quality standards in effect
self-regulatory standards for producing dietary supplements are
in place. These standards serve to ensure consistently high-quality
products. Here is a summary of current initiatives listed in alphabetical
Botanical Safety Handbook
handbook -- developed by the American Herbal Products Association
(AHPA) -- provides
information about practices affecting safety, such as cleanliness
and contamination. It also gives guidelines for serving size and
other labeling issues. The handbook serves as a guide for health
care practitioners and consumers.
Botanical Safety Handbook provides readily accessible safety data
in an easy-to-use classification system for more than 600 commonly
sold herbs.The handbook also features additional information regarding
international regulatory status, standard dosage, and certain
common toxicity concerns.The editors of this book are among the
most respected leaders in the herbal products industry. Their
experience includes years of clinical practice, manufacturing
and industry governance, and significant writhing and lecturing
includes a thorough listing and classification of herbs sold
in the United States.
includes technical information on important chemical constituents.
more than 500 botanical entries.
accurate data on the safe use of herbal products.
specific information relevant to prior health conditions, pregnancy,
guidelines on the information to be included on labels for herbal
Herbs for Commerce
reference developed by the American Herbal Products Association
a compilation of common names "standardized" to botanical names
for herbs. It is used in FDA labeling regulations that went into
effect in March 1999. The second edition will be issued in the
first quarter of 1999.
Methods Validation Progam (MVP)
are being developed as part of the Methods Validation Program
(MVP) currently under development by the Institute for Nutraceutical
MVP is the industry's most concerted effort to standardize test
procedures for botanical products. INA is a consortium formed
in 1998 by Industrial Labs, an independent testing laboratory
in Denver, Colorado. INA includes thirty manufacturers, suppliers,
and distributors; and seven industry trade associations. Methods
have been published for three raw materials so far: Kavalactones
in Piper Methysticum, Flavonol Glycosides in Ginkgo Biloba, and
Ginsenosides in Panax Ginseng and American Ginseng.
Hope Communications exhibitor standards for Natural Products Expo
Hope Communications sets exhibitor quality standards for suppliers
who participate in Natural Products Expo East and Expo West, the
industry's largest trade shows. Participants must sign an agreement
to abide by these standards. They include requirements and guidelines
GMP Compliance Program
National Nutritional Foods Association (NNFA)
began its Good Manufacturing Practices (GMPs) compliance program
in 1999, designed to be implemented over a three-year period.
Member manufacturing facilities are inspected by a third party
to determine whether NNFA specified performance standards are
being met. Practices involving personnel, plant and grounds, sanitation,
equipment, quality operations, production and process controls,
warehousing, distribution, and post-distribution are audited under
the program. Manufacturers who pass the inspection are certified
and allowed the use of the NNFA GMP seal of approval on their
products. Participation in the GMP program is optional for NNFA
TruLabel program of the National Nutritional Foods Association
(NNFA) is a
dietary supplement label registration and random-testing program
required of all NNFA supplier members who manufacture under their
own label. Products must be registered in order to be displayed
at the annual NNFA Marketplace trade show. Unregistered products
are removed from display shelves. The TruLabel is an NNFA-internal
program overseen by NNFA's Science and Quality Assurance department,
and does not authorize use of the TruLabel name or logo in product
advertising. TruLabel policies are governed by the NNFA's Committee
for Product and Label Integrity (ComPLI) and the board of directors.
products are subject to random testing conducted by independent
laboratories for consistency between contents and labels. Products
that pass testing are published as compliant. Should a test reveal
a product or ingredient deficiency, the member company is contacted
and given a brief period to correct the product or label. A company
that fails to comply is expelled from membership, and is thus
unable to exhibit at NNFA's annual convention and trade show.
NNFA plans to publish products that fail in their newsletter.
US Pharmacopoeia (USP) is a nonprofit corporation that functions
as a quasi-public institution whose standards are enforceable
by the US Food and Drug Administration. The USP establishes and
disseminates quality standards for the use of medicines and dietary
supplements. These standards are published in the United States
Pharmacopoeia and the National Formulary (USP-NF). Proposed revisions
are published for public review and comment in Pharmacopeial Forum
supplements products may be labeled with the USP or NF insignia
if they meet associated standards established by USP.
"USP" insignia indicates that the manufacturer claims that certain
vitamin and mineral ingredients contained in the product have
an FDA-approved or USP-accepted use, have been used extensively
without a significant safety risk, and that they meet the compendial
quality standards published in the United States Pharmacopoeia.
These standards specify allowable rates of disintegration and
dissolution, strength (accuracy of dosage units), range of acceptable
impurities, and existence of an expiration date.
"NF" insignia indicates that the manufacturer claims that herbal
ingredients contained in the product have been used extensively
without a significant safety risk and meet the compendial quality
standards published in the United States Pharmacopoeia National
Formulary (USP-NF). These standards specify allowable rates of
disintegration and dissolution, strength (accuracy of dosage units),
range of acceptable impurities, and existence of an expiration
date. Unlike the USP insignia, NF products are not required to
have an FDA-approved or USP-accepted use.