lunes, 7 de diciembre de 2015

FDA Law Blog: Aloe Vera Extract and Goldenseal Root Powder Added to Proposition 65 List of “Known” Carcinogens

FDA Law Blog: Aloe Vera Extract and Goldenseal Root Powder Added to Proposition 65 List of “Known” Carcinogens



Posted: 07 Dec 2015 01:53 AM PST
By Riëtte van Laack –

On December 4, 2015, the California Office of Environmental Health Hazard Assessment (OEHHA) added Aloe vera, non-decolorized whole leaf extract and Goldenseal root powder to the list of “chemicals known to the State of California to cause cancer for purposes of the Safe Drinking Water and Toxic Enforcement Act of 1986” commonly known as the Proposition 65 (or Prop. 65) list. On the same day, OEHHA published a document with its responses to the comments. [include link]

OEHHA’s responses clarify various aspects. The basis for the addition of these substances to the Prop. 65 list is their identification as “possibly carcinogenic to humans” with sufficient evidence of carcinogenicity in experimental animals by the International Agency for Research on Cancer (IARC). OEHAA claims, that as a result, the science is not open for discussion; OEHHA must add these substances to the Prop. 65 list. The listing of these chemicals is not “route-specific,” i.e., it applies to all routes of exposure including oral ingestion and topical application. The original notice of intent to list the aloe vera did not include the qualification that only non-decolorized whole leaf extract is a potential carcinogen.

Businesses now have 12 months to either reformulate their products or provide a “clear and reasonable” warning before knowingly and intentionally exposing anyone to these substances. If the past is any indication, plaintiff attorneys will be ready with notices of violation when the 12 month period expires.

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