FDA clarification on GMP's for practitioners

[Guest guest]

The American Herbal Products Association attended a meeting today in

Washington DC titled 'Traditional s Workshop'. Below

are comments from the AHPA president about the meeting:

 

 

" I don't want to get into a full report of the day's activities except

to say that there was a lot of useful information provided by numerous

presenters from both China and the U.S. One overriding message that

came through from our Chinese colleagues – including those from the

Chinese State Food and Drug Administration – is how strongly they

believe that these medicines make important contributions to the

health of their citizens.

 

But I am writing to focus on one presentation in particular, that of

Vasilios Frankos, Ph.D. Dr. Frankos is the Director of FDA's Division

of Dietary Supplements and so is the highest ranking official in this

FDA office.

 

Dr. Frankos reported on the U.S. regulation of dietary supplements

and, not surprisingly, discussed the new GMP regulation. He made

several statements in relation to how this new rule will affect

practitioners. These comments expanded on the information provided in

the Federal Register when the GMP rule was issued last June. The

following are direct quotes:

 

'We did invoke enforcement discretion insofar as the final cGMP

applies to practitioners in clinical settings.'

 

'To apply the GMP requirements [in these settings] would be quite

onerous.'

 

'We are not going to be enforcing the GMP for practitioners in

one-on-one consultations.'

 

'We are going to stay out of the individual practitioner relationship.' "

 

This is very encouraging news regarding FDA's enforcement of the GMP's.

 

- Bill Schoenbart