AyurvedicJama20041512.1103533481

ORIGINAL CONTRIBUTION

Heavy Metal Content ofAyurvedic Herbal Medicine ProductsRobert B. Saper, MD, MPHStefanos N. Kales, MD, MPHJanet Paquin, PhDMichael J. Burns, MDDavid M. Eisenberg, MDRoger B. Davis, ScDRussell S. Phillips, MD

AYURVEDIC MEDICINE ORIGI-nated in Indiamore than2000years ago and relies heavily onherbal medicine products(HMPs).1 Approximately 80% of In-dias 1 billion population uses Ayurv-eda through more than one-half mil-lionAyurvedic practitionersworking in2860 Ayurvedic hospitals and 22100clinics.2 Ayurvedas popularity inWest-ern countries has increased.3 In theUnited States, Ayurvedic remedies arenow available from South Asian mar-kets,Ayurvedicpractitioners,health foodstores, and the Internet. Because Ayur-vedic HMPs are marketed as dietarysupplements, they are regulated underthe Dietary Supplement Health andEducationAct (DSHEA),whichdoesnotrequire proof of safety or efficacy.4

Herbs, minerals, and metals areused in Ayurvedic HMPs.2 Lead toxic-ity has been associated with use ofAyurvedic HMPs, including statusepilepticus,5 fatal infant encephalopa-thy,6 congenital paralysis and sensori-neural deafness,7 and developmentaldelay.8 Since 1978, at least 55 cases ofheavy metal intoxication associatedwith Ayurvedic HMPs in adults andchildren have been reported in theUnited States and abroad.5-17

Although Ko18 raised concern aboutheavy metals in traditional Chinese

medicines (Richard Ko, PharmD, PhD,written communication, 2004) avail-able in California, no studies have spe-

cifically measured heavy metals inAyurvedic (traditional Indian) HMPssold in the United States. We deter-

Author Affiliations: Division for Research and Edu-cation in Complementary and Integrative MedicalTherapies, Osher Institute, Harvard Medical School,Boston (Drs Saper, Eisenberg, Phillips, and Davis);Division of General Medicine and Primary Care,Department of Medicine (Drs Saper, Eisenberg,Phillips, and Davis), and Division of Toxicology,Department of Emergency Medicine (Dr Burns), BethIsrael Deaconess Medical Center, Boston; The Cam-bridge Hospital, Harvard Medical School, Cambridge(Dr Kales); Occupational Health Program, Depart-ment of Environmental Health, Harvard School ofPublic Health, Boston (Dr Kales); and New EnglandRegional Laboratory, Environmental ProtectionAgency, North Chelmsford (Dr Paquin), Mass. DrSaper is now with the Department of Family

Medicine, Boston University School of Medicine,Boston, Mass.Financial Disclosure:Dr Eisenberg has received hono-raria for educational lectures relating to the epidemi-ology of complementary therapy use, ongoing re-search in this area at Harvard Medical School, andnational trends in complementary medicine researchbut has neither spoken on the topic of Ayurveda orthe efficacy, safety, or toxicity of Ayurveda, or re-ceived grant support (federal or private) for investi-gations of Ayurvedic products.Corresponding Author: Robert B. Saper, MD, MPH,Department of Family Medicine, Boston UniversitySchool ofMedicine,One BostonMedical Center Place,Dowling 5 S, Boston, MA 02118-2317 ([email protected]).

Context Lead, mercury, and arsenic intoxication have been associated with the useof Ayurvedic herbal medicine product (HMPs).

Objectives To determine the prevalence and concentration of heavymetals in Ayur-vedic HMPs manufactured in South Asia and sold in Boston-area stores and to com-pare estimated daily metal ingestion with regulatory standards.

Design and Setting Systematic search strategy to identify all stores 20 miles or lessfrom Boston City Hall that sold Ayurvedic HMPs from South Asia by searching onlineYellow Pages using the categoriesmarkets, supermarkets, and convenience stores, andbusiness names containing the word India, Indian cities, and Indian words. An onlinenational directory of Indian grocery stores, a South Asian community business direc-tory, and a newspaper were also searched. We visited each store and purchased allunique Ayurvedic HMPs between April 25 and October 24, 2003.

Main OutcomeMeasures Concentrations (g/g) of lead, mercury, and arsenic ineach HMP as measured by x-ray fluorescence spectroscopy. Estimates of daily metalingestion for adults and children estimated using manufacturers dosage recommen-dationswith comparisons toUS Pharmacopeia andUS Environmental Protection Agencyregulatory standards.

Results A total of 14 (20%) of 70 HMPs (95% confidence interval, 11%-31%) con-tained heavy metals: lead (n=13; median concentration, 40 g/g; range, 5-37000),mercury (n=6; median concentration, 20225 g/g; range, 28-104000), and/or ar-senic (n=6; median concentration, 430 g/g; range, 37-8130). If taken as recom-mended by the manufacturers, each of these 14 could result in heavy metal intakesabove published regulatory standards.

Conclusions One of 5 Ayurvedic HMPs produced in South Asia and available in Bos-ton South Asian grocery stores contains potentially harmful levels of lead, mercury,and/or arsenic. Users of Ayurvedic medicine may be at risk for heavy metal toxicity,and testing of Ayurvedic HMPs for toxic heavy metals should be mandatory.JAMA. 2004;292:2868-2873 www.jama.com

2868 JAMA, December 15, 2004Vol 292, No. 23 (Reprinted) 2004 American Medical Association. All rights reserved.

mined the heavy metal content in asample of Ayurvedic HMPs sold in Bos-ton-area retail stores. We also esti-mateddaily heavymetal intakes for eachHMP and compared these with maxi-mum allowable regulatory standards.

METHODSCollection of Ayurvedic HMPs

We identified Boston-area stores sell-ing Ayurvedic HMPs manufactured inSouth Asia by searching online YellowPages19 using the categoriesmarkets, su-permarkets, and convenience stores, andbusiness names containing the wordIndia, Indian cities, and Indian words;and an online national directory of In-dian grocery stores,20 a South Asiancommunity business directory,21 and anewspaper.22

Between April 25 and October 24,2003,we visited all identified stores thatwere 20 miles or less from Boston CityHall asmeasuredbyMicrosoft Streets andTrips 2002 (Microsoft Corp, Redmond,Wash). In each store, we purchased 1package of eachHMP available thatmetthe following inclusion criteria: Ayur-vedic herbal remedy, manufactured inSouth Asia, and intended for oral use.Whenmore than1 store carried the sameHMP (ie, identical name, manufac-turer, and formulation), the HMP waspurchased from 1 store only. If 2 HMPshad the samenamebutweremadebydif-ferentmanufacturersorhaddifferent for-mulations (eg, powder and tablets), theseHMPswere considered tobedifferent forthepurposesofour studyandwere there-fore both purchased. The name, manu-facturer, manufacturers location, lotnumber, formulation, indications, rec-ommended dosages, and cost per pack-age were recorded for all HMPs pur-chased. Non-English labels wereprofessionally translated. Because thisstudy did not involve human partici-pants, the Harvard Medical Schools in-stitutional reviewboarddetermined thatits approval was not required.

Data Collection

All HMPs were transferred to plasticpharmacy-grade vials (Tri-StateDistri-bution, Sparta, Tenn) and labeledwith

a numerical identifier only. Vials weresent without interruption in chain ofcustody to the New England RegionalEnvironmental Protection Agency(EPA) laboratory for analysis. Labora-torypersonnelwereblinded to the iden-tity of the HMPs. Solid HMPs wereweighed and homogenized thor-oughly to reduce the risk of matrixinterference from particle size differ-ences. To determine themetal concen-tration of the HMP, samples were ana-lyzed once by x-ray fluorescencespectroscopy23 using the SpectroX-Laboratory 2000XRF equippedwitha tungsten x-ray tube, a Si(Li)-semiconductor detector, and softwareversion 2.2R03 I (Spectro AnalyticalInstruments,Kleve,Germany).NationalInstitute of Standards and Technologysolid standard reference materials(SRMs) 2709, 2710, 2711,24 and liquidcertified standards (SCPScience,Cham-plain, NY) containing specified heavymetal concentrations served as posi-tive andnegative controls.We reportedmetal concentrations in g/g. Theinstruments minimum detection lim-its were lead 5 g/g, mercury 20 g/g,arsenic 10 g/g, and cadmium 10 g/g.To assess reproducibility, we re-

turned to the grocery stores from No-vember 17 to 26, 2003, and attemptedto repurchase 1 package of each HMPfound on initial testing to contain lead,mercury, arsenic, and/or cadmium.Wealso used a computerized randomnum-ber generator to select 14 HMPs for re-purchase among all HMPs found on ini-tial testing to have no detectable heavymetals. One package of each of the 14negative HMPs was repurchased. Posi-tive and negative HMPs were repur-chased irrespective of their lot num-bers. Each repurchased HMP receiveda new numerical identifier and wassimilarly transferred to vials, whichwere sent to the EPA. At the labora-tory, eachHMPwas split into 2 samplesand each sample was assayed twicealongside SRM controls.

Data Analysis

We calculated the proportion of HMPscontaining heavy metals. The coeffi-

cient of variation for themetal concen-trations was calculated using data fromthe split-sample duplicate assays. If anHMP contained lead, we used the leadconcentration (measured in the origi-nal set of HMPs purchased), unit doseweight, and recommended dosages tocalculate the amount of lead that wouldbe ingested daily. If there was a rangeof suggested dosages, the daily inges-tionwas presented as a range. For lead,we compared the daily ingestion for anadult with theUS Pharmacopeia (USP)specifications for themaximum allow-able lead content (4.5 g) in a 1500-mgdaily dose of calcium carbonate.25 Forchildren, we compared our estimatedranges with the USP specifications forthe maximum allowable lead content(1 g) in a 2.5-mL daily dose of fer-rous sulfate suspension (assumes 2-mgelemental iron per kg/d for a 10-kg childtaking a 0.8-g elemental iron per100-mL suspension).25,26 For HMPscontaining mercury, arsenic, or both,we similarly calculated the amount ofmercury, arsenic, or both that would beingested daily. We compared esti-mated ranges of mercury and arsenicintakes with their respective EPA es-tablished reference doses (RfDs) for oralchronic exposure (0.3 g/kg per day forboth mercuric chloride and arsenic).27

RESULTSGeneral Characteristicsof Ayurvedic HMPs

Using our search strategy, we pur-chased 70 unique Ayurvedic HMPs,manufactured by 27 companies (26based in India and 1 in Pakistan) in 30Boston-area stores. The HMPs carriedawide variety of indications,most com-monly gastrointestinal (71%). Theme-dian cost per packagewas $2.99 (range,$0.50-$5.99).

Heavy Metal Analyses

A total of 14 (20%) of 70 HMPs (95%confidence interval, 11%-31%) con-tained lead, mercury, and/or arsenic(TABLE 1). TABLE 2 lists the 14 prod-ucts containing heavy metals, theirmanufacturers, and their heavy metalconcentrations. Seven HMPs specifi-

HEAVY METAL CONTENT OF AYURVEDIC HERBAL MEDICINE

2004 American Medical Association. All rights reserved. (Reprinted) JAMA, December 15, 2004Vol 292, No. 23 2869

cally recommended pediatric use.Twenty-four of the 30 stores sold at least1 heavy metalcontaining HMP.

Estimates of Daily Heavy MetalIngestion Compared WithRegulatory Standards

Each estimate is based on daily inges-tion of the manufacturers recom-mended dose. The FIGURE displays theestimated daily lead, mercury, and ar-senic ingestion for heavy metalcontaining HMPs recommended foradults and children. All 10 HMPs con-taining lead and recommended foradults could result in ingestions higherthan the comparableUSP standard. SixHMPswere orders ofmagnitude higher.

The estimated daily lead ingestion foreach of the 6 lead-containingHMPs rec-ommended for children could result iningestions of equal to or above theUSPstandard.Similar comparisons were made for

arsenic and mercury. All 4 mercury-containing HMPs intended for adultscould result in estimated daily mer-cury intakes of at least 1 order of mag-nitude higher than the EPA referencedose for a 70-kg adult. Two of 3mercury-containing HMPs recom-mended for children have estimatedranges of daily mercury intake of 2 to3 orders of magnitude higher than theEPA reference dose for a 10-kg child.Four of 5 arsenic-containing HMPs

recommended for adults would resultin daily intakes of 1 to 3 orders ofmagnitude higher than the EPA refer-ence dose. Chronic ingestion of the 3arsenic-containing HMPs intended forchildren would also result in dailyintakes of more than the referencedose.

Duplicate HMP and SRM Testing

We were able to repurchase 10 of the14 positive HMPs for split-sample re-testing. For the HMPs unavailable forrepurchase, we performed split-sample retesting using the originalHMPs. All 10 repurchased HMPs hadheavy metal concentrations similar tothe original samples: lead, average of

Table 1. Heavy Metal Concentrations in Ayurvedic Herbal Medicine Products (N= 70)*

MetalAny

Metal*Lead Mercury Arsenic Tin Silver Gold Cadmium

No. of HMPs withdetectable levels ofthe metal (% of totalNo. of HMPs)

13 (19) 6 (9) 6 (9) 5 (7) 4 (6) 3 (4) 0 14 (20)

Median concentrationamong those HMPswith detectablelevels of the metal(IQR), g/g

40 (8-300) 20 225 (4380-72 100) 430 (54-2800) 22 800 (3940-23 500) 14 310 (2475-26 575) NA

Range, g/g 5-37 000 28-104 000 37-8130 150-26 400 230-29 250 NAAbbreviations: HMPs, herbal medicine products; IQR, interquartile range; NA, not applicable.*A total of 14 (20%) of 70 HMPs (95% confidence interval, 11%-31%) contained lead, mercury, and/or arsenic.Presence of gold detected qualitatively only.

Table 2. Ayurvedic Herbal Medicine Products Containing Lead, Mercury, and/or Arsenic*

Ayurvedic HMP Manufacturer Formulation% Stores

Selling HMP

Metal, g/g

Lead Mercury Arsenic

Bal Chamcha Jalaram Powder 3.3 10 ND ND

Bala Guti Zandu Tablet 3.3 5 ND ND

Bala Sogathi Navjeevan Powder 3.3 43 28 ND

Balguti Kesaria Kesari Ayurvedic Pharmacy Tablet 3.3 7 17 600 37

Gesari Harinarayan Pharmacy Tablet 3.3 7 ND ND

Karela Himalaya Capsule 6.7 7 ND ND

Maha Sudarshan Churna Dabur Powder 3.3 17 ND ND

Maha Sudarshan Churna Zandu Tablet 6.7 40 ND ND

Mahalakshmi Vilas Ras with gold Baidyanath Tablet 3.3 300 72 100 2800

Mahayograj Guggulu with silver and Makardhwaj Baidyanath Tablet 3.3 37 000 22 800 8100

Navratna Rasa Unjha Ayurvedic Pharmacy Tablet 3.3 600 104 000 60

Safi Hamdard Pakistan Liquid 70.0 ND ND 54

Shilajit Syncom Capsule 6.7 8 ND ND

Swarna Mahayograj Guggulu with gold Baidyanath Tablet 3.3 7870 4380 800Abbreviations: HMPs, herbal medicine products; ND, not detected (heavy metal assay reporting levels: lead 5 g/g, mercury 20 g/g, and arsenic 10 g/g).*A list of HMPs without detectable heavy metals is available from the authors.Label specifically recommended pediatric use.Concentration of metals in aqueous liquid herbal medicine products expressed as g/mL.



112% of original concentrations; mer-cury, average of 118% of original con-centrations; and arsenic, average of112% of original concentrations. Themean coefficients of variation for lead,mercury, and arsenic concentrations inthe split-sample retesting were 0.05,0.03, and 0.05, respectively. This

amount of variability is not significantenough to lower the estimated dailyamounts of metal ingestions from theHMPsbelowacceptable regulatory stan-dards. The 14 negative HMPs ran-domly selected for repurchase did notcontain any heavy metals on retesting.Measurements of heavymetals in solid

SRMs and certified liquid standards(data not shown, available on request)were on average less than 8% differentthan their certified concentrations (lead+4.8%, mercury +7.8%, and arsenic7.3%), consistent with the confi-dence limits of the standards and ourinstrumentation.

Figure. Estimated Daily Lead, Mercury, and Arsenic Ingestion for Heavy MetalContaining HMPs Recommended for Adults and Children

HMPs Containing Lead andRecommended for Adults

LeadAdults Children

1 10 103 104 105102

1 10 103 104 105102 1 10 103 104 105102

1 10 103 104 105102

Estimated Daily Lead Ingestion, g/d

Bala Guti

Gesari

Karela

Shilajit (Syncom)Maha Sudarshan Churna (Zandu)Maha Sudarshan Churna (Dabur)Mahalakshmi Vilas Ras With Gold

Navratna Rasa

Swarna Mahayograj Guggulu With Gold

Mahayograj Guggulu With Silverand Makardhwaj

USPStandard

HMPs Containing Lead andRecommended for Children

0.1 1 10210Estimated Daily Lead Ingestion, g/d

Bala Guti

Bal Chamcha

Gesari

Bala Sogathi

Balguti Kesaria

Navratna Rasa

USPStandard

HMPs Containing Mercury andRecommended for Adults



Mahalakshmi Vilas Ras With Gold

Navratna Rasa

EPAReference

DoseHMPs Containing Mercury and

Recommended for Children

Bala Sogathi

Balguti Kesaria

Navratna Rasa

EPAReference

Dose||

Estimated Daily Mercury Ingestion, g/d Estimated Daily Mercury Ingestion, g/d

Mercury

HMPs Containing Arsenic andRecommended for Adults

Navratna Rasa

Safi


Mahalakshmi Vilas Ras With Gold


EPAReference

Dose HMPs Containing Arsenic andRecommended for Children

1 10 102

Estimated Daily Arsenic Ingestion, g/d

Balguti Kesaria

Navratna Rasa

Safi

EPAReference

Dose||

Estimated Daily Arsenic Ingestion, g/d

Arsenic

The estimated daily lead, mercury, or arsenic ingestion levels were estimated using a single measure of lead, mercury, or arsenic concentration in the originally pur-chased herbal medicine products (HMPs), the unit dose weight, and recommended dosages stated on the label. If the manufacturer recommended a range of sug-gested dosages, a range of potential daily lead, mercury, or arsenic ingestion is displayed.*For adults, US Pharmacopeia (USP) maximum allowable lead content (4.5 g) for a daily dose of 1500 mg of calcium carbonate25; and for children, USP maximumallowable lead content (1 g) allowed in a daily dose of ferrous sulfate suspension (0.8-g elemental iron per 100 mL) administered to a 10-kg child at 2-mg elementaliron per kg/d.25,26

Name of manufacturer is given in parentheses.Estimated intake based on an assumption of 0.1 to 0.2 g of Bal Chamcha used per dose.US Environmental Protection Agency (EPA) reference dose for chronic (365 days) oral intake of mercuric chloride or arsenic for a 70-kg adult (21 g).27

EPA reference dose for chronic (365 days) oral intake of mercuric chloride or arsenic for a 10-kg child (3 g).27



COMMENTAyurvedicHMPs containing heavymet-als are readily available in most of theSouth Asian grocery stores in Boston,recommended for adults and chil-dren, and relatively inexpensive. Oneof 5 available Ayurvedic HMPs con-tained lead, mercury, and/or arsenic.Taken as recommended, each of the 14heavymetalcontainingHMPswe iden-tified may result in heavy metal intakeabove regulatory standards.Our data are consistent with studies

of Ayurvedic HMPs sold outside theUnited States and herbal remedies fromother indigenous healing traditions. InEngland, 30% of Ayurvedic HMPssampled contained lead,mercury, or ar-senic.17 Of 22 Ayurvedic HMPs pur-chased in India, 64%contained lead andmercury, and 41% contained arsenic.16

Traditionalmedicines fromChina,18Ma-laysia,28 Mexico,29 Africa,30 and theMiddle East31 have also been shown tocontain heavy metals.Two lines of evidence suggest our

sample of HMPs has unacceptably highheavy metal content. First, metal con-centrations in our specimens correlatewith concentrations associatedwithbothtoxic blood concentrations and symp-tomatic poisoning in previously re-ported cases.The lead concentrationsweobserved overlapped with those associ-atedwith toxicity in a recentUS case se-ries (range, 21-96000 g/g)5 and in pa-tients from Croatia (range, 0.90-72990g/g).15 SpecificHMPs containing heavymetals in our sample (eg, MahayograjGuggulu) have been associatedwith se-rious toxicity in case reports.5,9 Arsenicpoisoning was described in 47 childrenand adults in Singapore using a Chi-neseHMPwith 12000 g/g of arsenic.32

Second, epidemiological evidence of in-sidious adverse effects (eg, decreasedchildhood IQ,33 increased blood pres-sure,34 progression of chronic renal in-sufficiency35) from low levels of lead ex-posure previously thought to beacceptable suggests that evenHMPswithrelatively lower levels of lead (100g/g) may be deleterious.Ayurvedic theory attributes impor-

tant therapeutic roles tometals such as

mercury and lead.2,36 Ayurveda ex-perts estimate that 35% to 40% of theapproximately 6000 medicines in theAyurvedic formulary intentionally con-tain at least 1 metal.2 Metal-contain-ing HMPs are purportedly detoxi-fied through multiple heating/cooling cycles and the addition ofspecific herbs.36 Whether the heavymetals in our samplewere already pres-ent in raw plant materials37 or inten-tionally or incidentally added in themanufacturing process is uncertain.Our study has several limitations.

First, increased concentrations of leadof more than 5000 g/g or of mercuryof more than 15000 g/g could theo-retically produce spectral interferenceand falsely increase the results for othermetals. To assess this,we tested samplesofmetal salts at high concentrations andfound negligible spectral interferencewith other metals of interest. We alsoanalyzed diluted HMP samples andfound similar results to the originaldata. In addition, the spectra of non-target elements present in the HMPs(eg, sulfur, calcium, iron, copper) werefound not to interfere with the spectraof lead,mercury, or arsenic. Second,wewere not able to ascertain the metalschemical forms, which can impact bio-availability and toxicity, especially inthe case of mercury.38 Finally, our datawere limited to 70 Ayurvedic HMPsmanufactured in South Asia and foundin Boston-area stores. Whether thesefindings can be generalized to thoseHMPs sold elsewhere in the UnitedStates requires further study.Despite these limitations, the pres-

ence of heavy metals in AyurvedicHMPs and the numerous reports of as-sociated toxicity may have importantpublic health, clinical, and policy im-plications in the United States andabroad. Although the prevalence ofheavy metalcontaining AyurvedicHMP use is unknown, the number ofindividuals at potential risk is substan-tial. Recent analysis of the US Na-tionalHealth Interview Survey 2002Al-ternative Medicine Supplementestimates 750000 adults consulted anAyurvedic practitioner in the past.39 In

India, an estimated 80% of the popu-lation uses Ayurveda.2 Epidemiologi-cal studies of Ayurvedic HMP use andheavymetal toxicity in theUnited Statesand abroad are therefore warranted.Public health and community organi-zations should consider issuing advi-sories to current or previous Ayur-vedic HMP users, encouraging them toconsult their physicians about heavymetal screening. Use of specific heavymetalcontaining HMPs in our studyshould be discouraged. Physiciansshould also consider Ayurvedic HMPintake in the differential diagnosis ofunexplained heavymetal toxicity. Cur-rent US law stipulates that regulationsgoverning dietary supplements pro-duced and sold domestically (DSHEA)should also be applied to dietary supple-ments imported into theUnited States.40

Our findings support calls for reformof DSHEA that would require manda-tory testing of all imported dietarysupplements for toxic heavy metals.

Author Contributions: Dr Saper had full access to allof the data in the study and takes responsibility forthe integrity of the data and the accuracy of the dataanalysis.Study concept and design: Saper, Kales, Burns,Eisenberg, Davis, Phillips.Acquisition of data: Saper, Paquin.Analysis and interpretation of data: Saper, Kales, Burns,Eisenberg, Davis.Drafting of the manuscript: Saper, Kales, Burns.Critical revision of the manuscript for important in-tellectual content: Saper, Kales, Paquin, Burns,Eisenberg, Davis, Phillips.Statistical analysis: Saper, Davis.Obtained funding: Saper, Eisenberg, Phillips.Administrative, technical, or material support: Saper,Kales, Paquin.Study supervision: Saper, Burns, Eisenberg, Phillips.Funding/Support: Dr Saper was supported by an In-stitutional National Research Service Award for train-ing in Alternative Medicine Research (T32 AT00051)from the National Center for Complementary and Al-ternative Medicine (NCCAM), National Institutes ofHealth, Bethesda, Md. Dr Phillips is supported by aMid-Career Investigator Award (K24 AT00589) fromNCCAM. Herbal products were purchased with fundsfrom the Division for Research and Education inComplementary and IntegrativeMedical Therapies ofHarvard Medical School.Role of the Sponsor: Harvard Medical School had norole in the design and conduct of the study; collec-tion, management, analysis, and interpretation of thedata; or preparation, review, or approval of themanu-script for submission.Disclaimer: The content of this article is solely the re-sponsibility of the authors and does not necessarily rep-resent the official views of the NCCAM, the NationalInstitutes of Health, or the US Environmental Protec-tion Agency.Acknowledgment: We gratefully thank Mary BethHamel,MD,MPH, andMichael Shannon,MD, for theirreview of an earlier version of the manuscript; David



Solondz, BSE, for assistance with sample collection;Brian Ambrefe, RPh, CDE, for donation of sample vi-als; Naseem Hines, PhD, for label translation; AnushaSeghal, BAMS, for helpful discussions regarding Ayur-veda; and Nadia Khouri for editing.

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