Standards For Herbs/Dietary Supplements
The US Pharmacopeia (USP) is now setting quality standards for biologics and botanicals marketed as dietary supplements. Manufacturers who meet the standards may add "NF" (National Formulary) to the product label. This is consistent with the proposal from the FDA’s Commission on Dietary Supplement Labels to make labels more reliable and uniform. Dietary supplements can claim effects on body structures or functions, but cannot claim to prevent, treat or cure a disease.
The USP’s first recommendations on botanicals follow:
1) valerian — there is insufficient and conflicting evidence to support the indication for insomnia although drowsiness is the only reported side effect. A well-controlled clinical trial is needed.
2) comfrey - any use is discouraged due to reports of liver damage in animals and humans (following long or short-term oral ingestion of various doses and forms — leaves, roots, pills, or teas). Topical use on broken skin is also discouraged because of the potential for systemic absorption. Historically, comfrey has been suggested for arthritis, colitis, diarrhea, gallstones and pleurisy.
3) ginger for nausea/vomiting — there is insufficient study to support this indication. Product quality varies widely due to natural conditions and differences in brewing times for teas. A reported side effect is minor heartburn. Although there have been no reports in humans, ginger may increase bleeding if taken with anticoagulants. A well-controlled clinical trial is needed.
For additional USP information on botanicals and medications, consult www.usp.org. The search command allows access to medication information and related sites, e.g., InteliHealth drug data base. The drug information link allows access to recommendations on botanicals as they are released.
(US Pharmacopeia. The Standard. Jan/Feb 1998; usp.org/did/mgraphs/botanica/ginger2.htm)
COMMENT: The US Pharmacopeia creates reference and information standards for prescription and non-prescription medications, health equipment and —now —botanicals. They will soon post information on St. Johns’ wort. I use the USP Drug Information Advice for the Patient to inform teachers about students’ medications. The USP website includes this reference to help the school nurse access current information to educate students about their medications.—J.O.