ability of patients to access herbal medicines

from qualified practitioners.

 

When the Proposed Rule came out in March, 2003, both the Acupuncture and

Oriental Medicine Alliance ( " Alliance " ) and the American Association of

Oriental Medicine ( " AAOM " ) submitted comments to the FDA to assure that the

unique training of AOM practitioners and the specialized use of traditional

Chinese herbs were appropriately addressed in the regulations. In the four

years between the issuance of the proposed and final rules, the FDA received

hundreds of comments, and revised the proposed rules based on the

information that was received. It was not known until the Final Rule was

issued in June exactly what the requirements would be or how they might

impact AOM practitioners.

 

The Final Rule consists of specific requirements pertaining to the

manufacturing, packaging, labeling, and holding (storing) of dietary

supplements. It includes requirements for establishing quality control

procedures, designing and constructing manufacturing plants, testing

ingredients in final products, and recordkeeping. It contains information

for manufacturers who will be required to evaluate the identity, purity,

strength, and composition of their dietary supplements to guarantee that

they are not adulterated or misbranded.

 

The Final Rule, together with a preamble discussing comments received by the

FDA and other materials, is several hundred pages. In order to evaluate

thoroughly the requirements of the Final Rule and its possible impact on AOM

practitioners, the AAAOM retained counsel to work with us on the review and

analysis of this document. We are pleased to announce that this analysis is

nearly complete, and the full report will soon be available on our website.

Following is a summary of the key points. Please submit any comments or

questions to http://www.aaaomonline.org/interactive.asp?ID=22.

 

At the AAAOM *Strength Through Unification* Conference in Portland next

month, there will be an Herbal Medicine Update led by Claudette Baker and

Christine Chang, Co-Chairs of the Herbal Medicine Committee, on Thursday,

October 18, at 7:00 p.m. We encourage all of you who use herbal products in

your practice to join us there to find out more about what these regulations

mean for you and what the AAAOM is doing to assure that qualified AOM

practitioners are fully able to utilize herbal medicines in their practices

without undue burden or restrictions.

 

*Sincerely,*

 

 

Leslie McGee, RN, LAc, DiplAc/CH

President, American Association of Acupuncture and Oriental Medicine

 

*Key Points from the AAAOM Analysis of the FDA's Final Rule on Current Good

Manufacturing Practices for Dietary Supplements*

 

- *A practitioner whose only involvement with dietary supplements is

that the practitioner purchases herbal formulas which are packaged and

labeled as dietary supplements and resells these products to the

practitioner's patients for consumption in a course of treatment is exempt

from the Final Rule.*

 

The Final Rule says in §111.1(a) that the Final Rule only applies to you

" …if you manufacture, package, label or hold a dietary supplement " . In the

example above, the practitioner is not manufacturing, packaging or labeling

dietary supplements. The practitioner's only connection with the Final Rule

is holding dietary supplements pending sale to patients. The Final Rule then

goes on to say in §111.1(b) that the " …requirements pertaining to holding do

not apply to you if you are holding those dietary supplements at a retail

establishment for the sole purpose of direct sale to consumers " . The

preamble to the Final Rule explains that " retail establishment " includes not

just an herb shop and a health food store, but also includes an individual,

such as the practitioner in our example. Consequently, the practitioner in

the example above is exempt from the Final Rule.

 

There are limitations on the retail establishment exemption, but they should

not be a problem for most practitioners. To be eligible for the exemption

the practitioner cannot store the dietary supplements in a warehouse or

other storage facility or sell directly from a warehouse.

 

- *A practitioner who maintains an herbal pharmacy and prepares herbal

formulas for patients based on their individual needs is not exempt from the

Final Rule.*

 

According to the Final Rule, a practitioner who prepares herbal formulas may

be engaged in manufacturing, as defined by the FDA, and consequently subject

to the Final Rule, if what the practitioner is manufacturing is a dietary

supplement.

 

While declining to exempt herbalists from the Final Rule, FDA did say in the

preamble to the Rule that it might exercise its enforcement discretion in

favor of " herbalists, acupuncturists, naturopaths and related health care

providers " under certain circumstances. FDA explained that a " one-on-one

consultation by a practitioner adequately trained in their profession may

not necessitate the same type of controls as we are establishing in this

final rule for manufacturing activities on a larger scale " . FDA concluded,

" We believe that it would be appropriate to consider the exercise of our

enforcement discretion, on a case-by-case basis, to determine whether to

apply the requirements of the final rule to such persons " .

 

The FDA is retaining its right to enforce the requirements, while also

saying it will consider not enforcing the requirements against these

practitioners. While we would prefer that qualified practitioners were fully

exempt in these situations, we understand that without any clear guidance

distinguishing small from large scale manufacturers, it would be difficult

to grant such an exemption.

 

- *The FDA states that " Many products that are manufactured by

practitioners would not necessarily be considered to be dietary supplements

(e.g. certain products used by Traditional Asian medicine

practitioners) " . These products would not be subject to the Final Rules.

*

 

To the extent that these formulas are not dietary supplements, the Final

Rule does not apply to them. Yet, current law does not delineate which

herbal products are considered to be dietary supplements are which are not

in this category. The AAAOM plans to do further work in this area.

 

- *The Final Rule does not take effect until June 2010 for persons

employing fewer than 20 employees.*

 

This category should include most practitioners, so there is time to discuss

and plan for any action needed.

 

- *Academic institutions are not exempt from the Final Rule.*

 

While declining to exempt academic institutions, FDA did say it is not its

policy to inspect academic institutions providing training for therapeutic

disciplines that use dietary supplements in their practice. In addition FDA

would consider using its enforcement discretion in situations where dietary

supplements are dispensed after one- on – one consultation which includes a

practitioner with adequate training. FDA intends to issue further guidance

in this area.

 

*Link to the Final Rule:* More information will follow as it becomes

available. The regulation can be viewed at

http://www.accessdata.fda.gov/scripts/oc/ohrms/index.cfm Enter docket number

" 96N-0417 " in the search field. You may also visit the FDA website at

www.fda.gov.

 

Link to provide comments:

http://www.aaaomonline.org/interactive.asp?ID=22

 

*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 *

 

 

 

# # #

 

 

 

 

--

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