Manufacturers and distributors of natural and herbal supplements and products have submitted 34 separate comments criticizing the California Office of Environmental Health Hazard Assessment’s (OEHHA) proposed listing of Aloe Vera Whole Leaf Extract and Goldenseal.
A common theme throughout dozens of comments was the criticism of a study relied upon by the International Agency for Cancer Research (IARC) in its recently published monograph on the substances.
Representative of the critiques was this submission by Daid Wolfson, ND of Scientific Support Services of San Louis Obispo, Calif.
“The listing of goldenseal as a carcinogen is a travesty and an absurdity. The one study leading to consideration of this listing (Natl Toxicol Program Tech Rep Ser. 2010 Aug;(562):1-188) demonstrated carcinogenicity at astronomically high levels of goldenseal powder intake: 25,000 ppm, or 1400 mg/kg/day of goldenseal powder for two years is so far above any reasonable intake in humans that a carcinogenic outcome has absolutely no relevance to human health or safety, Wolfson wrote.
He called on OEHHA to abandon its proposed listing, “in light of a significant body of literature demonstrating anti-carcinogenic activity and other health benefits of goldenseal.”
Criticism of the study was not limited to the high dosing levels used in the two-year study.
IARC stated that the study demonstrates “sufficient evidence in experimental animals for carcinogenicity, would have been strengthened by the inclusion of positive controls,” noted Bethlehem Pennsylvania attorney Deborah A. Chadbourne.
Chadbourne also commented that the Boudreau study—the sole support for IARC’s listin–did not identify a carcinogenic compound or agent.
She notes that none of the chemical com-pounds described by IARC as part of Aloe Vera Whole Leaf Extract are carcinogenic.
But chemical constituents in Aloe Vera Whole Leaf Extract can become unbound by exposure to the intestinal microflora of humans and animals, although considerable variation in response among animal species occurs.
When the chemical bond is broken it results in the formation of aloe-emodin—a compound that is considered an anti-cancer agent in humans, but was identified as carcinogenic by IARC. Aloe-emodin is not a constituent of Aloe Vera Whole Leaf Extract.