|Company:||Herbs for cancer|
|Subject:||Current Good Manufacturing Practices for Finished Pharmaceuticals/Adulterated|
|Issuer:||Los Angeles District Office|
|Issued:||May 27, 2008||Closed:||
Department of Health and Human Services
Public Health Service
May 27, 2008
Herbs for cancer
12611 N 103rd Ave Ste A
Sun City, AZ 85351
Dear Ms. Spohn:
This letter concerns your marketing of the products. Bladder Cancer Tea Formula, Bone Cancer Tea Formula, Breast Cancer Tea Formula, Colon Cancer Tea Formula, Esophageal Cancer Tea Formula, Lung Cancer Tea Formula, Malignant Lymphoma Tea Formula, Nasal Cancer Tea Formula, Prostate Therapy Tea Formula, Skin Cancer Tea Formula, Special Tea Formula, Stomach Cancer Tea Formula, Tongue and Oral Cancer Tea Formula, Uterus and Cervical Cancer Tea Formula, and Ellagic Acid. According to information on your website, www.herbsforcancer.com these products are intended to prevent, treat, or cure disease conditions or to affect the structure or function of the body.
We note that you have attempted to disclaim some of the statements on your site that indicate that the products are, intended to prevent, treat, or cure disease conditions or to affect the structure or function of the body. For example, your site says regarding your products:
"Disclaimer: The FTC and FDA require us to place this disclaimer here, please read. Herbs for cancer is not intended to cure, treat, or diagnose your illness."
However, untrue or misleading information in one part of your site will not be mitigated by inclusion of such a "disclaimer." Cf 21 C.F.R 202.1 (e)(3)(i).
Statements on your website that document the intended uses of these products include, but are not limited to, the following:
Bladder Cancer Tea Formula
• "This formula should be taken even after surgery to insure the whole body has the benefits of the anti-cancer herbs."
Bone Cancer Tea Formula
• "Chondrosarcoma: This is a malignant tumor that attacks the chondrocytes, the cartilage cells. Giant Cell Tumor: This tumor begins in the interlobar tissue and is characterized by multiple giant nuclear cells. This herbal formula is very complex and used to treat all avenues of the disease. These avenues are the bone cells, cartilage and the nuclear cells. Along with the cancer fighting herbs, there are herbs to decrease swelling at the tumor site."
Breast Cancer Tea Formula
• "The herbs in this formula dissipate nodules and masses in the breast, [sic] It is full of Anti-cancer fighting herbs. Along with helping your body fight the cancer there are herbs to relieve pain and distention in the breast tissue."
• "This formula is being used in China to treat breast cancer.
Colon Cancer Tea Formula
• "The herbs in this herbal formula are to help those with colon cancer."
• "The herbs in this formula are known for their Anti-cancer fighting properties."
Esophageal Cancer Tea Formula
• "These herbs are widely used in China to treat esophageal cancer with great success."
Lung Cancer Tea Formula
• "The herbs in this formula are specifically to help those who have lung cancer."
• "They tonify the lungs and may increase the oxygen exchange in the lungs that have become impaired from the disease. Increasing the oxygen in the body helps aid in the destruction of the cancer cells."
• "These herbs in this formula will assist in the fight against cancer and will do no harm to the body."
Malignant Lymphoma Tea Formula
• "Taking this herbal formula helps to improve the immune system and may help the body fight the cancer."
• "Along with the cancer fighting herbs there are herbs . . ."
Nasal Cancer Tea Formula
• "This herbal formula has strong anticancer agents."
Prostate Therapy Tea Formula
• "This formula is designed to help your body fight the cancer . . ."
Skin Cancer Tea Formula
• "This formula has herbs to help with all types of skin cancers.
Special Tea Formula
• "Please use special formulas to order tea and capsule formulas for cancers not on our regular list."
• "please specify the details of your cancer . . ."
Tongue and Oral Cancer Tea Formula
• "Taking the herbal formula in raw form and holding in the mouth will coat the tongue and oral cavity with strong anti-cancer herbs that will start healing from the outside while drinking the herbal formula will help from within."
Uterus and Cervical Cancer Tea Formula
• "This is a great herbal formula that has strong anti-cancer fighting herbs. Along with helping your body fight the cancer . . ."
• "These herbs have been used in China for hundreds of years to treat women and now have been tested in modern medicine to show positive results in the treatment of uterus and cervical cancer."
• "This is a very balanced herbal formula to assist in the fight against cancer."
• "This formula can be used along with chemotherapy and radiation to protect the body and enhance the positive effects of those treatments . . ."
These claims are supplemented by use of the word "cancer" in most of your product names, as well as in the URL address for your website. Furthermore, the metatags used to bring consumers to your website include "cancer," "herbs for cancer" and " fight-cancer."
Bladder Cancer Tea Formula, Bone Cancer Tea Formula, Breast Cancer Tea Formula, Colon Cancer Tea Formula, Esophageal Cancer Tea Formula, Lung Cancer Tea Formula, Malignant Lymphoma Tea Formula, Nasal Cancer Tea Formula, Prostate Therapy Tea Formula, Skin Cancer Tea Formula, Special Tea Formula, Stomach Cancer Tea Formula, Tongue and Oral Cancer Tea Formula, Uterus and Cervical Cancer Tea Formula, and Ellagic Acid are drugs, as defined by section 201(g)(1) of the Federal Food, Drug, and Cosmetic Act (the Act), 21 U.S.C. § 321(g)(1), because they are intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease in man or other animals. Moreover, these are new drugs, as defined by section 201(p) of the Act, 21 U.S.C. § 321(p), because they are not generally recognized as safe and effective for their labeled uses. Under section 301(d) and 505(a) of the Act, 21 U.S.C. §§ 331(d) and 355(a), a new drug may not be introduced or delivered for introduction into interstate commerce unless an FDA-approved application is in effect for it. Your sale of the aforementioned products without approved applications violates these provisions of the Act.
Furthermore, since Bladder Cancer Tea Formula, Bone Cancer Tea Formula, Breast Cancer Tea Formula, Colon Cancer Tea Formula, Esophageal Cancer Tea Formula, Lung Cancer Tea Formula, Malignant Lymphoma Tea Formula, Nasal Cancer Tea Formula, Prostate Therapy Tea Formula, Skin Cancer Tea Formula, Special Tea Formula, Stomach Cancer Tea Formula, Tongue and Oral Cancer Tea Formula, Uterus and Cervical Cancer Tea Formula, and Ellagic Acid are offered for conditions that are not amenable to self-diagnosis and treatment by individuals who are not medical practitioners, adequate directions cannot be written so that a layman can use the products safely for their intended uses. Thus, your products' labeling fails to bear adequate directions for their intended uses, causing them to be misbranded under section 502(f)(1) of the Act, 21 U.S.C. § 352(f)(1).
The issues and violations cited in this letter are not intended to be an all-inclusive statement of violations that exist in connection with your products. You are responsible for investigating and determining the causes of the violations identified above and for preventing their recurrence or the occurrence of other violations. It is your responsibility to assure that your firm complies with all requirements of federal law and FDA regulations. We advise you to review your websites, product labels, and other labeling and promotional materials for your products to ensure that the claims you make for your products do not cause them to violate the Act.
You should take prompt action to correct the violations cited in this letter. Failure to promptly correct these violations may result in legal action without further notice, including, without limitation, seizure and injunction. Other federal agencies may take this Warning Letter into account when considering the award of contracts.
Within fifteen working days of receipt of this letter, please notify this office in writing of the specific steps that you have taken to correct violations. Include an explanation of each step being taken to prevent the recurrence of violations, as well as copies of related documentation. If you cannot complete corrective action within fifteen working days, state the reason for the delay and the time within which you will complete the correction. If you no longer manufacture or market the aforementioned products, your response should so indicate, including the reasons that, and the date on which, you ceased production.
Additionally, if another firm manufactures the products identified above, your reply should include the name and address of the manufacturer. If the firm from which you receive the products is not the manufacturer, please include the name of your supplier in addition to the manufacturer. If you have any questions or need clarification regarding this letter prior to your written response, you may contact MaryLynn Datoc, Compliance Officer at telephone number (949) 608-4428.
Please direct your response to:
Pamela B. Schweikert
Director, Compliance Branch
U.S. Food and Drug Administration
Irvine, CA 92612-2506
A description of the new drug approval process can be found on FDA's internet website at http://www.fda.gov/cder/regulatory/applications/default.htm . Any questions you may have regarding this process should be directed to the Food and Drug Administration, Division of Drug Information (HFD-240), Center for Drug Evaluation and Research, 10903 New Hampshire Ave., WO51-2201, Silver Spring, MD 20993.
Alonza E. Cruse
Los Angeles District
Cc: Jeff Farrar, DVM, PhD, MPH
Food and Drug Branch
California Department of Public Health
1500 Capitol Avenue - MS 7602
P.O. Box 997413
Sacramento, CA 95899-7413