If you’re a food manufacturer selling products in the United States, especially in California, chances are you’ve heard of Proposition 65 (also known as the Safe Drinking Water and Toxic Enforcement Act of 1986). While it’s not regulated by the FDA, Prop 65 has become a critical consideration for food businesses, particularly when it comes to product labeling and ingredient transparency.
Here’s what you need to know—and how to stay compliant.
Proposition 65 is a California state law requiring businesses to provide warnings on products that expose consumers to certain chemicals known to cause cancer, birth defects, or reproductive harm. These chemicals are listed by the California Office of Environmental Health Hazard Assessment (OEHHA) and currently number over 900.
While the FDA does not enforce Prop 65, it’s important to understand how it intersects with food labeling requirements, especially if you plan to distribute in California.
Prop 65’s relevance to food labeling lies in the fact that many common food ingredients or byproducts from processing can contain listed chemicals. Examples include:
Even naturally occurring levels of these substances can trigger Prop 65 warning requirements.
If your product contains a listed chemical above the state’s “safe harbor” limit, you are legally required to include a warning. These safe harbor levels are defined as either:
If no safe harbor level has been established for a particular chemical, you must determine through testing and risk assessment whether your product requires a warning.
For food products, a common Prop 65 warning label might read, “WARNING: Consuming this product can expose you to [Chemical Name], which is known to the State of California to cause cancer and birth defects or other reproductive harm. For more information, visit www.P65Warnings.ca.gov.”
This label should be both:
As of January 1, 2025, significant changes to California’s Proposition 65 “clear and reasonable warnings” regulations became effective. These changes impact how companies label their products to comply with Prop 65’s warning requirements, including “short-form” warning requirements.
Key updates include:
To avoid risk and ensure your food product is compliant with Prop 65, ensure you’re following these best practices:
Prop 65 may be a California-specific law, but its implications are national, especially for food manufacturers shipping products across state lines. By understanding how it works, keeping up with the OEHHA chemical list, and ensuring your labels meet both FDA and Prop 65 standards, you protect your brand, your customers, and your bottom line.
If you’d like to learn more about managing compliance and staying ahead of evolving food labeling regulations, reach out to our labeling experts today.