Inspections, Compliance, Enforcement, and Criminal Investigations
Trim International, Inc. 08-Jan-06
Department of Health and Human Services
Public Health Service
555 Winderley PI., Ste. 200
RETURN RECEIPT REQUESTED
January 9, 2006
Trim International, Inc.
9165 Roe Street
Pensacola, FL 32514
Dear Mr . Calhoun:
This letter concerns your firm's marketing of the product"TCR Cell Rejuvenator", which you describe as containing NreX 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:
"TCR helps prevent recurrent Herpes, common cold and flu, and is used to treat patients with Alzheimer's, Parkinson's, cancer and other infectious diseases and neurological disorders."
"N-reX is a revolutionary new product ... for the treatment of Neurodegenerative diseases: Alzheimer's, Parkinson's, amyotrophic lateral sclerosis, axonal and other neuropathies, Down's and other syndromes."
"V-reX (RNA) has proven successful for the treatment of a variety of conditions in which the etiologic factors appear to be related to specific viral infections. These are often related to the DNA group of viruses, which includes the papova-hepatitis B virus adenovirus, herpes virus group and poxvirus group... A group of the DNA viruses also are associated with recurrent respiratory problems, other infections and cancer (Burkitt's lymphoma, hepatocellular ar carcinoma, Kaposi's sarcoma and squamous and invasive cervical carcinoma). "
These claims are supplemental 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 U.S.C. 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 U.S.C. § 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 U.S.C. § 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 U.S .C. § 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 U. S. Food and Drug Administration, 555 Winderley Place, Suite 200, Maitland, Florida 32751, Attention: Shari H . Shambaugh, Compliance Officer.
Emma R . Singleton
Director, Florida District