Here is the FDA's latest on their new cGMP...


Comment 32) Many comments question the ruleUs 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 consumerUs 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.
...

What do you folks think??

dr.w