RE:Docket No.98N-0148;International Drug Scheduling;
.fo Second Comments of Durk Pearson & Sandy Shaw
DURK PEARSON & SANDY SHAW
People for the Constitution, Box 3666, Tonopah,
TO: Dockets Management Branch (HFA-305)
Food and Drug Administration
5630 Fishers Lane, Rm. 1061
Rockville, MD 20852
Second Comments for Docket No. 98N-0148
FOOD AND DRUG ADMINISTRATION
In re: International Drug )
Scheduling; Convention On )
Psychotropic Substances; Single )
Convention On Narcotic Drugs; )
World Health Organization )
Scheduling Recommendations for )
Ephedrine; Comments On Abuse )
Potential, Actual Abuse, Medical)
Usefulness, Usefulness as a )
Docket No. 98N-0148
Dietary Supplement Under DSHEA, ) (Second Comments)
and Trafficking in Ephedrine and)
Ephedra Sinica Herb; Limits to )
FDA Authority Under DSHEA; )
Limits to FDA's Authority to )
Accept and Adopt International )
Standards and Recommendations )
Fed. Reg. 64(6): 1629-1634 )
January 11, 1999
10 February, 1999
INTRODUCTION TO COMMENTS OF DURK PEARSON
& SANDY SHAW
Note: These comments pertain to ephedrine,
ephedra herb, ephedra herb and ephedrine containing dietary supplements,
the family of ephedra alkaloids found in ephedra sinica, and related isomers
such as pseudoephedrine and phenylpropanolamine. No comments are
hereby tendered regarding dihydroetorphine or remifentanyl.
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.
Commenters' First Amendment and APA (Administrative
Procedure Act) arguments were recently vindicated by the 3-0 decision of
the US Circuit Court of Appeals for the District of DC against the FDA
on January 15, 1999 in Pearson and Shaw et al v. Shalala et al. (Case No.
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
in the form of herbal teas 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 be endangered, rather than helped, by any
COMMENTS OF DURK PEARSON & SANDY SHAW
We hereby include with and incorporate into
these Comments our First Comments on 98N-0148 of 1 April 1998, and our
very closely related and relevant prior Comments on 95N-0304 of 18 August
1997, and on 97N-0218 of 30 September 1997. (See attached.)
Abuse of Ephedra Herb Containing Dietary Supplement
a Significant or Widespread Problem
FDA states that in the US, ephedrine and ephedrine
containing combination products have been abused. To prepare for
Commenters' Comments on 95N-0304 (see attached), the Commenters made a
FOIA (Freedom Of Information Act) request on the FDA for all documents
pertaining to the safety and abuse potential of ephedrine and ephedrine
containing products, including OTC drugs and dietary supplements.
The Commenters received several thousand pages of documents which clearly
and unequivocally demonstrated that abuse of ephedrine and ephedrine containing
products was not common, amounting at most to a few tens of cases per year
out of several million non-abusing users each year. The reported
abuse was almost entirely of OTC drug products, many of which were mislabeled
or misbranded. At most, this abuse led to no more than a few deaths
per year, and there was no evidence of abuse of ephedra herb containing
dietary supplement teas.
This is a far smaller problem than the abuse
of non-prescription NSAIDS (Non-Steroidal Anti-Inflammatory Drugs) such
as aspirin, ibuprofen, and sodium naproxen which result in approximately
9,000 deaths per year in the US. Moreover, it is widely accepted
by experts in the field that caffeine addiction is common among coffee
consumers, and that anyone who consumes about 800 milligrams or more of
caffeine per day will quickly become addicted, and suffer very severe headache
pain for a week or more during caffeine withdrawal. There are at
least several hundred thousand caffeine addicts in the US. (See Caffeine
and Behavior by B.S. Gupta and U. Gupta, CRC Press, 1999) Ephedrine
abuse in the US is a far smaller problem than either the abuse of caffeine
or NSAIDS, and abuse of dietary supplement teas containing ground whole
ephedra herb is essentially non-existent.
In its request for comments, FDA states, "In
addition, in the USA, combination products containing ephedrine in herbal
preparations have been abused." The several thousand pages of documents
that the Commenters received from the FDA in response to their 1997 FOIA
did not contain evidence of abuse of ephedra herb tea. Capsules or
tablets containing ephedrine are far more readily abused than the true
ephedra herb teas licensed by the Commenters for reasons discussed in Commenters'
comments to 95N-0304 and below.
Scientific Differences Between
OTC Drugs and Ephedra Herb Tea
Ephedra Herb Tea is Far
Less Likely to be Abused:
It is very easy for a drug abuser to swallow
several cheap 50 milligram ephedrine pills or 60 mg. pseudoephedrine pills,
and to repeat this foolish act every hour. Because of this, there
have been several reported hospitalizations due to overdoses of ephedrine
or pseudoephedrine pills, and one overdose death. This frequency
of abuse, hospitalizations, and death from misuse of ephedrine or pseudoephedrine
tablets is far lower than the reported frequency of abuse, hospitalizations,
and deaths from misuse of acetaminophen tablets (e.g. Tylenol®).
There is no rational scientific justification for limiting the availability
of ephedra herb containing dietary supplements on the basis of their relatively
low level of reported abuse. Finally, while it is quick and easy to take
10 ephedrine or pseudoephedrine tablets, it is not at all quick and easy
to take 20 to 30 cups of ephedra herb dietary supplement tea containing
the same amount of ephedrine.
Because of these prominent and fundamental
scientific differences between ephedra herb tea dietary supplements and
ephedrine or pseudoephedrine OTC tablets, there is no rational scientific
basis for Scheduling ephedra herb tea dietary supplements.
In addition to the statutory prohibitions mentioned
below against FDA's complicity in effectively banning (via supporting the
proposed Scheduling) dietary supplement teas containing ephedra herb, there
are compelling scientific reasons for distinguishing between ephedrine
or pseudoephedrine containing OTC drugs and ephedra herb containing dietary
supplement teas. Even if the proposed Scheduling is adopted for OTC
drugs, the reasoning on which it is based is inapplicable to dietary supplement
teas containing ephedra herb.
Ephedra Herb Containing Dietary Supplement Teas Are Not Subject
to Diversion to Illegal Drug Manufacture.
There are no reported cases in the scientific
or forensic literature of ephedra herb containing dietary supplement teas
being diverted to the illicit manufacture of methamphetamine or methcathinone,
whereas there have indeed been cases where hundreds of thousands of OTC
ephedrine and pseudoephedrine pills have been subject to such diversion.
The reason for this difference is simple. It is easy and highly profitable
to convert OTC ephedrine and pseudoephedrine pills to methamphetamine,
whereas it is extremely difficult and utterly unprofitable to perform such
an illegal conversion using a dietary supplement tea containing ground
ephedra herb as a precursor.
A typical ephedrine tablet may contain 50 milligrams
of ephedrine (or 60 mg. pseudoephedrine in common OTCs) and 150 milligrams
(180 mg.) of inert tablet filler-binder. The ephedrine or pseudoephedrine
content is 25%. The ephedrine and pseudoephedrine can be quickly,
easily, and economically extracted from the tablets and separated from
the inert and frequently insoluble tablet filler-binder using a small amount
A typical ephedra herb containing dietary supplement
tea contains 20 milligrams of ephedrine contained in about 2 grams of ground
ephedra herb (the amount of which is varied to standardize the ephedrine
content per serving of tea) which is mixed with 10 to 20 grams of other
constituents consisting of 10 to 20 other herbs, spices, vitamins, minerals,
flavor extracts, sugars, and other food ingredients. The ephedrine
content of the herbal tea dietary supplements is typically 0.1% to 0.15%,
not the 25% commonly found in ephedrine (or pseudoephedrine) tablets.
Because of this, at least 200 times as much solvents would be required
to extract the ephedrine from the mixture, and the illicit production equipment
would have to be at least 200 times larger than would be required for extracting
ephedrine from tablets. Extraction of 10 kilograms of ephedrine from
10,000 kilograms of herbal tea using 100,000 to 200,000 kilograms of solvents
is not an operation that can be hidden in a garage or an apartment, completely
unlike the case with ephedrine or pseudoephedrine tablets. Moreover,
many of the other constituents of the herbal tea would be far more difficult
to separate from the ephedrine, unlike simple tablet fillers and binders
such as dicalcium phosphate.
In addition, a typical ephedra herbal tea dietary
supplement sells for 50 cents to $1.00 per serving, a cost per milligram
of contained ephedrine (or pseudoephedrine or phenylpropanolamine) that
is about 10 to 100 times higher than ephedrine, pseudoephedrine, or phenylpropanolamine
OTC tablets. When one considers the added cost of at least 200 times
as much solvents, the difficulty of an illicit operation purchasing so
much solvents without arousing suspicion, the cost of processing equipment
that is at least 200 times larger, the far greater difficulty, cost, and
much lower efficiency of extracting the ephedrine from such a dilute complex
mixture, and the difficulty and cost of hiding such large extraction and
purification equipment and such large amounts of solvents (to say nothing
of disposing of the 100 to 200 tons of used solvents afterward!), it is
not surprising that ephedra herb tea dietary supplements have never been
diverted to methamphetamine manufacture, and never will be.
Although ephedrine can be used in the illicit
manufacture of methamphetamine, bulk sales of this substance are already
controlled in the US by the DEA as a "listed chemical" precursor compound
under the Controlled Substances Act. There is no record of ephedra
herb ever being used as a precursor by illicit drug manufacturers.
It would be economically impractical to do so as explained above and in
Commenters' First Comments to 98N-0148 and Commenters' Comments to 95N-0304.
The WHO proposed Scheduling is irrational,
arbitrary, and capricious because it will be completely ineffective unless
pseudoephedrine and phenylpropanolamine are controlled at least as stringently
Far more widely used than ephedra herb containing
dietary supplement teas and ephedrine containing OTC drugs are OTC drugs
that contain pseudoephedrine (e.g. Sudafed®) and phenylpropanolamine.
The same simple efficient palladium catalyzed hydrogenation (or the illicitly
popular iodine-red phosphorus method) that converts ephedrine to methamphetamine
will convert pseudoephedrine to methamphetamine and phenylpropanolamine
to amphetamine with equal ease and efficiency. Pseudoephedrine is
just as suitable as ephedrine as a precursor for the illicit manufacture
of methcathinone, too. The amounts of pseudoephedrine and phenylpropanolamine
used in the OTC drug industry are far larger than the amounts of ephedra
herb used, hence any rule that restricts ephedra herb containing dietary
supplement teas but not pseudoephedrine and phenylpropanolamine OTC drugs
is irrational, arbitrary, and capricious because it will be completely
ineffective in controlling the supply of precursors for the manufacture
of illicit methamphetamine, methcathinone, and amphetamine. Since
there is very little problem with the abuse of pseudoephedrine and phenylpropanolamine
OTC drugs, it is expected that the very large drug companies manufacturing
these products will apply for and receive Convention Article 3, paragraph
2 or 3 exemptions to prescription requirements. Recommending that
ephedra herb containing dietary supplement teas be Scheduled will therefore
have no effect on either abuse or diversion to as precursors to illicit
Because of these considerations, any FDA recommendations
that do not reject the proposed Scheduling violates the Administrative
Procedures Act and DSHEA (under which ephedra herb is a dietary supplement),
and therefore must be rejected.
Neither the Law
Nor the Facts Permits FDA to
Recommend Adoption of the
Proposed UN Scheduling
Applicable to Ephedra Herb Containing Dietary Supplement Teas
On the basis of both the law (DSHEA and APA)
and the administrative record of the facts, FDA cannot make any recommendation
to the UN that would interfere with the manufacture, availability,
and sale of properly labeled ephedra herb tea dietary supplements, for
to do so would be arbitrary, capricious, not in accord with the facts,
and contrary to law. Before FDA could make any recommendation to
any international body that would interfere with the manufacture, availability,
and sale of ephedra herb teas, FDA must first meet its DSHEA (Dietary Supplement
Health and Education Act) burden of proof that properly labeled ephedra
herb teas are unreasonably unsafe when used as directed. FDA has
not met that burden of proof.
FDA does not have the constitutional legal
authority to simply accede to the recommendation of an international organization
that ephedrine containing products be Scheduled under international psychotropic
convention drug laws in violation of U.S. statutes and the restrictions
on federal power under the U.S. Constitution.
The Limits of Federal
Authority Under Treaties
One legal argument on treaties is, of course,
that a treaty cannot go beyond the bounds of the Constitution by, for example,
giving away Constitutionally protected rights. As the U.S. Supreme
Court ruled in Geofroy v. Riggs (1890): "The treaty power,
as expressed in the Constitution, is in terms unlimited except by those
restraints which are found in that instrument against the action of the
government or of its departments, and those arising from the nature of
the government itself and of that of the States. It would not be
contended that it extends so far as to authorize what the Constitution
forbids, or a change in the character of the government or in that of one
of the States, or a cession of any portion of the territory of the latter,
without its consent." In 1957 in Reid v. Covert, the Court ruled
that "no agreement with a foreign nation can confer power on the Congress,
or on any other branch of Government, which is free from the restraints
of the Constitution." Moreover, the Court continued, "this Court
has regularly and uniformly recognized the supremacy of the Constitution
over a treaty."
An on-point argument as to why FDA cannot simply
accede to the recommendations of an international agency can be found in
a recent issue of the National Law Journal:
An analysis published in the March 17, 1997
National Law Journal (NLJ), Martin, Farber, Chajet "Determination on Silica
May Expose Flaw in Rule," offers a Constitutional argument to oppose standards
(such as the UN Scheduling of ephedra herb containing dietary supplement
products) supposedly binding upon the United States that are developed
under the auspices of the United Nations. These legal arguments are
equally applicable to the proposal that is the subject of this Comment.
The case of interest concerns an OSHA rule
in which OSHA incorporated certain standards and findings (on silica --
ordinary sand -- as a carcinogen) that were developed by the International
Agency for Research on Cancer (IARC). An important constitutional
issue was raised in the article concerning the OSHA rule: whether
an Executive agency which has received its rulemaking authority as a result
of delegation by Congressional statute can re-delegate that authority to
a third party. The Constitution states in Article I Section I: "All
legislative powers herein granted shall be vested in a Congress of the
As the NLJ article noted: "...the agency
[OSHA] has taken what is concededly a broad delegation of authority and
effectively redelegated that authority to an extragovernmental entity."
"Though OSHA may well have broad authority to decide issues under the OSH
Act, it does not follow that the agency can pass that same authority to
The issue arose, though indirectly, in the
context of a 1992 decision by the 11th U.S. Circuit Court of Appeals (AFL-CIO
v. Occupational Safety and Health Administration 965 F.2d 962, 984 (11th
Cir. 1992)), in which the Court considered the propriety of OSHA's incorporation
into its rules of the standards and findings of an outside organization.
In that case, the court vacated a "generic" OSHA rulemaking to set permissible
exposure limits for 428 substances identified by the agency as air contaminants.
"The court found that while OSHA may 'rely on the recommendations and documentation'
of outside organizations (such as the "threshold limit values" established
by the American Conference of Governmental Industrial Hygienists), the
outside body's findings 'did not relieve OSHA of the responsibility for
making detailed findings, with adequate explanations for all statutory
The NLJ article then goes on to say "The inevitable
debate over the marriage of OSHA regulations and the IARC silica findings
may also spill over into the constitutional realm. Necessarily, Congress
must delegate to the executive branch substantial, but not unbridled, authority
to implement the policy judgments of the legislative branch. The undelegable
essentials of the legislative function are the determination of the legislative
policy and its formulation as a defined and binding rule of conduct."
Commenters have argued in their recently filed
108 pages of public comments on an FDA rulemaking concerning ephedra alkaloid
containing dietary supplements (95N-0304) that the FDA cannot adopt the
standards for ephedra herb dietary supplements set by the Canadian government
because Canada is not bound by the U.S. Constitution, the U.S. Congress
cannot delegate its Constitutional legislative powers to the Canadian government,
the FDA cannot redelegate its rulemaking authority to the Canadian government,
and the Canadian government is not bound by (among other things) the procedural
requirements of the FACA (open meeting law) or the APA (Administrative
Procedures Act). All this applies as well to standards -- such as
drug control schedules -- set by the United Nations.
Note that the FDA's proposed rules on ephedra
herb containing dietary supplements -- considered a high priority by the
FDA -- were to go into effect in February 1998; however, the rules have
not yet been issued because the FDA could not meet its burden of proof
under DSHEA. FDA cannot legally take ephedra herb dietary supplement
products off the market via the back door method of acceding to an international
treaty which would effectively accomplish such removal without first meeting
the DSHEA burden of proof that such dietary supplements, when properly
labeled, are unreasonably unsafe when used as directed.
The Article 3, Paragraphs 2 and 3 Convention
FDA has stated that the 1971 UN Psychotropic
Convention provides that "Under Article 3, paragraphs 2 and 3, a party
may exempt from certain controls under the Convention, including the prescription
requirement, if the preparation is compounded in such a way that it presents
no, or a negligible, risk of abuse." However, This provision is expressly
applicable to drugs, not to dietary supplements. No dietary supplement
has ever received an exemption under this provision.
Adverse and Disparate Impact
on Small Businesses
and FDA Failure to Comply with Statutory
FDA has failed to fulfill its statutory obligation
to consider the impact of this proposed regulatory action on small businesses.
This failure is sufficient to require that the FDA exercise option #3,
"reject the recommendations [regarding Scheduling ephedrine containing
products] entirely." in its recommendations to WHO and CND (United Nations
Commission on Narcotic Drugs).
Non-prescription medications containing pseudoephedrine
are the most popular drugs in the US for the symptomatic relief of colds,
flu, and allergies. The most popular brands are made by large corporations
that may have the financial and legal resources to seek an Article 3, paragraph
2 or 3 exemption. The small businesses producing ephedra herb containing
dietary supplements do not have these resources, and the failure of FDA
to consider this difference in its Federal Register announcements of January
11, 1999, legally precludes the FDA from making any recommendation other
than option #3, "reject the recommendations entirely."
DSHEA, APA, the scientific facts, constitutional
limits on treaty powers and delegation, and statutes requiring assessment
of regulatory impact on small businesses require that FDA adopt option
#3; "reject the recommendations entirely."
Submitted 10 February 1999 by Durk Pearson
& Sandy Shaw,
© 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.