FDA CGMP for Dietary Supplements: Practitioners (Comment 32)

[Guest guest]

Here is the actual document concerning practitioners.

³adequate training² needs to be defined.

Would Chinese herb practitioners be in a better position if we developed a

³Compounding and GMP protocol exam² like the Clean Needle Technique exam?

 

Much to consider,

Bill Egloff

Crane Herb Co.

Crane Herb Pharmacy

 

 

 

 

 

 

(Comment 32) Many comments question the rule¹s applicability to various

practitioners such as herbalists, acupuncturists, naturopaths, and other

health care providers who prepare individualized herbal formulas for

specific individuals on a case-by-case basis. Most comments say such

practitioners should not be covered by the rule. These comments give various

reasons to justify their position, including:

€These practitioners do not broadly sell products;

These practitioners make very small quantities of individualized formulas,

and can therefore be very selective as to the quality of ingredients used;

The testing and storage requirements of each finished batch cannot apply

to a small dispensary where several different modified herbal formulas are

prepared each day;

Based on the projected costs to implement CGMPs, it would be virtually

impossible for an individual practitioner or university clinic to develop

the necessary quality control unit, maintain reserve samples, maintain the

required paperwork, or retrofit clinics to comply with the rule;

€Many States regulate or license these practitioners, so further Federal

regulation is unnecessary;

€Some practitioners do not consider themselves to be manufacturers;

In an analogous situation, compounding pharmacists are not required to

comply with drug CGMPs; and

Despite the growing number of such practitioners, there is no proof that

greater harm has occurred to the general public from the herbs these

practitioners sell.

 

(Response) We stated in the 2003 CGMP Proposal (68 FR 12157 at 12175) that

we declined to exempt herbalist practitioners from the proposed rule. We

continue to believe that the risks of adulteration are not eliminated just

because the practitioner is an herbalist, and therefore, such an exemption

should not be included in this final rule. However, after further

consideration, we have determined that it would be appropriate for us to

consider the exercise of our enforcement discretion in deciding whether to

apply the requirements of this final rule to certain health care

practitioners, such as herbalists, acupuncturists, naturopaths, and other

related health care providers.

We find it noteworthy that the comments identified two potential safeguards

that could support the exercise of our enforcement discretion on whether to

apply the requirements of the final rule to certain practitioners:

(1) Adequate training in the professional practice and (2) an individual

client and practitioner relationship. For example, comments claimed that the

practitioners receive adequate training to formulate dietary supplements and

that they provide the dietary supplements to individuals in the course of a

one-on-one consultation on the premises of the practitioner. One comment

from a practitioner states that she received her training from an accredited

4year university and it included didactic and clinical training in

acupuncture and Chinese herbs. Another comment from an organization provides

detailed training guidelines for practitioners, including 1,600 hours of

training, 400 hours of which should include clinical work. Moreover, many

comments also assert that the practitioners are different from dietary

supplement manufacturers because they formulate the dietary supplements in

the course of a one-on-one consultation at their premises. That enables them

to ensure the formulations are made to meet the specific needs of the

individuals.

We believe that a one-on-one consultation by a practitioner who is

adequately trained in their profession may not necessitate the same types of

controls as we are establishing in this final rule for manufacturing

activities that are on a larger scale. Such a practitioner may make some

formulations in advance of the consultation and still make the formulations

in very limited quantities for the individual client. 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

this final rule to such persons.

We do not expect the number of those subject to the consideration of our

enforcement discretion to be very large. 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). Further, we are not considering exercising our enforcement

discretion with respect to practitioners who prepare batches of herbs and

sell them to individual consumers without determining whether the dietary

supplement is appropriate for each consumer¹s needs in a one-on-one personal

consultation, or those that prepare batches of a dietary supplement for

which there is a known or suspected safety concern.

 

>

>

>

>

> FDA CGMP FOR DIETARY SUPPLEMENTS: FINAL RULE PUBLISHED ON 06/25/07

>

> On Monday, June 25, 2007, the FDA will publish in the Federal Register

> their final rule entitled " Current Good Manufacturing Practice in

> Manufacturing, Packaging, Labeling, or Holding Operations for Dietary

> Supplements " (Docket No. 1996N-0417). The Final Rule will take effect

> 60 days after publication.

>

> Compliance is expected within 12 months for firms with 500 or more

> employees. The compliance date is extended to 24 months for firms with

> 20 - 499 employees, and to 36 months for businesses with fewer than 20

> employees. For very small establishments, initial compliance (setup)

> costs are now estimated at $26,000, and annual compliance costs at

> $46,000. (Table 35, pre-publication copy of final rule)

>

> The Final Rule does not exempt individual herbalist practitioners or

> colleges that teach herbal medicine. However, the FDA states " ...we

> have determined that it would be appropriate for us to consider the

> exercise of our enforcement discretion in deciding whether to apply

> the requirements of this final rule to certain health care

> practitioners, such as herbalists, acupuncturists, naturopaths, and

> other related health care providers. " (p.156, pre-publication copy of

> final rule)

>

> That is to say, FDA will now have the authority to consider individual

> herbalists as manufacturers of dietary supplements. FDA may intervene

> with herbalists to enforce the final rule whenever it wants to.

> Considering the exercise of enforcement discretion is no guarantee of

> such discretion. No exemption from the rule has been granted to

> individual herbal practitioners.

>

> The final rule and its supporting documentation run over 800 pages,

> with many changes to the proposed rule. Full assessment will take

> some time, and I will file a more comprehensive report at a later date.

>

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

> Author, Quality In Complementary & Alternative Medicine

> http://www.convergentmedical.com

 

 

 

 

[Guest guest]

On 6/22/07, William Egloff <bill wrote:

 

> Would Chinese herb practitioners be in a better position if we developed a

> ³Compounding and GMP protocol exam² like the Clean Needle Technique exam?

>

 

 

 

 

 

For all the training that we're espoused to have had, I recall not a single

lecture on GMP. I think that a GMP exam or at least a class lecture like

CNT would be appropriate.

 

I myself treat my herb pharmacy like a kitchen in that I strive for the same

cleanliness standards as was evident in some of the finer restaurants where

I worked in my youth.

 

--

, DAOM

Pain is inevitable, suffering is optional.

 

 

 

[Guest guest]

I've done just a small amount of research on this but I will add my

perceptions on what I've seen so far. The GMP is of course concerned

with the safety of the herbs but they take that as given to be policed

by the FDA. This would include someone manufacturing pills in an

unclean manner, more or less in terms of what is needed in creating

and distributing food items.

But the GMP really is concerning itself with a tracebility and

accountability for these items. They want a consitant and realible

recall trail. The items manufactured or distributed must meet a

verifable consistency. This is where we that use raw Chinese herbs

might find ourselves in problematic waters. And I would include those

that do manufacturing from these herbs.

As I see it, powders from Taiwan would clearly be compliant as long as

records were kept up to the final dispersement to the patient and that

the (Taiwanese eg..) manufacturer had done a batch analysis.

 

 

Bill and David, is this an accurate assessment?

Douglas

 

 

 

, William Egloff <bill

wrote:

>

> Here is the actual document concerning practitioners.

> ³adequate training needs to be defined.

> Would Chinese herb practitioners be in a better position if we

developed a

> ³Compounding and GMP protocol exam like the Clean Needle Technique

exam?

>

> Much to consider,

> Bill Egloff

> Crane Herb Co.

> Crane Herb Pharmacy

(Comment 32) Many comments question the rule¹s applicability to various

> practitioners such as herbalists, acupuncturists, naturopaths, and other

> health care providers who prepare individualized herbal formulas for

> specific individuals on a case-by-case basis. Most comments say such

> practitioners should not be covered by the rule. These comments give

various

> reasons to justify their position, including:

> & #8364;These practitioners do not broadly sell products;

> These practitioners make very small quantities of individualized

formulas,

> and can therefore be very selective as to the quality of ingredients

used;

> The testing and storage requirements of each finished batch cannot

apply

> to a small dispensary where several different modified herbal

formulas are

> prepared each day;

> Based on the projected costs to implement CGMPs, it would be virtually

> impossible for an individual practitioner or university clinic to

develop

> the necessary quality control unit, maintain reserve samples,

maintain the

> required paperwork, or retrofit clinics to comply with the rule;

> & #8364;Many States regulate or license these practitioners, so further

Federal

> regulation is unnecessary;

> & #8364;Some practitioners do not consider themselves to be manufacturers;

> In an analogous situation, compounding pharmacists are not required to

> comply with drug CGMPs; and

> Despite the growing number of such practitioners, there is no

proof that

> greater harm has occurred to the general public from the herbs these

> practitioners sell.

>

> (Response) We stated in the 2003 CGMP Proposal (68 FR 12157 at

12175) that

> we declined to exempt herbalist practitioners from the proposed rule. We

> continue to believe that the risks of adulteration are not

eliminated just

> because the practitioner is an herbalist, and therefore, such an

exemption

> should not be included in this final rule. However, after further

> consideration, we have determined that it would be appropriate for us to

> consider the exercise of our enforcement discretion in deciding

whether to

> apply the requirements of this final rule to certain health care

> practitioners, such as herbalists, acupuncturists, naturopaths, and

other

> related health care providers.

> We find it noteworthy that the comments identified two potential

safeguards

> that could support the exercise of our enforcement discretion on

whether to

> apply the requirements of the final rule to certain practitioners:

> (1) Adequate training in the professional practice and (2) an individual

> client and practitioner relationship. For example, comments claimed

that the

> practitioners receive adequate training to formulate dietary

supplements and

> that they provide the dietary supplements to individuals in the

course of a

> one-on-one consultation on the premises of the practitioner. One comment

> from a practitioner states that she received her training from an

accredited

> 4year university and it included didactic and clinical training in

> acupuncture and Chinese herbs. Another comment from an organization

provides

> detailed training guidelines for practitioners, including 1,600 hours of

> training, 400 hours of which should include clinical work. Moreover,

many

> comments also assert that the practitioners are different from dietary

> supplement manufacturers because they formulate the dietary

supplements in

> the course of a one-on-one consultation at their premises. That

enables them

> to ensure the formulations are made to meet the specific needs of the

> individuals.

> We believe that a one-on-one consultation by a practitioner who is

> adequately trained in their profession may not necessitate the same

types of

> controls as we are establishing in this final rule for manufacturing

> activities that are on a larger scale. Such a practitioner may make some

> formulations in advance of the consultation and still make the

formulations

> in very limited quantities for the individual client. 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

> this final rule to such persons.

> We do not expect the number of those subject to the consideration of our

> enforcement discretion to be very large. 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). Further, we are not considering exercising our

enforcement

> discretion with respect to practitioners who prepare batches of

herbs and

> sell them to individual consumers without determining whether the

dietary

> supplement is appropriate for each consumer¹s needs in a one-on-one

personal

> consultation, or those that prepare batches of a dietary supplement for

> which there is a known or suspected safety concern.

>

> >

> >

> >

> >

> > FDA CGMP FOR DIETARY SUPPLEMENTS: FINAL RULE PUBLISHED ON 06/25/07

> >

> > On Monday, June 25, 2007, the FDA will publish in the Federal Register

> > their final rule entitled " Current Good Manufacturing Practice in

> > Manufacturing, Packaging, Labeling, or Holding Operations for Dietary

> > Supplements " (Docket No. 1996N-0417). The Final Rule will take effect

> > 60 days after publication.

> >

> > Compliance is expected within 12 months for firms with 500 or more

> > employees. The compliance date is extended to 24 months for firms with

> > 20 - 499 employees, and to 36 months for businesses with fewer than 20

> > employees. For very small establishments, initial compliance (setup)

> > costs are now estimated at $26,000, and annual compliance costs at

> > $46,000. (Table 35, pre-publication copy of final rule)

> >

> > The Final Rule does not exempt individual herbalist practitioners or

> > colleges that teach herbal medicine. However, the FDA states " ...we

> > have determined that it would be appropriate for us to consider the

> > exercise of our enforcement discretion in deciding whether to apply

> > the requirements of this final rule to certain health care

> > practitioners, such as herbalists, acupuncturists, naturopaths, and

> > other related health care providers. " (p.156, pre-publication copy of

> > final rule)

> >

> > That is to say, FDA will now have the authority to consider individual

> > herbalists as manufacturers of dietary supplements. FDA may intervene

> > with herbalists to enforce the final rule whenever it wants to.

> > Considering the exercise of enforcement discretion is no guarantee of

> > such discretion. No exemption from the rule has been granted to

> > individual herbal practitioners.

> >

> > The final rule and its supporting documentation run over 800 pages,

> > with many changes to the proposed rule. Full assessment will take

> > some time, and I will file a more comprehensive report at a later

date.

> >

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

> > Author, Quality In Complementary & Alternative Medicine

> > http://www.convergentmedical.com

>

>

>

>

[Guest guest]

While the FDA considered exempting licensed herbalists, I am unable

to find such an exemption in the final text of the rule.

 

Can someone point me to this text if it exists. Note section 111.1

describes who is subject to the rules and the sole exemption appears

to be retailers " holding " a finished product. The " discretion "

mentioned below was in a section where the FDA was responding to

public comments. There is no mention of this discretion in the final

rule itself if I understand this huge document correctly.

 

 

 

On Jun 22, 2007, at 4:56 PM, William Egloff wrote:

 

>

> The Final Rule does not exempt individual herbalist practitioners or

> > colleges that teach herbal medicine. However, the FDA states " ...we

> > have determined that it would be appropriate for us to consider the

> > exercise of our enforcement discretion in deciding whether to apply

> > the requirements of this final rule to certain health care

> > practitioners, such as herbalists, acupuncturists, naturopaths, and

> > other related health care providers. " (p.156, pre-publication copy of

> > final rule)

> >

> > That is to say, FDA will now have the authority to consider

> individual

> > herbalists as manufacturers of dietary supplements. FDA may

> intervene

> > with herbalists to enforce the final rule whenever it wants to.

> > Considering the exercise of enforcement discretion is no

> guarantee of

> > such discretion. No exemption from the rule has been granted to

> > individual herbal practitioners.

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Chinese Herbs

 

 

 

 

 

 

 

 

 

[Guest guest]

Dear

You cannot find an exemption of herbalists in the text of the final

rule because no such exemption has been granted. Individual herbal

practitioners are held under the rule to be manufacturers of dietary

supplements.

 

FDA's enforcement discretion is just that, discretionary. Hence it is

not mentioned or guaranteed in the portions of the final rule that

will be incorporated into the code of federal regulations. The FDA can

adopt enforcement discretion, and then later abandon it, through

processes entirely internal to the FDA.

 

Best Regards,

 

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

Author, Quality In Complementary & Alternative Medicine

http://www.convergentmedical.com

 

 

 

, < wrote:

>

> While the FDA considered exempting licensed herbalists, I am unable

> to find such an exemption in the final text of the rule.

>

> Can someone point me to this text if it exists. Note section 111.1

> describes who is subject to the rules and the sole exemption appears

> to be retailers " holding " a finished product. The " discretion "

> mentioned below was in a section where the FDA was responding to

> public comments. There is no mention of this discretion in the final

> rule itself if I understand this huge document correctly.

>

 

>

[Guest guest]

And there was an exemption somewhere in the preliminary FDA

communications about having an exemption for TCM & ma huang etc.

 

As far as I know it's not getting in regardless of who is using it.

Not enough grease for the squeaky wheel?

 

Geoff

 

, < wrote:

>

> While the FDA considered exempting licensed herbalists, I am unable

> to find such an exemption in the final text of the rule.