Prop 65 Listing May Not Apply to Existing U.S. Aloe Products

Photo © iStockphoto.com/g-miner

California’s Office of Environmental Health Hazard Assessment (OEHHA) recently added an Aloe vera extract to its list of known chemical carcinogens under Proposition 65, but the listing likely will not apply to any aloe products currently on the U.S. market, according to the International Aloe Science Council (IASC; Silver Spring, MD).

On December 4, OEHHA added Aloe vera “non-decolorized whole leaf extract” and goldenseal root powder to the Prop 65 list, requiring products with the ingredients to carry a warning that they contain “chemicals known to the State of California to cause birth defects or other reproductive harm.”

The labeling requirements apply to both topical and ingestible products containing the aloe extract, but it may not actually change anything for U.S. aloe suppliers. That’s because aloe products that meet IASC standards already do not contain non-decolorized whole leaf extract.

“The warning requirements only apply if the product actually contains the listed chemical ‘Aloe vera, non-decolorized whole leaf extract’,” says Jane Wilson, executive director, IASC. “IASC is not aware of any such products in the U.S. marketplace for either ingestion or topical use.”

Aloe supplier Aloecorp (Lacey, WA) says the Prop 65 listing will not impact any of its products.

“All of our products are decolorized and I am not aware of any U.S. supplier providing the type of material tested by the NTP [National Toxicology Program] and consequently listed in Prop 65,” says Jeff Barrie, regional sales manager, Eastern USA, Aloecorp. “All of our products are certified by the International Aloe Science Council for Content and Purity, and this unprocessed raw form of aloe could not be certified by the IASC.”

Will Consumers be Confused?

Yet, even if the Prop 65 listing doesn’t apply to aloe products already following IASC’s standards, will this news have a negative impact on consumer perceptions?

“Of course it does not help the aloe industry,” says Aloecorp’s Barrie. He adds that although the non-decolorized aloe now listed in Prop 65 is very different from aloe used in U.S. products, the listing could still be “alarming and confusing to consumers.”

IASC’s Wilson agrees that consumer confusion is a cause of concern and she says consumer outreach may be necessary to explain the impact of this listing. The listing could also prompt private plaintiffs to target marketers of aloe products, says IASC.

“While it is questionable as to whether any products containing 'Aloe vera, non-decolorized whole leaf extract' are actually sold in California, that may not stop private plaintiffs from initiating enforcement actions against aloe product marketers that are otherwise compliant,” says IASC’s Wilson. “IASC intends to support the aloe industry by continuing to raise awareness of the IASC certification program, which differentiates Aloe vera products as not containing the “Aloe vera, non-decolorized whole leaf extract” that has been listed under Proposition 65.”

Wilson also advises that the IASC certification seal offers an easy indicator for consumers to be certain they are purchasing a product that does not contain the extract newly listed in Prop 65.

Unheeded Objections

IASC has applauded OEHHA’s decision to include the language non-decolorized in the Prop 65 listing of this extract-a recommendation that IASC submitted to OEHHA in May of this year. However, other recommendations made by IASC and the American Herbal Products Association (AHPA; Silver Spring, MD) were not addressed in the final listing.

For instance, AHPA had requested that the Prop 65 listings for the non-decolorized aloe extract be limited to oral routes of exposure, because the NTP study that the listing is based on examined only oral administration in rodents. However, OEHHA chose not to follow the recommendation and topical and ingestible products are treated the same under the Prop 65 listing.

Additionally, IASC had requested that OEHHA specify which Aloe vera ingredients are not included in the listing, but again, OEHHA chose not adopt the recommendation.

On a separate note, AHPA had also protested the Prop 65 listing of goldenseal earlier this year because the carcinogenic effects observed in the supporting research were based on a significantly higher dosage of the ingredient than people typically ingest.

AHPA says it opposed the listing because it was “based only on a single carcinoma as observed in one test animal fed goldenseal root powder at a dosage of 2.5% of the animal’s diet over nearly its entire lifetime, equivalent to between about 72,000 and 116,000 mg per day for a 60 kg human, while the standard adult dose of goldenseal is 2 g daily and the herb is used only sporadically.”

Both AHPA and IASC will “be in active communication with experts and authorities on enforcement of California’s Proposition 65, and will provide additional guidance as information is collected and reviewed,” according to a press release from AHPA.

Read more:

What’s Next for Aloe Drinks?

Latest Prop 65 Draft Leaves “Room for Improvement,” Says AHPA

Michael Crane
Associate Editor
Nutritional Outlook Magazine
michael.crane@ubm.com