Import Alert 66-64

"Detention Without Physical Examination Of Essiac and Products Containing Essiac"

In March 1994, BUF-DO conducted an inspection of a distributor in Buffalo, NY, as a follow-up to a consumer complaint alleging Essiac Tea was being promoted as a cancer treatment. The inspection revealed that the firm takes 2 oz. bags of tea labeled as "CAISSE'S HERBAL TEA" and provides various literature, which accompanies the tea, indicating that it is effective in treating cancer.

The Caisse's Herbal Tea is blended and repacked at Organic Connections, Wainfleet, Ontario, Canada and brought into the U.S. by the vice president of the Buffalo distributorship, who also operates a similar business from a residence in Canada. The firm in Canada does business as New Action Products, P.O. Box 141, Sunnylea Crescent, Grimsby, Ontario.

Ingredients listed on the 2 oz. package include burdock root, sheep sorrel, slippery elm bark, and turkey rhubarb root. Two booklets entitled "ESSIAC" and "I Was Canada's Cancer Nurse; The Story of ESSIAC by Rene M. Caisse, R.N.," accompany the product. The literature describes an herbal mixture known as "Essiac" discovered by a Canadian nurse, Ms. Rene M. Caisse. Essiac is Caisse spelled backwards.

Essiac has been touted as a treatment for cancer and more recently for AIDS. Studies performed on the preparation of Essiac in Canada and by the National Cancer Institute found that the product had no anti-tumor activity. Moreover, this product is not the subject of an approved NDA.

*** Districts may detain, without physical examination,*** Caisse's herbal tea, Essiac, or products containing Essiac, from the manufacturers identified in the Red List.

Continued surveillance of herbal teas and preparations from other Canadian firms is warranted.

When districts encounter shipments of these products that may be considered new drugs without an approved new drug application (NDA) because of label claims or accompanying literature, the information, *INCLUDING ALL ACCOMPANYING LABELING CONTAINING DRUG CLAIMS TO SUPPORT THE 505(A) CHARGE*, should be forwarded to DIOP, HFC-170, for review by *** CDER/Office of Compliance (OC), Imports Exports Compliance Branch*** for possible incorporation into the Attachment to this alert. (*capitalized for added emphasis) ***The CDER/OC/Imports Exports Compliance Branch can be contacted at cderimportsexports@fda.hhs.gov***

Essiac and products containing Essiac, such as herbal teas and drinks, *PROMOTED AS A DRUG IN THE TREATMENT OF CANCER*. (*capitalized for added emphasis)

"The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be a new drug within the meaning of Section 201(p) without an approved New Drug Application (NDA)[Unapproved New Drug, Section 505(a)]."

OASIS Charge Code - UNAPPROVED