Regarding the FDA Guidance

[Guest guest]

All,

 

This thread came and went while I was working on an article titled

" Codex is Coming? " If anyone is still interested, it is located here:

 

http://www.paradigm-pubs.com/blog

 

Bob Felt

[Guest guest]

Dear Bob,

 

Thank you for your informative analysis of codex. I would like to

apologize for my use of the word " jargon " . I should have realized the

negative connotation of the word. However, I meant to indicate the

actual definition which is (according to encarta) - " language or

terminology used by a particular group, profession, or culture

especially when the words and phrases are not understood by other

people. " Terminology would have been a better choice of words.

 

Having said that, I still stand by my advice to the TCM profession as

a whole regarding the need to educate the public and government

entities as to what TCM is and is not.

 

I will grant that there are risks involved in this. The general

attitude among the TCM community in the past seems to have been one

of, " keep a low profile " . Perhaps this is best when dealing with great

powers of regulation, however I cannot help but wonder if we (and our

patients) might not be better served by a slightly more pro-active

approach regarding the protection of our rights.

 

I applaud your observation of the general political climate in this

country and concur.... hence my concern. Having (like many if not most

practitioners) pre-occupations with my practice, I admit to being

somewhat lax in staying abreast of these sorts of issues. Once

informed of the draft guidance issue, and upon reading it, I certainly

did become " alarmed " or even (to put it in the vernacular) " freaked

out " by what certainly appears to be clear language that could lay the

groundwork for future regulations that could have a negative impact on

the practice of TCM, particularly the use of herbs.

 

I am reasonably reassured that the draft guidance and codex issue may

not be an emergency, however I am not so reassured regarding the FDA

proposal on GMP for dietary supplements brought to this forum's

attention by David Kailin (digest # 3537).

This proposal, if implemented, could have a serious impact on the

ability to practice " Traditional " Chinese herbal medicine. I would be

very much interested in your assessment of this proposal.

 

I have not had time to read Sen. Kennedy's bill, but I will endeavor

to do so. I'm sure I will be utterly " alarmed " by it;)

 

I would like to thank all (especially our patient and hardworking

moderator) again for their response to these issues.

 

I would also like to ask Dr. Kailin if he might provide a bit more

information on how to respond to the OMB regarding the GMP proposal.

 

Regards,

dr.w