products are labeled with a certification insignia -- a type of
"seal of approval" -- indicating that the product meets the quality
requirements of a particular certification program.
are several different types of certifications found on labels. No
one certification program dominates the dietary supplement marketplace
at this time, nor do existing certification programs all indicate
the same types of quality standards.
are the different types of certification insignia found on a label
and what do they mean?
A "USP" insignia indicates that the manufacturer is claiming 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 meet the compendial quality
standards published in the United States Pharmacopeia. These standards
specify allowable rates of disintegration and dissolution, strength
(range of dosage variance), range of acceptable impurities, and
existence of an expiration date.
"NF" insignia indicates that the manufacturer is claiming 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 Pharmacopeia National
Formulary (USP-NF). These standards specify allowable rates of
disintegration and dissolution, strength (range of dosage variance),
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.
is a proprietary, patented certification owned by Paracelsian,
Inc. Products with the BioFIT [TM] label have passed tests for
consistency between batches and for consistent biofunctionality
associated with the health benefits claimed on the label. For
example, the known mechanisms of action for St. John's wort include
seratonin and dopamine re-uptake inhibition. If a brand of St.
John's wort being tested is able to replicate these two biological
activities within a specific range it is BioFIT [TM].
proprietary, patented certification is owned by Pharmaprint, Inc.,
and is very similar to BioFIT [TM]. PharmaPrint [TM] is licensed
to Whitehall-Robins Healthcare, a division of American Home Products
for use in its Centrum line of dietary supplements. The PharmaPrint
[TM] process standardizes the active ingredients within a plant
source and manufactures the herbal product based on a predetermined
quantity and mix of those active ingredients so as to ensure batch-to-batch
and pill-to-pill consistency.
that there are other certification programs that do not involve
label insignia such as the TruLabel ComPLI program run by the National
Nutritional Foods Association.
about reading the label:
labeling rules in effect
and recommended dosages
testing products for quality,
good manufacturing practices,
and self-regulatory standards
for more information about quality standards in the industry.