- Prop65 is a warning required in California on products with potential contaminants that could harm consumers
- Prop65 sets safety limits far below already-robust Federal Safety Regulations
- Prop65 warnings can now be found on almost all products sold in California
- A lucrative lawsuit industry has emerged, with hundreds of lawsuits filed against small companies
- Regardless of whether a company meets the requirements of Prop65, it is cheaper to put it on their products than risk a costly lawsuit to prove they don’t need to.
California law requires that our natural herbal products, like many other natural products, must be sold with the following notice in California:
In California, similar notices are posted in almost every hotel, gas station, or parking garage and on many other places and products.
WHAT IS PROP 65?
In 1986, the people of California passed a ballot initiative proposition, now commonly known as "Prop 65," primarily designed to prevent the dumping of toxic chemicals into California waters. However, it also required warnings on products that contained certain chemicals. The law is enforced solely by civil lawsuits, which public authorities or private persons may bring. 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's challenging to change.
Prop 65 applies to any product or service received or used in California. Prop 65 makes no distinction between natural and artificial chemicals when applied to foods. It excludes "naturally occurring" chemicals in foods that may end up in natural products through processes outside the manufacturer's control. Prop 65 does not distinguish between:
- chemicals that result from natural phenomena like volcanic activity
- chemicals that result from the worldwide soil, water, and air pollution that plants naturally absorb
- 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
- those that are introduced later in drying, processing, or manufacturing
As long as the warning is given, Prop 65 doesn't require information regarding the types of chemicals in a product or the levels in which they exist, giving consumers little information. If the regulatory "safe harbor" warning is given, then the seller is deemed to have complied with the law. Businesses with less than ten employees and products within certain "safe harbor" limits 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 do cause cancer, congenital disabilities, 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. By 2011, the list had grown to over 800 different chemicals. As a result, no natural product manufacturer can afford to test for more than a few of these chemicals routinely.
WHAT LEVELS OF CHEMICALS REQUIRE A PROP 65 WARNING?
Prop 65 doesn't limit 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. Unfortunately, that "safe harbor" is often about 1,000 times lower than "safe exposure" amounts in other regulations.
CAN YOU GIVE AN EXAMPLE?
Lead is an element found in almost all soil. The U.S. Geological Survey has estimated the average lead content of completely uncontaminated soil in the United States is about 16 parts per million (ppm). Over the last hundred years, lead-bearing fuels, paints, and other products have deposited lead contaminants into the soil throughout the U.S. (and developed countries worldwide). Crops that grow in this soil will absorb this lead. In the U.S., lead levels in the soil are now considered "low" if they're below 500 ppm and are considered "high" if they're above 1,000. The EPA requires soils in children's play areas must be under 400 ppm, and in other residential areas, must be less than 1,200 ppm. For comparison, the EPA requires that children's toys contain no more than 100 ppm of lead. The federal safety standard set by the FDA for lead in dietary supplements is no more than ten ppm. International standards are often five ppm, but the Prop 65 "safe harbor" standard is 0.5 micrograms per day.
Even where Federal and International safety standards are clearly met, if there's any likelihood that lead (or any of the other 800+ compounds on California's list) might exceed California's "safe harbor" levels, then displaying a Prop 65 warning label is the only way to avoid expensive lawsuits.
WHO ENFORCES PROP 65?
Prop 65 actions can be brought by the California Attorney General, certain public entities, or anyone who chooses to bring suit "in the public interest." Any plaintiff who wins or settles a lawsuit, including the State of California, is entitled to 25% of any civil penalties paid by the Prop 65 defendant. This has turned suing companies into something of a cash-cow industry. In 2010, private plaintiffs settled 187 lawsuits for nearly $14 million. One Prop 65 plaintiff filed hundreds of lawsuits 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. 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 that any listed chemical in the product is "naturally occurring." But most lead in herbs is of manufactured 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 held responsible for water, soil, and air pollutants.
If the manufacturer's defense is not successful, Prop 65 imposes a heavy penalty on the business for failure to warn, which increases every day the warning is not given, and the company is also required to pay the successful party's costs and legal fees. Even if the manufacturer wins, they still have to pay their legal fees, which are significant, and which they can't recover from the bounty hunter who brought the suit.
In the past, the State of California has taken some action to curb abusive litigation. But it has a strong interest in ensuring 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, practically all Prop 65 cases are settled for substantial sums without trial, whether the manufacturer did anything wrong or not.
RidgeCrest Herbals has seen good companies forced to pay exorbitant sums to settle Prop 65 claims, even though their products are well within federal safety standards and the required warnings provide no meaningful guidance to consumers.
This kind of injustice has no place in any legal system that pretends to be fair and impartial. And, of course, the consumer always pays these costs in the end.
WHAT CAN I DO?
Tell your legislators that Prop 65 is NOT working if you live in California. Even the California Supreme Court has acknowledged that Prop 65 has resulted in a forest of meaningless warnings that give no practical guidance for consumers. Instead, it makes lucrative work for lawyers and subjects innocent manufacturers to an unfair, yet legal, shakedown with costs that are ultimately passed on to consumers.
If you live outside California, write your representatives in Congress. Tell them that your supplements are already extensively regulated by the FDA and that where supplements and drugs are concerned, Prop 65 should be pre-empted by Federal Law.