Inspections, Compliance, Enforcement, and Criminal Investigations
Cell Quest, Inc. 01-Mar-05
Department of Health and Human Services
Public Health Service
555 Winderley PI ., Ste. 200
RETURN RECEIPT REQUESTED
March 1, 2005
Mr. James A. Jimenez
Cell Quest, Inc.
1302 W. Sligh Avenue
Tampa, Florida 33604
Dear Mr. Jimenez:
This letter concerns your firm's marketing of the products "CeIIQuest Liquid" and "CellQuest Gel" on your website, www.cellQuest.com. Both CeIIQuest products are promoted for "preventing or hafting abnormal cell divisions and growths which are known to weaken the immune system and cause disease." According to the products labeling, CellQuest Liquid and CeIIQuest Gel are intended to prevent, treat, or cure serious disease conditions. Statements documenting these intended uses include the
" This natural product has been tested in the laboratory to be both safe and effective in suppressing abnormal cell proliferation and destroying the abnormal cells of several tumor lines."
"Recently published research appearing in an lntemational Medical Journal strongly identifies CellQuest as having a positive effect in stopping the growth of certain tested malignant tumor lines."
"Recommended use for compromised immune systems and combating debilitating diseases is a period of one year.""
"CellQuest - Full Program [for] People suffering from debilitating and life-threatening illnesses or where the immune system is compromised."
Furthermore, the following product claims appear under the website heading "CeIIQuest-Testimonials:"
"stage 4 Ovarian Cancer . . . after the chemo and continued to drink CelIQuest . .
. CellQuest prevents the cancer cells from dividing . . . ."
"esophageal cancer . . . decided to take the chemo & radiation treatments . . . also corrtinued to take the CellQuest . . . amazed that the tumor disappeared . . . continue to drink CellQuest as preventative."
"a tumor on his colon . . . drank . . . a product called CelIQuest, made from plantain extracts- several times a day . . . . His cancer disappeared - without radiation or chemotherapy."
"Having made my mind up about CelIQuest, I would take my bottle to chemo with me and drink it while receiving the chemo juice . . . . The cancer in my colon is gone, and 1 have only two small spots left on my liver . . . . Having become somewhat educated on my cancer, chemo alone would not have been enough."
CellQuest Liquid and CellQuest Gel are drugs, as defined by the Federal Food, Drug, and Cosmetic Act (Act), 21 U.S.C.321(g)(1)(B), because they are intended to cure, mitigate, diagnose, treat, or prevent disease. Additionally, CeIIQuest Liquid and CellQuest Gel are drugs, as defined by the Act, 21 U.S.C. 321(g)(1)(C), because they are intended to affect the structure or any function of the body of man. Moreover, these products are new drugs, as defined by 21 U.S.C. 321(p), because there is no evidence that they are generally recognized as safe and effective for their labeled uses. Under 21 U.S.C.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. CellQuest Liquid and CellQuest Gel do not have approved applications and their introduction and delivery into interstate commerce violates 21 U.S.C. 331(d).
Further, contrary to the disclaimer on your website, these products are not dietary supplements. Under the Act, claims for CeIlQuest Liquid and CeIIQuest Gel showing that these products are intended to prevent, diagnose, mitigate, treat, or cure disease cause the products to be drugs, and not dietary supplements. 21 U.S.C. 321(p), 343(r)(6). The intended uses of a product may be established through product labels and labeling, catalogs, brochures, audio and videotapes, Internet sites, or other circumstances surrounding the distribution of a product.
CellQuest Gel also cannot be a dietary supplement because it is not intended for ingestion . The Act defines the term "dietary supplement" in 21 U.S.C. 321(ff)(2)(A)(i) to mean a product that is "intended for ingestion ." Topical products intended to enter the body directly through the skin or mucosal tissues do not meet this definition.
Furthermore, the conditions for which these products are offered (e.g ., treatment and prevention of cancer) are not amenable to self-diagnosis and treatment by individuals who are not medical practitioners. Therefore, adequate directions for these conditions cannot be written so that a layman can use these drugs safely for their intended purposes. Because your products' labeling fails to bear adequate directions for their intended uses, they are misbranded under 21 U.S.C. 352(f)(1).
The above violations are not intended to be an all-inclusive list of deficiencies. It is your responsibility to ensure that the drug products you manufacture or distribute meet all of the requirements of the Act and its implementing regulations. Federal agencies are advised of the issuance of all warning letters about drugs and devices so that they may take this information into account when considering the award of contracts.
You must immediately correct these violations. If you do not immediately correct them, you may be subject to an enforcement action without further notice. The Act provides for seizure of illegal products and for an injunction against the manufacturers- and distributors of illegal products. Individuals and businesses that violate the Act may also be subject to criminal prosecution.
You must notify this office in writing within 15 working days of receipt of this letter as to the steps that you have taken to correct the above-listed violations, and the steps taken to assure that similar violations will not recur. If corrective action cannot be completed within 15 working days, state the reason for the delay and the time within which the corrections will be made. Address your reply to the U.S . Food and Drug Administration, 555 Winderley Place, Suite 200, Maitland, FL 32751, Attention: Virginia L. Meeks, Compliance Officer. If you have any questions, please call Ms. Meeks at (407) 475- 4731.
Emma R . Singleton
Director, Florida District