Fox News is commenting on a study published in the August 27 issue of JAMA in which medical researchers say that one-fifth of Ayurvedic herbal medicines sold on the Internet contain dangerously high levels of lead, arsenic and mercury. How’s a consumer to protect themselves?
Ayurvedic supplements, which are said to be based on traditional Indian medicine, are used by the majority of India’s 1.1 billion residents, as well as by people worldwide. However, this analysis, by Boston researchers found, that there have been 80 cases of lead poisoning associated with the supplements.
In the study, Ayurvedic medicines were divided into two major types: herbal-only and rasa shastra, which is an ancient practice of deliberately combining herbs with metals such as mercury, lead, iron and zinc, as well as minerals such as mica and gems like pearl.
Then the researchers conducted an Internet search using the search terms Ayurveda and Ayurvedic medicine and identified 673 products, of which 230 Ayurvedic medicines were randomly selected for purchase between August and October 2005. One hundred ninety-three of the 230 requested medicines were received and analyzed.
Dr. Robert B. Saper, of Boston University School of Medicine and Boston Medical Center, and colleagues found that the prevalence of metals in U.S.-manufactured products was 21.7 percent, compared with 19.5 percent in Indian products.
Rasa shastra medicines were more than twice as likely as non–rasa shastra products to contain detectable metals and had higher median concentrations of lead and mercury.
Among the metal-containing products, 95 percent were sold by U.S. Web sites and 75 percent claimed “good manufacturing practices.” All of the metal-containing products exceeded one or more standards for acceptable daily metal intake.
“Several Indian-manufactured rasa shastra medicines could result in lead and/or mercury ingestions 100 to 10,000 times greater than acceptable limits,” the authors wrote in their study.
The authors suggested greater government oversight as to how much metal is allowed to be used in the supplements.
And, I could not agree more. As I wrote in my book, Alternative Medicine: The Christian Handbook:
Most European countries strictly regulate the manufacture and sale of herbal and other botanical products.
In Germany, the Federal Health Agency set up what became known as Commission E to evaluate the safety, efficacy, and quality of herbal products.
Although the Federal Health Agency does not test herbal products, manufacturers are required to submit proof of a product’s quality, safety, and effectiveness.
Each product’s license must be renewed every five years. Once established, Commission E functioned independently of the Federal Health Agency.
From 1978 to 1994, Commission E reviewed all available literature on the safety and efficacy of 360 herbal remedies. These technical reports were published and are now available in English.
In countries with such regulations, consumers are assured of the consistency and safety of what they purchase — and they have some confidence that the claims made about a substance are accurate.
Unfortunately, this is not true in the United States, as there are no such standards or regulations.
Consumers not only have no guarantee of the safety or efficacy of what they purchase; in many cases they can’t even be sure that the amount of the herb or other active ingredient indicated on the label is actually there.
Studies have shown the following:
• missing ingredients where what was listed on the label was not in the container.
• contaminants in some products, including dangerous chemicals or pharmaceuticals not listed on the label.
• differences in the contents of the same product from different manufacturers (or even from the same manufacturer).
• prescription medications found in “natural” remedies and supplements without being listed on the label.
• unacceptable variation in the amounts of active ingredients in different batches of the same product. For example, the Los Angeles Times commissioned a study to examine St. John’s wort, an herb known to be effective against some forms of mild to moderate general depression.
Times reporters purchased the ten most popular brands from several retail outlets and had the pills tested by an independent laboratory. The results were startling.
Only one had between 90 and 110 percent of what the label indicated (an acceptable standard for over-the-counter products, based on the German standards).
One manufacturer’s pills had only 20 percent of the amount of active ingredient claimed on the label. Two others had a third more than the labels claimed.
Such problems exist in the United States in large part because of the way dietary supplements are regulated. Prescription and over-the-counter drugs are heavily regulated and closely monitored.
For this reason, when you pick up a prescription at the pharmacy, you can be confident you have a high-quality product in your hands.
Manufacturers are required to show that these products are effective and safe and made to the highest standards before they are allowed on the market. Not so with dietary supplements.
The Food and Drug Administration (FDA) oversees the regulation of drugs, food, and dietary supplements. In the early 1990s, the FDA was concerned about the way dietary supplements were being regulated and sought to tighten its control over these products and their labeling.
However, manufacturers and consumers lobbied against the new regulations in Congress. The result was passage of the Dietary Supplement Health and Education Act of 1994 (DSHEA). This legislation expanded the list of items regulated as dietary supplements and limited the FDA’s role in their regulation.
Under DSHEA, the term “dietary supplement” includes dietary substances added to supplement the diet as well as vitamins, minerals, herbs, and extracts of any such ingredients. Manufacturers are not required to submit evidence of effectiveness or safety prior to marketing a dietary supplement.
The burden is on the FDA to prove that a dietary supplement is unsafe before it can be taken off the market. Hence, in spite of the many reports of adverse effects from ephedra, it took from 1997 to 2004 for the FDA to succeed in banning ephedra products.
By contrast, the manufacturer of a new pharmaceutical drug must prove the drug is safe and effective before the company is allowed to put it on the market.
Controversy reigns over precisely what claims can be made for a dietary supplement. General health claims — “maintains a healthy heart,” “helps relaxation” — are allowed. Claims cannot be made that a product prevents or treats a disease.
The DSHEA also requires all statements about health claims on dietary supplements to prominently display the words, “This statement has not been evaluated by the Food and Drug Administration. This product is not intended to diagnose, treat, cure, or prevent any disease.” The warning appears to have had little effect. Consumers continue to buy these products, believing manufacturer claims and ignoring the DSHEA warning. The warning actually gives the makers of these products an easy “out” — deniability.
So, what’s a person in the U.S. to do?
One great option is to utilize the results of independent testing labs that test herbs, vitamins, and supplements.
A trustworthy source of information is USP. They have a program to approve “USP Verified Dietary Supplements.”
A USP approval verifies that the product (1) is free of common contaminants; (2) dissolves quickly enough in the stomach for the active ingredient to be absorbed by the body; (3) was manufactured in a clean, professional facility; and (4) contents are accurately reflected on the label.
USP product reviews are now available via the subscription-based Natural Medicines Comprehensive Database. Unfortunately, USP has not tested that many herbs, vitamins, and supplements.
However, another lab has. It’s the subscription-based ConsumerLab, which provides independent test results and information to help consumers and healthcare professionals evaluate health, wellness, and nutrition products.
ConsumerLab publishes results of its tests online at www.consumerlab.com, including listings of brands that have not passed testing.
As of 2008, subscription for one-year (12 months) is $29.95 and includes access to the Natural Products Encyclopedia. 30 day access to individual reviews is $12.
I highly recommend these resources for healthcare professionals or consumers seeking evidence-based, trustworthy information on herbs, vitamins, and supplements – as well as help in finding safe products.