California law requires that our natural herbal products, like many other natural products, must be sold with the following notice in California:
Warning: This product contains chemicals known to the State of California to cause cancer and birth defects or reproductive harm.
Why is this warning needed?
Our products meet or exceed all applicable 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 in almost every hotel, gas station, or parking garage, and on a great many other places and products as well.
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. If the regulatory "safe harbor" warning is given, then the seller is deemed to have complied with the law. Businesses with less than 10 employees, and products that are within certain "safe harbor" limits, described further below, are exempt from the warning requirements.
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. [Note1] 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 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. [Note2] 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 (which also include herbal root products like angelica, echinacea, licorice, or poria).
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 above is the only way to avoid expensive lawsuits.
Who enforces Prop 65?
Prop 65 actions can be brought by the California Attorney General or certain other public authorities, or by anyone who chooses to bring suit "in the public interest". Any plaintiff, including the State of California, who prevails in a lawsuit, or which settles one, is entitled to 25% of any civil penalties paid by the Prop 65 defendant. Over the years, a number of bounty hunters and professional plaintiffs have brought Prop 65 lawsuits, the vast majority of which are settled. In 2010 private plaintiffs settled 187 lawsuits for amounts totaling nearly $14 million. One Prop 65 plaintiff filed hundreds of such suits against dietary supplement manufacturers in 2009-2010. Most were settled for significant sums, which could then be used to finance more demands and lawsuits.
Why not just fight Prop 65 lawsuits?
Prop 65 puts almost all of the burden of proof on manufacturers. For example, instead of requiring a plaintiff to show that the warning is required, the manufacturer is required to show that the warning is NOT required. In addition, the law requires the business to prove prove that any listed chemical in the product is "naturally occurring", meaning that it may not be man-made in origin, even if the process that got it into the plant is as natural as rain and plant transpiration. For lead in soil, this burden is impossible to meet-- most lead in herbs is of man-made origin, even when deposited by rain in the pristine forest lands where wild-crafted herbs are grown. Under Prop 65, farmers (and manufacturers of herbal products) are responsible for man-made pollutants in the water, soil or air, no matter who originally caused them.
If the manufacturer's defense is not successful, Prop 65 imposes a heavy penalty on the business for failure to warn, which increases for every day that the warning is not given, and the business is also required to pay the successful party's costs and legal fees. Even if the manufacturer wins, he still has to pay his own legal fees, which are significant, and which by law he cannot recover from the bounty hunter who brought the suit. Although in the past the State of California has taken some action to curb abusive litigation, it has a strong interest in ensuring that enforcement actions are filed. Because of these lopsided rules, the manufacturer has everything to lose, and almost nothing to gain, by going to trial. As a result, almost all Prop 65 cases are settled (for substantial sums) without trial, whether the manufacturer actually did anything wrong or not.
So far, RidgeCrest Herbals has never been forced to pay a settlement, so our prices have not been affected. But we have seen good companies (our competitors) forced to pay exorbitant sums to settle Prop 65 claims, even though their products are well within federal safety standards, and even though the required warnings provide no meaningful guidance to consumers. In our opinion, this kind of injustice has no place in any legal system that pretends to be fair and impartial. And of course, as with any business regulation, it is always the consumer who pays these costs in the end.
What can I do?
If you live in California, tell your legislators that Prop 65 is NOT working. Even the California Supreme Court has acknowledged that Prop 65 has resulted in a forest of meaningless warnings, which give no practical guidance for consumers. It makes lucrative work for lawyers, provides a way to publicly "spank" unpopular companies or industries, and subjects innocent manufacturers to an unfair but legal shakedown, with costs that are ultimately passed on to consumers.
If you live outside California, write your representatives in Congress. Tell them that California has no right to interfere with your supplements, that they are already extensively regulated by the FDA, and that where supplements and drugs are concerned, Prop 65 should be pre-empted under Federal law.
[Note1] http://www.uri.edu/ce/factsheets/sheets/lead.html, retrieved 2011-12-27.
[Note2] http://www.pjoes.com/pdf/16.1/57-62.pdf, retreived 2011-12-27.