California Proposition 65 (Prop 65), codified at California Health and Safety Code Section 25249.5 et seq. and administered by the California Office of Environmental Health Hazard Assessment (OEHHA), requires businesses with 10 or more employees to provide clear and reasonable warnings before knowingly exposing individuals to chemicals on the Prop 65 list.
For food and supplement brands, Prop 65 creates a parallel compliance obligation on top of federal FDA and FTC requirements — one that is enforced primarily through private litigation rather than agency enforcement, and that can reach brands selling into California through any channel, including Amazon and e-commerce.
The Prop 65 Chemical List
OEHHA maintains the Prop 65 list of chemicals known to the state of California to cause cancer, birth defects, or other reproductive harm. The list contains over 900 chemicals. Chemicals most commonly relevant to food and supplement brands include:
Lead — present in soil-grown ingredients, some herbal supplements, and certain protein powders
Cadmium — present in some plant-based ingredients, particularly root vegetables and cocoa
Arsenic (inorganic) — present in rice-based ingredients, some seafood-derived products
Acrylamide — formed in starchy foods cooked at high temperatures (coffee, chips, roasted nuts)
Mercury — relevant for fish oil and omega-3 supplements
Cocoa-related compounds — some processed cocoa products have elevated cadmium or lead
Certain herbal extracts — some botanicals contain naturally occurring compounds on the Prop 65 list
Safe Harbor Levels
A business is not required to provide a Prop 65 warning if the level of a listed chemical in a product is below the applicable No Significant Risk Level (NSRL) for carcinogens or Maximum Allowable Dose Level (MADL) for reproductive toxicants. Safe harbor levels are published by OEHHA and are set at levels of exposure posing no significant risk.
For food and supplement brands, the practical question is whether the daily dose of a listed chemical a consumer would receive from normal use of the product exceeds the safe harbor level. Brands typically commission third-party chemical testing to determine whether warnings are required.
Warning Requirements
If a product contains a listed chemical above the safe harbor level, the warning must be:
Clear and reasonable — the warning must adequately inform the consumer of the exposure
Provided before the exposure — a warning on a label counts as provided before purchase
In the prescribed format under California Code of Regulations Title 27, Section 25603 et seq.
Short-form warning for food products (required since August 30, 2018):
⚠ WARNING: Consuming this product can expose you to [name of chemical(s)], which is [are] known to the State of California to cause [cancer and/or birth defects or other reproductive harm]. For more information go to www.P65Warnings.ca.gov/food.
The warning symbol (⚠) and format are specified by regulation. Outdated warning language (pre-2018 format) is no longer compliant.
Private Enforcement and Litigation Risk
Prop 65 is primarily enforced by private plaintiffs — attorneys and advocacy organizations that test products, identify missing or inadequate warnings, and file lawsuits against brands. The state attorney general, district attorneys, and city attorneys can also enforce.
A 60-day notice of intent to sue must be sent to the business and to the California Attorney General before a private lawsuit is filed. This notice period allows brands to cure the violation by adding a warning, reformulating, or entering a settlement.
Settlements often include:
Payment to the plaintiff (attorney's fees and a portion to a state fund)
Reformulation to reduce chemical levels
Addition of a Prop 65 warning to the label or point of sale
Brands that do not address Prop 65 notices face civil penalties of up to $2,500 per day per violation.
Brands Selling on Amazon and E-Commerce
Prop 65 applies to products sold to California consumers regardless of the seller's location. Brands selling on Amazon, their own website, or other e-commerce platforms to California customers are subject to Prop 65 if their products contain listed chemicals above safe harbor levels. Amazon has its own Prop 65 compliance requirements and may require brands to provide warning language for product listings.
How Truli Helps with Prop 65 Compliance
Ingredient risk flagging: Truli identifies ingredients commonly associated with elevated Prop 65 chemical levels — lead, cadmium, arsenic, acrylamide — based on your product formulation
Warning requirement guidance: Truli surfaces Prop 65 warning requirements for your product category and distribution channels
Multi-state compliance tracking: Truli tracks California regulatory updates alongside federal FDA and FTC requirements
Related Regulations
21 CFR Part 101 — FDA food labeling requirements
FALCPA and FASTER Act — Federal allergen labeling requirements
Frequently Asked Questions
Does Prop 65 apply to supplements as well as food?
Yes. Dietary supplements sold to California consumers are subject to Prop 65. Many enforcement actions have targeted herbal supplements, protein powders, and other supplement products with elevated lead or cadmium levels.
If I add a Prop 65 warning, does that mean my product is unsafe?
Not necessarily. Prop 65 warnings indicate that a product contains a listed chemical at a level that could pose a risk under California's conservative thresholds — which are often set far below federal safety limits. Many products carry Prop 65 warnings while meeting all FDA safety standards.
Can I just add the warning to avoid litigation?
A Prop 65 warning is a valid compliance strategy, but some plaintiff groups have argued that warnings are not sufficient for food products if the chemical exposure is unnecessary. The safest approach for food and supplement brands is to test for listed chemicals and reformulate where feasible, adding a warning only when chemical levels cannot be reduced below the safe harbor level.
A note from Truli: Truli is not a law firm, and this article does not constitute or contain legal advice or create an attorney-client relationship. When determining your obligations and compliance with respect to relevant laws and regulations, you should consult a licensed attorney.
Last updated: April 2026. The Prop 65 chemical list is updated at least annually — Truli monitors OEHHA updates affecting food and supplement brands. Book a demo to see how.
