Ayurveda and Heavy Metals

The traditional medicine of India, Ayurveda, has become increasingly practiced throughout the world and is popular in the United States as a form of alternative medicine. Meaning life (Ayur) and science (veda), this 5,000-year-old form of medicine stresses balance and includes spirituality and dietary recommendations. The underlying tenets and inner-workings of Ayurveda can get complicated; but, the basic goal is to ensure harmony between the five senses and their environment. This is accomplished with a variety of tools such as herbs, diet, colors, aromas, lifestyle changes, yoga and meditation.

Common individual and combination herbal medicines have become popular retail items for U.S. consumers interested in Ayurveda. While it is only one part of the overall practice of Ayurveda, herbal supplementation is the part of this system that is drawing the most attention stateside, where quality control (QC) issues have surfaced.

Formulas that are purely herbal in composition are among the most common and popular Ayurveda products in America. Holy basil, gymnema, ashwaghanda, cinnamon, neem and bacopa are just a few herbs common to various Ayurveda formulas. As botanical raw materials, Ayurveda herbs are subject to all the variables of agricultural products, including soil content, climate and environmental surroundings. These factors have posed many QC challenges to the herbal products industry, namely heavy metal content.

In 2004, a group of Boston-based researchers from Harvard Medical School, Beth Israel Deaconess Medical Center, the Environmental Protection Agency (EPA) and Boston University School of Medicine investigated heavy metal content in Ayurveda herbal products manufactured in South Asia and sold in Boston-area retail stores (JAMA. 292(23): 2868-2873). They searched all area Boston markets and supermarkets, especially those featuring products from India, and also found stores and products in Boston from an online search. In the end, they visited each store and purchased unique Ayurveda herbal products between April 25 and Oct. 24, 2003.

They tested 70 products for lead, mercury and arsenic, as measured by x-ray fluorescence spectroscopy, and compared the results to estimates of daily metal ingestion for adults and children using manufacturers dosage recommendations, U.S. Pharmacopeia (USP) and EPA standards.

Of the 70 products tested, 14 (20 percent) contained heavy metals13 had lead, six had arsenic and six had mercury. According to researchers, each of these 14 products, if taken as directed, could result in heavy metal intakes above regulatory standards. They concluded users of Ayurveda medicines may be at risk for heavy metal toxicity, and they suggested testing of Ayurveda products for toxic heavy metals should be mandatory.

A few years later, the same basic team of researchers performed a more extensive survey of Ayurvedic products, this time concentrating on Internet sales, and randomly selected 230 Ayurvedic medicines for purchase between August and October 2005 (JAMA. 2008;300(8):915-923). After testing these products for heavy metals, they reporting 20 percent of Ayurvedic medicines manufactured in either the United States or India and purchased via the Internet contained detectable lead, mercury or arsenic. Of these, 17 percent of purely herbal products contained heavy metals, which were also found in 40 percent of Rasa shastra products.

Rasa shastra, which means mercury science, is an ancient practice of combining herbs with "purified" gems, minerals and metals. Shashank Sandu, director of Sandu Brothers Pvt Ltd. and a board member of the Ayurvedic Drug Manufacturers Association (ADMA), said Rasa remedies are quite popular in India, especially in the northern and western region, and most qualified Ayurveda physicians use these formulations. "Based on empirical evidence, 200 years before allopathic medicine came into the picture, in India, Ayurveda was mainstream medicine," he said.

Sandu called the JAMA research reports misleading. "These articles have definitely hurt the reputation of a well-established body of science and traditional medicine, namely Ayurveda, amongst its practitioners and loyal customers, especially those who are well read and well informed," he exclaimed. "The studies have not concluded and were not designed to investigate toxic effects, if any, of the Ayurvedic formulations containing metals, which should have been a prime concern of an investigator for a rational study."

For its part, ADMA took issue with several aspects of the JAMA research, calling it a regulatory aspects study in a scientific journal. The group noted the study authors failed to recognize new regulations enacted by the Indian government's Department of AYUSH in October 2005, which resulted in mandatory testing for heavy metal contamination in purely herbal formulations for export, effective Jan. 1, 2006, onwards. As the study researchers ended their purchasing of Ayurveda products in October 2005, the study featured products that were not subjected to this mandatory testing at pre-shipment level of exports from India. "Thus, prima facie the article is essentially outdated and substantially ill-informed on the current status of exports of Ayurvedic, Siddha, Unani (ASU) formulations from India," ADMA stated. The Department of AYUSH added testing for heavy metals and other contaminants in ASU products is already a part of GMPs (good manufacturing practices) established in 2003.

Mercurial Science

While only one out of every six herb-only products was found to contain lead, mercury or arsenic, more than 40 percent of Rasa shastra products had similar issues. However, critics of this research wonder why these products were included in the research, as they are known to contain such metals.

Jun Mao, M.D., University of Pennsylvania School of Medicine, and Krupali Desai, M.D., Thomas Jefferson University, Philadelphia, issued a rebuttal to the 2008 JAMA study, explaining "metals used in authentic Ayurvedic medicines go through a process of conversion of metals into their mixed oxides that may destroy their toxicity and induce their medicinal properties." The question to be answered, according to Mao and Desai, is whether the products contain metal content that is harmful when properly prepared and administered.

Lead researcher Robert Saper, M.D., then of Harvard Medical School and now a researcher and director of integrative medicine, Boston University School of Medicine, countered the use of Ayurvedic medicines, especially Rasa products, is an independent risk factor for "elevated toxic metal burdens." He added, "We disagree with Mao and Desai's claim that historical use of these medicines in India without apparent toxicity is evidence supporting their safety. India's known toxic metal burden is quite substantial: 51 percent of children and 40 percent of adults in Indian cities have blood lead levels of 10 mcg/dL or greater."

What constitutes a safety concern relative to heavy metal levels and Ayurveda products is another point of debate. In the JAMA research, Saper et al. utilized three standards of heavy metal limits: California Proposition 65, ANSI (American National Standards Institute) and FAO/WHO (Food and Agriculture Organization of the United Nations/World Health Organization).

The National Ayurvedic Medical Association-USA (NAMA), Ayurvedic Practitioners Association-UK (APA) and the Verband Europäischer Ayurveda Mediziner und Therapeuten-Germany (VEAT) jointly stated, "In the United States, there is no current national law precisely regulating the amount of lead, mercury and arsenic in dietary supplements. There are various opinions on what the maximum safe daily limits for lead, mercury and arsenic in dietary supplements should be."

ADMA pointed out Prop 65 does not prohibit the sale of products containing heavy metals, but only requires a warning for the metal content before retail in California. The group further noted while FDA has not determined acceptable limits for heavy metals in supplements, Indian law has fixed a maximum limit.

When queried, Saper said there is, in fact, a lot of consensus amongst the agencies on safe heavy metals limits. He said his team addressed this by showing how the metal content in the products compares to wide array of standards. "One point that could be taken is that there needs to be a scientific consensus on what are safe amounts of heavy metals, in terms of daily doses, that should be allowed in dietary supplements," he said. "There should be just one standard used, at least here is U.S."

The American Herbal Products Association (AHPA) has followed this issue closely and in 2008, adopted an interim guidance for quantitative limits of certain heavy metals in herbal supplements: 10 mcg/d arsenic, 4.1 mcg/d cadmium, 10 mcg/d lead and 2 mcg/d methylmercury. AHPA explained its guidance is based on suggested maximum daily use of an herbal product, and Prop 65 label warnings might still be necessary at these guidance levels.

Acknowledging there is a lack of FDA standard for permissible levels of metals in dietary supplements, USPs Anthony DeStefano, Ph.D., and Kahkashan Zaidi, Ph.D., noted heavy metals tests have been available in the USP's Natural Formulary, including general heavy metals screening tests and specific tests for individual elements such as arsenic, iron, lead and mercury indicated in the JAMA research. USP is working with the Institute of Medicine (IOM) on establishing better limits for heavy metals in dietary supplements, including Ayurveda herbal products, and scheduled a workshop for April 28, 2009, to discuss methodologies and toxicological limits.

To Meddle or Not to Meddle?

Beyond the standards, the question becomes: What does the JAMA research really say, and are Ayurveda products containing heavy metals harmful?

In the case of non-Rasa products (herb-only formulations), the presence of heavy metals could indicate a QC issue. Due to the era of industrialization, soil and plants commonly contain some level of heavy metals. Saper similarly noted, "Purely herbal Ayurvedic products contain some metals; some contamination may be that the plant absorbed heavy metals from environment, either from ground water, soil or air contact, or from contamination in manufacturing facilities.

This is where GMPs and industry self-regulation can help. AHPA noted its members performed better in the JAMA studies on heavy metal content in Ayurveda products, which is a direct reflection of measures the association has taken. Michael McGuffin, president of AHPA, said lead is ubiquitous. "All plants can pick up heavy metals from the environment," he said. "There is no reason that I am aware of to believe that the plant species traditionally used in Ayurveda are more or less likely to contain environmental-sourced metals." He explained plants grown in areas where metals are prevalent in the soil are more likely to contain these metals than those grown in more pristine areas. "Also, there are post-harvest handling issues that can come into play, such as use of, or restraint from use of gasoline fueled heaters." He also noted AHPA has advised its members to avoid manufacturing Rasa shastra products, if the metal content causes the product to be adulterated under labeled or ordinary conditions of use.

"Ayurveda has never denied that some of its formulations contain metals and minerals," Sandu affirmed. "Therefore, [the JAMA study] is meaningless, confirming that some of the Ayurvedic medicines contain metals when it is a known fact that these metals are part of the formula." He did concede the JAMA reports have lead to debates and discussions amongst the Ayurvedic community at large and, more particularly, at an industry level, focusing on how to better address this issue. Still, Sandu and others from the Ayurveda community take issue with the negative connotation the JAMA-heavy metals research gives on the safety of Ayurveda products.

"The presence of metals in Ayurveda products doesn't at all prove their toxicity," Saper conceded. "What is persuasive, however, is the combination of the presence of heavy metals in these products and the many case reports associated with these medicines, indicating these products may be harmful."

In a 2007 report, a Saper-led team identified 66 cases of adult lead intoxications using a 40-year spread on MEDLINE (Med Sci Monit. 2007;13(7):CR295-8); they linked 45 cases to Ayurveda and concluded "Ayurvedic poisoning produces greater hematopoietic toxicity than paint-removal poisoning."

A couple years later, Saper and a team of researchers potentially linked 76 cases of lead encephalopathy with traditional medicine (Curr Drug Saf. 2008;3(1):54-9). However, Ayurvedic medicines were only indicated in five of these cases, with the majority of cases (66 or 87 percent) being linked to Middle Eastern traditional medicines. Also, only 5 percent of the cases overall were in adults, with the other 95 percent in infants and young children.

Still, Rasa proponents reiterate how their products feature "detoxified" forms of metals, based on ancient Shodhan (purification or detoxification) processes. Sandu reiterated how Rasa shastra has been used quite effectively over thousands of years, saying, "If the Rasa medicines were so toxic, the Indian population would have been wiped out by now."

ADMA noted Ayurvedic texts, also called Granthas, contain detailed information of toxicity and harmful effects if such metals are used in the unpurified or Ashuddha form.

Saper stated although this practice of purification of metals is frequently cited, this detoxified form has never been characterized scientifically. "We have several planned studies looking at Rasa shastra products that have been classically prepared to see if these metals are truly detoxified."

The Department of AYUSH recognized the need for further study of this category of products, reporting the Golden Triangle Projectconnecting traditional medicine to modern science and modern medicineinvolves physicochemical characterization and toxicity studies of eight widely used Rasa formulas (Bhasmas) carried out by various laboratories of the premier Indian R&D firm Council of Scientific and Industrial Research (CSIR), such as the Indian Institute of Toxicological Research (IITR), Lucknow, Indian Institute of Chemical Technology (IICT), Hyderabad. The formulas were made by a reputable Rasa manufacturer, and after the first 28 days of study, no toxicity was found. Additional tests on 600 wild-cultivated Indian medicinal plants did not find lead, mercury and arsenic levels above the permissible limits set by WHO (10 ppm for lead, 1 ppm for mercury and 3 ppm for arsenic). AYUSH further cited its work on standard operating procedures (SOPs) for this category of medicine, in addition to GMPs for Rasa products.

Still, this category of Ayurveda products is not common in the United States, and with the main herbal products trade association discouraging its manufacture and distribution in this country, U.S. consumers should not fear these metal-containing formulas.

AYUSH reported herbo-metallic compounds are not being officially exported because of heavy metal concerns, and only purely herbal Ayurveda, Unani and Siddha medicines were being exported from India, effective 2006, and only after certification of heavy metals below the permissible limit.

Mark Blumenthal, executive director of the American Botanical Council (ABC), said Rasa products are not the form of Ayurveda consumers would find in a local health food or grocery store, noting the products used in the studies were from India import stores in the Boston area or from the Internet. "These were not found in the office of your chiropractor or your acupuncturist," he said.

In fact, Sandu confirmed the Rasa shastra formulations should not be offered to the general public as over-the-counter medicines. "They should be offered in coordination with Ayurveda consultants only, and their purchase should be limited," he stated. "Herbo-metallic compounds, if used judiciously by a qualified practitioner, do not pose a threat, but from a modern science perspective, more studies need to be done."

Dr. Pratap Chauhan, director of Jiva Ayurveda Center for Incurable Diseases, agreed with the need to investigate Rasa toxicity. "It would be interesting to do research on what these metallic medicines do when taken internally," he suggested. "Clinical studies should be done on people taking metallic medicines by checking their liver, blood and kidney functions on regular basis." He added Ayurvedic texts stipulate toxicity is limited to manufacturing or prescription faults. "Every Ayurvedic principle, treatment, medicine is pro-bioticsupports life and longevity."

Dheeraj Malhotra, M.D., an Ayurveda practitioner, argued mercury toxicity is dependent on the form of the metal ingested, and absorption of inorganic mercury compounds, such as mercurous chloride and mercuric chloride, are relatively low. He argued typical mercury content in Ayurveda/Rasa treatment is far below tolerable safe levels as determined by WHO and several toxicity studies, as well as compared to allowable consumption levels in certain fish. Despite this, he maintained, "None of this excuses herbal product manufacturers from stringent quality-control standards; it's just that we should put health risks in their proper perspective."

Even in India, where Rasa products are more commonas are Ayurveda practitionersthese medicines must bear a label warning To be used under medical supervision, according to the prevailing regulation of this category, Sch E1 of the Drugs & Cosmetics Act of 1940.

Ranjit Puranik, CEO of Shree Dhootapapeshwar Ltd., the oldest Ayurvedic company in the world, and secretary of ADMA, emphasized his organization's position that the JAMA heavy metals research goes beyond its proclaimed endpointsto determine heavy metal content of certain Ayurveda products and compare results between U.S.- and India-made formulas, as well as between Rasa and non-Rasa products. He said Saper and his team imply a traditional medicinal system in service of mankind for more than 3,000 years needs validation. "It is one thing to state that more needs to be understood or express the need for further study; but, to strategically involve qualified Ayurvedic scientists on a panel and limit their role to merely classify products as Rasa shastra and otherwise, does not reflect well on the utilization of the Ayurvedic wisdom at hand or efforts to understand traditional science on its own platform, especially the deliberate and intentional use of metallic compounds in Rasa shastra formulations."

Dr. CM Pradyumna, director of medicine, The Vedic Village, Kolkata, India, argued the JAMA heavy metals report is of poor relevance, as only 55 cases of known herbal medicine toxicity in more than a billion Ayurveda users worldwide is not a valid allegation against this traditional form of medicine. "But my advice as a responsible Ayurveda doctor is that people need to consult a qualified Ayurveda practitioner before they start taking any of the medicines," he recommended. "This is as simple as what you do when you need any medical attention from the conventional system of Allopathic medicine."

There is much to figure out in this case of heavy metals in Ayurveda products. A regulatory consensus on safe heavy metal limits for dietary supplements, especially herbal products, must be established, and manufactures should be held to this standard. As for Ayurveda products purposefully containing metals, it appears these are, and should be, relegated to physician-directed cases, although the toxicity of these "purified" herbo-metallic compounds should also be scientifically determined. Until these standards and research results are finalized, it is very difficult to definitively determine the existence and scope of any quality control problem in the Ayurveda supplement industry.

The Quality Control section is sponsored by Ethical Naturals; however, the company does not review or approve editorial content.