IA #66-64 - 3/12/97, "Detention Without Physical Examination and Surveillance of
Essiac and Products Containing Essiac", ATTACHMENT 5/7/97


SUBJECT           : ***Detention Without Physical Examination ***
                    and Surveillance of Essiac and Products Containing Essiac

TYPE OF ALERT     : ***Detention Without Physical Examination***
                    Surveillance

Note:  This alert is being revised to provide changes to format and/or
terminology and are bracketed by asterisks (***)

      ***(NOTE:  This import alert contains guidance to FDA field personnel
      only.  It does not establish any requirements, or create any rights or
      obligations on FDA or on regulated entities.)***

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

PRODUCT CODE      : 66[][][][][]

PROBLEM           : New Drug without an approved New Drug Applicaton
                    (NDA)-(DRND)

PAC FOR
COLLECTION        : 56008H

COUNTRY           : See Attachment

MANUFACTURER/
SHIPPER           : See Attachment

MANUFACTURER/
SHIPPER ID        : See Attachment

IMPORTER'S ID     : N/A

CHARGE            : "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)]."

RECOMMENDING
OFFICE            : Buffalo District

REASON FOR ALERT  : 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.

GUIDANCE          : ***Districts may detain, without physical examination,***
                    Caisse's herbal tea, Essiac, or products containing
                    Essiac, from the manufacturers listed on the Attachment.

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

                    When districts encounter shipments of these products that
                    may be considerd 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 for possible incorporation into the Attachment to
                    this alert. (*capitalized for added emphasis)

PRIORITIZATION
GUIDANCE          : N/A

FOI               : No purging is required

KEYWORDS          : Essiac, Caisse, herbal tea, tea, herbs

                                    ATTACHMENT IA #66-64                                   5/7/97

 FIRMS/PRODUCTS UNDER DETENTION WITHOUT PHYSICAL EXAMINATION

CANADA (CA, 260)

Mfr/Shipper:                                    Product:

Organic Connections                             CAISSE'S HERBAL TEA
P.O.Box 78                                      (shipped as kit)
Wainfleet, Ontario, L0S 1V0
MID #XOORGCON78WAI

New Action Products                             (Same as above)
P.O. Bx 141
Grimsby, Ontario, L3M 4G5
MID #XONEWACT141GRI

New Action Products                             (Same as above)
8 Waterloo Street
Fort Erie, Ontario
MID #XONEWACT8FOR

New Action Products                             (Same as above)
10 Sunnylea Crescent
Grimsby, Ontario
MID #XONEWACT10GRI

Yu-ccan Corporation                             CANAID HERBAL DRINK
426 Kaska Road
Sherwood Park, Alberta T8A 4G8
MID #XAYUCCOR426SHE

Easy-Ac                                         EASY-AC
Box 20111
Rideau Street
Ottawa, Ontario K1N 9N5
MID #XOEASAC2011OTT

Essiac International                            ESSIAC
2211-1081 Ambleside Drive
Ottawa, Ontario K2B 8L8
MID #XOESSINT2211OTT

Everest Foods                                   ESSIAC POWDER
Unit 407, 10 Caxton Close                       2/2/96
Halifax, Nova Scotia B3M 4J7
Canada
MID# XNEVEFOO407HAL

Flora Manufacturing & Distributing Ltd.         FLOR-ESSENCE
7400 Fraser Park Road
Burnaby, British Columbia V3J 5B9
MID #XCFLOMAN7400BUR

Enrich International                            NATIVE LEGEND TEA
(Summerland, British Columbia)
MID #XCENRINTSUM

The Herb House                                  ESSIAC
3232 Eglinton Avenue
Scarborough, Ontario
MID #XOHERHOU3232SCA

Essiac Products, Inc.                           ESSIAC
4 Howard Avenue                                 66V99, 54E99, 54F08, 54F99
Campbellton, New Brunswick                      54Y99, 31K99, 31P99
FEI #3000222866

Eddy's Herbs                                    Burdock Blend Capsules
aka Go Print Inc.                               Product Codes: 31K99
3 King Street                                   31P99, 54E99, 54F08,
P.O. Box 938                                    54F99, 54Y99, 66V99
St. Catharines, Ontario L2R 6Z4                 12/5/95
FEI# 1000450758 (Eddy's Herbs)
FEI# 1000450759 (Go Print Inc.)

Pearl E. Bally                                  Canadian Native Tea/
11 Bayside Private                              66V--99
Ottawa, Ontario K1V 9R3
Canada
MID# XOPEABAL11OTT
FEI# 1000556466

Wellness Pharmacy                               Essiac
884 Portage Avenue                              66V99, 54E99, 54F08,
Winnipeg, Manitoba  R3G 0P1                     54F99, 54Y99, 31K99,
FEI# 3000222865                                 31P99
                                                3/12/97