RE:Docket No.98N-0148;International Drug Scheduling;
DURK PEARSON & SANDY SHAW
People for the Constitution, Box 3666, Tonopah,
TO: Dockets Management Branch (HFA-305)
Food and Drug Administration
12410 Parklawn Dr., Rm. 1-23
Rockville, MD 20857
Comments for Docket No. 98N-0148
FOOD AND DRUG ADMINISTRATION
In re: Comments Concerning Abuse)
Potential, Actual Abuse, Medical)
Usefulness, Usefulness as a )
Docket No. 98N-0148
Dietary Supplement Under DSHEA, )
and Trafficking in Ephedrine and)
Ephedra Sinica Herb
Fed. Reg. 63(52): 13258-13259 )
March 18, 1998
3 April, 1998
INTRODUCTION TO COMMENTS OF DURK PEARSON
& SANDY SHAW
Note: These comments pertain to ephedrine,
ephedra herb, ephedra herb and ephedrine containing dietary supplements,
and the family of ephedra alkaloids found in ephedra sinica. No comments
are hereby tendered regarding dihydroetorphine or remifentanyl. These
comments apply to "isomers of psychotropic substances" only insofar as
any FDA recommended WHO rules would apply to the family of ephedra alkaloids
found in ephedra sinica.
Durk Pearson and Sandy Shaw are scientists
and authors, maintaining residences in Nevada and California. Their
three best-selling books include the million plus copy #1 best-seller Life
Extension, a Practical Scientific Approach (Warner Books, 1982).
Their fourth book, Freedom of Informed Choice: FDA v. Nutrient Supplements
argues that truthful, non-misleading speech on labels and in labeling is
protected by the First Amendment of the United States Constitution against
FDA censorship and discusses the cost to public health of such censorship.
Pearson and Shaw design dietary supplement
formulations and license them to small marketing and manufacturing companies.
The formulations designed by Pearson and Shaw include dietary supplements
containing ground ephedra herb leaves and stems. Pearson and Shaw
and their licensed marketers and manufacturers (all are small businesses)
would suffer substantial economic harm if the FDA were to recommend, and
WHO were to implement, restrictions on the sale of ephedra herb itself
or on DSHEA compliant dietary supplements containing ephedra herb.
Furthermore, Pearson & Shaw believe that consumers of ephedra herb
dietary supplements would actually be endangered by any such restrictions.
DSHEA (Dietary Supplement Health and Education
Act) places a substantial statutory burden of proof on FDA to demonstrate
that an herbal dietary supplement is unreasonably unsafe when used as directed
before FDA is legally permitted to take any action to restrict or prohibit
the sales of such a supplement or its ingredients. Under the provisions
of DSHEA, FDA has no statutory authority to recommend that WHO restrict
ephedra herb, ephedra herb containing dietary supplements, or their constituent
ingredients unless FDA has met their DSHEA burden of proof.
Pearson & Shaw do not believe that the
FDA has met their statutory burden of proof under DSHEA that ephedra herb
and ephedrine containing and ephedra herb containing dietary supplements
are unreasonably risky to consumers when used as directed.
On the contrary, the evidence presented by
the FDA's own Expert Committee on Ephedrine Alkaloid Containing Dietary
Supplements (which we review at length in the attached 107 page public
comment document previously filed by Pearson & Shaw with the FDA) shows
that extant ephedra herb supplements with extant labeling are generally
safer than food in common form. Please see Pearson & Shaw's 107
pages of Comments (attached). We filed these comments on FDA's Docket
No.95N-0304: Dietary Supplements Containing Ephedrine Alkaloids, and they
address the abuse potential, actual abuse, potential dangers, actual dangers,
and usefulness as DSHEA regulated dietary supplements of ephedrine and
ephedra herb containing products.
Note that the aforementioned FDA Expert Committee
on Ephedrine Alkaloid Containing Dietary Supplements found that millions
of Americans were using ephedrine containing dietary supplements.
They identified only a few abusers among these many millions of American
users, and found no evidence of abuse of either ephedra herb itself or
of ephedra herb containing dietary supplements.
Re illicit trafficking:
There is no illicit trafficking in ephedra
herb or in dietary supplements containing ephedra herb. Ephedrine
itself has already been designated as a listed chemical and is subject
to chemical diversion regulations under 21 CFR part 1310 which are enforced
by the Drug Enforcement Administration, due to its potential for use as
a precursor in illicit methamphetamine manufacturing.
Any recommendation by FDA to WHO (or any other
party) that ephedra herb (or ephedra herb containing dietary supplements)
be subject to the same restrictions as ephedrine itself would be arbitrary,
capricious, contrary to fact, and a violation of the Administrative Procedure
There is no record of ephedra herb ever having
been used as a precursor for illicit methamphetamine.
To make one kilogram of illicit methamphetamine
would require about 1.5 kg. of ephedrine, and a few kilograms of other
chemicals (e.g., red phosphorous) and solvents. The conversion would
be performed in reaction vessels of a few liters volume, and the whole
operation can be (and often has been) performed in a residential
kitchen or bathroom.
To make 1 kg. of illicit methamphetamine from
ephedra herb, however, would require that the ephedrine first be extracted
from approximately 200 kg. of raw ephedra sinica herb with the use of approximately 2,000 kg. of solvents in an extraction vessel of approximately 3,000 liters volume. Obviously, an operation of this scale cannot be readily hidden, and extraction solvent purchases of this magnitude would be both prohibitively expensive and highly suspicious, to say nothing of the difficulties involved in the illicit disposal of such huge amounts of used solvents. It is obvious, therefore, why ephedra herb has never been used as a source of ephedrine for illicit methamphetamine manufacture. It is also
obvious that ephedra herb containing dietary supplements would be an even
more difficult and less economic source of ephedrine than ephedra herb
For these reasons, and additional reasons stated
in the attached 107 pages of comments, if FDA makes any recommendations
to WHO regarding ephedrine, FDA must distinguish between ephedra herb (and
DSHEA regulated dietary supplements containing ephedra herb) on the one
hand and pure ephedrine on the other.
FDA, in accord with U.S. law, must recommend
to WHO that ephedra herb itself and ephedra herb containing dietary supplements
NOT be subject to any additional regulation, and under no circumstances
be regulated the same as ephedrine; any other recommendation would be a
clear violation of the intent of the DSHEA and of the APA.
© Copyright 1999
by Durk Pearson & Sandy Shaw
NOTICE: The "Durk Pearson
& Sandy Shaw Life Extension News" is for informational purposes only.
Its contents are not intended as advice for the diagnosis, treatment, or
cure of any medical condition. Pearson & Shaw are scientists, not doctors.
If you have a medical condition, see a physician. Durk Pearson & Sandy
Shaw® do not own any part of any dietary supplement company. They license
their formulations and receive royalties on sales. The formulations they
design and use are those which contain their names on the label.