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ABSTRACT
Objective: The purpose of this report is to evaluate to one dollar per 1200 mg of chondroitin sulfate were found
and present the results of analysis of actual contents of sev- to be seriously deficient in meeting label claim (less than
eral products in the marketplace containing glucosamine 10% of label claim). The permeability of the different mol-
and/or chondroitin sulfate and to determine if they signifi- ecular weight chondroitin sulfates was found to be signifi-
cantly deviate from label claim. In addition, the study cantly different (p<0.05), with the permeability coefficient
examined the intestinal transport of several marketed increasing with decreasing molecular weight. This suggests
sources of chondroitin sulfate. that molecular weight of chondroitin sulfate could be a pos-
Methods: A total of fourteen products containing glu- sible predictor of permeability.
cosamine hydrochloride or sulfate and eleven products con-
taining chondroitin sulfate were evaluated using a UV- INTRODUCTION
HPLC method. In addition, a total of 32 products contain-
Dietary supplements containing glucosamine and/or
ing chondroitin sulfate were tested using a titration method.
chondroitin sulfate are numerous and popular. Since the
The permeability of various marketed sources of raw mate-
Dietary Supplement Health and Education Act (DSHEA)
rials of chondroitin sulfate across Caco-2 cell monolayers
does not demand the same rigorous requirements for quali-
were assessed. This analysis was an attempt to evaluate
ty manufacturing as pharmaceuticals, many of the dietary
whether different suppliers of chondroitin sulfate use dif-
supplements marketed may not provide high quality mater-
ferent grades of material.
ial or meet labeled quantities.
Results and conclusions: The amounts of glu-
Over the last five years there has been a significant
cosamine and chondroitin found after analysis were signif-
increase in the number of dietary supplements that have
icantly different from the label claim in some products, with
been introduced into the market. The glucosamine and chon-
deviations from label claims ranging from as low as 0% to
droitin market has been estimated to be over five hundred
over 115%. Products with a retail price of less than or equal
million in retail sales between July 1998 and May 1999.1
Unfortunately the quality of dietary supplements remains in
* Correspondence: question due to the lack of regulatory provisions that direct-
Natalie D. Eddington, PhD ly evaluate the actual content of active ingredients.2 Hence
Department of Pharmaceutical Sciences consumers have limited ways to judge the quality of the
School of Pharmacy products they are purchasing. Independent analysis on many
University of Maryland supplements, including calcium, St. Johns Wort, carnitine,
20 North Pine Street Ginkgo biloba, and super oxide dismutase, showed that
Baltimore, Maryland 21201-1180 many marketed brands contained subpotent content, includ-
Phone: 410-706-6710 Fax: 410-706-6580 ing some with zero active ingredients.3,4
Email: neddingt@rx.umaryland.edu
Figure 3. Relationship between products label claim and their standard retail price (SP)
claims of dietary supplements and actual content found in Our initial hypothesis was that the quality of product
the product. Eleven chondroitin sulfate containing products, may be a function of retail price. In a separate analysis of
some also containing glucosamine, were analyzed for con- the data contained in Figure 3, the supplement retail pur-
tent with a validated HPLC method. The results of the label chased prices, not including any consumer rebates, were
claim testing are presented in Figure 2. The percentage transformed to reflect a standard retail price (SP) per daily
label claims ranged from as low as 33% to as much as dose of 1200 mg of chondroitin sulfate as reflected on the
110%. It should be noted that some products (eg, R and Y) label. The content-analyzed products and their percentages
displayed significantly large relative standard deviations. relative to each products label claim (PLC) were calculat-
This suggests that in addition to these products having per- ed. Figure 3 is a scatter plot showing that products with a
centage label claims of less than 40%, the variability in the standard retail price of less than or equal to one dollar are
amount of chondroitin sulfate found in each capsule also seriously deficient in meeting label claim (less than 10%
varies significantly. PLC). When the retail price exceeds one dollar, the figure
Figure 3 presents the percent label claim and adjusted indicates that there are two different clusters of products,
retail price of chondroitin sulfate in 32 chondroitin sulfate with the majority having less than acceptable label claim.
containing products purchased from pharmacies and health Only a few products (5 out of 32) satisfied the industry
food stores during the period of September 1998 through accepted 10% variation in label claim in levels of chon-
November 1999 and analyzed by the titration method. A droitin sulfate. Variation greater than 10% suggests poor
few of these products were labeled to contain chondroitin quality of raw material or poor manufacturing processes
sulfate alone but the majority was combined with glu- and lack of quality control.
cosamine. Twenty-six out of 32 products were found to con- The results of these studies demonstrate that in some
tain less than 90% of the chondroitin sulfate stated on the instances the amount of the chondroitin sulfate or glu-
label with 17 products containing less than 40% of label cosamine found to be present in the sample product varies
claim. Only five out of 32 products contained the labeled significantly from the amount reported on the label. The
amount of chondroitin sulfate in the product. This would greatest inconsistencies were obtained in products contain-
suggest that in many cases, 84% of brands that were tested ing chondroitin sulfate, especially when the daily 1200 mg
are inferior products. dose price was less than one dollar. The implications of
these results are significant and support the need for regu-