You may see this warning if ordering Allysian Genesis from California: “WARNING This product can expose you to chemicals including lead, which is known to the State of California to cause cancer and birth defects or other reproductive harm. For more information go to www.P65Warnings.ca.gov.”
Why is this warning needed?
Allysian products meet or exceed all applicable Health Canada and United States federal safety standards, which are extensive. However, a unique California law (Prop 65) requires the above warning in many situations. In California, similar warnings are posted on almost every product and almost every hotel, gas station, or parking garage, and on a great many other places.
Allysian Genesis requires the warning as it contains all natural ingredients that naturally contain trace amounts of heavy metals, including lead. It is not currently possible to process lead out of natural ingredients like ginkgo biloba, for example, or source the over 74 natural ingredients in Genesis where they all conform to the 0.05 ppm standard. To maintain highest levels of quality and safety we test each batch of Allysian Genesis in a third-party laboratory for heavy metal content under Health Canada guidelines and make sure each serving contains no more than 0.5 ppm of lead. The batch you are receiving has been lab tested and contains less than 0.5 ppm of lead per serving. If you are consuming more than one (1) serving it is over the California Prop 65 0.5 mcg daily maximum. However, please note that two servings contain up to 20 times less lead than the safe limit established by Health Canada, USA federal standards and international limits. Please contact us if you require the complete lab test results, and we will happily provide them to you.
What is Prop 65?
In 1986, the people of California passed a ballot initiative proposition, now commonly known as “Prop 65”, that was primarily designed to prevent dumping of toxic chemicals in California waters. However, it also required warnings on products that contain certain chemicals. The law is enforced solely by civil lawsuits, which may be brought either by public authorities or private persons. Although the law was well-intentioned, it has caused many unforeseen consequences. And because it was passed by a ballot initiative, avoiding the usual legislative process, it is difficult to change.
Prop 65 applies to any product or service received or used in California. As applied to foods, Prop 65 makes no distinction between natural and artificial products. And although it excludes “naturally occurring” chemicals in foods, that term does not include man-made pollutants that may end up in natural products through processes outside of the manufacturer’s control. Prop 65 does not distinguish between chemicals that result from natural phenomena like volcanic activity; chemicals that result from worldwide soil, water, and air pollution that are naturally absorbed by plants; those that are the result of local/regional problems like pesticide overspray or chemical leaks; those that are intentionally applied like synthetic fertilizers and pesticides; and those that are introduced later in drying, processing or manufacturing.
Prop 65 also does not limit in any way either the types or amounts of chemicals that can be put into a product, as long as the warning is given. Nor does the warning have to disclose the kinds or amounts of chemicals in the product.
What kinds of chemicals require this warning?
Prop 65 applies to chemicals identified by the State of California as carcinogens and reproductive toxins. Although there may be debates about which chemicals actually do cause cancer, birth defects, or reproductive harm, Prop 65 requires the State of California to publish a list of these chemicals. When Prop 65 went into effect in 1987, there were about 30 chemicals on the list, but as of 2011, the list had grown to well over 800 different chemicals. Obviously, no natural product manufacturer can afford to routinely test for more than even a very few of these chemicals.
What levels of chemicals require this warning?
Prop 65 does not set limits on how much of any listed chemical a specific product can contain, but it does set a “safe harbor” exposure level below which no warning is required. That “safe harbor” is often about 1,000 times lower than normal “safe exposure” amounts, and for many chemicals, that “safe harbor” level is so low that it cannot be reliably achieved in practice.
Can you give an example?
Lead is an element that is found in almost all soil. The US Geographic Survey has estimated that the average lead content of completely uncontaminated soil in the US is about 16 parts per million (ppm). Over the last hundred years, lead-bearing fuels, paints, and other products have deposited man-made lead contaminants into the soil throughout the United States (and developed countries all over the world). Crops that grow in this soil will absorb this man-made lead. In the US, lead levels in soil are now considered “low” below 500 ppm, and are considered “high” above 1000. The EPA requires that soils in children’s play areas must be under 400 ppm, and in other residential areas must be less than 1200 ppm. For comparison, EPA requires that children’s toys contain less than 100 ppm of lead.
The federal safety standard set by the FDA and Health Canada for lead in dietary supplements is no more than 10 ppm. International standards are often 5 ppm. But the Prop 65 “safe harbor” standard is 0.5 micrograms per day, meaning that a person may not be exposed to lead above this amount, for any product, without a Prop 65 warning. Setting aside the difficulties of translating this exposure level to a concentration level in a specific product, applying this standard to supplements means that lead content levels may need to be many times lower than federal levels, in order for a product to be sold without a Prop 65 warning. Above the “safe harbor” levels, a Prop 65 warning must be given to avoid lawsuits and potential liability. Similar “safe harbor” standards are set for over 800 other chemicals on the Prop 65 list.
When grown in soil with a relatively “low” lead content (500 ppm), spinach and radishes can have lead levels that exceed 3 ppm, while beets and carrots can exceed 6 ppm. Also, herbs may contain over 90% water by weight, so lead levels in dried herbs can be up to 10 times higher than their fresh counterparts. In addition, it is difficult to get root crops (like radishes, beets or carrots) entirely free of the soil they are grown in, even with power washing. Good washing is critical, because at 500 ppm, even 1% of remaining soil, all by itself, would exceed the international lead standards for supplements. Under these circumstances, it is easy to see how it might be difficult to keep lead levels low in natural herbal products, and especially in root crops.
Even where federal and international safety standards are clearly met, if there is any likelihood that lead (or any of the other 800+ compounds on California’s list) might exceed California’s “safe harbor” levels, then a Prop 65 warning like the one you see is the only way to avoid expensive lawsuits.
Please send any questions or comments to us at firstname.lastname@example.org.