>I gather that if I call the Commission's Information Response Center at
301-650-0382, they will send me the 77 page draft report of the Commission
on Dietary Supplement Labels. Given the time constraints in obtaining this
report fast enough to read it in entirety in order to file comments prior
to your August 4, 1997 deadline, I am formally requesting an extension on
the comments period in order to allow me sufficient time to procure the
report, read it as well as to draft more extensive  comments. I am
appraising my Senators and Congressmen of the following concerns about the
draft, which were called to my attention by International Advocates for
Health Freedom:
>
>On p.ii, pp.16-17, and p.20 I feel that you should strike all references
to ephedra posing a "safety issue" given the fact that a Medline Search
indicates that you have no peer reviewed evidence to support your
contention that ephedra has caused death, and given the fact that we are
currently undergoing a comments period with regards to ephedra regulation.
I do not feel that it is appropriate for you to cite ephedra as an example
of an "unsafe" product being marketed. A search of Medline turned up zero
reports of deaths caused by ephedra, and several reports of death caused by
ephedrine, and pseudoephedrine products, including many commonly used OTC
drugs such as children's cough syrup. If FDA is concerned with safety, let
FDA regulate ephedrine, and pseudoephedrine products which have been
documented to cause death. Leave ma huang/ephedra alone. We don't need or
want the FDA's double standards incorporated into this report. This
information comes from the affadavit of Miloslav Nosal, a biostatistician,
who is serving as an expert witness in a lawsuit filed by Freedom of Choice
in Health Care against the Canadian HPB.
>
>I  feel strongly that the creation of an OTC drug category for herbs and
botanicals (as described on p.vii in your report), is not in the long range
best interests to consumers. Foods are not drugs. By law, DSHEA established
a food definition for dietary supplements. We object strongly to the
proposal to create an OTC drug category for herbs and botanicals. Our gains
under DSHEA would be put at risk if an OTC drug category were created.  We
feel that expanded health claims should be allowed under DSHEA based on
overwhelming scientific evidence attesting to both the safety and efficacy
of dietary supplements for many medical conditions, and we feel that to
deny these truthful claims violates our first amendment rights to free
speech. We favor a split label in which FDA can say what they want on their
half, and the manufacturer can offer validated information on the other half.
>
>We object to a comments period which effectively excludes the views of
millions of concerned dietary supplement consumers who have not had
sufficient time to procure your draft report, much less to read it and to
submit comments. Given the enormous consumer push behind DSHEA, we feel
strongly that consumers are being largely disenfranchised, and we would
like the comments period to be extended until the end of October, 1997. We
are outraged by the ongoing push to regulate foods as "drugs." We would
like until the end of October to review your draft report and to file
comments. I am appraising my Senators and Congressmen of these concerns.
>
>Signed:
>
>Address:
                    						
>City:                        State:             Zip:
        	
>
>(Info courtesy I.A.H.F. 800-333-2553,
http://www.pnc.com.au/~cafmr/hammell/index.html, jham@concentric.net)
******************************************
International Advocates for Health Freedom
John C. Hammell, Legislative Advocate
2411 Monroe St.#2 Hollywood, FL 33020 USA
800-333-2553, 954-929-2905, FAX 954-929-0507,
FAX ON DEMAND 954-927-8795,jham@concentric.net
http://www.pnc.com.au/~cafmr/hammell/index.html
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