International Aloe Science Council, Inc. (March 23th, 2009)

 

IASC Board Approves New Labeling Guidance for Aloe Products

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IASC Board Approves New Labeling Guidance for Aloe Products, Use of Term ‘Whole Leaf’; Members Must Comply By March 2010


March 23, 2009 – The International Aloe Science Council (IASC) Board of Directors voted March 9 to adopt guidance on the labeling and marketing of Aloe vera products and the use of the term “whole leaf.” A working group of the council’s Regulatory Affairs Committee developed the guidance in an effort to reduce consumer and regulatory confusion and avoid unnecessary enforcement actions against marketers following a meeting with the FDA in which it was relayed that products labeled as “whole leaf” could be considered misbranded (as the product literally does not contain the “whole” leaf), as well as the future release of a National Toxicology Program (NTP) study on the long-term oral use of “whole leaf Aloe vera extract”. The guidance requires label changes for those products marketed in the U.S. and is recommended for products for sale globally.

The guidance for the use of the term “whole leaf” in product labeling and marketing is two-fold:

    1. The guidances requires IASC members to cease the usage of the term “whole leaf” without further clarifying language to identify the processing of the ingredient. Products produced by initially grinding the entire leaf must, under the new guidance, add to the term “whole leaf” appropriate descriptive language to further identify that certain components have been removed, such as “De-colorized”; “Active charcoal-filtered”; “Filtered,” etc. It is up to each individual company to determine the best terminology to use to describe their processes.
    2. While not required, the guidance recommends members cease usage of the term “whole leaf” entirely in order to avoid all issues and concerns likely to be raised from the NTP study.

The required addition of descriptive language to labels to further identify the processing of such products (e.g., De-colorized whole leaf; Active charcoal filtered whole leaf; Filtered whole leaf, etc.) will avoid a literal translation of the term “whole leaf” and likely satisfy FDA concerns regarding misbranding. However, such products will still be subject to scrutiny upon release of the NTP study, and as mentioned above, will likely become targets of legal (and possible enforcement) action, especially Proposition 65 lawsuits in California. For this reason, the IASC labeling guidance strongly recommends the complete cessation of the usage of the term “whole leaf”.

“IASC is sensitive to the fact that the ‘whole leaf’ market represents a significant share of the aloe industry and that the adoption of such a position will likely create difficulties for many companies and their revenues,” said Executive Director Devon Powell. “However, a proactive response; consistency among raw materials suppliers and manufacturers; and a strong PR push by the industry may potentially alleviate long-term market-share loss, and will more than likely prevent potential damage, including legal and enforcement actions.”

Terminology & Other Requirements

To address U.S. regulatory concerns regarding a lack of standardization in the identification of aloe ingredients, the adopted document requires IASC members, and recommends the global aloe industry, comply with the definitions identified in the IASC document “Definitions of Terms Commonly Used in Aloe Industry,” in so far as those terms are included in the document, for all terms used in the marketing and labeling of aloe vera products. All products marketed for sale in the U.S. must be labeled with the Latin binomial Aloe vera; the Standard Common name (SCN) “aloe vera,” and identify the plant part used (i.e., leaf, inner leaf, aloe latex). This is also recommended for products for sale globally for labeling standardization.

With regards to the labeling of concentrated Aloe vera products and aloe products in liquid form, the document provides guidance on the declaration of the percentage of juice, reconstitution and quantitative concentration. Also in compliance with the Federal Food Drug and Cosmetic Act (FFDCA), the guidance requires conventional foods and beverages bear a Nutritional Facts panel and dietary supplement products are labeled with a Supplement Facts panel.

Members have until March 9, 2010 to come into compliance with the newly adopted labeling guidance, but it is recommended that manufacturers consider making label changes as quickly as possible, as the exact date of the NTP study release is unknown.

“While the concerns facing the aloe industry are serious, I am confident that we can effectively address these issues and that IASC member companies can continue providing health-promoting internal-use Aloe vera products to consumers,” Powell said.

The complete guidance for industry, including the “Definitions of Terms Commonly Used in The Aloe Industry” is available here: IASC Labeling Guidance

Devon Powell
Executive Director
International Aloe Science Council
301.588.2420
dpowell@iasc.org