IASC Board Approves Quality Standard for Raw Materials; Meets with FDA

May 23, 2011 - Last week the IASC Board of Director's approved a quality standard for aloe vera raw materials that covers items such as polysaccharide content, isocitrate (also often called "whole leaf maker" or WLM), contaminants, and other constituents typically found within the botanical. "This is a notable accomplishment for the organization," said IASC Executive Director, Devon Powell, "having this standard will raise the bar on the aloe industry as well as further enhance the IASC certification program and further distinguish those products meeting the program requirements and legitimately displaying the seal."

The quality standard will be incorporated in the aloe vera leaf juice monograph still under development by the American Herbal Pharmacopeia (AHP). Interest in having the same information coordinated with a United States Pharmacopeia (USP) monograph also continues to be discussed. The standard was developed over the course of several months and with the efforts of a variety of member companies.

The IASC also met with FDA officials on May 10 in order to provide them with the analytical results of the NTP study sample material as well as the HPLC method that was developed. In addition, new studies on aloe vera that the NTP and FDA indicated will be conducting in the near future were also discussed.

The analytical results of the study material, which was used in the NTP 2-year study on mice and rats, was found to contain 10,000 - 13,000ppm of aloin A&B, 1,000-1,300 times the <10ppm limit established by the IASC in 2009. The method, which has been submitted for AOAC Single Lab Validation (SLV) was well received by the agency. "A good deal of work went into the development of the methodology and we're pleased that our results are apparently in line with the agency's own analytics regarding Aloin A," said Powell. "We're also glad to be able to enrich the body of scientific methodology with the development a method that also quantifies aloin B, which makes up nearly half of the total aloin content."

FDA officials at the meeting informed IASC participants that the agency would be a co-principal investigator on a new 13-week study on aloe vera as a follow up to the 2-year NTP study. There was a clear message from the agency that it expects the industry to engage in safety studies in order to demonstrate the safety of the ingredients in the marketplace - and that the clock is ticking. As at the 2009 meeting, FDA again questioned the characterization of aloe vera products available in the marketplace and made it clear that information was something it expected industry to provide. A marketplace survey has been discussed and is expected to be produced and delivered to the membership for response shortly.

"This is what the NTP studies done to date have concluded: there is something in the aloe vera material they tested that caused carcinomas in rats," said Powell. "Even though that material (non-decolorized whole leaf extract of aloe barbadensis Miller - a non-carbon filtered or unpurified material) is not what industry sells - it's not yet known what caused the issue in the rats, as they studied the broadest possible material. This new study is designed to find that out and the first thing they will be trying to see is if it's the aloe latex. I've seen biology info from toxicologists that say it's likely the aloin. At this point, however, we don't know definitively - as an industry - what "it" is or "they are" that caused the problem in the rats - and that's the problem. We need to prove it using the same toxicological methodologies."

Prior to adopting the quality standard, a report on the meeting was provided to the board which then discussed how to address the concerns and questions raised by the agency, particularly in regards to the safety studies that would likely need to be conducted by the industry. Steps that were identified by the board in the process included:

• Conducting a market survey of raw material suppliers & possibly finished product suppliers to identify the primary ingredients used in marketplace goods for oral consumption, currently believed to be decolorized inner leaf juice, decolorized whole leaf juice, and non-decolorized inner leaf juice. Provide such information to the agency to better assist them in understanding the ingredients currently available in the marketplace and reduce confusion.
• Characterize the ingredients identified by the market survey using the now adopted quality standard, supplier CofA's, IASC certification program data, and other means. This information will be useful both for assisting the agency in reducing confusion about the ingredient in the marketplace, but also will help IASC in determining what ingredients to look at for any safety studies to be conducted.
• Collect and review any toxicological or safety study data. Members will be asked to provide any toxicological or safety study data on the ingredients identified via the market survey for review and to determine if any of that data will be able to be made of use.
• Determination of any industry-developed safety studies that need to be conducted and obtain proposals. IASC has retained Life Sciences Research Organization (LSRO) to assist in the review of any current studies as well as develop any safety studies that are deemed necessary.
  

"The IASC and its members take consumer safety very seriously and IASC aloe vera marketers don't sell products that are unsafe," said Powell. "Even so, the FDA made it clear that the aloe vera industry needs to identify and characterize the ingredients in the marketplace definitively, and actively produce or develop toxicological data to clearly demonstrate safety and build a body of evidence for use against any forthcoming toxicological studies, and cannot rely on anecdotal or unqualified evidence. As the FDA said - the clock is ticking. We've been given what amounts to fair warning. It's time to act."