# FDA WARNING_LETTER - Plant Cures Incorporated - Unknown Date

Source: https://www.keypedia.com/records/warning_letter/plant-cures-incorporated/23208f61-2d84-4757-bc5d-f4ddcfc4ccaf

> FDA WARNING_LETTER for Plant Cures Incorporated on Unknown Date. Product: Drugs. Access full analysis and detailed observations.

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## Details

- Record Type: WARNING_LETTER
- Company Name: Plant Cures Incorporated
- Product Type: Drugs
- Office Name: Los Angeles District Office
- Summary: On May 27, 2008, the FDA issued a Warning Letter to Christopher Gussa of Plant Cures Incorporated, also known as The Herbal Healing Place, Desert Dragon Healing Center, and Desert Dragon Herbs. The letter states that a review of the website www.plantcures.com revealed that the products "Bloodroot Extract," "Ojibwa Tea or "Essiac,"" and "C-Cell 4 Destroyer" are promoted for conditions that classify them as drugs under section 201(g)(1)(B) of the Federal Food, Drug, and Cosmetic Act (the Act) [21 U.S.C. § 321(g)(1)(B)].

The FDA cited therapeutic claims on the website, including suggestions that Bloodroot could be developed as a cancer drug, claims of Ojibwa Tea curing cancer, and "C-Cell 4 Destroyer" providing defense against cancer. These claims, supplemented by metatags like "cancer" and "Herbal healing cures for . . . cancer," establish the products as drugs intended for disease cure, mitigation, treatment, or prevention.

The products are deemed "new drugs" under section 201(p) of the Act [21 U.S.C. § 321(p)] because they are not generally recognized as safe and effective for their claimed uses. Marketing these new drugs without prior FDA approval, as required by

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Company: https://www.keypedia.com/companies/plant-cures-incorporated/955f4bb3-383b-475d-8fd3-d3e47c2b7a87

Office: https://www.keypedia.com/offices/los-angeles-district-office/edcf1dfe-596a-43b8-8df4-07d9cd94763b