AHPA Revises Guidance on Prop 65 Warnings for Pulegone

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AHPA Revises Guidance on Prop 65 Warnings for Pulegone

Does Naturally Occurring Pulegone Represent 'Exposure' Under CA Prop 65?

Published: Friday, May 22, 2015

AHPA has updated guidance to help members understand and comply with California Proposition 65 requirements when selling products that contain pulegone, a ketonic monoterpene that is a naturally present constituent in various plant species, including mints.

The updates are based on notice letters issued to marketers of pennyroyal essential oil topical products. On April 20, 2015 several marketers of pennyroyal essential oil for topical skin application were given notices that allege violations of Proposition 65 for failure to provide warnings for these products. The plaintiff who issued this notice apparently takes the position that pennyroyal (or pennyroyal oil) is not a food or food ingredient so that while pulegone is known to be naturally occurring in pennyroyal the above discussed exemption should not apply. Note, however that both European pennyroyal (Mentha pulegium) and American pennyroyal (Hedeoma pulegioides) are listed in federal regulation as "natural flavoring substances ... [that] may be safely used in food" under certain conditions. This issue has not been resolved as of the date of issuance of this document and readers are advised to consult with qualified Proposition 65 counsel.

On April 18, 2014, the California Office of Environmental Health Hazard Assessment (OEHHA) added pulegone to the list of chemicals "known to cause cancer." Under Prop 65 regulations, a person who causes an exposure to a listed chemical must provide a "clear and reasonable warning" within 12 months from the date of OEHHA's listing, unless otherwise exempt. This means that beginning April 18, 2015 companies selling products with pulegone in California that are not exempt must include a warning that states, "WARNING: This product contains a chemical known to the State of California to cause cancer."

One exemption under Prop 65 is for "naturally occurring" food constituents. Last year, OEHHA identified pulegone as a "natural constituent of various plants, including mint and other herbs, and of their essential oils." OEHHA's regulations clarify that exposure to a Prop 65 listed chemical does not occur, and no warning is required:

  1. For a food, when the chemical is naturally occurring in the food and is a natural constituent of the food
  2. For a consumer product other than food, when the chemical is a naturally occurring chemical in food, and the food was used in the manufacture, production, or processing of the consumer product. Where a consumer product contains a listed chemical, and the source of the chemical is in part from a naturally occurring chemical in food and in part from other sources, "exposure" can only occur as to that portion of the chemical from other sources.

This can be interpreted to mean that foods, dietary supplements, cosmetics or other consumer products that contain pulegone due to the presence of a mint, another herb or spice, or an essential oil in which pulegone is known to be a natural constituent does not constitute an exposure for purposes of Prop 65 and no Prop 65 warning should be required.

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