|Company:||Road to Healing|
|Subject:||Current Good Manufacturing Practices for Finished Pharmaceuticals/Adulterated|
|Issuer:||New Orleans District Office|
|Issued:||May 29, 2008||Closed:||
Department of Health and Human Services
Public Health Service
New Orleans District
Telephone: ( 615) 366-7801
May 29, 2008
WARNING LETTER NO. 2008-NOL-12
DELIVERY SIGNATURE REQUESTED
Road to Healing
3121 Old Marksville Hwy
Pineville, Louisiana 71361
Dear Sir or Madam:
This is to advise you the U.S. Food and Drug Administration (FDA) reviewed your website, at the Internet address http://www.roadtohealine.com.on April 28, 2008, and has determined the products "Cat's Claw," "Chlora Plasma," "Melatonin," "Native Herbal Tea Rene Caisse's Original Formula," and "Red Clover Plus" are promoted for conditions which cause the products to be drugs under Section 201(g)(1)(B) of the Federal Food, Drug, and Cosmetic Act (the Act) [21 United State Code (USC) 321(g)(1)(B)]. The therapeutic claims we observed on your website establish the products are drugs, because they are intended for use in the cure, mitigation, treatment, or prevention of disease. The marketing of the products with these claims violates the Act.
Examples of some of the claims observed on your website include:
• "Cat's Claw appears to provide cystic action, thus preventing the development and growth of malignant cells in cancer and other tumorous conditions. It helps the immune system, including Aids [sic]. by increasing the production of leukocytes (white blood cells), and blocking the advance of many viral illnesses. Its anti-inflammatory effects are well known for the treatment of conditions such as arthritis (inflammation of the joint), rheumatism, . . . gout, fibromyalgia, and Carpal Tunnel Syndrome (CTS)."
• "This Proprietary formula . . . helps reduce cancer tumors, effectively combats viral infections . . . and is perhaps useful in the treatment of AIDS."
• "A Free radical scavenger (antioxidant) which destroys substances that causes disease, tumors, . . . and mutation in the body . Melatonin increases the body's antibody response to infections . . . "
• "It helps and treats many forms of cancer, especially breast cancer, prostate cancer and melanoma. Some studies and trials have shown it can improve the survival time and quality of life of patients with untreatable cancer."
Native Herbal Tea Rene Caisse's Original Formula
• "Rene Caisse's Herbal Tea is a rather famous combination of 4 herbs which has been proven to `treat' all forms of cancer. "
• "Products in the formulation [of Native Herbal Tea] have proven effective in dealing with tumors, tumorous growths and various forms of cancer."
Red Clover Plus
• "Red Clover plus . . . is good for skin inflammations such as . . . Jaundice, boils, leg ulcers, abscesses, psoriasis, leprosy. . . . Lyme disease .... It . . . helps fight against cancerous
growths, perhaps helps with lupus, helps with muscle atrophy and joint inflammation, . . .
perhaps is helpful in the treatment of AIDS . . . "
FDA also observed disease claims in the form of personal testimonials on your website, including:
• "D.H. was diagnosed with a brain tumor . . . . After chemotherapy treatments, radiation treatments and various other experimental allopathic remedies, the medical doctors gave him three months to live . He beg an taking the Native Herbal tea formula 3 times a day plus Chloro Plasma and Red Clover and he recovered from the brain tumor . . . "
• "After taking the Native Herbal tea for only three days, Van's skin cancer disappeared."
The testimonials and other claims quoted above are supplemented by the meta tags used to bring consumers to your website. The meta tags we observed during our review include "anti cancer treatment," "anti inflammatory." "arthritis treatment," "ulcer treatment," "cancer treatment," "alternative cancer treatment," and "natural cancer treatment."
Your products are not generally recognized as safe and effective for the above referenced uses, and therefore, the products arc "new drugs" under Section 201(p) of the Act [21 USC 321(p)].
New drugs may not be legally marketed in the U.S. without prior approval from FDA as described in Section 505(a) of the Act [21 USC 355(a)]. FDA approves a new drug on the basis of scientific data submitted by a drug sponsor to demonstrate the drug is safe and effective. Your products "Cat's Claw," "Chlora Plasma," "Melatonin," "Native Herbal Tea Rene Caisse's Original Formula" and "Red Clover Plus" are also misbranded within the meaning of Section 502(f)(1) of the Act as labeling for these drugs fails to bear adequate directions for use [21 USC 352(f)(1)].
The above violations are not meant to be an all-inclusive list of deficiencies in your products and their labeling. While reviewing your website, we noticed you promoted other products for disease treatment and/or prevention. The unlawful disease treatment and prevention claims on your website were too numerous to list in this letter. It is your responsibility to ensure products marketed by your firm comply with the Act and its implementing regulations. We urge you to review your website, product labels, and other labeling and promotional materials for your products to ensure the claims you make for your products do not cause them to violate the Act.
You should take prompt action to correct the violations described above and prevent future recurrence. Failure to do so 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 USC 332 and 334].
Please notify this office, in writing, within fifteen (15) working days of the receipt of this letter, as to the specific steps you have taken to correct the violations noted above and to assure similar violations do not occur. Include any documentation necessary to show correction has been achieved. If corrective actions cannot be completed within fifteen working days, state the reason for the delay and the time within which the corrections will be completed.
Your response should be sent to: Nicole F. Hardin, Compliance Officer. U.S. Food and Drug
Administration at the above address. If you have any questions about the content of this letter,
please contact Mrs. Hardin at (504) 219-8818, extension 102 or via fax (504) 219-8813.
H. Tyler Thornburg
New Orleans District
cc: Associate Director
Division of Advertising Practices
Federal Trade Commission
600 Pennsylvania Avenue, N.W.
Washington, D.C . 20580