Ephedra-containing
Supplements Produced by Members
Of Leading Trade Association Test Well in New Study
Washington,
D.C. (May 19, 2000)--- A recent analysis of ephedra-containing
supplements revealed that American Herbal Products Association
member companies manufacture products that perform well above
the norm in quality testing.
The study
was conducted by Dr. Bill Gurley of the College of Pharmacy
at the University of Arkansas for Medical Sciences and is
due to be published in the May, 2000 issue of the American
Journal of Health-System Pharmacy. Dr. Gurley analyzed
20 different products, 9 of which are marketed by AHPA member
companies. A total of 30 lots were tested including 12 from
the 9 AHPA companies.
The study�s
author was critical of manufacturers, based on his report
that the products contained anywhere from zero to 154% of
the amount of ephedrine alkaloids stated on labels. A review
of the result of AHPA member�s products, however, tells an
entirely different story.
Three
of the 12 tested products manufactured by AHPA members did
not state an alkaloid quantity on the label (1).
The other nine of these were found to contain between 84 and
109% of the claimed ephedrine alkaloids (2,3).
The mean ephedrine content of these samples was 98% of label
claim. Federal labeling guidelines require that naturally
occurring ingredients that are quantified on a label be present
in an amount "at least equal to 80 percent of the value�
declared on the label," and also permit reasonable excesses.
All of the AHPA manufactured products were found to be well
within this legal range.
Here follows
a graphic depiction of all products tested that made a label
claim for quantity:
"Although
Gurley�s report is technically sound, we have identified some
concerns with the conclusions that he has drawn," commented
Dr. Joseph Betz, AHPA�s Vice-President of Scientific &
Technical Affairs. "Nevertheless, we are pleased to see
that his analysis clearly shows that AHPA members, as responsible
companies in the herb industry, are manufacturing their products
in a manner that assures consumers that these products are
accurately labeled."
A close
reading of the entire study reveals that certain of the characterizations
in Gurley�s publication are, at best, confusing and in need
of clarification.
- Gurley
noted that five products contained (+)-norpseudoephedrine
(NPSE), a naturally occurring ephedrine group alkaloid found
in most of the Asian species of ephedra. His presentation
of this information implied that some flaw in the regulation
of supplements exempts ephedra products from the restrictions
associated with drug scheduling. It is true that NPSE, in
its purified form and under conditions specified in the
regulations of the Drug Enforcement Administration (DEA),
may be a Schedule IV controlled substance, subject to certain
restrictions on use, sale and possession. However, DEA,
while aware that ephedra may contain very small amounts
of NPSE, has explicitly stated that ephedra products are
not subject to scheduling, or even less restrictive "listing"
requirements under the Controlled Substances Act. In summary,
neither botanical ephedra nor crude extracts of ephedra
have been the subject of any scheduling restrictions, and
are therefore perfectly legal for use and sale.
- One
of the most sensational of Gurley�s conclusions was his
emphasis on what he described as "the dramatic variance
in alkaloid content" between different lots of the
same product. Ten products were tested for lot-to-lot variability.
The article stated that six of these "showed virtually
no difference in alkaloid content between lots." An
examination of the other four cases, however, shows that
the noted variations are based on comparisons in specific
alkaloids, even though these were not identified on any
of the products� labels. A review of the test data compared
to the actual statements made on labels shows that only
one product had a variation of more than 10% from one lot
to the next.
The American
Herbal Products Association was founded in 1983 by a group
of companies active in the trade in botanicals. AHPA is now
the national trade association and voice of the herbal products
industry, comprised of domestic and foreign companies doing
business as importers, growers, processors, manufacturers,
marketers, and distributors of herbs and herbal products.
AHPA serves its members by promoting the responsible commerce
of products that contain herbs and that are used to enhance
health and quality of life.
For more
information, contact Moira Saucer, AHPA, (301) 588-1171, ex.
107
(1)
AHPA revised its trade recommendation for ephedra products
in January, 2000 to require that alkaloids be quantified on
product labels. There was no industry or regulatory requirement
for such information prior to this.
(2)
Gurley
reports that all of his products were purchased in 1998 and
1999. Gurley informed AHPA staff that he believes his margin
of error to be �5%. While this may be overly optimistic, an
adjustment for this error would further limit the tested range
of these nine samples to 88 - 104% of label claim.
(3) One product contained 10.4
mg of total ephedra alkaloids of which 2.5 mg was specifically
ephedrine. The label stated that it contained 10.0 mg ephedrine,
and so was reported by Gurley to deliver only 25% of claim.
There is, however, standard accepted terminology for results
of analytical methods that do not separate the individual
alkaloids but rather measure the total of all of the contained
compounds. Such results are acceptably recorded as "Total
alkaloids stated as ephedrine." For purposes of this review,
it was assumed that this nomenclatural disagreement was not
relevant, and that sample is here reported as 104% of label
claim.
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