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Certification claims
January 1999

Increasingly, 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.

There 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.

What are the different types of certification insignia found on a label and what do they mean?

USP
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
An "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.
 
BioFIT [TM]
This 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].
 
PharmaPrint [TM]
This 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.
 

Note 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.

 

   
 

More about reading the label:

New labeling rules in effect

Health benefit claims

Ingredients and recommended dosages

Dosage units

Dosage amounts

Expiration date

Lot number

Dissolution and bioavailability

Certification claims

 

See also testing products for quality, good manufacturing practices, and self-regulatory standards for more information about quality standards in the industry.

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(c) Copyright 1999-2003 Dietary Supplement Quality Initiative. For permission to reprint, please contact our editor.