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

January 9, 2006
WARNING LETTER
VIA CERTIFIED MAIL, RETURN RECEIPT REQUESTED

Gary Calhoun
Trim International
9165 Roe St
Pensacola, FL 32514

Ref. No. FLA-06-09

Dear Mr Calhoun:

This letter concerns your firm's marketing of the product "TCR Cell Rejuvenator", which you describe as containing N-reX and V-reX, on your website, www.mytrim.com. As reviewed on December 8, 2005, according to the claims for this product on your website, it is intended to prevent, treat, or cure disease conditions. Statements documenting these intended uses include, but are not limited to, the following:

These claims are supplemented by the metatags for your website www.mytrim.com, which include "prostate cancer."

The product cited above is a drug, as defined by section 201(g)(1) of the Federal Food, Drug, and Cosmetic Act (the Act) , 21 USC 321(g)(1), because it is intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease. Moreover, this product is a new drug, as defined by section 201(p) of the Act, 21 USC 321(p), because it is not generally recognized as safe and effective for its labeled uses. Under sections 301(d) and 505(a) of the Act, 21 USC 331(d) and 355(a), the introduction or delivery of a new drug into interstate commerce without an FDA-approved application is a prohibited act. No such applications exist for this product.

Furthermore, many of the diseases or conditions for which this product is offered are not amenable to self-diagnosis and treatment by individuals who are not medical practitioners. Therefore, adequate directions for use for these conditions cannot be written so that a layman can use this drug safely for its intended purposes. Because your product's labeling fails to bear adequate directions for its intended uses for those diseases or conditions which are not amenable to self-diagnosis and treatment, it is misbranded under section 502(f)(1) of the Act, 21 USC 352(f)(1).

The above violations are not intended to be an all-inclusive list of your product's deficiencies. It is your responsibility to ensure that the drug products that you manufacture or distribute, whether through Trim International, Inc. or any other venture, meet all 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.

We expect you to correct these violations. If you do not correct these violations, you may be subject to an enforcement action against you without further notice. The Act provides for seizure of illegal products and for an injunction against the manufacturers and distributors of illegal products.

Notify the FDA in writing within 15 working days of receipt of this letter about the steps that you have taken to correct the above-listed violations, and the steps taken to assure that similar violations will not occur. 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. Additionally, if your firm does not manufacture the product identified above, your reply should include the name and address of the manufacturer. If the firm from which you receive the product is not the manufacturer, please include the name of your supplier in addition to the manufacturer.

Address your reply to the US Food and Drug Administration, 555 Winderley Pl #200, Maitland, FL 32751, Attention: Shari H. Shambaugh, Compliance Officer.

Sincerely,
/s/
Emma R. Singleton
District Director

This page was posted on February 12, 2008.

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