AHPA issued guidance to help members understand and comply with California Proposition 65 requirements when selling products that contain goldenseal root powder, Aloe vera (non-decolorized whole leaf extract), or the naturally occurring botanical constituents pulegone and β-Myrcene.
In 2014 and 2015, the California Office of Environmental Health Hazard Assessment (OEHHA) added goldenseal root powder, Aloe vera (non-decolorized whole leaf extract), pulegone and β-Myrcene 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, unless exempt, companies selling products with goldenseal root powder, Aloe vera (non-decolorized whole leaf extract), pulegone and β-Myrcene in California must include a warning that states, "WARNING: This product contains a chemical known to the State of California to cause cancer."
AHPA's Prop 65 guidance provides answers to common questions about these recently listed substances, including:
- What is this substance and where is it found?
- What exemptions may apply?
- Should Prop 65 warnings be provided on products that contain this substance as a naturally occurring constituent?
- Are Prop 65 warnings required on products that contain this substance?
- What, if anything, can marketers of products containing this substance do to protect against Prop 65 litigation?
One exemption under Prop 65 is for "naturally occurring" food constituents. For example, OEHHA has identified pulegone as a "natural constituent of various plants, including mint and other herbs, and of their essential oils." Similarly, OEHHA identified goldenseal root powder as "a natural constituent of the goldenseal plant."
OEHHA's regulations clarify that exposure to a Prop 65 listed chemical does not occur, and no warning is required:
- For a food, when the chemical is naturally occurring in the food and is a natural constituent of the food
- 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 a substance because it is a natural constituent of a plant does not constitute an exposure for purposes of Prop 65 and no Prop 65 warning should be required.
However, plaintiff lawyers may still target companies selling products with these substances. For example, several marketers of pennyroyal essential oil (which includes pulegone) and is intended to be applied topically to the skin were given notice alleging violations of Prop 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.
At present, it is unknown whether any private plaintiff will challenge if the naturally-occurring chemical exemption is applicable for β-Myrcene, goldenseal root powder, Aloe vera (non-decolorized whole leaf extract).
Prop 65 Guidance