Earlier this month, the California Office of Environmental Health Hazard Assessment (OEHHA) provided public notice that it plans to amend regulations governing Proposition 65 (Prop 65) short-form warning labels. OEHHA offered to hold a public hearing, upon request, which would need to be received by February 22, 2021 and it requested public comments on the proposed amendments by March 8, 2021. While these changes only apply to products sold in California, many companies take a broad approach to applying these labels to many, if not all, of their products sold in the US because of the size of the California tobacco consumer market. Therefore, these 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 (Jan. 2021). 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:

  • Businesses are not required to identify a chemical or chemicals in the short-form warning, which significantly limits the usefulness of the warnings to consumers;
  • Businesses use the short-form warning for products that can easily accommodate a longer warning; and
  • Businesses use the short-form warning prophylactically when no warning is required.

To address these concerns, OEHHA proposed several key changes.

  • The proposal would amend 27 CCR § 25602(a)(4) to only allow short-form warnings to be used if:
    • The total surface area of the product label available for consumer information is 5 square inches or less;
    • The package shape or size cannot accommodate the full-length warning described in 27 CCR § 25603(a), and;
    • The entire warning is printed in a type size no smaller than the largest type size used for other consumer information on the product.
  • The proposal would amend 27 CCR § 25602(b) to remove the option to provide a short-form warning label on websites.
  • The proposal would amend 27 CCR § 25603(b) to require short-form warnings to list specific chemicals that are listed as carcinogens or reproductive toxicants.

These proposed amendments could impact the tobacco industry in the several ways.

  • Companies that use the short-form Prop 65 warning on their websites would likely need to modify them. Instead, companies would be required to display the full-length warning described in 27 CCR § 25603(a) or a hyperlink to the full-length warning.
  • Products that qualify for use of the short-form Prop 65 warning labels may need to list chemicals the companies would not otherwise want to publicly advertise on its labels.
  • Products with labels that have total surface areas larger than 5 square inches would need to include the full-length warning described in 27 CCR § 25603(a), which could include several paragraphs listing chemicals, depending on the ingredients in the tobacco product.

Finally, if adopted, companies would have one year after the effective date to comply with the changes.

Please let us know if you would like to discuss the proposed amendments or if you are interested in submitting comments to OEHHA before the deadline.

 

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Photo of Nick Ramos Nick Ramos

Nick draws on years of military leadership, project management, and legal experience to help clients solve difficult business problems from a legal perspective. His practical advice enables clients to navigate regulatory compliance and licensing issues, complex investigations, and high stakes enforcement actions that

Nick draws on years of military leadership, project management, and legal experience to help clients solve difficult business problems from a legal perspective. His practical advice enables clients to navigate regulatory compliance and licensing issues, complex investigations, and high stakes enforcement actions that arise under state and federal law.

Photo of Agustin Rodriguez Agustin Rodriguez

Agustin is sought after by clients for his strategic counsel on their most challenging competitive and regulatory compliance issues, including tobacco Master Settlement Agreement issues, federal and state enforcement investigations, licensing and excise tax issues, developing compliance programs, and evaluating advertising and marketing…

Agustin is sought after by clients for his strategic counsel on their most challenging competitive and regulatory compliance issues, including tobacco Master Settlement Agreement issues, federal and state enforcement investigations, licensing and excise tax issues, developing compliance programs, and evaluating advertising and marketing practices. A partner in the firm’s Regulatory Investigations, Strategy + Enforcement (RISE) Practice Group as well as its Tobacco and Cannabis law practices, he represents manufacturers, distributors, retailers, and suppliers in all aspects of their businesses, including regulatory compliance, FDA requirements, administrative disputes involving federal or state governmental entities, mergers and acquisitions, commercial agreements, and taxation matters.