Proposition 65, also known as the Safe Drinking Water and Toxic Enforcement Act of 1986, is a California law that requires companies to display a warning label on any product containing certain chemicals with levels above a predetermined threshold.
Over 900 chemicals have been listed under California Prop 65 as carcinogens or reproductive toxicants or both. Examples of such chemicals include cadmium, mercury and lead. Certain listed chemicals like lead are widely distributed throughout the environment in air, soil, water and rocks. As a result, these types of chemicals are often naturally found in commonly eaten foods, even though these chemicals are not intentionally added.
The warning label simply means that the supplement contains small amounts of certain chemicals that may pose a small risk.
By law, a business must include a warning label if their product contains an identified chemical at certain levels, unless the amount is minimal enough that it poses no significant risk. “No significant risk” means that the likelihood of developing cancer is no more than one in 100,000 over the course of a 70-year lifespan as a result of the chemical exposure.
Chemicals known to cause birth defects or other reproductive harm undergo research to determine the level at which the chemical poses no threat to humans or animals. This level is known as the “no observable effect level,” Out of an abundance of caution, Prop 65 divides this level by 1,000 to ensure an adequate margin of safety. In other words, a warning label is required if the product contains more than 1/1000th of the “no observable effect level” for a particular chemical known to cause other reproductive harm and birth defects.
Proposition 65 only applies in California. A company that sells consumer goods in California—whether or not the company is located in California—is subject to Proposition 65’s warning notice requirement. Proposition 65 warning notices are not required to be included on the labels of products that are sold in other states.
When a manufacturer includes a Proposition 65 warning notice on a product, it does not mean the product is unsafe. Rather, the warning notice is intended to inform California consumers of the presence of a Proposition 65-listed chemical so the consumer can make an informed decision when purchasing the product. When used as directed, chemical exposure is minimal. Prop 65 regulations are particularly stringent and exceed guidelines established by the EPA and FDA.