Health Remedies as a Source of Lead, Mercury, and Arsenic Exposure, New York City, 2010–2019

Abstract

Objectives. To describe the types of health remedies collected during poisoning investigations in New York City over a 10-year period that were found to contain high levels of lead, mercury, or arsenic.

Methods. Between 2010 and 2019, the New York City Department of Health and Mental Hygiene collected 584 samples of health remedies during poisoning investigations and store surveys for lead, mercury, or arsenic analysis.

Results. There was a significant association between blood lead levels and estimated cumulative daily lead exposures among adult users of rasa shastra Ayurvedic medications. Also, average blood lead levels among adult rasa shastra users were significantly higher than levels among those using other types of non-Ayurvedic health remedies.

Conclusions. Rasa shastra Ayurvedic medications can contain very high levels of lead, mercury, and arsenic. This underscores the importance of screening for lead, mercury, and arsenic exposures within at-risk populations.

Public Health Implications. The general ease of accessibility to rasa shastra medications raises concerns. There is a need for systemic change that results in primary prevention, that is, removal of the source through policy development and regulatory enforcement in the country of origin. (Am J Public Health. 2022;112(S7):S730–S740. https://doi.org/10.2105/AJPH.2022.306906)

Lead poisoning continues to be a public health concern in New York City.¹ Although most New York City children and adults have blood lead levels much lower than the Centers for Disease Control and Prevention’s reference level of 5 micrograms per deciliter (µg/dL), in 2019 more than 3500 children and almost 2000 adults had elevated blood lead levels.^2,3 Lead exposure can result in a host of detrimental health effects across all age groups, including developmental and behavioral problems in children; increased risk of miscarriage during pregnancy; and cardiovascular, kidney, neurological, and reproductive health problems among adults.^4–9 Prevention is key to avoiding the health consequences of lead exposure and can be achieved by identifying and removing potential sources of lead.

Elevated blood lead levels among children and adults have been associated with a variety of lead sources, including certain lead-containing consumer products.^10,11 Between 2010 and 2019, the New York City Department of Health and Mental Hygiene (DOHMH) collected more than 4500 samples of consumer products during routine investigations of lead poisoning cases and surveys of local stores. Of these products, about 13% were health remedies, the second most frequently sampled types of products after food and spices (59%). Other types of frequently sampled consumer products included toys (11%), cosmetics and religious powders (10%), tableware (3%), and jewelry (2%). Most of the health remedies sampled were analyzed for lead, and some were also tested for mercury and arsenic.

The potential for heavy metal exposure from certain health remedies has been previously documented; however, published investigations have typically involved limited case reports or findings from product surveys.^12–14 In this article, we describe the characteristics of health remedies systematically collected as part of poisoning investigations during a 10-year period. The samples collected provide a unique glimpse into the types of health remedies used by residents of a diverse urban area and serve as examples of the types of products found to contain high levels of lead, mercury, and arsenic. We explored associations between potential exposures and blood lead levels among users of these health remedies.

METHODS

The DOHMH investigates child and adult lead poisoning cases among New York City residents to identify potential lead sources.¹⁰ As part of these investigations, the department tests consumer products for lead; health remedies are also often tested for arsenic and mercury. In this study, samples were collected during lead poisoning investigations involving children and adults or during store surveys (as described by Hore et al.¹⁰). An accredited laboratory analyzed samples for lead and arsenic using the Environmental Protection Agency (EPA) Inductively Coupled Plasma Mass Spectrometry Method SW6020 or Atomic Absorption Method SW7420 after acid digestion via EPA Method 3050. EPA Method 7470A/7471B (https://www.epa.gov/hw-sw846/sw-846-compendium) was used to analyze samples for mercury. We documented laboratory results, along with a description of each sample as reported by the family or retrieved from product packaging, electronically in a proprietary Structured Query Language Server database.

Categorization of Health Remedies

We included health remedies collected between 2010 and 2019 in the study. The remedies were grouped into 7 categories, including medications from the ancient medical systems of Ayurveda and Unani, traditional Chinese medicine, and homeopathy, as reported via cases or on the basis of product labels.

In the case of Ayurvedic medications, we incorporated a subcategory, rasa shastra—a type of Ayurvedic medication prepared with metal, mineral, or gem compounds—if (1) the medication name or a component ingredient was included in the list of herbo-mineral Ayurvedic formulations in the Ayurvedic Formulary of India (New York City Consulate General of India, e-mail communication, 2017) or (2) the medication name or a component ingredient was not included in the formulary but at least one term in its description or on the label indicated the addition of metals or minerals in the formulation. Common terms considered indicative of herbo-mineral components included bhasma, pisti, satwa (metallic or mineral ash or fine powder), shilajit (asphalt), naaga (lead), rasa, ras sindoor, kajjali, parada (mercury), hartal, and haratala (arsenic).^15–18

We categorized loose products with unknown packaging (e.g., powder, pellets, tablets, capsules, leaves, pills, or liquid) or the term “herbal” indicated on the product packaging as “traditional/herbal.” We categorized dietary supplements available over the counter as “supplements,” and conventional medicines, including prescription medicines and other conventional drugs, such as ibuprofen and acetaminophen, were tagged as “prescription.”

Statistical Analyses

Descriptive statistics for remedy types

For each health remedy type, we calculated the percentage of products containing detectable levels of lead, mercury, or arsenic. Among products with detectable levels, we calculated median and maximum concentrations. We also calculated the proportions of products exceeding various reference limits for lead, mercury, and arsenic.^19,20

Estimated daily lead, mercury, and arsenic exposures

We estimated potential daily lead, mercury, and arsenic exposures for each rasa shastra Ayurvedic medication by using the analyte concentration measured, the product-specific unit dose weight, and the dosage as reported by users or as indicated on the product packaging. When dosage or pill weight information was not available, we assumed a median unit dose weight and a median dosage of 0.3 grams and 2 pills per day, respectively, calculated according to overall rasa shastra reported usage.

Cumulative daily lead exposures and associations with blood lead levels

Concurrent use of multiple rasa shastra Ayurvedic medications is not uncommon; therefore, among adult users of rasa shastra medications, we explored associations between cumulative daily lead exposures from rasa shastra use and blood lead levels. Cumulative daily lead exposure was calculated for each user by summing the estimated daily lead exposures for the rasa shastra Ayurvedic products the individual reported using.

Comparisons of cumulative daily exposures

To evaluate differences in lead, mercury, and arsenic exposures between adults using rasa shastra medications and adults using other types of non-Ayurvedic health remedies while holding dosage constant, we calculated cumulative daily lead exposures using the analyte concentrations measured and assuming a unit dose weight of 0.3 grams and a dosage of 2 pills per day for all remedies. We also compared mean blood lead levels and median cumulative daily lead exposure estimates for adult users of Ayurvedic rasa shastra and non-Ayurvedic remedies.

Statistical tests

We used the χ² test to compare differences in proportions and the t test to compare differences in means. We used the Spearman ρ correlation and the Mann–Whitney U test to investigate associations between non–normally distributed variables and differences between groups on non–normally distributed dependent variables, respectively. We used SPSS version 28.0 (SPSS Inc., Chicago, IL) in conducting all analyses.

RESULTS

A total of 584 samples of health remedies were included in the study (Table 1). Health remedies were collected during lead poisoning investigations involving 133 children and 52 adults and during 22 store surveys. Of these remedies, 25% were classified as Ayurvedic (n = 147), with 39% of these products in the rasa shastra subcategory (n = 57); 24% of the remedies were classified as supplements (n = 142), 21% as traditional/herbal (n = 123), 14% as traditional Chinese medicine (n = 79), 12% as prescription (n = 69), 4% as homeopathic (n = 22), and only 2 as Unani.

TABLE 1—

Descriptive Statistics for Health Remedies Analyzed for Lead, Mercury, and Arsenic: New York City, 2010–2019

Remedy Type	No. of Samples (% of Total)	Lead			Mercury			Arsenic
No. of Samples Analyzed (% > Lab Reporting Limit)	Median Concentration,a ppm	Maximum Concentration, ppm	No. of Samples Analyzed (% > Lab Reporting Limit)	Median Concentration,a ppm	Maximum Concentration, ppm	No. of Samples Analyzed (% > Lab Reporting Limit)	Median Concentration,a ppm	Maximum Concentration, ppm
Ayurvedic	147 (25)	127 (78)	6.2	130 000	127 (73)	12	220 000	111 (48)	11	52 000
Rasa shastra	57 (10)	51 (96)	35	130 000	51 (98)	2445	220 000	46 (80)	21	52 000
Other	90 (15)	76 (66)	1.5	75 000	76 (57)	0.7	17 000	65 (25)	5.4	640
Homeopathic	22 (4)	22 (18)	5.2	11	7 (0)	. . . .b	ND	7 (0)	. . . .b	ND
Prescription	69 (12)	69 (6)	1.7	12	3 (0)	. . . .b	ND	3 (0)	. . . .b	ND
Supplement	142 (24)	142 (23)	0.9	13	66 (11)	0.02	0.2	67 (4)	1.1	1.4
TCM	79 (14)	79 (41)	2.8	750 000	31 (19)	0.3	200	30 (20)	2.0	3.0
Traditional/herbal	123 (21)	123 (50)	2.6	750 000	38 (34)	0.1	10	47 (32)	4.5	75
Unani	2 (0)	2 (50)	0.7	0.7	1 (100)	0.2	0.2	1 (0)	. . . .b	ND
Total	584 (100)	564 (41)	2.9	750 000	273 (44)	4.9	220 000	266 (29)	6.0	52 000

Note. ND = not detected at laboratory reporting limit; ppm = parts per million; TCM = traditional Chinese medicine.

^a In samples with detectable levels.

^b There were no samples from which to calculate the measure.

Descriptive Statistics for Health Remedy Types

Lead, mercury, and arsenic content

We analyzed most of the remedies for lead (97%; n = 564), and almost half (47% and 46%, respectively) were also analyzed for mercury (n = 273) and arsenic (n = 266; Table 1). Of the samples analyzed for lead, 41% had detectable levels, with concentrations up to 750 000 parts per million (ppm). Among the samples analyzed for mercury, 44% had detectable levels, with concentrations up to 220 000 ppm. Arsenic was detected in 29% of analyzed samples, with concentrations up to 52 000 ppm. Median concentrations across different health remedy types with detectable levels ranged from 0.7 to 35 ppm for lead, 0.02 to 2445 ppm for mercury, and 1.1 to 21 ppm for arsenic (for additional descriptive statistics, see Table A, available as a supplement to the online version of this article at http://www.ajph.org). The highest mercury and arsenic levels were measured in samples of rasa shastra Ayurvedic medications.

Although the products with the highest concentrations of lead were in the traditional Chinese medicine and traditional/herbal categories, 96% of medications in the rasa shastra Ayurvedic category had detectable lead levels, with a median lead concentration of 35 ppm. In comparison, 40% to 50% of traditional Chinese medicine and traditional/herbal remedies had detectable concentrations of lead, with median concentrations below 3 ppm.

Rasa shastra Ayurvedic medications were significantly more likely than other types of remedies to contain lead, mercury, and arsenic at levels above permissible limits (Figure 1). Of the 51 rasa shastra medications analyzed for lead, 94% exceeded 2 ppm (a permissible limit for lead in certain food additives used by the DOHMH as a guidance value), as compared with 18% across all other types of remedies (relative risk [RR] = 4.1; χ² = 147; P < .001). Similarly, 73% exceeded the 10 ppm permissible limit referenced by the World Health Organization and the Indian Ministry of Health and Family Welfare’s Ministry of Ayurveda, Yoga and Naturopathy, Unani, Siddha and Homoeopathy (AYUSH), whereas only 5% of all other types of remedies exceeded that limit (RR = 14.6; χ² = 213; P < .001).^19,20

FIGURE 1—

Lead, Mercury, and Arsenic Levels Above Permissible Limits, by Type of Health Remedy: New York City, 2010–2019

Note. ppm = parts per million; TCM = traditional Chinese medicine.

Eighty-eight percent of rasa shastra medications exceeded the AYUSH reference limit for mercury of 1 ppm, and 74% exceeded the AYUSH reference limit for arsenic of 3 ppm. These percentages are significantly higher than the 9% (RR = 8.2; χ² = 102; P < .001) and 11% (RR = 8.0; χ² = 129; P < .001) figures across all other types of remedies for mercury and arsenic, respectively. Less than one third of the products in any single category of non–rasa shastra health remedies contained mercury (0%–26%) or arsenic (0%–19%) above the respective reference limits.

Characteristics of rasa shastra Ayurvedic medications

Most of the rasa shastra Ayurvedic medications were collected during lead poisoning investigations involving pregnant and nonpregnant adults (n = 13); several were collected during lead poisoning investigations involving children (n = 3) and during store surveys (n = 4). Table 2 presents product details on the rasa shastra Ayurvedic medications (n = 27) associated with lead poisoning cases for which lead, mercury, or arsenic concentrations exceeded the AYUSH permissible limits of 10 ppm, 1 ppm, and 3 ppm, respectively.²⁰ A majority of these medications had detectable levels or exceeded permissible limits for more than 1 analyte (for additional information on rasa shastra medications from community surveys, see Table B, available as a supplement to the online version of this article at http://www.ajph.org).

TABLE 2—

Characteristics of Rasa Shastra Ayurvedic Medications With Concentrations of Lead, Mercury, or Arsenic Exceeding AYUSH Guidelines and Associated Blood Lead Levels and Estimated Daily Lead Exposures: New York City, 2010–2019

Product Name	Manufacturer	Concentration, µg/g			Estimated Daily Exposure, µg/da
Lead	Mercury	Arsenic	Lead	Mercury	Arsenic	Blood Lead Level, µg/dL	Cumulative Daily Lead Exposure, µg/db
Adult case 1								96	177 612
Vasant Kusumakar Ras With Gold & Pearl	Dabur India Ltd.	33	39 000	ND	6.6	7 800	ND
Gita Madhumehantak Vati	Gita Bhawan Ayurved Sansthan	74 000	310	24	177 600	744	58
Chandraprabah	Jaihind Pharmacy, prescriberc	17	1.0	ND	5.1	0.3	ND
Adult case 2								90	26 298
Puspadhanwa Ras	Shree Baidyanath Ayurved Bhawan Pvt. Ltd.	130 000	170 000	4.3	26 000	34 000	0.9
Shukramatrika Bati	Shree Baidyanath Ayurved Bhawan Pvt. Ltd.	16	43 000	6.0	9.6	25 800	3.6
Manmath Ras	Shree Baidyanath Ayurved Bhawan Pvt. Ltd.	480	42 000	14	288	25 200	8.4
Adult case 3: Pregnita	Ajmera Pharmaceuticals Pvt. Ltd.	12 000	NA	NA	18 480	NA	NA	64	18 480
Adult case 4								55	2 824
Vasant Kusumakar Ras with Gold and Pearl	Dabur India Ltd.	29	31 000	ND	3.6	3 875	ND
Mahashakti Rasayan	Vyas Pharmaceuticals	9 400	70 000	1 700	2 820	21 000	510
Adult case 5								52	9 929
Garbha Dharak Yog	Vyas Pharmaceuticals	110	100 000	140	44	40 000	56
Laxmana Louh	Vyas Pharmaceuticals	180	120	12	216	144	14
Ovarin	Ban Labs Ltd.	24 000	70 000	100	9 600	28 000	40
Garbha Chintamani Ras (Vrihat; Swarna Yukt)	Shree Baidyanath Ayurved Bhawan Pvt. Ltd.	120	NA	52 000	60	NA	26 000
Pigmento	Charak Pharma Pvt. Ltd.	7.3	29 000	27	8.8	34 800	32
Adult case 6: Honey Mixture	Amruth Ayurvedic Centre, prescriberc	3 200	290	ND	8320	754	ND	51	8 320
Adult case 7								51	12 363
Swarnamahayoga	Om Pharmaceuticals Ltd.	41 000	38 000	1 400	12 300	11 400	420
Chandraprabha Vati (with Shudh Shilajeet)	Maharishi Ayurveda Products Pvt. Ltd.	11	5.1	3.4	2.8	1.3	0.9
Zulcer Capsules	Gufic Biosciences Ltd.	50	0.6	2.4	60	0.8	2.9
Adult case 8: Garbhapal Ras	NAc	22 000	19 000	410	8 800	7 600	164	49	8 800
Adult case 9: Ovarin	Ban Labs Ltd.	12 000	18 000	1 200	9 600	14 400	960	42	9 600
Adult case 10: Garbhapal Ras	Shri Vishwamitra Ayurved Pharmaceuticals Pvt. Ltd.	15 000	4 400	81	6 000	1 760	32	24	6 040
Adult case 11: VigoRoyal	NAc	2.9	96	5.9	2.6	86	5.3	18	2.6
Adult case 12: Vatvidhwansan Ras	Shree Baidyanath Ayurved Bhawan Pvt. Ltd.	20 000	15 000	130	3 000	2 250	19.5	16	3 000
Adult case 13: Arogyawardhini Bati (Shilajit & Kutaki)	Shree Baidyanath Ayurved Bhawan Pvt. Ltd.	15	4 800	21	9.0	2 880	12.6	2	9.0
Child case 1								47	9 301
Laxmi Vilas Ras (Nardiya)	Dabur	2.4	59 000	ND	1.0	23 600	ND
Swarna Malini Vasant	Amrita Drugs	31 000	32 000	1 300	9 300	9 600	390
Child case 2: Praval Pishti	Rashtriya Ayurvedic Oushadhi Nirmanshala	17 000	1.0	ND	6 314	2.6	ND	16	6 314

Note. NA = not available; ND = not detected at laboratory reporting limit. The AYUSH (Ministry of Ayurveda, Yoga and Naturopathy, Unani, Siddha and Homoeopathy) permissible limits are 10 µg/g for lead, 1 µg/g for mercury, and 3 µg/g for arsenic. Thirteen adults and 3 children with elevated blood lead levels reported use of Ayurvedic rasa shastra products. One child was excluded from the table because analyte concentrations for the products used were below the AYUSH permissible limits. All of the products collected during case investigations, except Vatvidhwansan Ras, were purchased in India.

^a Estimated daily lead, mercury, and arsenic exposures were calculated for each rasa shastra Ayurvedic medication by using the analyte concentration measured, the reported or recommended dosage, and the measured pill weight; when dosage or pill weight information was unavailable, a dosage of 2 pills per day and a weight of 0.3 grams per pill was assumed on the basis of median data (lead, mercury, or arsenic concentration in µg/g × weight per pill in g/pill × number of pills/day). US Pharmacopeia permissible daily exposure limits are 5 µg/day for lead, 30 µg/day for mercury, and 15 µg/day for arsenic.

^b Cumulative daily lead exposures were calculated for each user by summing the estimated daily lead exposures for the rasa shastra Ayurvedic products the individual reported using. This included rasa shastra Ayurvedic medications with detectable concentrations below AYUSH permissible limits that were not included in the table.

^c Manufacturer information not available.

These rasa shastra medications had a wide variety of indications primarily related to reproductive issues, such as improving fertility, regulating the menstrual cycle, and having a healthy pregnancy, and several individuals indicated using these products to conceive a male child. Treatment of diabetes and treatment of skin problems were the next commonly reported indications. Almost all of the rasa shastra medications associated with lead poisoning cases were manufactured in India, and a majority were also purchased in India.

Estimated Daily Exposures

Estimated daily lead exposures for 80% of rasa shastra medications exceeded the US Pharmacopeia oral permissible daily exposure (PDE) limit for lead of 5 µg per day, with daily exposures as high as 177 600 µg per day.²¹ Most of the rasa sastra Ayurvedic medications also exceeded the US Food and Drug Administration (FDA) Interim Reference Level for lead of 12.5 µg per day for adults (63%) and 3 µg per day for children (82%).²² Similarly, 69% of rasa shastra medications exceeded the PDE limit of 30 µg per day for mercury, and 46% exceeded the PDE limit of 15 µg per day for arsenic.²¹ Estimated daily exposures were as high as 88 000 µg per day for mercury and 26 000 µg per day for arsenic.

Lead Exposure and Blood Lead Levels

Cumulative daily lead exposures from rasa shastra medications for adult users (n = 13) ranged from 2.6 to 177 612 µg per day (Table 2); blood lead levels ranged from 2 to 96 µg/dL. Only 2 of the users had estimated cumulative daily exposures below the FDA’s Interim Reference Level of 12.5 µg per day. There was a significant association between blood lead levels and estimated cumulative daily lead exposures among adult users of rasa shastra medications (Spearman ρ = 0.775; P = .02), but the numbers of observations were small.

Comparisons of Cumulative Daily Exposures

We compared mean blood lead levels and estimated cumulative daily exposures for lead, mercury, and arsenic among adult rasa shastra users and those who used other types of non-Ayurvedic health remedies only (Table 3). Mean blood lead levels were significantly higher among adult rasa shastra users than among users of non-Ayurvedic remedies (47 µg/dL vs 22 µg/dL; Cohen d = 1.4; t = 3.1; P = .007). The percentage of individuals with blood lead levels of 45 µg/dL or greater was also significantly higher in the rasa shastra user group (62%) than among non-Ayurvedic users (6%; RR = 10.3; χ² = 17.9; P < .001). The Mann–Whitney test indicated that cumulative median daily exposures for lead (9012 vs 0.5 µg per day; U = 28; P < .001), mercury (10 801 vs 0 µg per day; U = 19.5; P < .001), and arsenic (49 vs 0 µg per day; U = 35; P < .001) were significantly higher among users of rasa shastra Ayurvedic medications than among users of other types of non-Ayurvedic health remedies.

TABLE 3—

Mean Blood Lead Levels and Median Estimated Cumulative Daily Exposures of Lead, Mercury, and Arsenic Among Adult Users of Ayurvedic and Other Types of Non-Ayurvedic Health Remedies: New York City, 2010–2019

Users by Health Remedy Type	No.	Mean Blood Lead Level, µg/dL (95% CI)	Median Cumulative Daily Exposure, µg/d
Lead	Mercury	Arsenic
Ayurvedic—rasa shastra	13	47a (30.3, 63.5)	9 012b	10 801c	49d
Ayurvedic—other	4	21 (NA)	0.38	0.00	0.30
Non-Ayurvedic	35	22a (17.3, 26.6)	0.50b	0.00c	0.00d

Note. CI = confidence interval; NA = not applicable (the sample size of 4 was too small to determine the CI). Daily lead, mercury, and arsenic exposures were estimated for all of the health remedies by using the analyte concentrations measured, 2 pills per day and a weight of 0.3 grams per pill (both assumed on the basis of median data calculated for Ayurvedic rasa shastra remedies). Cumulative daily exposures for each user, regardless of the type of remedy used, were calculated as the sum of the daily exposures for each remedy reportedly consumed.

^a,b,c,dSuperscripts indicate that the t test for differences in means or the Mann–Whitney U-test was statistically significant at P < .05; means or distributions with the same superscript were compared.

DISCUSSION

One of the main findings from this study was that rasa shastra Ayurvedic medications were significantly more likely than other types of health remedies to contain lead, mercury, and arsenic above permissible limits, as high as 220 000 times the regulatory limits. In addition, estimated daily lead, mercury, and arsenic exposures for most of the rasa shastra medications greatly exceeded PDE limits. This is not surprising as rasa shastra, meaning “science of mercury,” is a specialized branch of Ayurveda and involves the ancient practice of deliberately combining herbs with metals and minerals for therapeutic purposes.¹⁶

Experts in Ayurvedic medicine assert that these medications, if properly prepared and administered, are safe.^23,24 However, there are studies that raise concerns around issues of consistency of production and quality control during the manufacturing of rasa shastra medications that may consequently affect the final product.²⁵ There have also been numerous documented cases of adverse health effects associated with the use of such products nationally and internationally.^14,26–30 In this study, we found a significant association between blood lead levels and estimated cumulative daily lead exposures among adult users of rasa shastra medications. We also found that average blood lead levels among adult users of rasa shastra medications were significantly higher than those among adults using other types of non-Ayurvedic health remedies. Although individuals with elevated blood lead levels may not always exhibit overt symptoms, some of the rasa shastra users in this study were hospitalized.³⁰ In addition, at least 2 of the pregnant users miscarried before 15 weeks of gestation.²⁶

The potential for adverse health effects from lead, mercury, and arsenic exposures has been abundantly documented. Therefore, a concerted global effort should be made to eliminate or reduce exposures to known sources of such metals. This recommendation is echoed by other researchers.²⁵ However, existing policy gaps make it challenging to regulate rasa shastra Ayurvedic medications. In the United States, for instance, remedies such as rasa shastra medications are considered dietary supplements and are not subject to the same rigorous quality control requirements the FDA has in place for prescription medicines.

In addition, although AYUSH requires exported herbal Ayurvedic medications to meet permissible limits for lead, mercury, arsenic, and cadmium,³¹ rasa shastra medications with elevated heavy metal content have been found available for sale in US stores, as demonstrated by this study and previous investigations.^10,12 The FDA has issued import alerts to stop such products at US borders and local jurisdictions (e.g., the DOHMH) have taken enforcement actions and removed thousands of harmful products from store shelves¹⁰; however, challenges remain with respect to informal distribution of rasa shastra medications, with users often obtaining these medications abroad and hand carrying them into the United States. There is a need for systemic change that results in primary prevention, that is, removal of the source altogether through policy development and regulatory enforcement in the country of origin.

In our experience, rasa shastra users and health care providers are generally unaware of the practice of deliberate addition of metals into these types of medications. Most of the individuals involved in this study were unaware of the possibility of elevated lead, mercury, or arsenic in the health remedies they were taking. Even with increased awareness, a user may not be able to discern between purely herbal and rasa shastra Ayurvedic medications. Although a well-informed consumer may want to review the product ingredients for herbo-mineral components, this may not always be feasible if the ingredient list is missing or the ingredients are provided in a foreign language. To address this issue, the DOHMH recommends that users of Ayurvedic medications consult their primary health care providers about being tested for heavy metals such as lead, mercury, and arsenic.

Raising awareness among not only potential users but health care providers charged with their care is important. Health care providers play a critical role because they are on the front line attending to patients who may be symptomatic as a result of heavy metal poisoning. With respect to asymptomatic users, such individuals may be identified during routine blood lead screening; however, although certain populations in NYC are required to be screened for blood lead (e.g., children 1 and 2 years of age and pregnant or occupationally exposed individuals who are at risk for lead exposure), nonpregnant adults and older children are not routinely screened.

In addition, a similar testing requirement is not present for biomonitoring of mercury and arsenic. As a result, asymptomatic individuals who are using health remedies containing harmful levels of lead, mercury, or arsenic may go unnoticed until more severe chronic health effects become evident. Some publications remind physicians to be cognizant of potential lead toxicity from rasa shastra Ayurvedic medications if faced with a patient exhibiting anemia and abdominal pain without an obvious cause¹⁴; however, it is not common for providers to ask about use of complementary and alternative medicine products during patient consultations or to test patients for lead, mercury, and arsenic if such product use is reported. For this reason, the DOHMH reminds health care providers to ask patients about their use of prescription and nonprescription medications, including Ayurvedic and other complementary and alternative medicine products.

In the case of patients who report using such products, providers are encouraged to consider testing for metals, including blood lead, urine mercury, and urine arsenic, in consultation with an expert in heavy metal poisoning.³⁰ In some instances, even if a provider astutely probes, a patient may not disclose use of such products.³² Further compounding the issue of identifying poisonings associated with rasa shastra Ayurvedic medications is the potential for cross-cultural use, which has been observed in some of the DOHMH’s case investigations. This is not unexpected given the proliferation of complementary and alternative medicine use in the United States and other Western countries.³³

Local education and outreach strategies to boost awareness among potential rasa shastra users and health care providers are implemented routinely, but there is a need for cooperative interventions involving global stakeholders to effectively address this issue. Also, although in our study overall lead, mercury, and arsenic concentrations were lower for products in the traditional Chinese medicine category, the potential for metal exposures from traditional Chinese medicine use is evident in the literature³⁴ and therefore should not be overlooked during poisoning investigations.

Limitations

Our study involved a few limitations. Many of the health remedies tested were collected during lead poisoning case investigations, limiting the generalizability of our findings. In addition, some of the medications may have been miscategorized. For example, the products that were included in the traditional/herbal category; these medications consisted of unlabeled and loose products that, if properly labeled, could have been included under a different category. Although this limitation may have affected product categorization, it is likely that incorrect categorizations would have overestimated metal concentrations for the traditional/herbal category while underestimating the Ayurvedic category (including the rasa shastra subcategory) and the traditional Chinese medicine category. Nonetheless, our findings corroborate those reported by others.²⁹

Public Health Implications

Users of rasa shastra Ayurvedic medications may be at an increased risk for lead, mercury, or arsenic exposure. Although there is limited information in the literature about the prevalence of rasa shastra use worldwide, many individuals consult complementary and alternative medicine practitioners who may prescribe such health remedies for a wide variety of ailments.³⁵ The accessibility of rasa shastra medications over the counter and via the Internet also raises concerns, particularly given that these types of products may be used when people are most vulnerable, for example during pregnancy to support reproductive health.^10,12,13,26 Therefore, it is imperative to raise awareness about the potential for heavy metal exposures among users and prescribers of rasa shastra medications. Screening for lead, mercury, or arsenic among users is also advised.

Use of traditional medications can be ingrained in deeply held cultural beliefs. For this reason, public health approaches to address potential heavy metal exposure risks associated with these products require a combination of dialogue, data, and solutions that preserve cultural heritage while protecting health. Buy-in from global stakeholders—potential users, physicians, and advocates as well as governmental health agencies—is needed.