Safety of Ayurvedic Metallic Preparations:
The Story ...
The December 14, 2004 issue of the Journal of the American Medical Association included a report of research done at Harvard by a team led by Robert B. Saper, MD, MPH,(1) that exploded across the U.S. and even overseas. The news resulted in worried patients calling their Ayurvedic practitioners for assurance that their recommended herbal protocols were not those containing toxic metals. In turn, practitioners were turning to their herbal suppliers for confirmation that the herbs they offered were “safe”.
Let’s take a look at this report and discuss some of the issues that have been brought up by the research. Included with this discussion are reports on safety practices supplied by various domestic herbal companies and excerpts from articles published in the Spring 2005 issue of Light on Ayurveda Journal.(2),(3)
The Harvard study reports:
High levels of Lead, Mercury, Arsenic found in Ayurvedic products sold in U.S. (1)
The Harvard based study reported that one in five Ayurvedic medicines that were stocked in Asian groceries for their Indian clientele contain toxic levels of lead, mercury, or arsenic. According to the research team, these products put users at risk for metal poisoning. The researchers collected and analyzed 70 different Ayurvedic medicines produced by 27 companies, mainly from India, one from Thailand, and sold in 30 Boston-area stores. Most of the products, although not the ones containing heavy metals, were targeted for gastrointestinal problems and most cost $2.99 a bottle.
Their findings were that 20% of the examined products contained lead, mercury, and/or arsenic, and that seven were specifically recommended for children. Among the supplements mentioned with high levels of Mercury, Lead, and Arsenic were Mahayograj Guggulu with silver, Makardhwaj, Swama Mahayograj Guggulu with gold, Navratna Rasa, Mahalakshmi Vilas Ras with gold, and Balguti Kesaria. Saper noted that it was not known whether the heavy metals were already present in the plants from which the medications were derived or whether they had been added intentionally or unintentionally during the manufacturing process.
The levels were high enough to result in an intake above published safety standards, even in the quantities recommended.
It was noted that studies in England found similar results, and that traditional medicines from China, Malaysia, Mexico, Africa, and the Middle East have also been shown to contain metals. The researchers called for better regulation of the imported dietary supplements containing toxic metals.
LOAJ Editorial Commentary:
The samples obtained were inexpensive products available in Indian grocery stores and illegally imported. The study did not examine the high quality products produced by domestic Ayurvedic herbal companies.
The investigation did not distinguish between Ayurvedic herbal supplements and bhasmas. The ìsupplementsî with the reported highest heavy metal content fall into the category of bhasma and there is a vast difference between herbal supplements and bhasmas. There is a special branch of Ayurvedic medicine that concerns itself with the creation of medications called Rasa. Rasas are derived primarily from the ashes (bhasmas) of heavy metals, gemstones, and toxic substances. The preparation process is intricate and requires specialized training and education,(4) and the resulting product is quite expensive. The resulting medication would not be available at the low prices offered in the grocery stores.
The products containing these bhasmas were properly identified by their Sanskrit names. However, the Indian population who frequent these markets and purchase these products, may not have understood that the traditional formulation contained heavy metals requiring special care and supervision.(5)
The researchers assumed that the heavy metals they found were toxic, but did not test them for toxicity. They also did not cite any of the research studies or books showing the safety and salutary effects of these bhasmas.(6)
LOAJ feels that the authorsí conclusion that laws should be created to prevent the importation of these dangerous products is inappropriate as there is already DSHEAlegislation prohibiting the importation of heavy metals.(7) Further regulation would only penalize legitimate manufacturers and raise costs for consumers.
References:
(1) Saper, RB, Kales, SN et al. Heavy Metal Content of Ayurvedic Herbal Medicine Products. JAMA 292:2868-73, Dec. 15, 2004.
(2), (5) Glaser, Dr. Jay. Bhasma Therapy: Panacea or Poison? LOAJ, Vol. III, issue 3, p. 31-34, Spring 2005. click here to read excerpt
(3), (4) †Chauhan, Dr. Partap. Ayurvedic View on Rasa Shastra Metallic Medicines or Bhasmas. LOAJ, Vol. III, issue 3, p. 35-36, Spring 2005. click here to read excerpt
(6) Reference and Research Papers on Bhasmas and Heavy Metals. LOAJ Vol. III, issue 3, p. 37. Spring, 2005. click here to read online
(7) Dietary Supplement Health and Education Act of 1994 (DSHEA), Federal Food, Drug and Cosmetic Act (1938). Pure Food and Drug Act (1906).
Excerpts from an interview of LOAJ by Mantram Magazine:
Mantram: What is your take on the recent JAMA report implying that most Ayurvedic medicines sold in the U.S. have toxins?
LOAJ: The research was focused on Ayurvedic preparations that were obtained from Indian grocery stores. This is akin to one purchasing oneís medications from low-cost chain stores. The preparations in question are called bhasmas, a unique type of medication that requires specialized knowledge both in the preparation and in the administration. The large-scale manufacture of these products, without the care, skill, knowledge and judgement of the qualified specialist may result in substandard, if not dangerous preparations.
When toxic metals are appropriately present in an Ayurvedic preparation, they are or should be identified as such. When prepared for the Indian consumer utilizing the Indian grocery store, the identification is in Sanskrit. Indians purchasing these bhasmas should know they are obtaining a product that should only be taken under the direction of a highly specialized Ayurvedic practitioner but may not fully realize the import of the presence of heavy metals. Bhasmasare highly effective, very powerful medications. In relation to their speed and efficacy, they bear a direct parallel to Western medicines that are well understood to require proper supervision.
Mantram: Given that there are many practitioners of ayurveda in the US, why isnít there a lobby that can help ayurveda gain more acceptance in the mainstream and counter research reports like the one circulated by JAMA?
LOAJ: Ayurveda was introduced in the U.S. by Maharishi Mahesh Yogi and Dr. Vasant Lad in the 1980ís and itsí growth has been steady. In recent years, organizations have taken root that may one day enjoy greater stature and effectiveness in addressing such issues. Among these fledgling organizations are the National Ayurvedic Medical Association, Light on Ayurveda Foundation for Health Education with its publication, Light on Ayurveda Journal, Las Vegas Institute of Ayurveda, California Association of Ayurvedic Medicine, The American Academy of Ayurvedic Medicine, and the International Society for Ayurveda and Health.
These organizations are working hard to advance the recognition and acceptance of Ayurveda as a purveyor of healthcare in this country.
Mantram: What are the implications of such a report on the mainstream market and people using or planning to use Ayurvedic formulations?
LOAJ: The great majority of Ayurvedic medicine comes from reputable suppliers who take great care in the procurement of their products. The preparations are carefully tested for contaminants before being offered for sale. These companies are also working to implement the highest possible standards Ayurvedic products.
The recommendation to the Ayurvedic consumer continues to be: Ayurvedic formulations should not be taken at the whim and discretion of the consumer, but only under the care of a qualified practitioner who is capable of evaluating both the source and administration of the medication. All people should be educated and discriminating about the medications they choose to take into their bodies, no matter what healthcare system they utilize.
Mantram: What is your advice to prospective as well current users of Ayurveda trying to wade through the plethora of Ayurveda products available on the market? What separates fact from fiction?
LOAJ: While all consumers of healthcare, whether Western or Ayurvedic, are well-advised to assume responsibility for their own state of health, this does not preclude the responsibility to seek out a qualified practitioner. Healthcare is a shared responsibility between patient and practitioner. Only then can we hope to achieve the a state of health and well-being.
Excerpts from a Commentary by Dr. David Frawley:
"While herbs do have medical properties and potential toxicity if taken in the wrong dosages or if wrongly prescribed, they are generally much safer than the drugs that would otherwise be used, not try to scare people away from herbs by highlighting only the negative[...]. Relative to toxic metal contents, the amounts mentioned in the articles are still low but should be dealt with.[....]The real issue should be how we can improve herbal and other alternatives to drugs."
Protocols for Safety of Ayurvedic Herbs
LOAJ inquired into the safety of herbs from distributors and domestic suppliers of Ayurvedic herbal supplements. Banyan Botanicals and Bazaar of India were two responders from the U.S., and Ayushakti responded from India.The following is a summary compiled from the information supplied by the herbal companies.
Numerous organizations and agencies are involved in the testing and certification of herbal products. Among them are the AHPA (American Herbal Products Association), NSF (National Sanitation Foundation), European Pharmacopoeia, the USP (United States Pharmacopoeia), and the FDA (Federal Drug Administration). The FDA is responsible for drug regulation, the NOP (National Organics Program) is involved in the certification of organic herbal farms. The DSHEA (Dietary Supplement health Education Act) sets standards that affect herbs and their importation. The NSF is one of the premier labs in the world and has written the standard for testing heavy metals (ANSI standard 173).
The following are accepted testing protocols for botanicals:
Identification (one or more of the following may be used)
- Organoleptic testing ñ physical examination using the senses
- HPLC (High Pressure Liquid Chromatography)
- TLC (Thin Layer Chromatography) to identify herbs and measure their quality by "fingerprinting" the herb sample and comparing it to a library of known standards.
- Microscopic examination to determine the species, plant segment (root, stem, leaf or flower), and any contamination thereof.
Microbiological testing - Bacteria, Molds & Yeasts, E. Coli and Salmonella by government regulated labs, either in the U.S. or Europe. This testing results in a CofA (Certificate of Analysis) supplied by the testing lab.
Pesticide testing - (This is implicit in the certification standards of organic farms).
Heavy metal testing - is done by special laboratories such as NSF.
Foreign materials detection - the ash residue resulting from burning away the organic material via microwave technology is analyzed for mineral content.
Testing protocols of various herbal suppliers
Banyan Botanicals: Is in the process of becoming a 100% certified organic manufacturer utilizing farms in the U.S. and abroad. Due to the certification process of organic farms, only spot pesticide testing is performed. Their testing includes:
Identification:
-Organoleptic ID testing
Microbiological testing
Pesticides -uses certified organic suppliers
Heavy Metal Testing - by NSF
Bazaar of India:
Sources its raw materials from around the world to enable the collection of quality products from each harvest season. Quality checks start at the selection process and continue throughout the various stages of manufacturing. Testing includes the following:
Identification:
- Organoleptic ID testing
- Microscopy
- Thin Layer Chromatography (TLC)
Heavy Metal Testing random testing by independent labs.
Microbiological testing
Foreign Materials Testing
Ayushakti Herbs: Produced in India and distributed both in India and the U.S.
A sample of each batch of herbs is sent to a European laboratory for testing to international standards. Herbs are released for export only when the heavy metals content is within regulatory limits prescribed by international authorities.
LOAJ wishes to thank Lorraine Zack of Colorado for her assistance in obtaining information from various sources for this report.
References for Heavy Metals
Bajaj S, Ahmad I, Raisuddin S, Vohora SB. Augmentation of non-specific immunity in mice by gold preparations used in traditional systems of medicine. Indian J Med Res. 2001 May;113:192-6. Online Paper: <http//www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=pubmed&dopt=Abstract&list_uids=11968954>
Bajaj S, Vohora SB. Analgesic activity of gold preparations used in Ayurveda & Unani-Tibb. Indian J Med Res. 1998 Sep;108:104-11. Online paper: <http// www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=pubmed&dopt=Abstract&list_uids=9798337>
Bajaj S, Vohora SB. Anti-Cataleptic, Anti-Anxiety and Anti-Depressant Activity of Gold Preparations used in Indian Systems of Medicine Indian J. Pharmacol. 2000 32: 339-346 [Arsenic] Online paper: http://www.medind.nic.in/ibi/t00/i6/ibit00i6p339.pdf
Chandra, D., Mandal, AK. Toxicological and pharmacological study of Navbal Rasayan, a metal based formulation. Indian Journal of Pharmacology, 2000 32: 369-371 [Arsenic, lead, mercury] Online paper: <http://medind.nic.in/ibi/t00/i6/ibit00i6p369.pdf>
Joshi, D. Rasamritam. Chaukhambha Sanskrt Bhawan. Varanasi, India.
Mitra A, Chakraborty S, Auddy B, Tripathi P, Sen S, Saha AV, Mukherjee B. Evaluation of chemical constituents and free-radical scavenging activity of Swarnabhasma (gold ash), an Ayurvedic drug. J Ethnopharmacol. 2002 May; 80(2-3):147-53. [Lead] Online paper:<http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=PubMed&list_uids=12007704&dopt=Citation>
Pattanaik, N, Singh, AV, Pandey, RS, Singh, BK, Kumar, M, Dixit, SK, Tripathi, YB. Toxicology and free radicals scavenging property of Tamra Bhasma. Indian Journal of Clinical Biochemistry, 2003 18 (2) 181-189 [Copper with mercury sulpher,other metals] Online paper:<http://www.medind.nic.in/iaf/t03/i2/iaft03i2p181.pdf>
Richards DG, McMillin DL, Mein EA, Nelson CD. Gold and its relationship to neurological/glandular conditions. Int J Neurosci, Volume 112, Number 1 / January 2002 [Arsenic] Online paper:<http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=PubMed&list_uids=12152404&dopt=Citation>
Shah ZA, SB Vohora SB. Antioxidant/Restorative Effects of Calcined Gold Preparations Used in Indian Systems of Medicine. Pharmacol & Toxicol. 2002 May;90(5):254-9 [Mercury. Arsenic] Online article: <http://www. ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=PubMed&list_uids=12076306&dopt=Citation>
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Yegnanarayan R, Sangle SA, Sirsikar SS, Mitra DK. Regression of cardiac hypertrophy in hypertensive patients comparison of Abana with propranolol. Phytother. Res, 1997. Volume 11, Issue 3 , Pages 257 ˆ 259 [Mercury/Makardhwaj] Online Paper: <http://www3.interscience.wiley.com/cgi-bin/abstract/12633/ABSTRACT>
