FDA WARNING_LETTER - Precision Herbs, L.L.C.

On May 21, 2008, the FDA issued a Warning Letter to James R. Overman of Precision Herbs, L.L.C. and Overman's Healthy Choices, Inc., regarding the marketing of products including Activase, Amorph, Apritum, CanAlk, CancerGene, Carcinogex, Fungustum, Molex, Neoplasmex, Pau d Arco Bark, ThermaPop, TNF-Max, TumGo, Tumorex, and VX-O.

The FDA found that statements on the firm's website, www.precisionherbs.com, indicated these products were intended to prevent, treat, or cure disease conditions or affect the body's structure/function, despite a disclaimer. Specific claims cited included "Historically used to help activate the immune system to attack tumors," "Historically used to help dissolve some malignant tumors," and "Historically used to help switch on all three genes that inhibit cancer."

These products are deemed "drugs" under section 201(g)(1) of the Federal Food, Drug, and Cosmetic Act (the Act) due to their intended uses. Furthermore, they are classified as "new drugs" under section 201(p) because they are not generally recognized as safe and effective for their labeled uses. The sale of these products without FDA-approved applications violates sections 301(d) and 505(a) of the Act.