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.
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.
Acetaminophen was chosen for review by OEHHA in part because the Prop 65 regulation emphasizes chemicals with “widespread exposure.” The Carcinogen Identification Committee will review the information on acetaminophen and cancer to determine whether acetaminophen should be listed as a carcinogen under Proposition 65.
Imposing Proposition 65 state-level requirements on chemicals actively regulated under federal purview risks duplicative warnings that undermine public trust in national safety determinations. Since the FDA derives allowable limits from the best available science, overriding federal risk-benefit guidelines with California-specific thresholds triggers unnecessary labeling not reflecting real-world exposures from routine product usage shown to be safe.
CHPA does not believe that the Beneficial Nutrients Regulatory Concept is necessary or supportive of the intent of the Safe Drinking Water and Toxic Enforcement Act of 1986.
Comments on proposed revisions to the Proposition 65 prioritization procedure submitted by the Consumer Healthcare Products Association, Grocery Manufacturers of America, and the National Food Processors Association.
Imposing Proposition 65 state-level requirements on chemicals actively regulated under federal purview risks duplicative warnings that undermine public trust in national safety determinations. Since the FDA derives allowable limits from the best available science, overriding federal risk-benefit guidelines with California-specific thresholds triggers unnecessary labeling not reflecting real-world exposures from routine product usage shown to be safe.
