Heavy Metal Content of Ayurvedic Herbal Medicine Products (Full Article)f1

Robert B. Saper, MD, MPH; Stefanos N. Kales, MD, MPH; Janet Paquin, PhD; Michael J. Burns, MD; David M. Eisenberg, MD; Roger B. Davis, ScD; Russell S. Phillips, MD

JAMA. 2004;292:2868-2873.

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

Objectives To determine the prevalence and concentration of heavy metals in Ayurvedic HMPs manufactured in South Asia and sold in Boston-area stores and to compare estimated daily metal ingestion with regulatory standards.

Design and Setting Systematic search strategy to identify all stores 20 miles or less from Boston City Hall that sold Ayurvedic HMPs from South Asia by searching online Yellow Pages using the categories markets, supermarkets, and convenience stores, and business names containing the word India, Indian cities, and Indian words. An online national directory of Indian grocery stores, a South Asian community business directory, and a newspaper were also searched. We visited each store and purchased all unique Ayurvedic HMPs between April 25 and October 24, 2003.

Main Outcome Measures Concentrations (µg/g) of lead, mercury, and arsenic in each HMP as measured by x-ray fluorescence spectroscopy. Estimates of daily metal ingestion for adults and children estimated using manufacturers' dosage recommendations with comparisons to US Pharmacopeia and US Environmental Protection Agency regulatory standards.

Results A total of 14 (20%) of 70 HMPs (95% confidence interval, 11%-31%) contained heavy metals: lead (n = 13; median concentration, 40 µg/g; range, 5-37 000), mercury (n = 6; median concentration, 20 225 µg/g; range, 28-104 000), and/or arsenic (n = 6; median concentration, 430 µg/g; range, 37-8130). If taken as recommended by the manufacturers, each of these 14 could result in heavy metal intakes above published regulatory standards.

Conclusions One of 5 Ayurvedic HMPs produced in South Asia and available in Boston 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.

Author Affiliations: Division for Research and Education in Complementary and Integrative Medical Therapies, 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), Beth Israel Deaconess Medical Center, Boston; The Cambridge Hospital, Harvard Medical School, Cambridge (Dr Kales); Occupational Health Program, Department of Environmental Health, Harvard School of Public Health, Boston (Dr Kales); and New England Regional Laboratory, Environmental Protection Agency, North Chelmsford (Dr Paquin), Mass. Dr Saper is now with the Department of Family Medicine, Boston University School of Medicine, Boston, Mass.

JAMA Article Finds Heavy Metals in Ayurvedic Products
2004-12-14 - American Herbal Products Association (AHPA)

(Silver Spring, MD) -- An article to be published in the December 15, 2004, issue of the Journal of the American Medical Association (JAMA) reports that 20 percent of Ayurvedic "herbal" medicines made in India or Pakistan and sold in South Asian grocery stores in the Boston area contain "potentially harmful levels of lead, mercury and/or arsenic."(1) The authors fail to clarify, however, that many of these products contain non-herbal ingredients, such as sulfide of mercury, which no doubt accounts for the high levels of heavy metals detected in these imported products. One product, for example, was found to contain more than 10 percent mercury, and four others were noted to exceed one percent of total heavy metals.

Many traditional Ayurvedic formulas that are sold in India contain metallic ingredients for purported health benefits, though those with high levels of these are generally used under practitioner supervision. The use of such ingredients in dietary supplements marketed in the United States is not allowed, however, as the presence of lead, mercury, and arsenic at levels that cause dietary supplements or foods to be adulterated are unlawful under the Dietary Supplement Health and Education Act (DSHEA), and have been unlawful under the Federal Food, Drug, and Cosmetic Act since 1938 (and even under the Pure Food and Drug Act since 1906).

Oddly, the JAMA article both correctly notes that "regulations governing dietary supplements ... should also be applied to dietary supplements imported into the United States," and, in the very next sentence, calls for "reform of DSHEA" to require mandatory testing of all imported dietary supplements for toxic heavy metals. As noted above, however, U.S. law already makes it unlawful to import or sell products that are adulterated with high amounts of heavy metals. No change in the law is required, though manufacturers, importers and retailers need to assure that the products they manufacture, import, and sell are free of adulteration. AHPA encourages its members to test products for heavy metals.

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 Codex - Bridging the Great Divide (Full Article)f2
2004-12-09 - James J. Gormley

The Codex Alimentarius Commission (CAC) was officially created in 1963 by the Food and Agriculture Organization (FAO) and World Health Organization (WHO) to "develop food standards, guidelines and related texts such as codes of practice." The main purposes of this commission are now said to be: "protecting health of the consumers,""ensuring fair trade practices in the food trade," and "promoting coordination of all food standards."

Codex & CCNFSDU.

There are 20 main Codex committees ("subsidiary bodies") hosted by different countries, including: the Codex Committee on Food Additives and Contaminants (Netherlands), the Codex Committee on Food Labelling (Canada), the Codex Committee on Cereals, Pulses and Legumes (U.S.) and, perhaps most importantly right now, the Codex Committee on Nutrition and Foods for Special Dietary Uses [CCNFSDU] (Germany).

The CCNFSDU is a pivotal committee that has responsibility for several vitally important areas that impact consumer health, including (but not limited to):

• guidelines for vitamin and mineral supplements;
• infant formula standards;
• foods for infants and children
• scientific basis of health claims;
• risk analysis; and
• trans fats.

U.S. consumers respond

In advance of the Bonn Codex meetings, on September 9, 2004, on behalf of 33,000 members of Citizens for Health (http://www.citizens.org/), I had the opportunity to address the U.S. Codex delegation to CCNFSDU, which is headed by Dr. Barbara O. Schneeman, director of the FDA's Office of Nutritional Products, Labeling and Dietary Supplements.

I expressed serious concern over a number of especially troubling guidelines in the pre-Bonn version of this committee's draft text and worked with non-governmental organization (NGO) representatives to develop a letter to the U.S. delegation (http://www.healthactioncenter.org/action/index.asp?step=2&item=21232). More importantly, many of these same questions were echoed by at least 5,000 consumers who e-mailed letters to Dr. Schneeman before the official U.S. delegation finalized its recommendations prior to Bonn. Consumers focused on the following:

• "Upper safe limits" for vitamins and minerals. Consumer concern: Sub-optimal upper levels of vitamins and minerals, perhaps eventually a restricted list à la the European Food Supplements Directive (EFSD), should never be allowed.
• Infant formula and foods for infants/children: Consumer concern: DHA and ARA are listed as "optional additions" to infant formula (not required), even though the UN/WHO itself has recommended that all infant formula contain these necessary fatty acids.
• Health claims: Consumer concern: According to the pre-Bonn draft, the Codex text read: "Health claims should be forbidden if they cannot be substantiated." Who is establishing what constitutes "substantiation"?
• Risk analysis: Consumer concern: The concept of "risk analysis" refers to toxic chemicals not to nutritional supplements.
• Trans fatty acids: Consumer position: There is no place for unhealthful hydrogenated fat or trans fat in human nutrition.

So what happened in Germany in November?

It depends on whom you ask, or more precisely, whether you ask our industry or consumer health advocates.

If you ask U.S. industry, which represents thousands of companies, you are likely to hear the following:

• Government and industry cooperated and came up with a science-based approach to setting upper limits for vitamin and minerals supplements.
• The stage is now set for science-based implementation of the European Food Supplements Directive (EFSD).
• We now have a risk assessment model for supplements.
• Now countries can rest assured that vitamins and minerals are safely regulated in trade.
• Now worldwide consumers are protected.

If you ask U.S. consumer leaders who represent hundreds of thousands of consumers, you're likely to hear:

• Industry caved to the pressure of Germany and the EU bloc and is happy over vitamin and mineral guidelines that will be considered binding by the World Trade Organization (WTO) and international treaties and would likely adopt the incredibly restrictive EFSD framework; these "guidelines" may potentially lead to the FDA's eventual harmonization of its regulations to international standards.
• Hello, who asked for a toxic chemical risk assessment model for dietary supplements?
• Thank you, the U.S. has DSHEA and doesn't need international "guidelines" (read: standards) potentially undermining U.S. law. U.S. products, ergo DSHEA, can be challenged as a "Technical Barrier to Trade" (TBD), the trump card that, along with the threat of trade sanctions, can bend any country to international will - yes including the U.S.
• Considering that U.S. consumers are already protected, and that most overseas consumers are already hyper-protected by drug/medicine standards that regulate supplements as drugs, why do worldwide consumers need a web of international regulation added on to what is already regulated by individual nations and blocs of nations (e.g., the EU)?

Why such a great divide?

In fairness to our industry, there are committed representatives who have worked hard on these issues for years and who did, without a doubt, help consumer groups to achieve important objectives in Bonn, including: (1) establishing that vitamins and minerals are food supplements, (2) stipulating that upper safe limits are to be based on science-based principles rather than the "precautionary principle" (which would have guaranteed arbitrary and capricious standards for setting levels), and (3) stipulating that when maximum levels are set, this provision "should not lead to setting of maximum levels that are solely based on recommended nutrient intakes."

It, likewise, should be noted that the official U.S. delegation did take a good stand on certain key points, and prevailed on a few of these along with countries such as South Africa and Zimbabwe.

U.S. consumer health-freedom leaders also made profoundly important contributions in Bonn, too, especially but not limited to the National Health Federation (http://www.thenhf.com/) (Scott Tips and Paul Anthony Taylor [U.K.]) and the American Holistic Health Association (http://www.ahha.org/codexwalter2004.htm) (Suzan Walter).

Unasked questions still remain

Nevertheless, we should all be aware that, as the approved CCNFSDU draft stands now, the following provisions are sailing to Rome, July 4-9, 2005, for codification unopposed by industry:

1) The "upper safe levels" principle is approved with a carte blanche on dosage levels that is, according one umbrella trade group, "fully in line with EU developments and science-based implementation of the European Food Supplements Directive."The Directive has developed a restricted list of approved supplements which will effectively ban about 300 out of the 420 forms of vitamins and minerals now included in supplements overseas as of August 1, 2005 (in the U.K.).

2) DHA and ARA are not required for infant formula (only listed as "optional additions") even though they are recommended as essential nutrients according to the UN/WHO. In addition, GMO-source ingredients are allowed for infant formula and infant's/children's foods, as are hydrogenated/trans fats, cheap quality oils, high-fructose corn syrup, and a host of synthetic additives.

Shocking, isn't it, for the natural products industry? Nevertheless, this is the state of affairs which some of us are applauding. If you are as stunned as I was about what the guidelines will allow, or not exclude, than we all have a lot of work to do before Rome.

In point of fact, in Rome, from July 4-9, 2005, the 28th session of the full Codex commission will formally ratify and adopt the aforementioned CCNFSDU guidelines and many others.

Building a bridge?

How can we bridge the divide, then, between our industry and consumers?

Industry must not lose sight of the consumer and should not assume that U.S. consumers are being protected or will benefit from something of which they have not been part and to which they have not agreed. Consumer health-freedom leaders should be cognizant of industry goals when they rally the grassroots masses.

If consumers blaze a path through the very heart of Codex, then industry can follow without trepidation since it is consumers, after all, that keep our industry in business and give what we do meaning and context.

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