In 2021 we wrote about the California Office of Environmental Health Hazard Assessment’s (OEHHA) plans to amend regulations governing Proposition 65 (Prop 65) short-form warning labels. On May 20, 2022, however, OEHHA notified the public that it was unable to complete the regulatory process within the required time period (i.e., one year of the date it was first noticed to the public), and that it instead intended to restart the process with a new regulatory proposal. OEHHA issued its Notice of Proposed Rulemaking Clear and reasonable Warnings: Short-form Warnings on October 27, 2023, and on November 30, 2023 issued a notice that it will hold a public hearing on December 13, 2023.  The public may submit comments until December 20, 2023.

While these proposed changes only apply to products sold in California, companies may take a broad approach to applying these labels to their products sold in the US because of the size of the California tobacco consumer market. Therefore, these proposed changes could have far-reaching effects for any tobacco-related businesses that sell tobacco products in California or broadly use Prop 65 warnings.

In general, Prop 65 “requires businesses to provide a ‘clear and reasonable’ warning before they knowingly and intentionally cause an exposure to a chemical listed as known to the state to cause cancer or reproductive toxicity.” OEHHA, Initial Statement of Reasons (Oct. 2023). In 2016, OEHHA provided businesses with the option to use “short-form” warnings on product labels and websites. In its initial statement of reasons for the proposed amendments, OEHHA stated that it seeks to address the following concerns:

• Unintended uses and lack of information in current short-form warnings;
• Need for clarification on warnings for products purchased on the internet or through a catalog;
• Other adjustments needed for consumers product safe harbor warnings;
• Additional options for warnings for passenger or off-highway motor vehicle; and recreational marine vessel parts exposures.

To address these concerns, OEHHA proposed several amendments to the regulatory text, which is available here. Below is a summary of some of the key proposed changes.

• For internet purchases, the warning will need to be displayed on the product display page, clearly hyperlinked to a page that links to the warning, or an otherwise prominently displayed warning made to the purchaser prior to completing the purchase.
• For internet purchases, the warning must be included on or with the product when delivered to the consumer.
• Options for the warning language will include “WARNING,” “CA WARNING,” or “CALIFORNIA WARNING.”
• The short-form warning will be expanded to include a specific phrase naming one or more listed chemicals for which the safe harbor warning is being given. This change will take effect two years after the effective date of the amendments.

These proposed amendments could impact the tobacco industry in a few ways. Companies that use the short-form warning on their websites would likely need to modify them. OEHHA estimates that the cost to businesses that choose to modify their warnings to comply with the amendments will be $14,538.327.67 total, or $4,273.46 per business.

Companies will need to include a warning on or with products shipped directly to California consumers. This impacts companies’ order fulfilment processes as they likely will need to ensure warning labels are pre-affixed to products or included in shipping packages. Companies that use third-party logistics providers for order fulfilment services likely will need to ensure they are complying with these changes.

Finally, products that qualify for use of the short-form warning labels may need to list chemicals the companies would not otherwise want to publicly advertise on its labels or websites.