Introduction: Navigating California's Unique Warning Landscape
California's Proposition 65 warnings, officially the Safe Drinking Water and Toxic Enforcement Act of 1986, aims to protect drinking water and inform Californians about exposure to chemicals linked to cancer or reproductive harm.
The California Office of Environmental Health Hazard Assessment (OEHHA) annually updates the list of regulated chemicals, which now includes around 900 naturally occurring and synthetic substances found in many products, including food. While its original focus was environmental, Prop 65's most visible impact has shifted to widespread consumer product labeling, posing unique challenges for the food industry.
Its broad scope and unique enforcement make compliance complex for food businesses. This article will explain Prop 65's basics, recent changes, legal challenges, and enforcement trends, crucial for food businesses to ensure compliance and consumer trust.
The Shifting Landscape: Key Recent Changes to Prop 65
The Evolution of Warning Labels: A Move Towards Specificity
Proposition 65 (Prop 65) is dynamic, with recent updates significantly altering its application, especially for food products. The most impactful recent change, effective January 1, 2025, revises "short-form" warning labels. Previously concise and often omitting chemical names, these warnings have been “lengthened” by the OEHHA:
Chemical Identification: The new regulations now require short-form warnings to identify at least one chemical that is responsible for the warning (for each applicable endpoint – cancer and/or reproductive harm). This is a major departure from the previous rules, which allowed for generic warnings.
Expanded Text Options: Businesses now have two options for the text of the short-form warning, both of which are more descriptive than before, clearly linking the chemical to the risk (e.g., "Cancer risk from exposure to [name of chemical]" or "Can expose you to [name of chemical], a carcinogen.").
Wider Applicability, with a Twist: OEHHA decided against limiting short-form warnings to small packages. They can still be used on any package size, provided they meet font and conspicuousness requirements.
Food Product Inclusion: For the first time, short-form warnings are explicitly authorized for food products, with a specific web address (www.P65Warnings.ca.gov/food) for food-related information.
Transition Period: Businesses have a three-year grace period, until January 1, 2028, to comply with these new short-form warning requirements for products manufactured and labeled on or after that date. Products manufactured before this date can still utilize the old short-form warnings indefinitely.
Online warning regulations have been adjusted. Rather than a dual warning, final rules clarify that online warnings can be provided via a product display page warning or a clearly marked hyperlink. Online retailers have a 60-day grace period to update webpage warnings after receiving notice from a manufacturer or a notice of violation.
"Bounty Hunter" Provision and Legal Challenges
Proposition 65's "bounty hunter" provision allows private lawsuits for violations, even without proven harm, leading to frequent litigation and penalties up to $2,500 per day plus attorney's fees. Settlements exceeded $100 million in 2024. Food and herbal supplements are prime targets for chemicals like lead, cadmium, phthalates, and PFOA, contributing to high costs and warning fatigue. Enforcement typically follows within a year of new chemical listings.
A significant development is successful First Amendment challenges to Prop 65 warnings, notably for dietary acrylamide. A federal court permanently enjoined California from requiring warnings for it due to an "unresolved scientific debate" on its carcinogenicity in humans, potentially opening the door for similar challenges concerning other debated chemicals.
Navigating Compliance: What Food Businesses Need to Know
Beyond California: A National Impact
Prop 65's influence extends nationwide as many companies reformulate products for all sales channels rather than creating separate California-specific lines. This "California effect" is driven by a desire to avoid complex labeling and a reluctance to place "cancer" warnings on products, making Prop 65 a de facto national driver for chemical reformulation and supply chain transparency.
The Burden on Businesses
Food businesses are responsible for determining if their products require warnings. If OEHHA hasn't set a "safe harbor level" for a chemical, businesses must scientifically prove that exposure won't pose a significant risk, which can be complex and costly. Businesses with fewer than 10 employees are exempt.
Industry Adaptations: Reformulation vs. Blanket Warnings
Even though Prop 65 has pushed the food industry to reformulate products to eliminate listed substances, as many manufacturers use the Prop 65 list as a guide for chemicals to avoid in raw materials, some companies still opt for "blanket warnings" across products, finding it more cost-effective than extensive testing, which contributes to the widespread nature of these warnings.
Implications for Supplier Compliance and Management
For food businesses, effective supplier compliance and management are crucial under Proposition 65. Meeting the increasingly specific warning requirements necessitates robust systems for identifying and tracking chemicals throughout supply chains.
A key challenge is securing complete and accurate chemical composition data for all raw materials. Obstacles include unresponsive suppliers, incomplete data, and the complexity of global supply chains. Food businesses must rigorously communicate with suppliers to identify and eliminate listed chemicals, fostering greater transparency and control over ingredients. It's vital to ensure all business partners and affiliates are aware of upcoming warning changes and align their testing and labeling processes. Meticulous record-keeping of manufacturing and labeling dates is also essential for defending against potential lawsuits. Here's a breakdown of essential documents and information to collect:
I. Core Compliance Documents:
Supplier Declaration / Certificate of Compliance (CoC):
Clearly identifies products covered.
Definitive statement on Prop 65 compliance (contains/does not contain listed chemicals above safe harbor levels).
If a warning is required, it identifies the specific chemical(s).
It's dated and signed by an authorized representative.
References the Prop 65 list version used for evaluation.
Full Material Disclosure (FMD):
A complete breakdown of all materials/substances in the product (down to the chemical level).
Laboratory Testing Reports (if applicable):
Specific test methods used.
Detection limits.
Results for relevant Prop 65 chemicals.
Accreditation of the testing laboratory.
II. Supporting & Supplementary Information:
Safety Data Sheets (SDS):
For raw materials or components, if available and relevant.
Manufacturing Contract Agreements (with Prop 65 Clauses):
Stipulates the supplier's obligation for Prop 65 compliance and information sharing.
Product Labels / Packaging Scans (if the supplier applies warnings):
Evidence of a "clear and reasonable" Prop 65 warning (wording, symbol, placement).
Records of Communication:
A log of all inquiries and responses related to Prop 65 compliance.
III. Ongoing Management:
System for Regular Review:
A process for re-evaluating supplier documentation as the Prop 65 list updates.
Supplier Education:
Ensuring suppliers understand their Prop 65 obligations.
The Road Ahead: Debates and Future Directions
California's Proposition 65 (Prop 65) is a dynamic and constantly evolving law, shaped by continuous regulatory updates, court rulings, and private enforcement. OEHHA will likely continue to refine warning requirements and potentially add new chemicals to the list.
The "bounty hunter" provision of Prop 65 remains contentious. Critics, like the California Chamber of Commerce, argue it facilitates "shakedown" lawsuits, increasing costs and consumer confusion, thereby undermining the law's public health aims. They advocate for reforms to curb frivolous litigation and refocus the law on meaningful risks. Recent legal challenges further highlight the tension between public information and First Amendment free speech protections, particularly when scientific consensus on a chemical's risk is debated.
Future amendments to Prop 65 are likely to focus on clarifying warning requirements, streamlining business compliance, and addressing warning fatigue to make warnings more impactful.
Despite challenges like the significant compliance costs, Prop 65 has driven positive changes in the food industry, including product reformulation and increased supply chain transparency. Understanding these ongoing changes and debates is crucial for food businesses to navigate compliance and maintain consumer trust. Staying informed about this influential California law remains key for everyone in the food industry as science, law, and markets continue to evolve.
