Heavy Metals, Chinese Herbs & California's Proposition 65

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Heavy Metals, Chinese Herbs & California's Proposition 65

September 2001

Mayway has been in operation for 32 years and has been privileged to be a part of the growth and acceptance of traditional Chinese medicine in America today. Through the years we have worked to bring an awareness of the value of traditional Chinese medicine in promoting health and wellness.

Our role is one of leadership. We have participated in solidifying the status of traditional Chinese medicine through the support of trade organizations, research programs, community outreach and political activism.

Mayway has been at the forefront of raising the standards of quality control within our industry. Over time we have become more vigilant in the sourcing of herbs, as well as the manufacturing and quality control of the goods we import. We have built our own herb processing facility in China to control the quality of herbs from the field to your door. Working with internationally certified GMP factories, we have created the Plum Flower® Brand line to ensure that high quality traditional medicines are available in the American and European marketplaces.

Mayway is a responsible supplier that maintains strict quality control standards for heavy metals, independent of Proposition 65. These standards as well as Proposition 65 issues are described below.

Our Pledge Mayway will continue to do the following for all products intended for sale in California:

  • We will provide the Proposition 65 warning on all products that do not have test data confirming that all heavy metals are below Proposition 65 "no significant risk" and "no observable effect" levels.
  • We will continue to reject batches of Plum Flower® and Min Shan® Brand products if heavy metals exceed Company standards (outlined below) regardless of warnings.
  • We will endeavor to look for new sources and new technologies in an effort to further reduce or eliminate the presence of heavy metals in our products.

Our Quality Control Standards
Each and every batch of Plum Flower® and Min Shan® Brand pills is tested for heavy metals. As there are presently no State or Federal heavy metal guidelines for traditional Chinese medicines, we researched our own. We were guided to the U.S. Pharmacopoeia (USP) to determine safe heavy metal levels for our products. USP levels are lead 10 ppm*, cadmium 3 ppm, arsenic 3 ppm, and mercury 3 ppm. However, as the factories we work with have GMP certification granted by the Australian Therapeutic Goods Administration (Australia's FDA equivalent), we also looked at their heavy metal guidelines. We found their levels to be even lower for lead at 5 ppm, and adopted the Australian standard as our own. Each batch of Plum Flower® and Min Shan® Brand pills is tested to these standards both at the factory and at third party labs for extra quality assurance.

Our ongoing commitment to improve quality control
We work to continually improve the quality of our products. We have always done microbial, sulfur and general heavy metals testing on our Plum Flower® Brand un-sulfured bulk herbs. In addition, since January of 2001, we have also been testing our bulk herbs specifically for lead, arsenic, mercury and cadmium. We have also been testing and setting limits for DDT and benzene hexachloride, two very toxic and banned pesticides. Our most recent achievement (July, 2001) of source improvements have allowed us to further lower our heavy metal limits for Plum Flower® and Min Shan® Brand formulas to 3 ppm for lead, 2 ppm for arsenic, 0.5 ppm for mercury, and 1 ppm for cadmium. We continue to gather data on soil pollution where herbs are grown allowing us to make ever more informed choices regarding herb sourcing as we strive for cleaner, more pure herbs and herbal products.

Analysis of Proposition 65 with Reference to Chinese Herbal Medicine

What is California's Proposition 65?
Proposition 65 is a statewide initiative passed in 1986 known as The Safe Drinking Water and Toxic Enforcement Act of 1986. This legislation was designed to address public concern about exposure to toxic chemicals. Proposition 65 requires that a list of chemicals which are known to cause cancer or reproductive harm be published by the Governor of California. Proposition 65 imposes certain controls over the listed chemicals, and is intended to allow California's consumers to make informed choices about the products they purchase.

How does Proposition 65 affect Chinese herbal medicine?
The Governor of California's list contains over 700 naturally occurring and synthetic chemicals. Heavy metals are listed and are the grounds upon which Proposition 65 is being brought to bear on Chinese herbal medicine. Proposition 65 requires California businesses to provide a "clear and reasonable" warning before exposing anyone to a listed chemical. The warning reads: "WARNING: This product contains chemicals known to the State of California to cause cancer and/or birth defects or other reproductive harm." Proposition 65 applies to companies which operate in, or sell products into California. Even if a company has its own standards for heavy metals, as Mayway does, it still must comply with the Proposition 65 warning requirements.

What are Proposition 65's standards?
Proposition 65 states that a warning must be given unless a business demonstrates that the exposure it causes poses "no significant risk". "Significant risk" is very narrowly defined in Proposition 65. For a chemical listed as a carcinogen (such as lead, arsenic and cadmium) the "no significant risk level" (NSRL*) is defined as the level which is calculated to result in not more than one excess case of cancer in 100,000 individuals so exposed over a 70-year lifetime. In other words, if you are exposed to the chemical in question at this level every day for 70 years, theoretically it will increase your chances of getting cancer by no more than 1 case in 100,000 individuals so exposed. For chemicals listed as reproductive toxins (such as lead and mercury) the "no significant risk" level is defined as the level of exposure, which even if multiplied by 1,000 will not produce birth defects or other reproductive harm. In other words, the level of exposure is below the "no observable effect level" (NOEL*) divided by 1,000, or stated another way, 1/1000th of the "no observable effect" level.

How does Proposition 65 work?
Proposition 65 was designed to provide a market-based incentive for manufacturers to remove listed chemicals from their products. Initially Proposition 65 provided a means for reducing certain exposure that may not have been adequately controlled under existing laws. Despite its successes this initiative has become problematic.

What are the problems with Proposition 65?
One of the more obvious problems with Proposition 65 is that it does not directly affect the levels of listed chemicals in a product or require products to be safe; it merely requires that the product carry a warning. Additionally, it does not create safety standards for individual industries. Perhaps the most problematic element of Proposition 65 relates to the way in which it is enforced. It allows private individuals and entities to act as enforcers by bringing lawsuits against violators.

Private enforcers and their lawyers collect huge settlement sums through this process. This has encouraged an industry of "enforcers" in California, some with serious concerns for health and environment and others who are little more than vigilante bounty hunters. As a result, many California businesses have had hyper-technical enforcement efforts brought against them that are motivated by profits rather than to seek consumer protection.

What does a Proposition 65 warning really mean?
It is important to remember that it is not illegal in California to sell products with heavy metals above the Proposition 65 levels, but it is illegal to sell them without a Proposition 65 warning. Proposition 65 does not set new regulations for the manufacturing of products, nor does it require that businesses improve their products. It merely requires that those products not in compliance with its strict standards provide a warning. When a warning is given by a business it means one of two things:

1) The business has evaluated the exposure and has concluded that it exceeds the "no significant risk" level as defined by Proposition 65; or

2) The business has chosen to provide a warning simply based on its knowledge of the presence of a listed chemical without attempting to evaluate the exposure. The exposure in this instance could be below the Proposition 65 levels, could be none at all, or could be exceedingly high.

It is also important to note that many industries have succeeded in getting their own industry wide standards, making them exempt from Proposition 65. Unfortunately the Chinese medicine industry currently has no such protection.

How does this affect you?
Because Proposition 65 enforcement has been selective and gradual, there will be products on the market that don't yet contain warnings, but may have heavy metal concentrations in excess of the standards of Proposition 65, as well as the standards adhered to by Mayway. Ironically, it is possible that herbal products that carry Proposition 65 warnings could be safer than those that do not.

Initially, looking for products to sell in California that do not carry the warning may seem appealing. This would be acceptable only if the product is within Proposition 65 NSRL levels. Otherwise, the seller is in violation of the law.

Some customers may feel that since they employ less than ten people the law may not apply. However, some enforcers have taken the position that both the California Unfair Business Practices Act and the California Sherman Drug Act make it illegal to sell products with dangerous heavy metals without warnings. If correct, they could proceed against any seller, regardless of the number of employees.

We began labeling our products for sale in California with Proposition 65 warnings in September, 2001. This information is provided to help you understand this change. Mayway remains committed to providing the highest quality and safest herbal products possible. We face this challenge to our industry with the hope that it will bring an even higher standard to Chinese herbal medicine, and to you, our customers.

*Glossary of Terms

PPM - parts per million: a unit of measure equivalent to milligrams per kilogram. Measured in milligrams (mg) per unit of measure: 5 ppm = 5 mg/Liter and 5 mg/Kg.

PPB - parts per billion: a unit of measure equivalent to micrograms per kilogram. Measured in micrograms (mcg) per unit of measure: 5 ppb = 5 mcg/Liter and 5 mcg/Kg.

GMP - Good Manufacturing Practices: manufacturing guidelines pertaining to the adherence to certain standards in regards to manufacturing environment and equipment, personnel training, processing, quality control, and record keeping.

NSRL - No Significant Risk Level: the level at which it is calculated to result in not more than one excess case of cancer in 100,000 individuals exposed over a 70-year lifetime.

NOEL - No Observable Effect Level: the highest dose level at which it has not been associated with an observable reproductive harm in humans or test animals.

Heavy Metals - metals that exist in the environment or in the body at very low levels and have molecular densities at least five times greater than water.

Helpful Resources
Office of Environmental Health Hazard Assessment www.oehha.org
Environmental Law Foundation www.envirolaw.org
Proposition 65 News www.prop65news.com
The Ecology Center Berkeley, CA (510) 548-2220

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