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Article Title

Determination of undeclared prescription drugs in black pearl products

Abstract

Black Pearls are a type of Chinese herbal preparation generally marketed to American consumers suffering from arthritis and back pain. Their importation and sale in the United States has been banned by the Food and Drug Administration since the 1970s. However, they are still available by mail order and occasionally in specialty shops. The FDA is concerned over the use of black pearls because some products have been adulterated with undeclared prescription drugs. Using a combination of GC/MS and HPLC to analyze methanol/ether extracts of black pearl products, we have detected the following prescription drugs: diazepam, diclofenac, hydrochlorothiazide, indomethacin and mefenamic acid. The levels and combinations of drugs present varied significantly, even within the same manufacturer and the presence or absence of the drugs was not consistent within different packages of the same product. Because of the adulteration and lack of control in the contents of these products, the FDA is actively trying to stop the sale and use of black pearls in the United States.

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