![](media/image2.png){width="0.8027777777777778in"
height="0.14166666666666666in"}

Section 9 of the Dietary Supplement Health and Education Act of 1994
(DSHEA) authorized the FDA to promulgate GMPs modeled after those GMPs
already in existence for conventional foods ("shall be modeled after
current good manufacturing practice regulations for foods...") or that
the Agency's definition of "model" to mean "a preliminary pattern" is
consistent with the intent of Congress in this matter, especially
considering that the Agency appears to have chosen a relatively narrow
definition of "model" from many that are available in various
dictionaries. While we are supportive in general of the idea that
manufacturers should adequately test raw materials used in the
production of high quality herbal dietary supplements, in reviewing the
Agency's proposed rules for GMPs published in March, we are not
convinced that the proposal reflects processes and techniques that are
consistent with GMPs required for conventional foods, and it appears
that the Agency has gone outside of the domain of such GMPs to include
specific GMP requirements that seem to be drawn from those required of
drugs (i.e., finished pharmaceuticals) and medical devices.

Furthermore, we are aware that the basic premise for GMPs for foods is
based on principles related to *sanitation*, while GMPs for drugs are
based on principles of protecting the public from *adulteration* and
related problems, based on the premise that drugs may be inherently
unsafe. We do not believe that it is appropriate for the Agency to
presume the general lack of safety of dietary supplements in general,
and herbal dietary supplements in particular. We believe that the market
experience related to the vast majority of herbal dietary supplements
sold in the United States confirms the strong evidence supporting the
relative safety of most herbal dietary supplement products,
notwithstanding a few notable exceptions (e.g., ephedra).

We are also concerned about some of the language in the preamble to the
proposed rules in which the Agency suggests that dietary supplements are
not subject to the Agency's regulatory overview, and that the Agency is
unable to adequately inspect or enforce current GMPs for conventional
foods.

**[2. Consumer Complaints and Adverse Event Reporting]{.underline}**

The Agency has proposed that consumer complaints about dietary
supplements be incorporated into record-keeping procedures as a part of
the proposed GMPs. As an educational nonprofit organization concerned
with educating the public about the benefits and potential risks of
herbal dietary supplements, ABC considers such information that can be
gained from such reporting to be valuable. However, we are not aware of
any such requirement in current food GMPs. Further, we are aware that
the Agency is currently revising and improving its adverse event
reporting system (CFSAN Adverse Event Reporting System, CAERS) and we
believe that this and other appropriate mechanisms should be developed
outside the framework of GMPs to gather and evaluate consumer comments,
complaints and adverse event reports on foods, dietary supplements,
cosmetics and other consumer products that fall within the scope of the
Agency's regulatory authority.

**[3. Recognition of Compendial Standards]{.underline}**

In section 111.35 of the proposed rules, the Agency discusses numerous
laboratory methods that can be utilized for the identification and
quality assessment of botanical ingredients. These methods include
macroscopic, microscopic, and chemical analytical methods of various
types. The analytical methods developed and validated by AOAC
International and the methods included in United States Pharmacopeia
(USP) monographs have been cited as acknowledged as valed by FDA. ABC
believes them to be authoritative sources for such methods. In addition,
ABC believes that there are other reliable sources of appropriate
analytical methods that the Agency should acknowledge, including the
botanical monographs of the American Herbal Pharmacopoeia (AHP), the
European Pharmacopeia (Ph Eur), and other EU national pharmacopeias,
e.g., the German Pharmacopeia (DAB), among numerous others. These
botanical monographs are among the most useful and scientifically
credible source of identification testing and quality control
information for botanical ingredients. For example, the AHP monographs
contain methods of identification for authentic materials as well as
potential adulterants, plus guidance information regarding the sourcing
of botanical material materials of acceptable quality. Taken together,
these sources (including two volumes of monographs produced by the World
Health Organization, WHO) provide guidance and testing methods for over
100 botanical materials. ABC believes that FDA should recognize and
explicitly acknowledge the authoritativeness of these monographs (i.e.,
AHP, Ph. Eur., DAB et al.) as authoritative sources of scientifically
valid analytical methods, and quality standards for botanical dietary
supplements and botanical ingredients.

[**4.** **Exemption for Clinicians and Compounding
Pharmacists**]{.underline}

ABC believes there should be an exemption in the GMPs for practitioners.
Other nations, notably Australia and Canada, have developed GMPs and
related guidance for botanicals that recognize that there are various
types of practitioners who dispense herbs and herbal preparations in a
clinical setting. This includes some licensed acupuncturists as well as
compounding pharmacists, who operate in an appropriately licensed retail
establishment that is designed for pharmacy dispensing and compounding.
Such practitioners dispense small quantities of herbal preparations
directly to patients and consumers, often providing a unique service of
blending custom formulations that are specific for each patient/consumer
and which may not be available in a pre-prepared retail supplement
product. For example, the Therapeutic Goods Act of Australia makes such
an exemption from GMP requirements for such practitioners.\* Further,
the newly developed Canadian Natural Health Products Directorate (NHPD)
has also published guidelines that exempt practitioners.\*\* We believe
that such an exemption from the Agency's GMP regulations is reasonable
and appropriate and is in the public's interest.

\*The actual wording of the Australian exemption is shown in a table at
the end of this letter.

\*\* The wording of the Canadian exemption is a follows: "These
Regulations place requirements on persons who sell NHPs, namely
manufacturers, distributors, importers, packagers and labellers. The
NHPD considers that growers, who handle and/or treat a product in order
to preserve the integrity of the raw material, are not considered
manufacturers. Health care practitioners (for example, pharmacists,
Traditional Chinese Medicine (TCM) practitioners, herbalists,
naturopathic doctors, etc.) who compound products at the request of a
patient are not included within the manufacturer definition. The NHP
Regulations are not aimed at regulating the practice of complementary
and alternative health care practitioners or the practice of traditional
Aboriginal medicine. The NHPD intends to adopt a guidance document
regarding the distinction between manufacture and sale of NHPs and
compounding and distribution of compounded products by complementary and
alternative health care practitioners and Aboriginal healers."
\[Canadian Natural Health Products Directorate (NHPD) Regulatory Impact
Analysis Statement concerning the Natural Health Product (NHP)
Regulations; available at:
<http://canadagazette.gc.ca/partII/2003/20030618/html/sor196-e.html>\]

**[5. Recognition of Benefits of Dietary Supplements and Impact on
Consumers]{.underline}**

The FDA writes in its proposal that GMP regulations "will help to ensure
that the potential health benefits that Congress identified as the basis
for DSHEA are obtained and that consumers receive the dietary
ingredients that are stated on the product label." We concur with the
Agency that adherence to appropriate GMPs is important to help ensure
that "potential health benefits" of dietary supplements are delivered to
consumers and that consumers are receiving what they are paying for. We
believe that in the interests of greater public health that it would be
appropriate for the Agency to begin to publicly recognize some of the
scientifically documented "potential health benefits" of dietary
supplements and that the agency become more proactive in educating the
public in this area.

Further, ABC believes that implementation of the currently proposed GMP
regulations will create financial burdens that are not attainable by
many small manufacturers of herbal dietary supplements, some of whom
produce high quality unique products that are unavailable elsewhere in
the marketplace. Thus, implementation of the currently proposed GMPs
could be counterproductive to consumer choices in natural healthcare.

The American Botanical Council is grateful for the opportunity to
present its views on this important issue and is willing to work with
the Agency in any appropriate manner to produce rational, meaningful,
and appropriate rules to govern the manufacture of high quality herbal
supplements.

Sincerely, ![](media/image4.png){width="2.232638888888889in"
height="0.7361111111111112in"}

Mark Blumenthal

Founder, Executive Director

American Botanical Council

Editor, *HerbalGram*

Cc: ABC Board of Trustees

**\*Schedule 8 Persons exempt from the**

**operation of Part 3-3 of the Act**

(regulation 18)

\[Format of schedule in TGA is slightly modified for inclusion herein;
text is verbatim.\]

1\. medical practitioners, dentists and other health care workers
registered under a law of a

State or Territory:

the manufacture of:

\(a\) a medicine by a medical practitioner or a dentist specifically for
a patient under his or her care; or

\(b\) a therapeutic device by a health care worker specifically for a
patient under his or her care;

2\. pharmacists the manufacture of therapeutic goods produced by the
pharmacist:

\(a\) in a pharmacy where the pharmacist practices and the pharmacy is
open to the

public; or

\(b\) on the premises of a dispensary conducted by a Friendly Society;
or

\(c\) on the premises of a private hospital;

for supply (other than by wholesale) on or from those premises;

3\. biomedical engineers, radiochemists and pharmacists in public
hospitals:

the manufacture of therapeutic goods by the person when employed by a
public hospital or a

public institution and produced by that person for supply in hospitals
or public institutions in the same State or Territory:

4\. herbalists, nutritionists, naturopaths, practitioners of traditional
Chinese medicine or homoeopathic practitioners engaged in the
manufacture of any herbal, homoeopathic or

nutritional supplement preparation where the preparation is for use in
the course of his or her business and:

\(a\) the preparations are manufactured on premises that the person
carrying on the business occupies and that he or she is able to close so
as to exclude the public; and

\(b\) the person carrying on the business:

> \(i\) supplies the preparation for administration to a particular
> person after

consulting with that person; and

> \(ii\) uses his or her own judgment as to the treatment required.

5\. a person who applies supplementary labelling to a manufactured
product the application of supplementary labelling, where the
supplementary label contains only a name and address or the

registration or listing number of goods.

Source: Australian Therapeutic Goods Regulations 1990, Statutory Rules
1990 No. 394 as amended, made under the Therapeutic Goods Act of 1989,
as revised July 1, 2003, the exemption \[Schedule 8: Persons exempt from
the operation of Part 3-3 of the Act (regulation 18) (p. 220-1)\].