FDA WARNING_LETTER - TriHerba Marketing - May 21, 2008
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On May 21, 2008, the FDA issued a Warning Letter to TriHerba Marketing, specifically to Carson Krogh Christensen, regarding products promoted on their website, www.triherba.com. The FDA determined that Triherba Black Salve, Triherba Black Salve Tonic, Herbal Horizons Heart Drops, and Glucose Balance are promoted with claims to mitigate, prevent, treat, or cure diseases in humans or affect body structure/function.
Specific claims cited include Triherba Black Salve and Tonic for "Skin Growths and Tumors," "Prostate and Colon Tumors," and "Breast Tumors," with testimonials about slowing colon tumor growth. Herbal Horizons Heart Drops are claimed to "Prevent heart attacks, strokes, aneurysms!" and "Eliminate angina pain." Glucose Balance is marketed for "diabetes" and to "balance your sugar levels, increase insulin activity."
The FDA classified these products as "drugs" under section 201(g)(1) of the Federal Food, Drug, and Cosmetic Act (the Act) due to their intended uses. Furthermore, they are deemed "new drugs" under section 201(p) because they are not generally recognized as safe and effective. Their sale in the U.S. without an FDA-approved application violates sections 301(d) and 505(a) of the Act.
Additionally, the products are considered "misbranded
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