Organic Report Fall 2021 - Flipbook - Page 31
REGULATORY FE ATU RE
Pullulan — A path to certified organic dietary supplement capsules
H
ave you ever wondered how the capsules used for
encapsulated dietary supplements are regulated under
the National Organic Program (NOP)? If so, you can
rest knowing they are carefully reviewed by USDA accredited
certifying agents and considered an ingredient.
Capsules must be either “certified organic” or made up of
ingredients compliant with the NOP National List of Allowed
and Prohibited Substances. The capsule, as an ingredient, is
also counted in the weight of the total product when
calculating the organic percentage, and since the capsule is
quite significant (always more than 5% of the weight), the only
way to meet the 95% organic requirement and use the USDA
organic seal, is to use certified organic capsules. The challenge
(and opportunity), however, is that certified organic capsules
have been next to impossible to source, and NOP-compliant
options that are vegan or vegetarian are also very limited.
REGULATORY UPDATE TO THE RESCUE
Recently, USDA released a final rule amending the National
List of Allowed and Prohibited Substances (National List) to
allow the ingredient pullulan for use in capsules for dietary
supplements labeled “made with organic (specified
ingredients or food group(s)).” The amendment was made in
response to a National Organic Standards Board (NOSB)
recommendation and a petition that was submitted by the
Organic Trade Association on behalf of our organic trade
members that manufacture and sell USDA-NOP certified
dietary supplements.
The petition was for the continued allowance of nonorganic Pullulan used in dietary supplements, but only for
products that are labeled “made with organic (specified
ingredients or food group(s))” and do not use the USDA
Organic seal. Notably, there is no other alternative for a
vegetarian, organic-compliant capsule. Without the continued
allowance of pullulan and without an alternative option, we
estimated the economic impact to the organic dietary
supplement sector would be over $825 million. The damage
would also extend to the entire organic raw material supply
chain that fills the capsules, hurting organic herb farmers and
handlers throughout the world.
WHAT IS PULLULAN?
Pullulan is a product of natural fermentation. It is excreted by
the yeast-like fungus Aureobasidium pullulans. It is not
genetically modified, and it is commercially produced by a
non-pathogenic and non-toxigenic strain of the organism
using a liquid starch syrup as the fermentation substrate.
Pullulan can be made into very thin films with high tensile
strength and stability over a range of temperatures, making it
an ideal material to be used in the manufacture of empty
capsules for encapsulating dietary supplements or as a coating
Organic Report • Fall 2021
for dietary supplement tablets.
Encapsulation of organic raw materials and active blends is
essential to the handling of dietary supplements because it
allows the delivery of materials without the use of excipients,
and without the risk of damaging those materials through
tablet compression. It also allows controlled dosage, which
bulk powders do not, and the lack of heat used during
processing helps preserve the bioavailability of the active
compounds.
WHY DID PULLULAN NEED TO BE ON THE
NATIONAL LIST?
Encapsulated vegetarian dietary supplements
certified under USDA-NOP rely on the use of
pullulan as the primary ingredient in the capsule.
Currently, a U.S. commercial supply of organic
pullulan is unavailable.
Although the development of an organic version is currently
underway, there are no other NOP-compliant vegetarian
options available. Gelatin capsules (animal based) may be
used, provided they are non-GMO. However, they are not
appropriate for vegetarian products and may cause issues
among kosher and halal consumers.
The use of pullulan has been allowed by USDA-accredited
certifiers for many years. However, a USDA-NOP policy
change in how microbial products are regulated required
pullulan to be specifically listed on the National List, which
prompted the trade association to quickly submit the petition.
In response to the new policy interpretation, we requested that
pullulan be added to the National List so that it would
continue to be allowed only as an ingredient in capsules for
dietary supplements labeled “made with organic (specified
ingredients or food group(s)).” Products carrying the USDA
Organic seal must use certified organic capsules.
HOW DID OUR MEMBERS WORK TOGETHER
TO ENSURE THE SUCCESS OF THE PETITION?
Following the submission of the petition, NOSB engaged in its
public review and public comment process, and unanimously
passed a recommendation to allow the use of pullulan in the
designated 30% non-organic portion of supplements certified
to the “made with organic ingredients” labeling category
(70%+ organic). USDA’s NOP accepted the NOSB
recommendation, and released a Proposed Rule with a second
comment period in June 2020.
Thanks to the technical support of the Dietary
Supplements Council and member participation in the trade
association’s Pullulan Task Force, there was a strong and
meaningful submission of public comments throughout both
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