Attendees at the recent annual Botanical Congress hosted by the American Herbal Products Association were offered a breakout session put on by the International Aloe Science Council. The sessions were held in conjunction with the SupplySide West trade show in Las Vegas, NV. Andrew Shao PhD, of Herbalife, laid out the international regulatory climate for the ingredient. Worldwide sales of aloe products bring in a significant portion of Herbalife’s more than $4.5 billion in annual revenue. The common thread of his presentation was continued confusion among regulators around the globe. What is meant by whole leaf aloe? What does the term ‘non-decolorized’ mean, and why is that important? Where is the ingredient regulated as a drug because of the laxative properties of some preparations of the botanical, and where is it regulated as a food or as a dietary supplement? The picture is a jumbled one, Shao said, with no clear thread connecting the various markets.
“Despite the fact that aloe is used a lot as an herb in various markets, there seems to be a lot of confusion about aloe, especially among regulators,” Shao said.
“Aloe is used as drug, as a laxative. It is used in topical formulations, as a food additive, as a dietary supplement and as a food directly in the form of juice. All of these demonstrate the wide appeal and application of aloe but it also turns out they are a source of confusion. The picture is complicated by the chemical complexity of aloe and the challenges of standardization and consistency,” he said.
Removing the aloins
A big issue for aloe is the presence of aloins in the plant before processing. Aloins are compounds that are known digestive irritants and have been implicated in the development of intestinal cancers in lab animals. The ‘decolorizing’ process mandated by IASC for properly manufactured aloe ingredients removes these chemicals. It is unknown how many aloe products that are on the market globally have not gone through this process, but none are sold by IASC members and the belief is that non-decolorized ingredients are not on the market in the US in any meaningful quantity.
But a US National Toxicology Program study that was published in early 2013 omitted this crucial qualifier and further muddied the regulatory waters. The report, titled “Clear Evidence of Carcinogenic Activity by a Whole Leaf Extract of Aloe barbadenis Miller (Aloe vera) in F344/N Rats”, was roundly criticized at the time. Steven Dentali, PhD, who has been active with IASC and who was also until recently on the staff at Herbalife, said the material used in the NTP study had a combined aloin content more than 1,000 times greater than the industry standard. Failure to disclose this left many who read the paper without a sufficiently informed and critical eye with the impression that the results referred to products on the market, he said.
“Failure to disclose this important distinction in the identity of the tested ingredient is simply inaccurate and grossly misleading. In failing to identify the test article as nondecolorized, this article presents an inaccurate and misleading impression of the test article and implies that commercial products were studied,” Dentali wrote in a rebuttal that same year that was published in the journal Toxicological Sciences.
NTP confusion proliferates
But the effect of the NTP’s imprecision continues to reverberate and influence regulators and others around the globe. The advocacy group Center for Science in the Public Interest put aloe on its “avoid” list after the NTP study came out. And more recently a California regulatory body listed aloe among its list of ‘known carcinogens’ under Prop 65 (though in that case the final listing language did include the nondecolorized qualifier).
Ann Grimaldi, an attorney who heads her own firm in San Francisco, told attendees that the requirement for a Prop 65 warning on aloe products in California goes into effect on Dec. 4 of this year. She said the work IASC did to make California’s Office of Environmental Health Hazard Assessment (OEHHA) aware of the nondecolorized distinction was good, but that the final language of the listing requirement left something to be desired in terms of making this distinction crystal clear, so there may still be some risk of lawsuits based on a failure by companies marketing aloe products in California to include a carcinogen warning on their labels.
“The monetary incentives for private enforcement in Prop 65 are very significant. It has created a thriving cottage industry that feels like and in fact is intended simply to extort money from companies. I haven’t seen any Internet chatter on this subject yet which I think is good, as the private enforcers are always looking for the low hanging fruit. But if you are using a decolorized ingredient, I would strongly recommend saying ‘decolorized’ on the label,” she said.