California Proposition 65

CHPA monitors Proposition 65 activities to ensure its members who manufacture, distribute, and sell over-the-counter (OTC) medicines in California remain compliant with all applicable regulations.

The Safe Drinking Water and Toxic Enforcement Act of 1986, also known as Proposition 65, was passed in California in 1986. The goal of this legislation is to protect drinking water sources from substances which may cause cancer or birth defects and to reduce or eliminate exposures to those chemicals in consumer products by requiring a warning notifying of the exposure. Each year, the California government publishes a list of chemicals known to the state to cause cancer or birth defects.

Proposition 65 applies only to those chemicals included on the published list and does not ban or restrict the use of any given chemical. Exposures below a certain level for a particular chemical (a safe harbor level) do not require a warning. Proposition 65 enforcement is through lawsuits filed against businesses by various groups and penalties may be assessed for failing to provide the required warnings.

Chemicals can be included on the Prop 65 list via one of four separate ways:

  • Authoritative Body Mechanism: If an organization designated as an authoritative body by the state identifies a chemical as causing cancer or birth defect, it can be listed. Authoritative bodies are the U.S. Environmental Protection Agency; the U.S. Food and Drug Administration (FDA); the National Institute for Occupational Safety and Health; the National Toxicology Program; and the International Agency for Research on Cancer.
  • Formally Required to Label Mechanism: Typically, chemicals listed under this mechanism are prescription drugs required by FDA to include a warning related to cancer or reproductive harm.
  • Labor Code Listing Mechanism: Chemicals meeting criteria specified in the California Labor Code may be listed.