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Ephedra-containing Supplements Produced by Members Of Leading Trade Association Test Well in New Study

Washington, DC (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 valueÖ 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
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(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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