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Prop 65

Because of California’s Proposition 65, we have to post the following warning:

WARNING: This product contains chemicals known to the State of California to cause cancer and/or birth defects or other reproductive harm.

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 our suppliers do, 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 our suppliers. 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.

Our suppliers 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. Our suppliers remain 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.