USP Quality Review

No. 65, Issued 04/99

“USP” vs. “NF”

To date, USP has published several botanical standards monographs. These monographs include specifications for identity, strength, quality, purity, packaging, and labeling and appear in the National Formulary. Nine monographs were published in the Ninth Supplement to the USP 23-NF 18 (see Figure 1). The difference between “USP” and “NF” recognition is distinguished by the criteria for admission into the compendia. Standards found in the “USP” designate that the article has an FDA-approved or USP-accepted use. Otherwise, an article may be included in the “NF” if it has been widely used for a significant time and does not demonstrate any significant safety risk. The first few authoritative information monographs for botanicals have also been completed. These monographs include information on the chemistry, pharmacology, precautions, potential risks, possible interactions, and toxicity of the botanical.

More information about the standards and the information monographs will be published in upcoming USP Quality Reviews.

Herbal and plant-derived products have been used throughout history. In general, botanical products used as dietary supplements have a good safety profile. These “natural” products, however, do contain biologically active components. By developing unbiased standards and authoritative information for botanicals used as dietary supplements, the USP is trying to bridge the information void created by current regulations and market forces.

Currently over 50 reports concerning botanical products have been reported to the Drug Product Problem Reporting Program (DPPR). The scope of these problems range from efficacy concerns to serious adverse reactions. Health care professionals should remember to ask patients and consumers specifically about botanical product use. Often patients do not mention them when asked about current medications. The use of botanicals as dietary supplements is very popular. As the United States' experience with these products becomes better established, it is important to collect and share information that is learned to ensure public health and safety. Product safety concerns or possible adverse reactions should be reported. Practitioners are encouraged to report problems with botanical products to the USP.

Figure 1

Botanical Monographs Currently Appearing in the National Formulary
Published in the Ninth Supplement to the USP 23-NF 18

  • Feverfew
  • Powdered Feverfew
  • Ginger
  • Ginkgo
  • Oriental Ginseng
  • Powdered Oriental Ginseng
  • St. John's Wort
  • Powdered St. John's Wort
  • Saw Palmetto