Inspections, Compliance, Enforcement, and Criminal Investigations
Healing With Essiac Tea 4/12/12
Department of Health and Human Services
|Public Health Service|
Food and Drug Administration
RETURN RECEIPT REQUESTED
April 12, 2012
Ms. Brenda D. Heimann
Healing With Essiac Tea
5300 100th Way North
St. Petersburg, FL 33708-3437
Dear Ms. Heimann:
This is to advise you that the U.S. Food and Drug Administration (FDA) reviewed your website at http://healingwithessiactea.com in March 2012 and has determined that your "Essiac Tea" product is promoted for conditions that cause the product to be a drug under section 201 (g)(1)(B) of the Federal Food, Drug, and Cosmetic Act (the Act) [21 U.S.C. § 321(g)(1)(B)]. The therapeutic claims on your website establish that the product is a drug because it is intended for use in the cure, mitigation, treatment, or prevention of disease. The marketing of your product with these claims violates the Act. You may find copies of the Act and FDA's regulations through links on FDA's home page at http://www.fda.gov.
Examples of some of the claims observed on your website include the following, all of which are from web pages that are available through links from your website's home webpage (http://healingwithessiactea.com):
On the webpage titled "Ingredients":
Under the heading, "Burdock Root":
• "Some say it is good against arthritis and rheumatism."
• "It has been used in treating psoriasis. Burdock root have also been reported to destroy bacteria and fungus cultures. Anti-tumor properties have also been reported"
Under the heading "Sheep Sorrel":
• "Alleged to break down tumors ... "
• "It has been anecdotally reported to ... relieve stomach hemorrhage and jaundice."
On the webpage titled, "Story of Essiac":
• "[R]eceived Essiac Tea from a middle-aged female patient. .. suffering from breast cancer. The patient recovered from her cancer and saw no reoccurrence during a span of the next thirty years."
• "Rene Caisse used the same recipe on her aunt who was terminally ill with stomach and liver cancer. Her aunt lived another 21 years, eventually dying of old age."
• "Over the years, many people with various ailments and illnesses have benefited from the Essiac recipe. Although there is no clinical evidence to support the effectiveness of Essiac on cancer or other diseases, it is believed to be beneficial to those suffering from AIDS, Allergies, Arthritis, Alzheimer's, Asthma, Chronic Fatigue Syndrome, Circulatory problems, Diabetes, Fibroids, Hemorrhoids, Hypoglycemia, Impotence, Malignancies, Multiple Sclerosis, Parkinson's, Prostate and urinary problems, Psoriasis, Sleeping Disorders, Thyroid Problems, Ulcers, Warts, and more."
On the webpage titled, "Benefits":
• "Essiac tea prevents the build up of fatty deposits in the artery walls, heart, kidney, and liver."
• "Essiac tea regulates cholesterol levels ... "
• "Essiac tea can destroy parasites in the digestive system and throughout the body."
• "Essiac tea reduces and possibly eliminates heavy metal deposits in tissues to reduce inflammation and stiffness."
On the webpage titled, "FAQs":
• "Q. Why should I continue drinking the tea after I am cured?
o A. As a preventative so your illness hopefully does not return."
• "Q. Can I drink the tea while taking Chemotherapy treatments?
o A. Yes, in fact the tea will diminish some of the side effects of chemo treatments."
On the webpage titled, "About Me" accessed through a link on a tab by the same name on your homepage:
• "Dad ... discovered he had cancer of the lymph nodes .... He began drinking the tea ... three times a day ... Dad's cancer had completely disappeared within six months."
• "I cannot legally say essiac tea cured my dad, but he took no form of chemotherapy, radiation, or other conventional medications."
Your website also contains disease claims in the form of personal testimonials on the webpage, "Testimonials", including:
• "[M]y 52 year old husband was diagnosed with metastatic colon cancer. .. He has been off of chemo last 7 weeks ... I brewed your essiac tea and gave him as much as he could tolerate everyday for the last few weeks. He had his scan last Thursday and we were holding our breath until his oncologist called with results ... The scan results show NO METASTATIC DISEASE but look similar to Simple Cystic Disease. No more tumors. The doctor said they had shrunk to microscopic in size and will have the Director of Oncology review scan results because she has never seen such a dramatic turnaround in her career!!!"
• "My friend ... is doing wonderful!. She took the essiac tea for three days and she called to tell me that there was ho blood in her urine -- the first time in three years ... she said that if the cancer did not leave her body -- she was happy with the current results she is experiencing. BUT she has already claimed victory for the cancer being removed by having faith in God to heal her with this "stump water"."
• "I am happy to tell you all that the ct-scan I had on Tuesday revealed good news on the battle against my canter. The tumor has shrunk dramatically or disappeared altogether... The cancer in the lymph nodes between my lungs appears to be gone. The spot on my upper right lung appears to be gone."
Your "Essiac Tea" product is not generally recognized as safe and effective for the above referenced uses and, therefore, the product is a 'new drug" under section 201(p) of the Act [21 U.S.C. § 321(p)]. New drugs may not be legally marketed in the United States without prior approval from FDA as described in section 505(a) of the Act [21 U.S.C. § 355(a)]. FDA approves a new drug on the basis of scientific data submitted by a drug sponsor to demonstrate that the drug is safe and effective.
Furthermore, your product is offered for conditions that are not amenable to self-diagnosis and treatment by individuals who are not medical practitioners. Therefore, adequate directions for use cannot be written so that a layperson can use this product safely for its intended uses. Thus, your product is misbranded within the meaning of section 502(f)(1) of the Act [21 U.S.C. § 352(f)(1)], in that the labeling fails to bear adequate directions for use. The introduction of a misbranded drug into interstate commerce is a violation of section 301(a) of the Act [21 U.S.C. § 331(a)].
The above violations cited in this letter are not meant to be an all-inclusive list of violations in your product and its labeling. It is your responsibility to ensure that your product and its labeling comply with the Act and its implementing regulations. You should take prompt action to correct the violations described above and prevent their future recurrence. Failure to promptly correct these violations may result in enforcement action without further notice. The Act authorizes the seizure of illegal products and injunctions against manufacturers and distributors of those products [21 U.S.C. §§ 332 and 334].
Please notify this office in writing within fifteen (15) working days from your receipt of this letter as to the specific steps you have taken to correct the violations noted above and to ensure that similar violations do not occur. Your response should include any documentation necessary to show that correction has been achieved. If you cannot complete all corrections within fifteen working days, please explain the reason for the delay and state the date by which the corrections will be completed.
Please send your written response to the attention of Andrea Norwood, Compliance Officer, Food and Drug Administration, at the address noted in the letterhead. If you have any questions with regard to this letter, Ms. Norwood can be reached at 407-475-4724 or Andrea.Norwood@fda.hhs.gov.
Emma R. Singleton
Director, Florida District