|Company:||Plant Cures Incorporated|
|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
Los Angeles District
May 27, 2008
Plant Cures Incorporated
The Herbal Healing Place
Desert Dragon Healing Center
Desert Dragon Herbs
P.O. Box 1735
Benson, AZ 85602
Dear Mr. Gussa:
This is to advise you that the Food and Drug Administration (FDA) has reviewed your website at the Internet address www.plantcures.com and has determined that the products "Bloodroot Extract," "Ojibwa Tea or "Essiac,"" and "C-Cell 4 Destroyer" are promoted for conditions that cause the products to be drugs 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 products are drugs because they are intended for use in the cure, mitigation, treatment, or prevention of disease. The marketing of these products with these claims violates the Act.
Examples of some of the claims observed on your website include:
• The scientists that research for drug companies have actually suggested Bloodroot to be developed as a cancer drug."
• "See Research at the American Association for Cancer Research: You will note at the end of many of the paragraphs it says: 'We suggest that sanguinarine (Bloodroot) could be developed as an anticancer drug."
Ojibwa Tea or "Essiac"
• "For Cancer, they (the Ojibwas) used this as an underlying formula and then, history says, 'cured the cancer with Bloodroot.' However, a few people claimed to have been cured with the tea alone. (Most likely because they just needed colon cleansing to rid what ever was 'feeding' the cancer)"
• "We recommend using 10-20 drops of Bloodroot Tincture with each cup you drink if you do have cancer."
C-Cell 4 Destroyer
• "I have combined the key herbs from some of the most successful formulas in history along with herbs for the latest research into Chinese Herbs[.] We are calling it 'C-Cell 4 Destroyer[.]' The individual formulas and Chinese herbs have all had a history of success.
. . . The reason this combination is in four different forms . . . is to assure the most direct, effective, palatable, and easily assimilated path of these herbs into the system ultimately providing the strongest defense against cancer."
These claims are supplemented by the metatags used to bring consumers to your website through Internet searches. The metatags include "cancer" and "Herbal healing cures for . . . cancer."
Your products are not generally recognized as safe and effective for the above referenced uses and therefore, the products are "new drugs" under section 201(p) of the Act [21 U.S.C. § 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 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. Your products "Bloodroot Extract," "Ojibwa Tea or "Essiac,"" and "C-Cell 4 Destroyer" are also misbranded within the meaning of section 502(f)(I) of the Act, in that labeling for these drugs fails to bear adequate directions for use [21 U.S.C. § 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 that you were promoting 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 that products marketed by your firm. comply with the Act and its implementing regulations. We advise you to review your website, 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 described above and prevent their 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 §§ U.S.C. 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 that similar violations do not occur. Include any documentation necessary to show that 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 written response should be sent to Pamela B. Schweikert, Director, Compliance Branch, U.S. Food and Drug Administration, Los Angeles District Office, 19701 Fairchild Road, Irvine, CA 91612. If you have any questions about this letter, please contact Compliance Officer MaryLynn Datoc at (949) 608-4428.
Alonza E. Cruse
Los Angeles District
Cc: Associate Director
Division of Advertising Practices
Federal Trade Commission
600 Pennsylvania Avenue, N.W.
Washington, D.C. 20580
Jeff Farrar, DVM, PhD, MPR
Food and Drug Branch
1500 Capitol Ave., MS-7602
P.O. Box 997413
Sacramento, CA 95899-7413