AAAOM Analysis: Neither Practiitioners Nor Educational Institutions Exempt from FDA's cGMPs
Written by John Weeks
AAAOM Analysis: Neither Practitioners Nor Educational Institutions Exempt from FDA's cGMPs
Summary: Recent Integrator columns
have explored the meaning of the FDA's current Good Manufacturing
Practices for dietary supplements. But what impact will these cGMPs
have on the actions of individual practitioners who prepare products
for their patients? Might they influence educational programs and
institutions where instruction in herbal preparations, for instance,
may be part of the clinical practicum? The American Association of
Acupuncture and Oriental Medicine (AAAOM) recently sent its members
advance notice of the AAAOM's analysis of these issues. Their answers
are yes, and yes, with caveats. Here are the AAAOM's key points.
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As a complementary or integrative
practitioner, or as a leader of an educational program involved with
natural health products, how is one to view the US Food and Drug Administration's
recently issued current Good Manufacturing Practices on dietary
supplements? Is this a document that only influences one's trade show
exhibitors? Or might the regulations touch closer to home.
The American Association of Acupuncture and Oriental Medicine (AAAOM)
made a useful contribution to efforts to understand the reach of the
cGMPs via an electronic notice to their members. The AAAOM's short
answer: Neither practitioners nor educators are necessarily exempt. The
FDA has considerable "discretion" in applying the regulations.
Here are the "Key Points" the AAAOM sent to their members, together with an opportunity to comment. The cGMP can be viewed by clicking here and entering the docket number "96N-0417" in the search field.
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For Practitioners & Educational Institutions:
AAAOM "Key Points" on the FDA's cGMPs
A practitioner whose only involvement with dietary
supplements is that the practitioner purchases herbal formulas which are
packaged and labeled as dietary supplements and resells these products to
the practitioner’s patients for consumption in a course of treatment is
exempt from the Final Rule.
The Final
Rule says in §111.1(a) that the Final Rule only applies to you "…if you
manufacture, package, label or hold a dietary supplement." In the example
above, the practitioner is not manufacturing, packaging or labeling dietary
supplements. The practitioner's only connection with the Final Rule is holding
dietary supplements pending sale to patients. The Final Rule then goes on to
say in §111.1(b) that the "requirements pertaining to holding do not
apply to you if you are holding those dietary supplements at a retail
establishment for the sole purpose of direct sale to consumers." The
preamble to the Final Rule explains that "retail establishment"
includes not just an herb shop and a health food store, but also includes an
individual, such as the practitioner in our example. Consequently, the
practitioner in the example above is exempt from the Final Rule.
There are
limitations on the retail establishment exemption, but they should not be a
problem for most practitioners. To be eligible for the exemption the
practitioner cannot store the dietary supplements in a warehouse or other
storage facility or sell directly from a warehouse.
A practitioner who maintains an herbal pharmacy and prepares
herbal formulas for patients based on their individual needs is not exempt
from the Final Rule.
According
to the Final Rule, a practitioner who prepares herbal formulas may be engaged
in manufacturing, as defined by the FDA, and consequently subject to the Final
Rule, if what the practitioner is manufacturing is a dietary supplement.
While
declining to exempt herbalists from the Final Rule, FDA did say that it might exercise its enforcement discretion in favor of
"herbalists, acupuncturists, naturopaths and related health care
providers" under certain circumstances.
While
declining to exempt herbalists from the Final Rule, FDA did say in the preamble
to the Rule that it might exercise its enforcement discretion in favor of
"herbalists, acupuncturists, naturopaths and related health care
providers" under certain circumstances. FDA explained that a
"one-on-one consultation by a practitioner adequately trained in their
profession may not necessitate the same type of controls as we are establishing
in this final rule for manufacturing activities on a larger scale.” FDA
concluded: "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 the final rule to such persons."
The FDA is
retaining its right to enforce the requirements, while also saying it will
consider not enforcing the requirements against these practitioners. While we
would prefer that qualified practitioners were fully exempt in these
situations, we understand that without any clear guidance distinguishing small
from large scale manufacturers, it would be difficult to grant such an
exemption.
The FDA states that "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).” These products would not be subject to the Final
Rules.
To the
extent that these formulas are not dietary supplements, the Final Rule does not
apply to them. Yet, current law does not delineate which herbal products are
considered to be dietary supplements are which are not in this category. The
AAAOM plans to do further work in this area.
The Final Rule does not take effect until June 2010 for
persons employing fewer than 20 employees.
This
category should include most practitioners, so there is time to discuss and
plan for any action needed.
Academic institutions are not exempt from the Final
Rule.
While
declining to exempt academic institutions, FDA did say it is not its policy to
inspect academic institutions providing training for therapeutic disciplines
that use dietary supplements in their practice. In addition FDA would consider
using its enforcement discretion in situations where dietary supplements are
dispensed after one- on – one consultation which includes a practitioner with
adequate training. FDA intends to issue further guidance in this area.
Comment: A note of thanks to the AAAOM for this work. The tone of the FDA's caveats cited here suggests a rather understanding FDA. Yet, it is clear also that if the FDA goes adversarial, it has a grounds to harass.
For those who view the FDA through fear-tinted lenses, the agency's
"discretion" may be the better part, not of valor, but of of paranoia.
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