California’s “Proposition 65,” the much-criticized law that requires prolific warnings of potential exposure to chemicals and fuels copious lawsuits by private citizen groups, is poised to undergo fundamental changes that are likely to make compliance more burdensome. The state’s Office of Environmental Health Hazard Assessment (“OEHHA”) is considering comments received last month on its latest proposal to overhaul the regulations governing Proposition 65 warning label requirements.

For marketers of dietary supplements, the proposed amendments do not address, and in fact will exacerbate, confusion stemming from inconsistencies between the text of Proposition 65 warnings and the labeling determinations and contaminant assessments in FDA regulation of these products. The proposal would require more specificity in the Proposition 65 warning text that must accompany food products, including dietary supplements. To be compliant, supplements would have to bear the word “WARNING” in bold text in a font no smaller than the largest type size used for other consumer information on the product.  The following statement would be required: “Consuming this product can expose you to [name of one or more chemicals], a chemical [or chemicals] known to the State of California to cause [cancer, birth defects, or other reproductive harm].”  Finally, the warning must include reference to a new Proposition 65 website where consumers can find additional information about the chemical(s) in the product and potential exposures: “For more information go to www.P65Warnings.ca.gov/food.” The proposed revised warning text is more detailed and lengthy than the current standard warning, thereby exacerbating space limitations for products, like dietary supplements, that are typically marketed in small packages.

While OEHHA originally proposed to require identification of a “dirty dozen” list of chemicals that would have had to be disclosed in the warning, the new proposal requires naming “one or more chemicals.” The ambiguity of the provision – e.g., is naming one chemical sufficient even if multiple are contained in a product?  how to choose which one? – makes it ripe as an issue for a plaintiff to challenge the sufficiency of a warning.

Another significant change is that the proposed new warning replaces the existing “may contain” language with the statement that the product “can expose” the consumer to a listed chemical. That change fails to recognize that, for dietary supplements and other food products, often the chemical for which a warning is required (e.g., lead) is naturally occurring and highly variable in terms of its presence and potential quantity. Accordingly, the “may contain” statement is more accurate and allows flexibility in describing the potential exposure to listed chemicals. This raises perhaps the most important Proposition 65 issue for dietary supplements: the exemption for “naturally occurring” chemicals in food products.  Unfortunately, OEHHA has yet to act on industry requests to clarify the exemption, which has proved burdensome to satisfy and a common aspect of litigation in this area.

The proposed amendments include several other provisions worth noting: 

  • Replaces the mandate to provide a warning “prior to exposure” with a requirement to provide the warning “prior to or during the purchase of the product.”
  • Internet purchases:  Specific regulatory text is proposed to address warnings provided for internet purchases. The proposal would require that the warning be provided by a clearly marked hyperlink using the word “WARNING” on the product display page, or otherwise be prominently displayed before the purchase is complete.
  • Warnings must be provided in foreign languages if the product labeling contains information in these languages.
  • Clarifies when retailers may be held responsible for providing product exposure warnings. These provisions respond to a statutory mandate to minimize burdens on retailers, and in short, require that the manufacturer, producer, packager, importer, or distributor is responsible for adding the warning to a product label or providing a written notice to the retailer regarding the required warning for the product. The responsibility for providing a warning falls on the retailer only under certain conditions, such as when the retailer receives warning information and materials from a supplier and fails to post them. 

In a separate rulemaking, OEHHA has finalized a regulation for developing a new Proposition 65 website, to which reference must be made in warnings as noted above. This regulation provides OEHHA authority to require companies to submit information related to a chemical for which a warning is given within 90 days of request. That information can include: chemical identity; concentration and location of the chemical(s) in a product; anticipated routes or pathways of exposure; and estimated levels of exposure to the chemical(s).