Chinese Herbal Medicines

Chinese herbal medications have a history, dating back to 1974, of containing strong prescription drugs.

In 1974, four cases of agranulocytosis, resulting in the death of one person and extensive hospitalization of three others, were linked to use of these preparations. FDA analysis of pills involved in the illnesses found phenylbutazone and aminopyrine, and analyses of other "herbal medications" found methyl testosterone, prednisolone, diazepam, chlorzoxazone, and acetaminophen.

In 1980, several illnesses and another death were linked to use of Chinese herbal medications, particularly chuifong toukuwan. Analysis of chuifong toukuwan from various sources found indomethacin, hydrochlorothiazide, chlordiazepoxide, lead, and cadmium.

In 1983, an additional brand of the chuifong toukuwan variety labeled only in Chinese (translated as product number 13 of attachment A below) appeared in the Portland, Oregon area. Trademark is a pair of concentric units surrounding a dragon intertwined about the numeral "7" (Seven Dragon Brand). The pills come 60 to a bag in a white plastic bag with a zip lock closure. FDA analysis has found phenylbutazone at 10 to 18 milligrams per pill in the product.

In 1988, the Food and Drug Branch of the California State Department of Health Services issued a press release announcing an enforcement initiative against dangerous Chinese and other Asian ethnic medicines. Attachment B lists the products involved, the reputed manufacturer, and the hazardous ingredients contained.

Currently, herbal pills are being marketed containing a combination of four drugs: diazepam, indomethacin, hydrochlorothiazide, and mefanamic acid. These pills are marketed under a variety of names and in a variety of packagings. They are spherically shaped, approximately 3/8" in diameter, and have a shiny black exterior. When the pills are cracked open, white crystalline material is observed to be imbedded in the brown interior.

None of the products list the drug substances as ingredients. Investigation has shown that the pills originate from several sources, and usually enter the country via air mail shipments to health food stores, oriental food stores, novelty shops, and individual consumers. They are occasionally sold door to door. These products are listed in attachment A.

Please inform your local U.S. Customs and Postal Service officials of our interest in these types of products, especially mail entries.

Chinese herbal medicines

When accompanied by drug claims, charge:

"The article is subject to refusal of admission pursuant to 801(a)(3) in that it appears the labeling fails to bear adequate directions for use for its intended purposes [Misbranded, 502(f)(1)].¿

OASIS Charge Code - DIRECTIONS

and

¿it appears to be a new dug without an effective new drug application [Unapproved new drug, 505(a)].¿

OASIS Charge Code - UNAPPROVED

When unaccompanied by drug claims, charge:

"The article is subject to refusal of admission pursuant to 801(a)(3) in that it appears the labeling fails to bear adequate directions for use for its intended purposes [Misbranded, 502(f)(1)].¿

OASIS Charge Code - DIRECTIONS