FDA comment

[Guest guest]

This link below is how one gets on the docket page, then select docket

search. then enter the number Mercy gave (1996N-0417) and you will come

to the GMP rule with a comment link. I include my attempt to comment

below. Unfortunately, it did not go through and I gave up trying. feel

free to use in any way you want.

 

http://www.accessdata.fda.gov/scripts/oc/dockets/comments/commentdocket.cfm

 

As a licensed practitioner of chinese herbal medicine (L.Ac. 7761 in the

state of CA), I believe this profession should be exempt from the proposed

FDA rule if we follow certain food handling and record keeping rules (just

like pharmacists do).

 

I do not support the supplement manufacturers who are dumping worthless

and dangerous products on the market due to no real GMP regulations in

place nor the unlicensed lay herbalists. I have no interest in protecting

either group. However our profession is trained in the disp[ensing of

herbal medicines in a tradition much older than modern pharmacy. Since we

are a regulated profession, it would only be necessary to establish rules

for us that are equivalent to those that govern pharmacy in order to

protect public safety.

 

We have a covenant with our patients. Our communications are privileged.

In California, we are primary care providers. Unlike non-professional lay

herbalists who cannot be sanctioned by revocation of licenses and

corporations whose sole motivation is profit, we are professionally

constrained in our behavior and there are already legal mechanisms in

place to sanction us. It would serve no public good to declare us as

manufacturers in our private offices. That would deprive patients of

herbs that were dispensed by a fully trained licensed healthcare

practitioner.

 

I believe we should follow the Canadian model in this regard. their

regulation proposes: 'manufacturer' means a person who fabricates or

processes a

natural health product for the purpose of sale, but does not include a

pharmacist or other health care practitioner who, at the request of a

patient, compounds a natural health product for the purpose of sale to

that patient.

For entire text, see:

http://www.hc-sc.gc.ca/hpfb-dgpsa/nhpd-dpsn/regs_cg1_doc3_e.html

Proposed Regulations - Natural Health Products Directorate

 

I believe the above exemption would sufficiently protect the public from

adulterated substances, yet not disrupt professional commerce and practice.

While herb purity, potency and adulteration are major ongoing concern of

myself and my organization, the regulated profession of

has been exemplary in our safety record. Incidents involving Chinese

herbs have invariably involved use by laypersons without medical

supervision. I fully support the the FDA in their goal to regulate

dangerous and adulterated substances available over the counter to

laypersons and/or dispensed by laypersons. My sole argument is that the

practitioner can protect his own patient with the patient's consent, just

as a pharmacist can.

 

I would urge the FDA to include language in their proposed rule similar to

that proposed for the regulation of ma huang/ephedrae in California,

adapted as follows:

 

" This rule shall not apply to a licensed health care practitioner who is

practicing within his or her scope of practice and who prescribes or

compounds, or both, an herbal mixture in the course of the treatment of a

patient under the direct care of the licensed health care practitioner. "

 

Sincerely,

 

 

Chinese Herbs

 

 

 

 

Chinese Herbs

 

 

" Great spirits have always found violent opposition from mediocre

minds " -- Albert Einstein

[Guest guest]

, <@i...> wrote:

Unfortunately, it did not go through and I gave up trying.

 

However there was also an email link for comment:

 

fdadockets

 

If you send my email to this address, please change the signature to your own.

 

I don't want the FDA to think I am spamming them. :-)

 

I really urge everyone to take a few minutes and do this.