By Mokkie (Own work) [CC BY-SA 3.0], via Wikimedia Commons
Countless Cosmetic and Dietary Supplement Products Implicated

Effective Friday, December 4, the California Office of Environmental Health Hazard Assessment (OEHHA) listed Aloe vera (non-decolorized whole leaf extract) and goldenseal root powder as carcinogens on its list of Chemicals known to the State of California to Cause Cancer or Reproductive Toxicity (Proposition 65 List), pursuant to the Safe Drinking Water and Toxic Enforcement Act of 1986 (commonly known as Proposition 65). This action will affect countless dietary supplement and cosmetic products, which will now be required to bear a warning that the products contain a chemical known to the State of California to cause cancer.

OEHHA’s basis for listing these ingredients derives from Califortnia Labor Code section 6382(b)(1) (and the listing process is known as the “Labor Code Mechanism”). The law requires that certain substances identified by the International Agency for Research on Cancer (IARC) be listed as known to cause cancer under Proposition 65. Per OEHHA, IARC has published a list titled “Agents classified by the IARC Monographs, Volumes 1-112” (IARC, 2015). IARC has concluded that Aloe vera, whole leaf extract and goldenseal root powder are each classified in Group 2B (i.e., “possibly carcinogenic to humans”), and that there is “sufficient evidence of carcinogenicity in experimental animals” for each (Grosse et al., 2013). Therefore, OEHHA concluded that both substances qualify for listing via the Labor Code Mechanism.

It is worth noting that in its April 23, 2015 Notice of Intent to List Chemicals by the Labor Code Mechanism: Aloe Vera, Whole Leaf Extract and Goldenseal Root Powder, OEHHA referred to Aloe vera, whole leaf extract, whereas the official Prop 65 listing is now Aloe vera, non-decolorized whole leaf extract. Please see our previous client alert on OEHHA’s April 23 Notice of Intent for additional background information. As a reminder, once a chemical is listed, businesses have 12 months to comply with Prop 65 warning requirements.

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Claudia A. Lewis

Claudia Lewis, co-chair of Venable’s FDA Group, counsels clients on matters involving Food and Drug Administration (FDA) regulation, labeling, and marketing of foods, over-the-counter (OTC) drugs, medical devices, and other products. With deep knowledge of dietary supplement labeling regulations, Claudia represents scientists, physicians…

Claudia Lewis, co-chair of Venable’s FDA Group, counsels clients on matters involving Food and Drug Administration (FDA) regulation, labeling, and marketing of foods, over-the-counter (OTC) drugs, medical devices, and other products. With deep knowledge of dietary supplement labeling regulations, Claudia represents scientists, physicians, nutritionists, healthcare associations, and citizen groups. She has also aided international clients in establishing a U.S. market for their products. She has prepared and presented constitutional and administrative law cases before the FDA, Federal Trade Commission (FTC), Department of Justice (DOJ), Bureau of Land Management (BLM), and Environmental Protection Agency (EPA).

Todd A. Harrison

Todd Harrison, co-chair of Venable’s FDA Group, guides clients through the myriad government regulations associated with food and drug labeling and marketing. Working extensively in the areas of food and dietary supplement safety, labeling, and advertising claims, Todd helps clients in the consumer…

Todd Harrison, co-chair of Venable’s FDA Group, guides clients through the myriad government regulations associated with food and drug labeling and marketing. Working extensively in the areas of food and dietary supplement safety, labeling, and advertising claims, Todd helps clients in the consumer products, drug and medical device, and dietary products industries comply with government regulations. He regularly achieves favorable results in defending clients against Federal Trade Commission (FTC) advertising complaints, enforcement actions, and prosecutions, and overcoming competitor challenges in courts and other fora.