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When Do Aloe Vera Products Require Warnings?

As of December 2016, products sold in California containing “Aloe-vera, non-decolorized whole leaf extract” must contain clear and reasonable warnings in accordance with Proposition 65. This requirement follows the addition of this substance to the list of chemicals maintained by the California Office of Environmental Health Hazard Assessment (OEHHA) in December 2015. In its listing, OEHHA expressly identified Aloe-vera, non-decolorized whole leaf extract as “a natural constituent,” but it has yet to be determined whether the naturally-occurring chemical exemption would apply in a Proposition 65 challenge.

What is Aloe Vera?

The Aloe vera plant contains complex components. During the course of processing for consumer products, the plant’s whole leaves are ground and then further decolorized/purified in order to remove the latex anthraquinoid constituents. Those latex anthraquinoid constituents were the substances identified by the International Agency for Research on Cancer (IARC) as potentially carcinogenic – and it is that component of the Aloe vera plant that is the subject of OEHHA’s listing. “Aloe vera, non-decolorized whole leaf extract” is therefore an unpurified compound and is not present in consumer products that use Aloe vera, such as supplements and cosmetics.

OEHHA’s Classification of Aloe-vera, non-decolorized whole leaf extract

OEHHA identified Aloe vera, non-decolorized whole leaf extract as a natural constituent such that a warning is not required for: (i) a food when the chemical is naturally occurring and a natural constituent of the food or (ii) a consumer product when the chemical is naturally occurring in the food and the food was used in the manufacturing of the product. Nevertheless, since this component is not intentionally added to consumer products, whether foods or otherwise, OEHHA’s clarification – although welcome – probably is not required to establish that products containing Aloe vera components need no Proposition 65 warning.

How Should Manufacturers and Retailers Handle Warnings for Aloe Vera?

An important distinction lies in the classification by OEHHA. The chemical listed under Proposition 65 is not the same as Aloe vera, decolorized whole leaf extract, or Aloe vera leaf juice, or any of the other Aloe vera-based ingredients commonly found in consumer products. Thus, the processed form of Aloe vera is not subject to Proposition 65 warnings or to possible enforcement actions.

 

Grimaldi Law Offices has been advising clients for over 20 years on chemical and product law. For knowledgeable advice and in-depth analysis on your Prop 65 compliance obligations, contact Grimaldi Law Offices at (415) 463-5186 or email us at [email protected].

Ms. Grimaldi maintains a diverse environmental law practice focusing on chemical and product regulation and litigation defense. Her practice areas include Proposition 65, California's Safer Consumer Products Regulations, California's Rigid Plastic Packaging Container Act and the federal Toxic Substances Control Act. Ms. Grimaldi graduated from the University of California Hastings College of the Law magna cum laude and holds a Bachelor of Science Degree in Bacteriology from University of California, Davis. Prior to attending law school, she worked as a research assistant in laboratories at the University of California, San Francisco Cancer Research Institute and at the University of California, San Francisco School of Medicine.