Dear Valued Practitioners,
According to new FDA regulations, herbal formulas are required to go through an extensive ingredient identification process before and after blending. This new requirement demands costly laboratory testing. Due to the nature of Chinese herbal formulation, it is too difficult to fulfill these requirements. After careful consideration of these factors, we have decided to discontinue our formula lines, both special formula and patent formulas. We apologize for the short notice and any inconvenience caused. We will continue to provide single herbs, and should you decide to mix formulas in your own practice, we would be happy to offer you our complete line of single herbs, patent recipes and formulation supplies.
Sincerely,
Blue Light Inc.
FDA response to comment 32, Federal Register Vol. 72, No. 121, page 34793
www.gpo.gov/fdsys/pkg/FR-2007-06-25/pdf/E7-12127.pdf
(Comment 32) Many comments question the rule's 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
4-year 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
consumer's 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.
