Alert 66-64

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Import Alert 66-64

(Note: This import alert represents the Agency’s current guidance to FDA field personnel regarding the manufacturer(s) and/or products(s) at issue. It does not create or confer any rights for or on any person, and does not operate to bind FDA or the public).
Import Alert # 66-64
Published Date: 11/22/2013
Type: DWPE with Surveillance
Import Alert Name:

“Detention Without Physical Examination Of Essiac and Products Containing Essiac”

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 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***

Product Description:

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

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)].”OASIS Charge Code – UNAPPROVED

List of firms and their products subject to Detention without Physical Examination (DWPE) under this Import Alert (a.k.a. Red List)

 

CANADA


 

Easy Ac

Date Published : 09/10/2009
Rideau Street , Box 20111 , Ottawa, ON CANADA

31 P – – — </i> Tea Substitutes

Date Published: 09/10/2009
Notes:Essiac

66 – – – — Human and Animal Drugs

Date Published: 09/10/2009

Eddys Herbs

Date Published: 09/10/2009
3 King Street , PO Box 938 , St Catharines, ON CANADA
31 K – – 99 Tea, N.E.C.Date Published: 09/10/2009
Notes:Burdock Blend Capsules12/5/1995

31 P – – 99 Tea Substitutes, N.E.C.

Date Published: 09/10/2009
Notes:Burdock Blend Capsules12/5/1995

54E – – 99 Herbals & Botanical Teas, N.E.C.

Date Published: 09/10/2009
Notes:Burdock Blend Capsules 12/5/1995

54 F – – 08 Enchinacea, Herbal & Botanicals (not teas)

Date Published: 09/10/2009
Notes:Burdock Blend Capsules12/5/1995

54 F – – 99 Herbals & Botanicals (not Teas), N.E.C.

Date Published: 09/10/2009
Notes:Burdock Blend Capsules12/5/1995

54 Y – – 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C.

Date Published: 09/10/2009
Notes: Burdock Blend Capsules12/5/1995

66 V – – 99 Miscellaneous Patent Medicines, Etc

.

Date Published: 09/10/2009
Notes: Burdock Blend Capsules 12/5/1995

Enrich International

Unknown , Summerland, BC CANADA

Date Published : 09/10/2009

31 P – – — Tea Substitutes

Date Published: 09/10/2009
Notes: Native Legend Tea

66 – – – — Human and Animal Drugs

Date Published: 09/10/2009
Notes:Native Legend Tea

Essiac Canada International

Date Published : 09/10/2009
P.O. Box 23155 , Ottawa, Ca-On CANADA

31 P – – — Tea Substitutes

Date Published: 09/10/2009
Notes: ESSIAC extract 8/11/2006

66 – – – — Human and Animal Drug

s

Date Published: 09/10/2009
Notes: ESSIAC extract 8/11/2006

Essiac Canada International

Date Published : 09/10/2009
164 Richmond Rd , Ottawa, ON CANADA

31 P – – — Tea Substitutes

Date Published: 09/10/2009
Notes: ESSIAC extract8/11/2006

66 – – – — Human and Animal Drugs

Date Published: 09/10/2009
Notes:ESSIAC extract 8/11/2006

Essiac Corporation

Date Published : 09/10/2009
2211-1081 Ambleside Drive , Ottawa, ON CANADA

31 P – – — Tea Substitutes

Date Published: 09/10/2009

66 – – – — Human and Animal Drugs

 

Date Published: 09/10/2009

Essiac Products Inc

Date Published : 09/10/2009
4 Howard Avenue , Campbellton, NB CANADA

31 K – – 99 Tea, N.E.C

Date Published: 09/10/2009

31 P – – 99 Tea Substitutes, N.E.C

Date Published: 09/10/2009

54 E – – 99 Herbals & Botanical Teas, N.E.C

Date Published: 09/10/2009

54 F – – 08 Enchinacea, Herbal & Botanicals (not teas)

Date Published: 09/10/2009

54 F – – 99 Herbals & Botanicals (not Teas), N.E.C.

Date Published: 09/10/2009

54 Y – – 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C.

Date Published: 09/10/2009

 

66 V – – 99 Miscellaneous Patent Medicines, Etc.

Date Published: 09/10/2009
Everest Food
Unit 407, 10 Caxton Close , Halifax, NS CANADADate Published : 09/10/2009

31 P – – — Tea Substitute

Date Published: 09/10/2009
Notes:ESSIAC powder

66 – – – — Human and Animal Drugs

Date Published: 09/10/2009
Notes: ESSIAC powder

Flora Manufacturing & Distributing Ltd.

Date Published : 09/10/2009
7400 Fraser Park Drive , Burnaby, CANADA

31 P – – — Tea Substitutes

Date Published: 09/10/2009
Notes: Flor-essence

66 – – – — Human and Animal Drug

Date Published: 09/10/2009

Notes:Flor-essence

Go Print Inc

.

Date Published : 09/10/2009

 

3 King Street , PO Box 938 , St Catharines, ON CANADA

31 K – – 99 Tea, N.E.C.

Date Published: 09/10/2009

 

Notes:Burdock Blend Capsules12/5/1995

31 P – – 99 Tea Substitutes, N.E.C.

Date Published: 09/10/2009
Notes: Burdock Blend Capsules12/5/1995

54 E – – 99 Herbals & Botanical Teas, N.E.C

Date Published: 09/10/2009
Notes: Burdock Blend Capsules12/5/1995

54 F – – 08 Enchinacea, Herbal & Botanicals (not teas)

Date Published: 09/10/2009
Notes: Burdock Blend Capsules12/5/1995

54 F – – 99 Herbals & Botanicals (not Teas), N.E.C.

Date Published: 09/10/2009
Notes: Burdock Blend Capsules12/5/1995

54 Y – – 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C

Date Published: 09/10/2009
Notes: Burdock Blend Capsules12/5/1995

66 V – – 99 Miscellaneous Patent Medicines, Etc.

Date Published: 09/10/2009
Notes:Burdock Blend Capsules 12/5/1995

New Action Products

Date Published : 09/10/2009
10 Sunnylea Crescent , Grimsby, ON CANADA

31 P – – — Tea Substitutes

Date Published: 09/10/2009
Notes: CAISSE’S Herbal Tea (shipped as a kit)

66 – – – — Human and Animal Drugs

Date Published: 09/10/2009
Notes:CAISSE’S Herbal Tea (shipped as a kit)

New Action Products

8 Waterloo Street , Fort Erie, ON CANADADate Published : 09/10/2009

31 P – – — Tea Substitutes

Date Published: 09/10/2009
Notes:CAISSE’S Herbal Tea (shipped as a kit)

66 – – – — Human and Animal Drug

s

Date Published: 09/10/2009

 

Notes:CAISSE’S Herbal Tea (shipped as a kit)

New Action Products

Date Published : 09/10/2009
P.O. Box 141 , Grimsby, ON CANADA

31 P – – — Tea Substitute

Date Published: 09/10/2009
Notes:CAISSE’S Herbal Tea (shipped as a kit)

66 – – – — Human and Animal Drugs

Date Published: 09/10/2009
Notes: CAISSE’S Herbal Tea (shipped as a kit)

Organic Connections Ltd.

Date Published : 11/22/2013
33230 Pettit Rd. , Box 78 , Wainfleet, CA-ON CANADA

31 P – – — Tea Substitute

s

Date Published: 11/22/2013
Notes: CAISSE’S Herbal Tea (Shipped as a Kit)

66 – – – — Human and Animal Drugs

Date Published: 11/22/2013
Notes; CAISSE’s Herbal Tea (Shipped as a kit)

Pearl E. Bally

11 Bayside Private , Ottawa, ON CANADA Date Published : 09/10/2009

66 V – – 99 Miscellaneous Patent Medicines, Etc.

Date Published: 09/10/2009
Notes: Canadian Native Tea

The Herb House

Date Published : 09/10/2009
3232 Eglinton Avenue , Scarborough, ON CANADA

31 P – – — Tea Substitutes

 

Date Published: 09/10/2009

66 – – – — Human and Animal Drugs

Date Published: 09/10/2009

Wellness Pharmacy

 

Date Published : 09/10/2009
884 Portage Avenue , Winnipeg, MB CANADA

31 K – – — Tea

Date Published: 09/10/2009

 

Notes: 3/12/1997

31 P – – — Tea Substitutes

Date Published: 09/10/2009
Notes:3/12/1997

54 E – – 99 Herbals & Botanical Teas, N.E.C.

Date Published: 09/10/2009
Notes:3/12/1997

54 F – – 08 Enchinacea, Herbal & Botanicals (not teas)

Date Published: 09/10/2009
Notes:3/12/1997

54 F – – 99 Herbals & Botanicals (not Teas), N.E.C

Date Published: 09/10/2009
Notes: 3/12/1997

66 V – – 99 Miscellaneous Patent Medicines, Etc.

Date Published: 09/10/2009


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