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Quality
Control for the Natural Products Industry
(Continued
from previous page)
Phytosanitary Requirement and the Animal Plant Health Inspection
Service Most nations also have systems in place to prevent the
accidental import of foreign agricultural pests in shipments
of agricultural products. All exporters to the US must obtain
a permit from the USDA Animal Plant Health Inspection Service
(APHIS). All shipments of plant products also must be accompanied
by a "phytosanitary certificate" from an official in the exporting
country that ensures that the shipment is free from viable pests.
APHIS works in collaboration with some foreign governments to
establish "pre-clearance programs" that speed up the process
and reduce the risk of having a shipment denied at a US port
of entry. However, APHIS reserves the right to hold agricultural
products in a quarantine facility until adequate testing has
determined that the products pose no threat. Both the food product
and the packaging materials are inspected for seeds, insects,
and pathogens. APHIS also has the unique role of enforcing the
plant protection articles of the Convention on International
Trade in Endangered Species of Wild Fauna and Flora (CITES),
a treaty regulating international shipments of rare and endangered
wildlife. To obtain a permit or for more information, contact
the USDA-APHIS.
Industry Standards
Most businesses in the botanical industry employ a set of criteria
to ensure that the quality of their products far exceeds the
legal minimum requirements. The criteria used by different companies
can vary depending on the end use of the botanical product.
For example, a tea company may place a higher value on the taste,
odor, and color of the botanical, while a dietary supplement
manufacturer may be more concerned with levels of marker compounds.
Because criteria vary from company to company, it is crucial
for producers and exporters to clarify expectations and policies
about quality control and testing with potential buyers. Many
companies will not pay for botanical shipments until they have
passed all quality control procedures, and they may refuse payment
for products that do not meet their specifications. Currently,
there are no universally accepted methodologies used to test
and rank the quality of botanical products, although several
important efforts have been initiated. One example is the Methods
Validation Program (MVP), "an international effort to validate
and make available analytical methods that will meet the demand
for global consistency in the testing of botanicals." The MVP
is administered by the Institute for Nutraceutical Advancement,
a non-corporate division of Denver-based Industrial Laboratories
(an independent laboratory that provides analytical and consulting
services to the natural products industry). The United State
Pharmacopoeia (USP), an organization that develops quality standards
for the pharmaceutical industry, has developed standards based
on marker compounds for 11 medicinal herbs and is currently
developing standards for nine more. These standards are available
in USP publications. The American Herbal Pharmacopoeia (AHP)
is also developing quality control and therapeutic monographs
for botanicals used as herbal remedies.
Quality Analysis Techniques
Analytical labs use a variety of techniques to test natural
products. High-pressure liquid chromatography (HPLC) measures
levels of the active constituents, or "marker compounds," in
botanicals. While there is still considerable debate about which
compounds are important to the activity of a botanical and whether
chosen single marker compounds are actually indicative of botanical
potency, HPLC provides a tool for determining the consistency
of botanical products. Other tests include thin layer chromatography
(TLC) and acid insoluble ash (AIA). TLC is used to determine
the species of the test sample and is important for detecting
adulturation of the desired herb with other plant materials.
AIA is used to measure the amount of physical debris (for example,
dirt) in the sample. Other techniques are used to test for moisture
content, heavy metals, sulfur, and contamination by organisms
such as yeasts, molds, and bacteria. Lastly, each herb is also
tested for flavor, color, and odor via "organoleptic testing"-
in other words, by using the senses of taste, sight, and smell.
Good Agricultural and Manufacturing Practices
Various organizations have helped to create and distribute
"good manufacturing practices" (GMPs), in order to help producers,
processors, and manufacturers meet high quality control standards.
The first GMPs were developed in rudimentary form in the original
1956 FFDCA, which was intended for use by processed food and
pharmaceutical manufacturers. The FDA has continued to refine
the original GMPs and to publish them in a reader-friendly format.
The FDA also has defined strict methodologies for preventing
microbial contamination in its new food safety program, the
"Hazard Analysis and Critical Control Point" (HACCP) program.
In the United States, "good agricultural practices" (GAPs) are
still under development by industry groups and government agencies.
However, members of the botanical industry have used the GMP
format to promote quality control measures at the agricultural
production level. The Herbal Medicinal Products Working Party
of the European Agency for the Evaluation of Medicinal Products
has published a draft of GAPs for medicinal and aromatic herbs.
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Coming soon! A-SNAPP Update Goes to Print 