AHPA has seen a recent trend of 60-day Notices of Violation (NOVs) alleging California Proposition 65 warning violations for naturally occurring chemicals in food products. The first of these is the March 16, 2021 filing of a 60-day notice for failure to warn for exposure to β-myrcene in thyme leaves (the first and only NOV for this chemical). AHPA also identified five 60-day notices alleging warning violations for pulegone in peppermint extract products. These 2021 notices follow a single NOV filed in April 2015 alleging a violation for failure to warn for the presence of pulegone in pennyroil oil for topical use. AHPA finds the filing of these NOVs to be troubling, given that the OEHHA announcements of the Proposition 65 listings of pulegone and β-myrcene clearly identify these chemicals as natural constituents in numerous common plant species that are used as food.
On February 7, 2014, the California Office of Environmental Health Hazard Assessment (OEHHA), the agency responsible for the administration of Proposition 65 (the Safe Drinking Water and Toxic Enforcement Act of 1986) announced the intent to list both pulegone and β-myrcene as chemicals “known to the State of California to cause cancer.” The listing of pulegone became effective on April 18, 2014 and β-myrcene on March 27, 2015. Under Proposition 65 regulations, a person who causes an exposure to a listed carcinogen must provide a “clear and reasonable warning” within 12 months from the date of the chemical’s listing, unless otherwise exempted for the warning provisions.
The most relevant exemption in the cases of pulegone and β-myrcene is for chemicals that are “naturally occurring” food constituents. In its 2014 Notices of Intent to List both pulegone and β-myrcene, OEHHA specifically identifies these compounds as naturally occurring in numerous plant species. The notice for pulegone2 states “pulegone is a natural constituent of various plants, including mint and other herbs, and of their essential oils,” and the notice for β-myrcene3 indicates this chemical is a “natural constituent of food plants, such as hop, bay, verbena, lemongrass, citrus, pomegranate, and carrot, and of their juices and essential oils.” Such acknowledgements clearly allow for application of the naturally occurring exemption for any exposure associated with food products containing these chemicals, such as peppermint extract and thyme leaves.
Private plaintiffs do not always respect certain provisions of the Proposition 65 regulations or OEHHA’s findings regarding certain listed chemicals. These filings represent aggressive private plaintiff actions in which companies must defend their products even in situations where a Proposition 65 warning is clearly not warranted. The defense of a lawsuit brought under California Proposition 65 is a complex process requiring special expertise. It is strongly advised that anyone in receipt of a 60-day notice of violation contact an attorney who is knowledgeable about this law. AHPA maintains communications with several legal firms who specialize in environmental and consumer product law and can provide introductions to interested parties. AHPA has published several freely available guidance documents regarding the application of Proposition 65 to herbal products, both generally and to several specific herbal product categories such as teas and infusions and hemp products.