A Quality Standard

As a result of DSHEA and the recently published CGMP regulations for dietary supplements, manufacturers and regulators need access to sources of independent and unbiased public standards for quality.

The U.S. Pharmacopeia (USP; Rockville, MD) provides a good number of these public standards for dietary ingredients and supplements.

However, until now, the dietary supplement standards were intermingled with drug standards or food ingredient standards within three different publications: the United States Pharmacopeia (USP), the National Formulary (NF), and the Food Chemical Codex (FCC).

With this in mind, the USP has decided to compile and organize these standards in one place-the new USP Dietary Supplements Compendium (DSC), published in May. The new compendium also features additional useful information for dietary supplement manufacturers.

Why should a dietary supplement manufacturer use the new DSC?
The new dietary supplement CGMPs emphasize that dietary supplement manufacturers must determine the quality of their supplements and the ingredients therein. They require that manufacturers set their own specifications for quality-including identity, purity, strength, and composition.

Manufacturers of dietary supplements now have the power and responsibility to set the specifications for the dietary ingredients that they buy from their suppliers. Therefore, manufacturers are looking for guidance on how to set these specifications and what values should be considered acceptable.

USP provides all of these elements. USP has set these types of standards for almost 200 years and therefore is in an excellent position to serve the dietary supplement manufacturing and regulating communities. The new DSC is intended to serve as a resource to dietary supplement manufacturers to find suitable, unbiased, and scientifically sound specifications for their products, and associated analytical methodology, for ingredients they buy and for products common to many manufacturers.

How does the DSC differ from other Pharmacopeia compendiums?
This publication is exclusively dedicated to dietary supplements, unlike the USP, NF, and FCC, so dietary supplement manufacturers will not have to weed through a lot of information they don't need. We also have some features different from USP and NF, including international reference amounts for vitamins and minerals and several hundred full-color images.

Will FDA recognize standards from the DSC?
No, but the DSC is designed to assist dietary supplement manufacturers as they comply with CGMPs, and thus, FDA inspections.

How can the DSC help small and medium- sized companies that are trying to meet CGMP regulations?
It can assist by helping them find suitable, unbiased, and scientifically sound specifications for their products; relevant analytical methodology; and reference standards for ingredients they buy, for which they will be responsible under the CGMPs.

How can companies access the new compendium?
The DSC is available as of this month. Visit www.usp.org/products/dietarysupplementscompendium for more information.

James C. Griffiths is vice president of food, dietary supplement, and excipient standards for the U.S. Pharmacopeia (USP). Gabriel I. Giancaspro is director of dietary supplements for USP.