# FDA WARNING_LETTER - Organa International Corp - October 13, 2021

Source: https://www.keypedia.com/records/warning_letter/organa-international-corp/6dc9c899-f0a8-41e7-8772-b67bbd274d64

> FDA WARNING_LETTER for Organa International Corp on October 13, 2021. Product: Food. Access full analysis and detailed observations.

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## Details

- Record Type: WARNING_LETTER
- Company Name: Organa International Corp
- Inspection Date: 2021-10-13
- Product Type: Food
- Office Name: Office of Human and Animal Food Operations Division East 6
- Summary: On October 13, 2021, the FDA issued a Warning Letter to Organa, citing significant violations of the Federal Food, Drug, and Cosmetic Act based on a June 2021 review of their websites (www.organa.net and www.facebook.com/organainternational).

The FDA determined that Organa's products, including Copper, Rhodium, Ruthenium, Zinc, Uplift, Immune Boost, Essiac Tea, Gold, Indium, Iron, Magnesium, Manganese, Molybdenum, Palladium, Vanadium, MSM, Relieve Progesterone Cream, and Silver Gel, are unapproved new drugs and misbranded drugs. This determination is based on numerous therapeutic claims made on their websites and social media, as well as in customer testimonials, indicating the products are intended for the diagnosis, cure, mitigation, treatment, or prevention of diseases (e.g., anemia, cancer, HIV, infections, osteoporosis, heart problems, diabetes, migraines, inflammation, and various skin conditions). As "new drugs," they require prior FDA approval, which Organa lacks. Furthermore, these products are misbranded because they lack adequate directions for use by a layperson, as they are intended for conditions requiring professional supervision.

Even if not classified as drugs, several products (Copper, Rhodium, Ruthenium, Zinc, Essiac Tea, Gold, Indium, Iron, Magnesium, Manganese, Molybdenum, Palladium, Vanadium,

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- [E.](https://www.keypedia.com/people/mark-harris/b51ccb1e-3e75-427e-92da-78eb6f218366)

Company: https://www.keypedia.com/companies/organa-international-corp/ad6f57ab-e82c-4499-aa11-1690106ceb89

Office: https://www.keypedia.com/offices/office-of-human-and-animal-food-operations-division-east-6/6e2ef03d-3318-49d8-8ce1-8f187f91edbd