A Lesson In Lead: Contamanents in Herbal Medicines and California Proposition 65

You may have noticed the California Proposition 65 Warning labels appearing on many herbal medicines. These warnings state that the products contain lead, which is a substance known by the state of California to cause cancer and birth defects. These warnings may have given you pause for thought about how safe these products really are. Unfortunately there has been scant information about the nature of this problem, if indeed there is a problem.

Modern detection equipment has revealed trace amounts of lead in plants and water, as well as the large amounts already found in petroleum, paint, toys, furniture, drugs, crayons, glass, and many other household items. Hearing these reports, we grow concerned and afraid. But is our fear really justified? Is this trace lead in the environment really something to be alarmed about? Is the trace lead found in herbs , plants, animals, food, and water the same hazard as the gross amounts of lead found in gasoline, plumbing, and paint?

The fact is that herbal medicines have likely always contained trace amounts of lead and this lead has never been shown, or even suspected, of causing any disease associated with lead poisoning. Its also a fact that the compounds of lead found in herbal medicines are less likely than free lead to bind with molecules in our body, and are thus slower to be absorbed.

Unfortunately, facts such as these are missing from both government and media sources, which tend to provoke hysteria rather than educate. As a result, many people have become as mistrustful of herbs as they are of pharmaceuticals.

But are these warnings really accurate? For example, labels warn that lead causes cancer, but what evidence supports such a conclusion. Apparently, the warning is based on evidence that high doses of lead have been shown to cause kidney cancer in laboratory animals bred to be susceptible to cancer. However, where is the evidence that such exposure causes cancer in humans? The one study of workers, exposed to high concentrations of lead, showed no increase in the incidence of kidney cancer. Is this really evidence enough to make people fearful of herbal medicines?

After surveying all the science available, Kyle Steenland, PhD and Paolo Boffetta, MD, in their article Lead and Cancer in Humans: Where Are We Now (The American Journal of Industrial Medicine, September 2000, vol. 38, issue 3, pages 295 - 299), conclude that the evidence that lead causes cancer in humans - is weak.

This doesn't mean that lead is safe for us. Far from it, lead is toxic to humans because it can replace other metals in our body such as calcium, zinc, and iron, creating abnormal molecules in our enzymes which then fail to carry out normal body functions. Lead poisoning, also known as painter's colic or plumbism, can result in damage to the kidneys, heart, and nervous system.

This is not new information. In ancient Rome, many ills were attributed to lead, which was used in medicine, jewelry, wine, plumbing, and make-up. As early as 250 BC, Nicander of Coloform wrote about lead-induced anemia. The Roman remedy for lead poisoning was documented to be mallow or walnut juice with wine. Lead has been with us since the beginning of civilization. Lead is an element found in all the earth's soils, rivers, lakes, and oceans. Lead is also found in the air as a component of dust. Lead levels vary from ? per million (ppm) to about 10 ppm in soils sampled far from industrial pollution. Lead exists in anything eaten, including all food, beverages, drugs, and supplements.

There is no doubt that some environmental lead comes from industrial pollution. Over 300 million tons of lead, mined in the twentieth century, has returned to our environment via leaded paint, leaded fuels, leaded “tin” cans, and leaded plumbing. However it's incorrect to single out pollution alone for the presence of lead. Even without any human activity, lead would still exist everywhere, as it does in the ancient igneous rocks formed from our planet's natural volcanic activity. Our bodies always contain some lead, normally about .05 ppm. Healthy human bones contain 20-40 ppm of this element.

The typical American diet is said to contain 15 – 25 micrograms or more of lead daily, mainly originating in fruits and vegetables. Other exposures to the air, water, and industry can result in up to 200 millionths of a gram consumed daily. Typical doses of herbal medicine can add 3 to 15 millionths of a gram per day. 
Though these figures might sound high, they are actually quite low. The amount of lead in our bodies today is actually the lowest in recorded history. Ten years ago we absorbed ten times as much lead as we do today. In 1970, when lead was still in gasoline and paint, we absorbed 20 times as much. Despite this feast of lead, there is absolutely no evidence that our parents or grandparents suffered from mental retardation, cancer, birth defects or any ailments whatsoever because of their exposure to atmospheric lead. If lead really did cause cancer, as Proposition 65 warnings suggest, might not the precipitous decline in lead exposure result in a similar decline in cancer rates? On the contrary, while lead exposure has declined, most cancer rates have risen. Is it possible that fears of lead may have been inflated, and that lead may not be the environmental bogey man we have presumed it to be.

No one doubts that lead is bad for you at toxic levers, but at what levels? Chinese herbal practitioners know that lead can actually be good for you in certain instances. Lead has a long history of cautious use as medicine. The herbal formula “Lead Special Pill” harnesses the “weight” of lead to settle the lungs in certain cases of asthma. The formula is prescribed at precise doses for periods of no longer than two weeks, and is not given to children or pregnant women. It has been in use safely since the year 1040.

That lead can be medicine is not an apology for lead in the environment. Eight thousand years of observation has shown us that lead is mostly not good for you, so there is absolutely no reason to introduce it into the environment, no excuse for putting lead paint on children's toys.  Laws have solved this problem to a great degree, drastically reducing the lead in our surroundings.

Removing lead from our plants, animals, earth and water is much more difficult.  Eons of volcanoes and chimney smoke have dusted our planet with trace amounts of lead. The latest detection technology shows that both the ocean's foam and the organic greens you purchased at the health food store, probably contain lead. A chocolate bar may contain more lead than ten doses of most herbal medicines.

If this is so, why are there no Prop 65 warning labels on a chocolate bar? The curious reason is, of course, money. The chocolate industry had the millions of dollars needed to go to court and prove that all the lead in chocolate occurs there naturally, so it cannot be considered a contaminant. Unfortunately, few of the small herb companies sued under proposition 65 had the resources to prove that all the lead occurring in all the herbs in all their products was also natural. That's the only reason why you'll find lead warnings on herbal medicines, but not on candy.

But is chocolate or herbs really a health problem deserving of warning? There's a lot of evidence that a lot of people have eaten a lot of chocolate and taken a lot of herbs without succumbing to mortal disease. Are California proposition 65 warning labels overly alarming? We know that reduced lead pollution has already reduced the amount lead in our bodies.  The same process is already reducing the amount of lead in plants, and today's plant medicines probably have less lead in them than they might have a generation ago.

There is, and probably always has been, lead in every herbal medicine. This is why many governments throughout the world have created appropriate standards for lead in herbal medicines. For example, Japan allows 20 parts per million (ppm) for total metals in herbal medicines. The World Health Organization allows 10 ppm for lead. The Australian TGA allows 5 ppm for lead in a product. Germany allows 5 ppm as well. The US Pharmacopoeia has no standards for herbs, but allows 3 ppm in drugs.

Most Chinese herbal products test at an average of 1-3 ppm, which is considered safe and incidental by all international standards for medicine. However, California’s Proposition 65 requires warning at only 1/2 ppm in food, and in California, herbal medicines are considered food rather than drugs. Prop 65 allows the sale of these products, however it requires a warning.

Though they might be technically correct, whether or not these warnings are actually educational or even informative is another matter. Certainly Prop 65 warnings create fear among consumers; fears that become associated not only with lead, but the product, the brand, and by association, all of herbal medicine. We believe that this fear of herbs, based on misinformation, is bad for everyone except the pharmaceutical industry, which by the way, is allowed six times as much lead in their products - without posting any lead warning.

Prop 65 warnings create fear, and people who are afraid lose their perspective. The next time you encounter someone worried about trace lead in herbal medicine, please remind them of the 200,000 people who actually die every year from taking over-the-counter, non-prescription drugs.

Besides creating unnecessary fear, Prop 65 warnings are also maddeningly confusing. Some Chinese medicines have warnings and some don't. Warning labels can also vary slightly from brand to brand. Does this mean that some brands are purer than others? Not at all; inconsistency of labeling has everything to do with Prop 65, lawyers, and money and nothing to do with the contents of your medicine bottle. There are several reasons for this.

First of all, companies with fewer than 10 employees are exempt from Prop 65. Their products might contain any amount of contamination, however you will not see warnings on products made or imported by these small companies.

Second, this law is enforced by the public, rather than by the state's attorney general. Under prop 65, public enforcers (ie. lawyers) are entitled to legal fees plus 25% of damages. Since the penalty is $2,500 per day per product on the shelves, and since many of these products have been available for years, penalties can be quite intimidating, and large settlements can be easy to extract.

Enforcing Proposition 65 can indeed be profitable and has been the meat and potatoes for about a dozen law firms and individuals. These enforcers are generally known as Proposition 65 bounty hunters. Throughout the years, various bounty hunters have reached various settlements with different manufacturers. Because small companies are exempt and because large companies have the legal resources to tie up bounty hunters in court for years, bounty hunters usually pick on medium size companies.

Inconsistency in prosecution has created a confusing patchwork of settlements. For example: Seven Forest brand and Health Concerns brand are both made in the same factory with basically the same raw materials. On average, the lead content in both brands is essentially the same. Yet in California, Seven Forest brand will post lead warnings on every product and Health Concerns brand will not. This is because each company reached a different agreement with the Prop 65 lawyer suing them.

Settlements have varied according to penalties assessed, legal fees paid, label wording, and the amount of lead allowed. Forget about the experience gained from generations of daily use, the sad fact is that bouty hunting attorneys, the California attorney general, and govenment functionaries have far more say than knowledgable herbologists as to which herbal products are brought to market, how they are sold, their ingredients, and the dosage prescribed.

What should be of concern to us, is not that these agencies have legitimate interests in herbs, they do; but rather that they make their determinations and judgments without a word from the TCM community of herbologists, who presumably have something to contribute to this process.