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current as of August 27, 2008.Online article and related content http://jama.ama-assn.org/cgi/content/full/300/8/915. 2008;300(8):915-923 (doi:10.1001/jama.300.8.915)
JAMA
Robert B. Saper; Russell S. Phillips; Anusha Sehgal; et al.
 
InternetIndian-Manufactured Ayurvedic Medicines Sold via theLead, Mercury, and Arsenic in US- and
 
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Alternative Medicine; Drug Therapy; Adverse EffectsInternet in Medicine; Internet; Neurology; Neurotoxicology; Complementary andDrug Therapy, Other; Quality of Care; Patient Safety/ Medical Error; Informatics/ 
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ORIGINAL CONTRIBUTION
Lead, Mercury, and Arsenicin US- and Indian-ManufacturedAyurvedic Medicines Sold via the Internet
Robert B. Saper, MD, MPHRussell S. Phillips, MD Anusha Sehgal, MD(Ayurveda)Nadia Khouri, MPHRoger B. Davis, ScDJanet Paquin, PhDVenkatesh Thuppil, PhDStefanos N. Kales, MD, MPH
A
YURVEDA IS A TRADITIONAL
medicalsystemusedbyama- jority of India’s 1.1 billionpopulation.
1
AyurvedaisalsousedworldwidebytheSouthAsiandi-aspora and others.
1
However, since1978 more than 80 cases of lead poi-soningassociatedwithAyurvedicmedi-cine use have been reported world-wide.
2,3
Ayurvedic medicines aredivided into 2 major types: herbal-only and
rasa shastra
. Rasa shastra isanancientpracticeofdeliberatelycom-bining herbs with metals (eg, mer-cury, lead, iron, zinc), minerals (eg,mica),andgems(eg,pearl).
4,5
Rasashas-traexpertsclaimthatthesemedicines,if properly prepared and adminis-tered,aresafeandtherapeutic.
4,5
Of70AyurvedicmedicinesmanufacturedinSouth Asia and sold in Boston, Massa-chusetts,storesin2003,wefoundthat20%containedlead,mercury,and/orar-senic.
6
Estimated daily lead, mercury,and arsenic intakes for these productswere all higher than regulatory limits. Weidentifiedseveralrasashastramedi-cines that could cause lead and mer-curyingestionsexceedingUSEnviron-mentalProtectionAgency(EPA)limitsby 3 to 4 orders of magnitude. SimilarresultshavebeenfoundinotherNorthAmerican cities.
7-10
Author Affiliations
are listed at the end of thisarticle.
Corresponding Author:
Robert B. Saper, MD, MPH,Department of Family Medicine, Boston MedicalCenter, One Boston Medical Center Place, Dowling5 S, Boston, MA 02118-2317 (robert.saper@bmc.org).
Context
Lead, mercury, and arsenic have been detected in a substantial proportionof Indian-manufactured traditional Ayurvedic medicines. Metals may be present dueto the practice of
rasa shastra
(combining herbs with metals, minerals, and gems).WhethertoxicmetalsarepresentinbothUS-andIndian-manufacturedAyurvedicmedi-cines is unknown.
Objectives
To determine the prevalence of Ayurvedic medicines available via theInternet containing detectable lead, mercury, or arsenic and to compare the preva-lenceoftoxicmetalsinUS-vsIndian-manufacturedmedicinesandbetweenrasashas-tra and non–rasa shastra medicines.
Design
Asearchusing5Internetsearchenginesandthesearchterms
Ayurveda
and
Ayurvedic medicine
identified 25 Web sites offering traditional Ayurvedic herbs, for-mulas, or ingredients commonly used in Ayurveda, indicated for oral use, and avail-able for sale. From 673 identified products, 230 Ayurvedic medicines were randomlyselected for purchase in August-October 2005. Country of manufacturer/Web sitesupplier, rasa shastra status, and claims of Good Manufacturing Practices were re-corded. Metal concentrations were measured using x-ray fluorescence spectroscopy.
Main Outcome Measures
Prevalence of medicines with detectable toxic metalsin the entire sample and stratified by country of manufacture and rasa shastra status.
Results
One hundred ninety-three of the 230 requested medicines were receivedand analyzed. The prevalence of metal-containing products was 20.7% (95% confi-denceinterval[CI],15.2%-27.1%).TheprevalenceofmetalsinUS-manufacturedprod-ucts was 21.7% (95% CI, 14.6%-30.4%) compared with 19.5% (95% CI, 11.3%-30.1%) in Indian products (
P
=.86). Rasa shastra compared with non–rasa shastramedicines had a greater prevalence of metals (40.6% vs 17.1%;
P
=.007) and higher median concentrations of lead (11.5 µg/g vs 7.0 µg/g;
P
=.03) and mercury (20800µg/g vs 34.5 µg/g;
P
=.04). Among the metal-containing products, 95% were soldby US Web sites and 75% claimed Good Manufacturing Practices. All metal-containingproductsexceeded1ormorestandardsforacceptabledailyintakeoftoxicmetals.
Conclusion
One-fifth of both US-manufactured and Indian-manufactured Ayur-vedic medicines purchased via the Internet contain detectable lead, mercury, or arsenic.
 JAMA. 2008;300(8):915-923
www.jama.com
©2008 American Medical Association. All rights reserved.
(Reprinted) JAMA,
August 27, 2008—Vol 300, No. 8
915
at University College London on August 27, 2008www.jama.comDownloaded from 
 
The prevalence of metals in Ayur-vedic medicines sold via the Internetand in those manufactured in theUnitedStatesisunknown.Whetherrasashastra medicines account for mostAyurvedic medicines containing met-als and whether they are manufac-turedbyUScompaniesorwidelyavail-abletoUSconsumersisalsounknown.Thus, this investigation was de-signed with 3 major objectives: (1) todetermine the prevalence of Ayur-vedicmedicinesavailableviatheInter-net containing detectable lead, mer-cury, or arsenic; (2) to compare theprevalenceoftoxicmetalsbetweenUS-andIndian-manufacturedproducts;and(3) to compare the prevalence of toxicmetalsinrasashastravsnon–rasashas-tra medicines. We also compared thedailyamountsoflead,mercury,andar-senic that would be ingested by per-sons taking these products accordingtopackagingrecommendationswithac-ceptablemetalconsumptionlimitssug-gestedbygovernment,industry,andthe World Health Organization.
METHODS
Selection of Ayurvedic Medicines
To select Internet-available Ayurvedicmedicines for analysis, a strategy usedbyMorrisandAvornwasadapted.
11
AnInternet search was conducted in No-vember-December2004using5searchengines (Google, Yahoo, AOL, MSN,and Ask Jeeves) and the key words
 Ayurveda
and
 Ayurvedicmedicine
.Websites listed on the first page of resultsfrom each search engine were re-viewedandallproductsthatmetthefol-lowinginclusioncriteriaidentified:(1)traditional Ayurvedic herbs, formu-las, or containing ingredients com-monly used in Ayurveda; (2) indi-catedfororaluse;and(3)availableforsale.The673identifiedproductswereentered in a database and a computer-generated random number sequencewasusedtoselect230productsforpur-chase.PresumingequalnumbersofUS-andIndian-manufacturedproducts,thissample size provided 90% power todemonstratea10%differenceinmetalprevalence(
=.05).Productswereor-dered online during August-October2005. Web site suppliers were not in-formed of the reason for our pur-chase.
Data Collection
 We recorded the name of each medi-cine,itsmanufacturer,andtheWebsitesupplier selling the product. Countryofmanufacturewasdefinedasthecoun-try where the product was formulated(eg, made into a capsule or tablet) andpackaged for sale. The country of the Websitesupplierwasdeterminedfromthecontactinformationprovidedonthe Web site. We also recorded formula-tion, indications, dosage(s), and cost.An Indian-trained Ayurvedic physi-cian(A.S.)classifiedmedicinesasrasashastra if they contained metals, min-erals, or gems traditionally used ac-cording to 2 classic texts.
4,5
Manufac-turers claiming Good ManufacturingPractices or metal testing were noted. We determined whether US manufac-turers were members of the AmericanHerbal Products Association (AHPA),a trade organization committed to“high-quality herbal products” and“promotion of self-regulation”
12
frommembership lists available on the as-sociation’sWebsite.ForIndianmanu-facturers, membership in the Ayurv-eda Drug Manufacturers’ Association(ADMA),committedto“standardsandquality amongst its members,”
13
wassimilarly noted. We asked US manu-facturers anonymously by telephonewhere the herbs used for their prod-ucts were grown. We presumed thatherbs used by Indian manufacturerswere grown in India. Classification of medicinesbythesecharacteristicswasdone without knowledge of the medi-cines’ metal content.Products were transferred to plasticvials (Tri-State Distribution, Sparta,Tennessee) with anonymous uniqueidentifiersandtransportedtotheNewEnglandRegionalEPAlaboratorywith-out interruption in chain of custody.FromMarchtoOctober2006,sampleswere analyzed in duplicate for lead,mercury, and arsenic concentrationsusing x-ray fluorescence spectroscopyas previously described.
6
The mini-mum lead, mercury, and arsenic con-centrations that could be detected inthe medicines with x-ray fluorescencewere 5 µg/g, 20 µg/g, and 10 µg/g, re-spectively. Analysts were blinded tothe medicines’ rasa shastra status,country of origin, and manufacturercharacteristics.Standardreferencema-terials were analyzed alongside theproductsaspositiveandnegativecon-trols.
Data Analysis
Product characteristics were summa-rizedusingdescriptivestatistics.Thera-tio of products with detectable lead,mercury, and/or arsenic to the num-ber of products analyzed defined theprevalence of metal-containing Ayur-vedicmedicinesinthesample.Ninety-five percent confidence intervals werecalculated using the exact binomialdistribution. Products were stratifiedby country of manufacture and themetal prevalences of US- and Indian-manufactured products were com-pared using the Fisher exact test. Re-ported metal concentrations are themeans of the 2 determinations. In du-plicateanalysisof4products,oneleadmeasurementwasbelowthedetectionlimit of 5 µg/g and the other was at orslightlyabovethelimit;foreachoftheseproducts the reported lead concentra-tion is the mean of the latter measure-ment and 0. Median metal concentra-tions in US- and Indian-manufacturedmetal-containing products were com-pared using the Wilcoxon rank sumtest.Similaranalysestocomparemetalprevalence and concentrations be-tween rasa shastra and non–rasa shas-tra medicines were performed. TheFisher exact test was used to comparecharacteristicsofmetal-andnon–metal-containingproductssuchasthecoun-try of manufacture and Web site sup-plier,rasashastrastatus,manufacturermembership in AHPA and ADMA,GoodManufacturingPracticesclaims,formulation,herbsource,cost,andin-dication.Allanalyseswere2-tailed,and
P
.05 was considered statisticallysignificant.
LEAD, MERCURY, AND ARSENIC IN AYURVEDIC MEDICINES
916
JAMA,
August 27, 2008—Vol 300, No. 8
(Reprinted)
©2008 American Medical Association. All rights reserved.
at University College London on August 27, 2008www.jama.comDownloaded from 
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