California Residents – California Proposition 65

What is California Proposition 65?
In 1986, the people of California passed a ballot initiative proposition called the Safe Drinking Water and Toxic Enforcement Act of 1986, now commonly known as “Prop 65”, primarily designed to prevent dumping of toxic chemicals in California waters. However, it also required warnings on products that contain certain chemicals. While we certainly agree that keeping industrial chemicals out of food products is a good idea, that is not what Prop 65 does. 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 means outside of the manufacturer’s control. Prop 65 does not distinguish between chemicals resulting from external sources like worldwide soil, water, and air pollution, pesticide over-spray or chemical leaks, which are then absorbed by plants, and those that are intentionally applied like synthetic fertilizers and pesticides or chemicals introduced later in drying, processing or manufacturing.

Comparison of the Prop 65 Standards vs National Standards

Let’s use lead as an example. Lead is a naturally occurring element that is found in the environment, including soil. According to the EPA, natural levels of lead in soil can range between 50 parts per million (ppm) and 400 ppm. Human-spread lead contamination widens this range, of course, with reports of over 10,000 ppm in certain types of areas, such as industrial facilities. International standards for lead in dietary supplements and food are often set at no more than 5 ppm. The Prop 65 Safe Harbor Maximum Allowable Dose Level for lead is 0.5 micrograms per day, meaning that a person may not be exposed to lead above this amount, by 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 herbs and supplements means that lead content levels would 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. 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 entirely free of the soil they are grown in. 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 herbal root products.

Why did my purchase arrive with a warning label?
While all of our products meet or exceed federal and international safety standards, this law requires that many kinds of consumer goods sold in California, including herbs and other dietary supplements, must contain a label with language similar to the following: Warning: This product contains chemicals known to the State of California to cause cancer and birth defects or reproductive harm. In California, this label is typically found on electrical components (especially wiring), luggage, flashlights, jewelry and glassware, to name just a few items — it’s even found on fresh fruits, vegetables and nuts. This warning is also required to be posted in a conspicuous place at hotels, restaurants, gas stations and other public places. We include the warning label on our products to remain fully compliant with this law.

Does this mean that the product is dangerous?
No, it does not. However, although the intent of the warning label is to protect consumers, it does little to inform them. In other words, the law requires the inclusion of this label even though it says nothing about the actual safety of the product itself or what, if any, harmful substance is present and in what amount. In addition, the “safe harbor” of acceptable levels for certain substances set forth in Proposition 65 are often significantly lower than federal or international standards. Not only are these levels nearly impossible to detect with routine testing, but their inclusion is usually the result of naturally occurring processes.

What kinds of substances are we talking about?
While the list of offending chemicals is extensive, the majority are understandable. Some, however, are naturally occurring substances that have increased in volume due to human activities. For example, arsenic is a deadly poison, but is also a trace element found in low concentrations in soil, air and water. Some comes from volcanic ash, but most environmental arsenic persists as the direct result of burning fossil fuels.

Another example is lead. In the U.S., lead exists in virtually all soil at an average of 16 parts per million (ppm). Due to the extensive use of lead-containing paints, fuels and other products in previous decades, low-level lead concentration in soil is now considered to be 500 ppm and 1,000 ppm at the high end. A small amount of this lead is absorbed by plants. For dietary supplements, including herbs, the safety standard set by the U.S. Food and Safety Administration (FDA) for lead is 10 ppm. The Proposition 65 standard is 0.5 micrograms per day – almost 1,000 times lower than the level at which the FDA deems a potential health risk. To put this into perspective, spinach and carrots, whether organically grown or not, contain between 3 ppm and 6 ppm of lead.

Here’s the thing… Although the spirit of the law is intended to ensure public safety, the way it is currently implemented undermines consumer confidence and makes companies in the natural products industry—even farmers and wild crafters—responsible for environmental pollutants caused by other, less regulated industries. It also places the burden of proof relating to the safety of any product on companies who are forced to demonstrate that a warning label is not necessary. Finally, because enforcement of Prop 65 is conducted via civil litigation, the law, as written, triggers frivolous lawsuits that are difficult, if not impossible, to defend against.

If you’re a resident of California, tell your legislators that the FDA already has a handle on regulating your dietary supplements and that Prop 65 is more harmful than helpful. Find your legislator on the California State Legislation Directory.

If you live in a different state, communicate your concerns about Prop 65 to your Congressional Representative. Find yours by state and district on the House of Representatives Directory.