Warning letter · FDA Warning Letters

Organa International Corp.: FDA Warning Letter 613018 (Oct 13, 2021)

Agency action: Oct 13, 2021Record ID: fda_warning_-03f9a5822400b9d5
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What happened

Original notice title

Organa International Corp. MARCS-CMS 613018, October 13, 2021

From the archived source record

Based on our review, FDA identified significant violations of the Federal Food, Drug, and Cosmetic Act (the Act). Unapproved New Drugs and Misbranded Drugs FDA reviewed your website at the Internet address www.organa.net in June 2021 and has determined that you take orders there for your products Copper, Rhodium, Ruthenium, Zinc, Uplift, Immune Boost, Essiac Tea, Gold, Indium, Iron, Magnesium, Manganese, Molybdenum, Palladium, Vanadium, MSM (Methylsulfonylmethane), Relieve Progesterone Cream, and Silver Gel. Examples of some of the website claims that provide evidence that your products are intended for use as drugs include: Organa.net Copper product page • “Anemia…A copper deficiency can lead to anemia…” • “Heart Problems…Low intakes of copper may be associated with increased LDL ‘bad’ cholesterol and decreased HDL ‘good’ cholesterol. This may account for low copper levels being a potential contributing factor in heart and circulatory problems, which may lead to full blown heart disease.” • “Infections: A lack of copper in the diet may lower the body’s immune system. Normal intakes may help to reduce the risk of infection.” • “Osteoporosis: …[A] mild deficiency of copper may trigger, then worsen, osteoporotic lesions in bones. Boosting…intakes may help reduce the risk of osteoporosis.” • “Wound and Burn Treatment: …Colloidal copper promotes healing of skin burns and cuts. . .. [C]opper applied directly to the wound promotes faster healing and skin regeneration.” • “According to researchers…free radicals can offer a “pathway for cancer…and a variety of diseases.” Antioxidants, like those found in Colloidal copper, eliminate free radicals from the body.” Organa.net Rhodium product page • Product label: “May be effective in treating HIV and cancer.” • “Early research has shown that rhodium has a positive effect on tumors in mice… Later research has determined that mismatched DNA is associated with carcinogenesis.

What the official notice says to do

Check the original notice for the instructions that apply to the named product, company, and affected lots.

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Status and source details

Status recorded in the archive
FDA closeout listed
Source checked
Jul 16, 2026
Record revision
57b093bc02dd

This is a dated record. Its current status may have changed since the source was captured. A record applies to its stated scope; it is not a safety rating for every product from a company.

Sources, dates, and coverage →

What is affected

Product
Essential Oil Blend [an ingredient in Uplift]: Antibacterial and antiviral properties…; Depression; Anti-inflammatory; Palladium; Rhodium; Ruthenium; Silver; Vanadium; Essiac Tea; Copper; Indium; Magnesium; Manganese; Molybdenum; Take 2 tsp. once or twice daily as needed; Supplement Facts; Supplemental Facts; Servings Per Container; Purified Water; Distilled Water
Company
Organa International Corp.
Lot / identifier
The source does not specify this field.
Market / distribution
The source does not specify this field.