FDA Proposed Rule on cGMP for Dietary Supplements

May 1, 2007

In 2003, the FDA published a proposed rule that would alter the

requirements for current Good Manufacturing Practices (cGMP) for

dietary supplements. The category of dietary supplements includes

herbs. This proposed rule defines individual herbalists (who compound

herbal formulas for individual patients) as manufacturers, small

entities who are subject to the rule. It is already well established

that interstate commerce includes herbal formulas only sold in one

State, but composed of ingredients from other States or countries. The

FDA estimates first year compliance costs for small entities at $62,000.

Put all those facts together, and the result is plain: the legal

practice of in-office herbal compounding will no longer be financially

viable, if the proposed rule is enacted as written. Last I checked,

the proposed rule was still on hold at Office of Management & Budget,

presumably by request of the Executive Branch. The proposed rule, when

released, goes to Congress for approval, and then needs to get the

signature of the President. Note that only major agency rules must go

through Congressional approval, and that only one such rule has been

defeated in Congress in the past decade.

You would imagine that this proposed rule would be a matter of concern

in the Oriental Medicine world. However, our national associations

only responded to the FDA at the very end of the comment period,

providing little of substance. And then the matter seems to have

fallen off the radar. There has been a move (by the Traditional

Medicines Congress) to create a new regulatory framework for

traditional medicines such as herbs. But that seems like a diversion,

a very long term project that has no impact on the proposed rule.

I've been trying to get AAAOM to respond to this issue for a couple of

months, and it appears that they will be publishing a statement on it.

They recently refused to publish my article on the subject in American

Acupuncturist, and so I have posted it on my own web site

(http://www.convergentmedical.com, under News Desk). The refusal was

based on " clarity of policy " ...whatever that means. Perhaps AAAOM

wants to put their own spin on it, and would rather not have my

perspective available to their members. We shall see.

In any event, dealing with the proposed rule requires a well focused

and consistent national effort. It is a project that does require the

participation of AAAOM and its members. So I can only hope that AAAOM

charts a clear and functional response, and sets to it with a will.

And I hope that you will become informed about this issue, and will

also contribute to its resolution. The impact of the proposed rule is

so great...yet we have been expending our political resources dealing

with single-herb issues such as ephedra!

Best Regards,

David Kailin, Ph.D., M.P.H., L.Ac.

Author, Quality In Complementary & Alternative Medicine

http://www.convergentmedical.com

May 2, 2007

Dear Folks,

UNBELIEVABLE

dr.w

May 4, 2007

The AAAOM has just published (May 4, 2007) a position paper on the FDA

Proposed Rule on cGMP for Dietary Supplements. I presume you have

received it directly by email from them, and will not reiterate it in

whole. Suffice it to say that to the extent AAAOM has failed to

correctly comprehend the Proposed Rule, mounting an effective response

to prevent it from being enacted is pretty much out of the question

for the Oriental Medicine profession. This is indeed regrettable.

Here is the response I sent AAAOM:

The AAAOM Position Paper on FDA cGMP for Dietary Supplements states

the following: " Only herb manufacturers and distributors have to

comply with GMPs, not AOM practitioners or school pharmacies, who

obtain herb supplies from them. "

This is not what the FDA Proposed Rule states, as clearly presented in

the Federal Register of March 13, 2003 (68FR12157), pages 12175-6:

" One comment to the ANPRM, relating to the scope of the CGMPs,

requested an exemption from the CGMP for " herbalist " practitioners who

individually manufacture dietary supplements for their clients. We

decline to exempt herbalist practitioners from the proposed rule. If

an herbalist practitioner introduces or delivers for introduction into

interstate commerce, a dietary ingredient or dietary supplement, that

practitioner must use the same good manufacturing practices as other

manufacturers to ensure that their clients receive dietary supplements

that are not adulterated. "

" Herbalist practitioners who introduce or deliver for introduction

into interstate commerce, a dietary ingredient or dietary supplement,

are manufacturers who must meet CGMPs. "

Note that an herbal formula composed of products from other States or

countries thereby meets the FDA definition of an article of interstate

commerce, even if it is then sold in only one State and sold to only

one person. For chapter and verse, refer to FDA Compliance Policy

Guide 7153.11. See

http://www.fda.gov/ora/compliance_ref/cpg/cpggenl/cpg100-200.html

AAAOM's current and long term failure to comprehend the FDA Proposed

Rule has led to a lack of appropriate responses. The FDA estimates the

first year cost of compliance for small entities at $62,000. This will

effectively bring in-office herbal compounding to an end.

I have posted a more extensive article on the topic, under the News

Desk heading, at http://www.convergentmedical.com

Best Regards,

David Kailin, Ph.D., M.P.H., L.Ac.

Author, Quality In Complementary & Alternative Medicine

http://www.convergentmedical.com

May 4, 2007

, " convergentmedical "

<kailin wrote:

>Suffice it to say that to the extent AAAOM has failed to

> correctly comprehend the Proposed Rule, mounting an effective

response

> to prevent it from being enacted is pretty much out of the question

> for the Oriental Medicine profession. This is indeed regrettable.

I am a bit confused here. If I mix up an herbal formula in my office,

and my patient buys it from me in my office and then goes home in the

same city with that formula, is this interstate commerce? If it isn't

then I am not sure how the rule would apply to me.

Brian C. Allen

May 4, 2007

Dear Brian Allen,

If the herbs were all grown and supplied to you from within your

State, and you then supply them to patients in your State, you would

not be engaging in interstate commerce.

If the herbs come from other States or countries, and you supply them

to patients in your State, then you would be engaging in interstate

commerce, as defined by FDA. And then the cGMP rule would apply to you.

Thanks for your request for clarification!

David Kailin, Ph.D., M.P.H., L.Ac.

Author, Quality In Complementary & Alternative Medicine

http://www.convergentmedical.com

>

> I am a bit confused here. If I mix up an herbal formula in my office,

> and my patient buys it from me in my office and then goes home in the

> same city with that formula, is this interstate commerce? If it isn't

> then I am not sure how the rule would apply to me.

>

> Brian C. Allen

>

May 4, 2007

This means that one can only sell sealed, unopened packages of herbal

medicines manufactured in GMP plants. Is that correct by your reading?

I've seen a clean room at Lian-China Herb in Switzerland where Simon

Becker works. That company puts together individually written

prescriptions from single herb extracts and then overnights them to

patients. Definitely an expensive proposition that would be out of the

question for most, if not all, American L.Ac.s dispensing formulas

made from singles.

Looks like we might have to adopt the Taimwanese model of prescribing.

Bob

May 4, 2007

Dear Bob Flaws,

If the proposed rule is enacted as written,

then the practitioner with an in-office compounding herbal pharmacy

will either have to comply with the new cGMP rule (at prohibitive

expense), or close the in-office herbal pharmacy and find another

avenue to supply custom herbal prescriptions.

As you point out, there are herbal pharmacies that have the capacity

to comply with the FDA proposed rule for cGMP, and have the capacity

to expeditiously prepare and ship individual herbal prescriptions they

receive from herbalists.

We can expect more expensive herbs for patients as one result of this

arrangement, as well as the prospering of those herbal pharmacies with

the size and capability to tap this market.

You are probably correct about sales of sealed, unopened packages from

cGMP-compliant sources.

Best Regards,

David Kailin, Ph.D., M.P.H., L.Ac.

Author, Quality In Complementary & Alternative Medicine

http://www.convergentmedical.com

, " Bob Flaws "

<pemachophel2001 wrote:

>

> This means that one can only sell sealed, unopened packages of herbal

> medicines manufactured in GMP plants. Is that correct by your reading?

>

> I've seen a clean room at Lian-China Herb in Switzerland where Simon

> Becker works. That company puts together individually written

> prescriptions from single herb extracts and then overnights them to

> patients. Definitely an expensive proposition that would be out of the

> question for most, if not all, American L.Ac.s dispensing formulas

> made from singles.

>

> Looks like we might have to adopt the Taimwanese model of prescribing.

>

> Bob

>

May 5, 2007

, " convergentmedical " <kailin

wrote:

>Dear David,

This seems pretty clear to me as well.

I have also requested an explanation from aaom regarding their rationale.

Regards,

dr.w

> The AAAOM has just published (May 4, 2007) a position paper on the FDA

> Proposed Rule on cGMP for Dietary Supplements. I presume you have

> received it directly by email from them, and will not reiterate it in

> whole. Suffice it to say that to the extent AAAOM has failed to

> correctly comprehend the Proposed Rule, mounting an effective response

> to prevent it from being enacted is pretty much out of the question

> for the Oriental Medicine profession. This is indeed regrettable.

>

> Here is the response I sent AAAOM:

>

> The AAAOM Position Paper on FDA cGMP for Dietary Supplements states

> the following: " Only herb manufacturers and distributors have to

> comply with GMPs, not AOM practitioners or school pharmacies, who

> obtain herb supplies from them. "

>

> This is not what the FDA Proposed Rule states, as clearly presented in

> the Federal Register of March 13, 2003 (68FR12157), pages 12175-6:

>

> " One comment to the ANPRM, relating to the scope of the CGMPs,

> requested an exemption from the CGMP for " herbalist " practitioners who

> individually manufacture dietary supplements for their clients. We

> decline to exempt herbalist practitioners from the proposed rule. If

> an herbalist practitioner introduces or delivers for introduction into

> interstate commerce, a dietary ingredient or dietary supplement, that

> practitioner must use the same good manufacturing practices as other

> manufacturers to ensure that their clients receive dietary supplements

> that are not adulterated. "

>

> " Herbalist practitioners who introduce or deliver for introduction

> into interstate commerce, a dietary ingredient or dietary supplement,

> are manufacturers who must meet CGMPs. "

>

> Note that an herbal formula composed of products from other States or

> countries thereby meets the FDA definition of an article of interstate

> commerce, even if it is then sold in only one State and sold to only

> one person. For chapter and verse, refer to FDA Compliance Policy

> Guide 7153.11. See

> http://www.fda.gov/ora/compliance_ref/cpg/cpggenl/cpg100-200.html

>

> AAAOM's current and long term failure to comprehend the FDA Proposed

> Rule has led to a lack of appropriate responses. The FDA estimates the

> first year cost of compliance for small entities at $62,000. This will

> effectively bring in-office herbal compounding to an end.

>

> I have posted a more extensive article on the topic, under the News

> Desk heading, at http://www.convergentmedical.com

>

> Best Regards,

>

> David Kailin, Ph.D., M.P.H., L.Ac.

> Author, Quality In Complementary & Alternative Medicine

> http://www.convergentmedical.com

>

May 5, 2007

Dear Dr. Waldrope,

You had requested more information on how to approach OMB with respect

to the FDA proposed rule on cGMP for Dietary Supplements. This is not

an approach that should be undertaken by individual proponents of any

measure under OMB review. This avenue is more appropriate for

national organizations that pack some clout. Largely in response to my

urging, the Council of Colleges of Acupuncture and Oriental Medicine

(CCAOM) did submit an excellent letter to OMB on February 28, 2007.

CCAOM (unlike AAAOM) understands that individual herbalists and

acupuncture colleges will be sorely impacted by the proposed rule.

Let me emphasize that approaching OMB is a small but important action

in the campaign that is needed. But if AAAOM, as the national

practitioners organization, is not on board, then the campaign is

probably over and lost before it has been begun.

The most pressing question then is how AAAOM members can move AAAOM to

reverse its policy and effectively protect the interests of Oriental

Medicine herbal practitioners. That does not seem like too much to ask

of a dues-charging national association.

Best Regards,

David Kailin, Ph.D., M.P.H., L.Ac.

Author, Quality In Complementary & Alternative Medicine

http://www.convergentmedical.com

May 6, 2007

Dear David,

Thanks so much for your time and effort. Your info and advice have

been very helpful. ...really sad about aaaom. I, for one, will voice

my concerns to them.

Thanks again,

dr.w

May 18, 2007

The FDA Final Rule entitled Current Good Manufacturing Practice in

Manufacturing, Packing, or Holding Dietary Ingredients and Dietary

Supplements was released by the Office of Management and Budget (OMB)

on 5/8/07 after a lengthy stay. The FDA is now preparing to publish

the Final Rule in the Federal Register. No one outside of FDA and OMB

has had access to the language of the Final Rule.

CCAOM comprehends that the Proposed Rule includes individual

herbalists and college herbal pharmacies. CCAOM President Lixin Huang

submitted an excellent letter to OMB on February 28, 2007, raising

many key issues with the Proposed Rule. At the recent New Orleans

conference, CCAOM also hosted an eye-opening presentation on

compliance issues for colleges.

On the basis of AAAOM's 5/4/07 policy statement, and their additional

response today, AAAOM apparently is not on the same page as CCAOM. If

this were just a matter of divergent opinions, we could all let it

slide. But a great deal rests on correct comprehension of the Proposed

Rule, and then the Final Rule.

There are also some stark political realities to consider. Could we

effectively fight this rule without AAAOM being on board? Could we

effectively fight this rule even with AAAOM on board? Does AAAOM have

the organizational capacity to run a successful national grass-roots

Congressional lobbying campaign? Furthermore, note that we do not have

many allies in the herbal products industry. Many of the larger herbal

companies want the rule, and they can exercise significant

countervailing political and financial clout. Lastly, the FDA has

powerful friends on the Democratic side of the aisle, such as Sen.

Kennedy. After some pondering of the matter, I frankly do not see an

opposition campaign as having much of a chance of prevailing. We're

probably going to have to live with the Final Rule, no matter what it

says.

We will soon see what the Final Rule has to say, and will then discuss

its meaning at greater length.

Time will tell whether AAAOM or CCAOM correctly comprehends the

Proposed Rule.

Best Regards,

David Kailin, Ph.D., M.P.H., L.Ac.

Author, Quality In Complementary & Alternative Medicine

Convergent Medical Systems, Inc.

P.O. Box 2115

Corvallis, OR 97339