FDA WARNING_LETTER - IMedDo - March 26, 2019
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The FDA issued a Warning Letter to iMedDo, Inc. on February 19, 2019, following a review of their website (http://www.imeddo.com/) in October 2018. The FDA determined that iMedDo, Inc. was taking orders for NeuSilver™ Colloidal Silver by iMedDo (NeuSilver™) and NeuKids™ lower dose silver for pets and children (NeuKids™).
The FDA found that the claims on the website established these products 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)] because they are intended for use in the cure, mitigation, treatment, or prevention of disease in humans or animals.
**Violations and Deficiencies:**
* **Unapproved New Drugs (Human Use):** NeuSilver™ and NeuKids™ are considered "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. Introducing or delivering these products into interstate commerce without prior FDA approval violates sections 301(d) and 505(a) of the Act [21 U.S.C. 33
ID · 19aa2c50-46e3-4685-8e4f-361126bda81e
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