August 20, 1999

Dockets Management Branch (HFA-305)

Food and Drug Administration

5630 Fishers Lane, Room 1061

Rockville, MD 20852

SUBJECT: Docket No. 99N-1174

Dear Sir or Madam:

Thank you for the opportunity to comment on the Food and Drug
Administration's Center for Food Safety and Applied Nutrition to develop
a strategy to achieve effective regulation of dietary supplements. The
physician members of Texas Medical Association are concerned about the
health and wellbeing of our patients and therefore support the
Administrations attempts to balance consumer's access to dietary
supplements while assuring the safety and proper labeling of these
products.

The following comments are grouped according to the focus questions
published in the June 18, 1999 Federal Register.

1.  In addition to ensuring consumer access to safe dietary supplements
    that are truthful and not misleadingly labeled, are there other
    objectives that an overall dietary supplement strategy should
    include?

Comments: The FDA should continue to encourage and support research in
the area of dietary supplements. The research should focus on assessing
the safety of dietary supplement active ingredients, and the use of
dietary supplements in the maintenance of health and/or prevention of
disease. TMA supports the continued input from the Food Advisory
Committee to provide FDA with scientifically founded recommendations
concerning the safety of dietary supplement products. TMA also
recommends that FDA continue to develop and enforce regulations that
require dietary supplement manufacturers to ensure the efficacy of their
products.

2.  Are the criteria for prioritizing the tasks within the supplement
    strategy appropriate? Which specific tasks should FDA undertake
    first?

Comments: Consumer safety and truth in labeling should be FDA's first
priority for dietary supplements. The FDA should define acceptable
manufacturing practices by which the industry can guarantee that a
product's ingredients and amounts are truthful. FDA should also develop
a standard set of definitions for (1) dietary supplements and (2)
adverse events. For example, should there be differences in
definition/classification of dietary supplements such as garlic and
ginseng, and weight loss supplements with identifiable active
ingredients like ephedrine.

In order to provide the public with "good information" on dietary
supplements, the FDA must first have good data. TMA agrees that FDA
should be the one to conduct follow-up investigations to substantiate
any adverse events reported. This data collection and analysis requires
proper funding so that accurate information can be disseminated.

TMA also supports increased education and accessibility to the MedWatch
reporting system. Many physicians are not aware of the various reporting
avenues, and are reluctant to report adverse events because of the
length of time spent completing the form. The FDA may want to consider a
two-step process for reporting. The first report could utilize a
one-page report and include information such as the patient name,
suspected name of substance, suspected adverse event, physician or name
of individual making report. Additionally, the report could list the
preferred method to contact the reporter in the event that additional
information is needed. FDA analysts could review the case and assess the
need for further information.

3.  What factors should FDA consider in determining how best to
    implement a task?

Comments: TMA supports the use of regulations to improve labeling and
safety requirements of dietary supplements. While guidance documents
play an important role in explaining how industry and the agency may
comply with those statutory and regulatory requirements. TMA supports
FDA efforts to develop regulations and legally enforce those regulatory
requirements.

4.  What tasks should be included under the various dietary supplement
    program elements in the CFSAN 1999 Program Priorities document?

Comments: Finalize the June 1997 proposed regulations on ephedra. The
public health risks associated with these products have not changed
since promulgation of these rules and top priority should be placed on
finalizing these regulations to address the risks.

5.  Are there current safety, labeling, or other marketplace issues that
    FDA should address quickly through enforcement actions to ensure,
    for example, that consumers have confidence that the products on the
    market are safe, truthful, and not misleadingly labels?

Comments: If there is a known active ingredient in a dietary supplement,
it should be listed as the pharmaceutical name along with the amount per
dosage. Manufacturers should also be required to list possible drug
interactions and safety concerns.

6.  Toward what type or area of research on dietary supplements should
    FDA allocate its research resources?

Comments: The FDA should focus its research to issues of safety.
Manufacturers should be responsible for conducting research to determine
a product's efficacy

7\. Given FDA's limited resources, what mechanisms are available, or
should be developed, to leverage FDA's resources to meet effectively the
objective of the strategy.

Comments: FDA should increase its surveillance through MedWatch and
other current sources. FDA could prioritize based on selected hot topics
or the current fad and research safety studies and provide meta-analysis
of scientifically developed studies. Additionally, FDA should continue
to work closely with state regulatory agencies and should increase
education and outreach to health professionals about the role of
MedWatch in identifying potentially unsafe products.

Thank you for the opportunity to provide comments into the Center's
overall strategy to achieve effective regulations of dietary
supplements.

Sincerely,

Robert H. Emmick, Jr. MD

Vice Chair, Council on Public Health

Butler, Jennie C

From: Gayle_H@texmed.org

Sent: Friday, August 20, 1999 3:00 PM

To: FDADockets@test.oc.fda.gov

Subject: Comments on CFSAN 1999 Program Priorities

Attached are comments from Texas Medical Association in response to

Docket 99N-1174.

A hard copy of the letter has also been mailed to FDA, Dockets

Management Branch. Thanks for the opportunity to provide our comments.

Gayle Harris

Director, Public Health Department

Texas Medical Association

401 W. 15th Street

Austin, TX 78701

\(512\) 370-1670

gayle_h@texmed.org