About ILaaom
Articles
Join ILaaom
Contact Us
CEU Information
Legislative Information

Newsletter
What is Oriental Medicine?
Students' Page
Find a Practitioner
Links
Book Reviews
Home




FDA Interferes Unlawfully with the Practice of Chinese Herbal Medicine

By Claudette Baker, L. Ac., Dipl. Ac. & Herbs (NCCAOM)

The ability to continue utilizing our Chinese Herbal Pharmacy has reached a critical juncture. The information in this article is not new. It has been going on for years, however the attacks on herbs recently have been intensifying and becoming more frequent. We must all contact our federal and state representatives immediately. Please go to aaom.org for information and how to respond.

The rule banning ephedrine alkaloids specifically exempts “traditional Chinese herbal remedies.” The FDA assured us that the ephedra ban would not apply to OM practitioners, providing that ephedra was not used for dietary or performance purposes. Yet ever since the ban went into effect in April of 2004, the FDA has blocked “traditional Chinese herbal remedies” from being distributed in the United States. We regard this action as falling outside the jurisdiction of the FDA and as a direct interference with our practice rights. The FDA has been disregarding their own ruling in this respect and herbal vendors cannot get their products with ephedra across US borders.

The FDA has a long ‘hit list’ of herbs that are being detained and sometimes destroyed at US borders. The FDA has also been detaining all of the animal products like earthworm, cicada, fossilized bone (long gu) and similar products. They are calling these items ‘new drugs’ even though they have been used in this county prior to DESHA. Wu Ling Zhi (flying squirrel feces) has also been blocked. The EU has banned all mineral and animal related products in Chinese herbal products. This could have complicated implications for the US.

The FDA is now calling Shen Qu a dangerous drug, most likely because the common name is ‘Medicated Leaven’. This is a mixture of fermented wheat and other benign Chinese herbs.

Since 1989 there has been an import alert for Trichsanthin. This substance is an isolated protein from the plant Trichosanthes kirilowii Maxin that has been used in HIV drugs. This year they have denied entry to all three plant parts of Trichosanthes kirilowii Maxin, Tian Hua Fen, Gua Lou Pi and Gua Lou Zi. These plant parts have never been denied entry before. The import alert makes no mention of these herbs, only the isolated protein.

We keep hearing about the intention of the FDA to take action against Zhi Shi/Bitter Orange because it contains synefrine and Zhi Shi is used as a Ma Huang substitute. This could affect the whole citrus category. There are 11 single herbs and 105 herbal formulas that contain such citrus herbs. It seems that they do not have a legitimate case, only fabricated cases. If we lose access to citrus products will the practice of Chinese herbal medicine even be viable in the US?

The list of herbs most threatened is a very long list.
Here are just a few:

Anything that contains aristolochic acid:, Aristolochia contorta, Aristolochia debilis , Aristolochia fangchi , Aristolochia kaempferi, Aristolochia manshuriensis, Arist-olochia mollissima, Aristolochia, moupinensis, Aristolochia shimadi, Asarum forbgesii, Asarum, heteropoides var. mandshuricum, Asarum sieboldii. Anything that contains ephedrine: Ephedra sinica , Ephedra equisetina , Pinellia ternata; animal products and Illicium verum & Tussilago farfara for alleged potential liver problems. .


- Top - Back