Department of Health and Human Services' logo Department of Health and Human Services

Public Health Service
Food and Drug Administration
Florida District

 

555 Winderley Pl #200
Maitland, FL 32751

March 1, 2005
WARNING LETTER
VIA CERTIFIED MAIL, RETURN RECEIPT REQUESTED

James A. Jimenez
Cell Quest, Inc.
1302 W Sligh Ave
Tampa, FL 33604

Ref. No. FLA-05-21

Dear Mr Jimenez:

This letter concerns your firm's marketing of the products "CellQuest Liquid" and "CellQuest Gel" on your website, www.CellQuest.com. Both CellQuest 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 CellQuest Gel are intended to prevent, treat, or cure serious disease conditions. Statements documenting these intended uses include the following:

Furthermore, the following product claims appear under the website heading "CellQuest-Testimonials":

CellQuest Liquid and CellQuest Gel are drugs, as defined by the Federal Food, Drug, and Cosmetic Act (Act), 21 USC 321(g)(1)(B), because they are intended to cure, mitigate, diagnose, treat, or prevent disease. Additionally, CellQuest Liquid and CellQuest Gel are drugs, as defined by the Act, 21 USC 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 USC 321(p), because there is no evidence that they are generally recognized as safe and effective for their labeled uses. Under 21 USC 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 USC 331(d).

Further, contrary to the disclaimer on your website, these products are not dietary supplements. Under the Act, claims for CellQuest Liquid and CellQuest 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 USC 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 USC 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 USC 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 enforcement action without notice. The Act provides for seizure of illegal products and for injunctions against the manufacturers and distributors of illegal products [21 USC 332 and 334]. 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 US Food and Drug Administration, 555 Winderley Pl #200, Maitland, FL 32751, Attn: Virginia L. Meeks, Compliance Officer. If you have any questions, please call Ms Meeks at (407) 475-4731.

Sincerely,
/s/
Emma K. Singleton
District Director

This page was posted on March 28, 2006.

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