What is this warning?
You may see this warning label on some products that means the following: this product contains a chemical known to the State of California to cause cancer or reproductive harm.
This warning can also appear at the point of purchase or checkout for an online retailer or catalog item.
California has two different types of warnings – warnings for cancer, and warnings for reproductive health effects. Some products may have one of the warning labels, and some may have both. Proposition 65 means these warnings are required by California labeling laws to notify buyers in California of exposure to Proposition 65-listed chemicals. Using these warning labels does not mean these items are banned by Proposition 65 in California: it only requires notice that the product contains certain chemicals.
What’s the difference between cancer and reproductive toxicity?
A chemical listed under Prop 65 as a carcinogen has been associated with studies (often in laboratory animals) indicating a potential association with cancer. A chemical listed under Prop 65 as a reproductive toxin has been shown (again, often in laboratory animal studies) to potentially cause male or female reproductive toxicity or developmental toxicity. These tests are usually performed with very high doses of the chemicals.
Does this law apply everywhere?
The "Prop 65" warnings are only required to be shown and placed under California law. California and Prop 65 standards are far more stringent than federal standards, and are among the harshest standards found. Because California’s thresholds are set so low, California law requires disclosures on products even when no evidence suggests a health concern for the consumer.
What kinds of substances require warnings?
Over 800 chemicals have been listed under California Prop 65. They include pesticides, heavy metals, and common ingredients like Vitamin A at certain levels.
Practically all known foods contain certain levels of one or more of those 800+ chemicals listed by the State of California. In many cases, the exposure levels that were established by Proposition 65 are far less than what may occur naturally in fruits, veggies, grains, and even common non-filtered drinking water.
Proposition 65 requires warning statements on products that contain listed chemicals, including lead. Lead is an element that exists in nature, and is found in varying degrees across the globe. It is also widely distributed in the environment.
Proposition 65 has affected dietary supplements and herbal ingredients that naturally contain very low levels of certain elements found in common natural sources such as soil, plants and water - one of which is lead. As a trace element in the environment, lead is often unavoidable. The published literature indicates that very low levels of lead commonly ingested with items such as fruits and vegetables does not present a health risk.
The Proposition 65 limit for lead is 0.5 mcg / day, which is far below the amount of lead found naturally in ingredients and food around you that grows on clean, non-contaminated soils. Various countries and safety organizations have reviewed published studies and science to produce guidelines on the levels of heavy metals that can be consumed daily without causing harm that take that fact into account.
The Proposition 65 levels, however, are the most stringent and incorporate a 1000-fold safety factor below the level where there is no observable effect for chemicals such as lead that are naturally occurring. That means the State of California has found no observable effect at amounts up to 1,000 times the threshold that would trigger a Proposition 65 disclosure. The lead in herbal products is no more or less risky than lead found in the traditional American diet, which is reported to provide about 15-25 mcg of lead per day or more from natural ingredients.
For comparison, while Proposition 65 triggers a warning at just 0.5 mcg / day for lead, other lead threshold limits include:
- 6 mcg / day US FDA
- 20 mcg / day AHPA - Canada's Natural Health Dictorate
- 15 mcg/L US EPA
Should I be concerned?
You should always take heed and be aware of label warnings. However, a warning under Prop 65 does not necessarily mean the product will actually cause cancer or reproductive harm. The listing of a chemical under Prop 65 could be the result of tests on laboratory animals. The Prop 65 thresholds for warnings are very stringent and set far below the level where any significant health risk has been established. For example, for reproductive toxicants, the level for warnings is 1000 times lower than the lowest level at which animal studies reported no reproductive health effect. A Prop 65 warning does not mean that the product is unsafe, merely that it contains those elements. Proposition 65 does not prohibit the sale of products containing these chemicals. A warning is required when a product may expose consumers to a listed chemical, but the warning does not necessarily implicated safety concerns.
No scientific evidence suggests, establishes, or implies that any of our products are unsafe for consumption or daily use simply because those products contain low levels of any Prop 65 listed chemical.
How are these warnings determined?
California has a formal process for adding chemicals to the Prop 65 list. Prop 65 allows chemicals to be listed in various ways, including through reports that are based on animal studies. In many instances, these animal studies involve extremely high doses of chemicals to test at more stringent levels.
What kinds of substances are we talking about?
Many dietary supplements and nootropics contain substances that require a warning in California. One vitamin that requires a warning above a certain level is Vitamin A. Incidental contaminants such as lead and mercury also require warnings above a certain level even if they are not added intentionally to a product.
How do the California warnings compare to federal limits?
It's important to note that California label warning requirements are often different from federal safety requirements. As a result, there can be a mismatch between warnings on products sold in California and what is required throughout the rest of the United States. This can explain why sometimes you may see a California Prop 65 warning on a product sold in California but no warning on the same product sold elsewhere. The products are the same, but Prop 65 warnings are required for sales to California consumers.
Additionally, there are various substances that require a California Prop 65 warning at levels that are far more stringent than federal action limits. One example is lead. The Prop 65 standard for warnings for lead is 0.5 micrograms per day, which is far more stringent than federal and international standards for lead.
Why don’t all similar products carry the warning?
There are a lot of reasons. If a company has been involved in a Prop 65 lawsuit, and if that company reaches a settlement, that settlement may require Prop 65 warnings for products. Other companies that are not involved in the settlement, although they may nonetheless sell similar products, may not provide a warning on their product. Due to inconsistent Prop 65 enforcement, this sometimes explains why you will see certain products in the market with warnings, and virtually identical products without warnings. Other companies may elect not to provide warnings because, in their assessment, they conclude that they are not required to do so under Prop 65 standards. A lack of warnings for a product does not necessarily mean that the products is free of the same substances at similar levels, only that it has not yet been subjected to Prop 65 enforcement.
Many natural foods and dietary supplements contain low levels of lead. The presence of lead is attributable to natural sources in the environment, like soil conditions. California’s Proposition 65 exempts chemicals from naturally occurring sources. However, the law places a difficult burden on businesses to prove that lead is naturally occurring in the environment. Many business therefore choose to provide the Prop 65 warnings, even though their products are likely exempt under the law.
I’m confused, now what?
Prop 65 warnings are seen all over California no matter where you go -- in restaurants, grocery stores, hotels, schools, hospitals, and on a wide variety of consumer products. In addition, some internet and mail order retailers have chosen to provide Prop 65 warnings on their websites or in catalogs for all their products and for all consumers.
If you want more information, the one thing to do is to ask the manufacturer to explain the warning. But please, remember that just because another brand does not have the warning, this does not automatically mean that the other brand is free of the substance or has lower levels. And the presence of a warning does not indicate that a product is unsafe or adulterated.