Organa International Corp.

Warning LetterClosed

Larry Mills President Organa International Corp. 533 N 1650 W Springville , UT 84663 United StatesFEI 3010768897Issued Oct 13, 2021Office of Human and Animal Food Operations Division West 4

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Source: FDA, published letter. FDA published this warning letter; View Letter opens FDA's copy. To check it, open FDA's record for this establishment, listed under FEI 3010768897.

Violations19

Issue DateOct 13, 2021

Product TypeDrugs

StatusClosed

Closeout LetterOct 4, 2024

Letter Details

Firm: Organa International Corp.
Location: Larry Mills President Organa International Corp. 533 N 1650 W Springville , UT 84663 United States
FEI Number: 3010768897
Country: United States
Issue Date: October 13, 2021
Issuing Office: Office of Human and Animal Food Operations Division West 4
Product Type: Drugs
Status: Closed
Closeout Letter: October 04, 2024

Summary

Organa International Corp. was cited for marketing unapproved new drugs and misbranded products, including mineral supplements (Copper, Zinc, Iron, Magnesium, and others) and topical products (Progesterone Cream, Silver Gel) through their website and Facebook page without FDA approval. The company made disease claims on their websites that established these products as drugs under federal law—for example, claiming copper could treat anemia and heart disease, and that products could prevent infections—without having obtained the required new drug applications. These marketing practices on www.organa.net and social media violated the Federal Food, Drug, and Cosmetic Act by introducing or delivering unapproved drugs into interstate commerce.

Organa International Corp. FDA Warning Letter, October 13, 2021