Proposition 65

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.

white tablets being shaken from a bottle into a hand
California Prop 65: Acetaminophen

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.

Jan 16, 2020

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Proposition 65 (Prop 65) in the States

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.

Browse Proposition 65 Content

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Polibrief

California Proposition 65

In 1986, California voters overwhelmingly approved the State Drinking Water and Toxic Enforcement Act of 1986, commonly known as Proposition (Prop) 65. Prop 65 was designed to safeguard the state’s drinking water against chemicals known to the state to harm humans by requiring industry to inform Californians about exposures to such chemicals within the products or services they provide for sale to the public.

Nov 19, 2024

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Submission

Coalition Letter Regarding Warning Content for Acrylamide Exposure from Food

May 20, 2024

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Submission

Comments to OEHHA: Prioritization of Chemicals (Titanium Dioxide Nanoparticles)

These comments address titanium dioxide nanoparticles, which serve an important function in numerous consumer products, including sunscreens.

Nov 16, 2020

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Submission

Comments to OEHHA: Prioritization of Chemicals (Benzophenone-3)

As FDA is recognized as an authoritative body by Proposition 65, we believe that OEHHA should await the outcome of FDA's review rather than bringing BP-3 to the DARTIC for review.

Nov 16, 2020

Flask with Chemicals in Gloved Hand

Submission

Comments to OEHHA: Prioritization of Chemicals (Manganese)

Enclosed are comments on the recent notice from the California Office of Environmental Health Hazard Assessment regarding 22 chemicals to be discussed at a meeting of the Developmental and Reproductive Toxicant Identification Committee. These comments address manganese.

Nov 16, 2020

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Submission

Comments to OEHHA: Prioritization of Chemicals (Methyl-, Propyl-, Butyl-, and Isobutylparaben)

These comments address the four parabens that are on the prioritization list. As these ingredients serve an important preservative function and have been extensively reviewed and approved by expert bodies, they should be considered low priority for DARTIC review.

Nov 16, 2020

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Submission

Comments to OEHHA Regarding Neurobehavioral Effects of Food Dyes

Enclosed are comments regarding the OEHHA draft report entitled " Health Effects Assessment: Potential Neurobehavioral Effects of Synthetic Food Dyes in Children."

Nov 12, 2020

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Articles

California Prop 65: Acetaminophen

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.

Jan 16, 2020

Pink Medicine Tablets pouring out of a bottle

Submission

Acetaminophen Prop 65 Briefing Packet

FDA has determined that the currently available evidence does not support the conclusion that acetaminophen causes cancer. Accordingly, a Proposition 65 cancer warning on the labeling of products containing acetaminophen would not be scientifically accurate, and such labeling would be false or misleading.

Dec 13, 2019

white tablets being shaken from a bottle into a hand

Submission

Prop 65 Acetaminophen Coalition Comments to OEHHA

We strongly urge the CIC not to “list” acetaminophen as a carcinogen due to the lack of evidence that it has been “clearly shown” to cause cancer, and due to the unnecessary confusion and fear it could cause among consumers and patients.

Nov 5, 2019

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